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2018 Medicines in Development for Cancer Bladder Cancer Product Name Sponsor Indication Development Phase ABI-009 AADi Bioscience non-muscle invasive bladder cancer Phase I/II (nab-rapamycin/mTOR inhibitor) Los Angeles, CA www.aadibio.com ALT-801 Altor BioScience non-muscle invasive bladder cancer Phase I/II (tumor antigen-specific T-cell Miramar, FL www.altorbioscience.com receptor linked to IL-2) NantKwest Culver City, CA ALT-803 Altor BioScience non-muscle invasive bladder cancer Phase II (IL-15 superagonist protein complex) Miramar, FL (BCG naïve) (Fast Track), www.altorbioscience.com NantKwest non-muscle invasive bladder cancer Culver City, CA (BCG unresponsive) (Fast Track) B-701 BioClin Therapeutics 2L locally advanced or metastatic Phase I/II (anti-FGFR3 mAb) San Ramon, CA bladder cancer www.bioclintherapeutics.com Bavencio® EMD Serono 1L urothelial cancer Phase III avelumab Rockland, MA www.emdserono.com (anti-PD-L1 inhibitor) Pfizer www.pfizer.com New York, NY BC-819 BioCanCell Therapeutics non-muscle invasive bladder cancer Phase II (gene therapy) Cambridge, MA (Fast Track) www.biocancell.com Medicines in Development: Cancer ǀ 2018 1

2018 Medicines in Development for Cancer...Vicinium Eleven Biotherapeutics BCG-refractory high-grade non-muscle Phase III recombinant fusion protein Cambridge, MA invasive bladder

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Page 1: 2018 Medicines in Development for Cancer...Vicinium Eleven Biotherapeutics BCG-refractory high-grade non-muscle Phase III recombinant fusion protein Cambridge, MA invasive bladder

2018 Medicines in Development for Cancer

Bladder CancerProduct Name Sponsor Indication Development Phase

ABI-009 AADi Bioscience non-muscle invasive bladder cancer Phase I/II

(nab-rapamycin/mTOR inhibitor) Los Angeles, CA www.aadibio.com

ALT-801 Altor BioScience non-muscle invasive bladder cancer Phase I/II

(tumor antigen-specific T-cell Miramar, FL www.altorbioscience.com

receptor linked to IL-2) NantKwest

Culver City, CA

ALT-803 Altor BioScience non-muscle invasive bladder cancer Phase II

(IL-15 superagonist protein complex) Miramar, FL (BCG naïve) (Fast Track), www.altorbioscience.com

NantKwest non-muscle invasive bladder cancer

Culver City, CA (BCG unresponsive) (Fast Track)

B-701 BioClin Therapeutics 2L locally advanced or metastatic Phase I/II

(anti-FGFR3 mAb) San Ramon, CA bladder cancer www.bioclintherapeutics.com

Bavencio® EMD Serono 1L urothelial cancer Phase III

avelumab Rockland, MA www.emdserono.com

(anti-PD-L1 inhibitor) Pfizer www.pfizer.com

New York, NY

BC-819 BioCanCell Therapeutics non-muscle invasive bladder cancer Phase II

(gene therapy) Cambridge, MA (Fast Track) www.biocancell.com

Medicines in Development: Cancer ǀ 2018 1

Page 2: 2018 Medicines in Development for Cancer...Vicinium Eleven Biotherapeutics BCG-refractory high-grade non-muscle Phase III recombinant fusion protein Cambridge, MA invasive bladder

Bladder CancerProduct Name Sponsor Indication Development Phase

Capzola® Spectrum Pharmaceuticals non-muscle invasive bladder cancer application submitted

apaziquone Henderson, NV (Fast Track) www.sppirx.com

Cavatak® Viralytics bladder cancer (+pembrolizumab) Phase I

coxsackievirus Sydney, Australia www.viralytics.com

CG0070 Cold Genesys non-muscle invasive bladder cancer Phase II

(oncolytic immunotherapy) Santa Ana, CA www.coldgenesys.com

Cotellic® Genentech urothelial cancer (+atezolizumab) Phase I

cobimetinib South San Francisco, CA www.gene.com

CV-301 Bavarian Nordic bladder cancer (+anti-PD-L1) Phase II

(CEA-MUC-1-TRICOM cancer vaccine) Morrisville, NC www.bavarian-nordic.com

Cyramza® Eli Lilly bladder cancer Phase III

ramucirumab Indianapolis, IN www.lilly.com

enfortumab vedotin (ASG-2ME) Astellas urothelial cancer Phase II

(antibody-drug conjugate) Northbrook, IL www.astellas.com

Seattle Genetics www.seattlegenetics.com

Bothell, WA

Halaven® Eisai bladder cancer Phase I/II

eribulin Woodcliff Lake, NJ www.eisai.com

Medicines in Development: Cancer ǀ 2018 2

Page 3: 2018 Medicines in Development for Cancer...Vicinium Eleven Biotherapeutics BCG-refractory high-grade non-muscle Phase III recombinant fusion protein Cambridge, MA invasive bladder

Bladder CancerProduct Name Sponsor Indication Development Phase

Imfinzi® MedImmune 1L bladder cancer (+tremelimumab) Phase III

durvalumab Gaithersburg, MD www.medimmune.com

1L unresectable stage IV bladder Phase II

cancer (+olaparib) www.medimmune.com

INCB54828 Incyte bladder cancer Phase II

(FGFR1/2/3 inhibitor) Wilmington, DE www.incyte.com

INO-5401 Inovio Pharmaceuticals bladder cancer Phase II

(T-cell activating DNA immunotherapy) Plymouth Meeting, PA www.inovio.com

MAGE-A10 TCR Adaptimmune bladder cancer Phase I/II

(T-cell receptor therapy) Philadelphia, PA www.adaptimmune.com

MV-NIS Vyriad bladder cancer Phase I

(oncolytic virus cancer vaccine) Rochester, MN www.vyriad.com

nadofaragene firadenovec FKD Therapies superficial bladder cancer Phase III

(IFNA2B gene therapy) Kuopio, Finland 

NC-6004 NanoCarrier bladder cancer (+gemcitabine) Phase II

(cisplatin micellar nanoparticle) Chiba, Japan www.nanocarrier.co.jp

NEO-PV-01 Neon Therapeutics bladder cancer Phase I

(personal neo-antigen vaccine) Cambridge, MA www.neontherapeutics.com

Medicines in Development: Cancer ǀ 2018 3

Page 4: 2018 Medicines in Development for Cancer...Vicinium Eleven Biotherapeutics BCG-refractory high-grade non-muscle Phase III recombinant fusion protein Cambridge, MA invasive bladder

Bladder CancerProduct Name Sponsor Indication Development Phase

Opdivo® + Yervoy® Bristol-Myers Squibb urothelial cancer Phase III

nivolumab + ipilimumab Princeton, NJ www.bms.com

Rubraca® Clovis Oncology advanced or metastatic bladder cancer Phase II

rucaparib Boulder, CO www.clovisoncology.com

(PARP inhibitor)

RX-3117 Rexahn Pharmaceuticals metastatic bladder cancer Phase II

(DNA and RNA synthesis inhibitor) Rockville, MD www.rexahn.com

sacituzumab govitecan Immunomedics metastatic urothelial cancer Phase II

(anti-TROP-2-SN-38 ADC) Morris Plains, NJ www.immunomedics.com

TAR-200 TARIS Biomedical non-muscle invasive bladder cancer, Phase I

(DNA synthesis inhibitor) Lexington, MA muscle invasive bladder cancer www.tarisbiomedical.com

(Fast Track)

Tecentriq® Genentech muscle-invasive bladder cancer, Phase III

atezolizumab South San Francisco, CA 1L metastatic urothelial cancer www.gene.com

(+/- chemotherapy)

non-muscle invasive bladder cancer Phase I

www.gene.com

VesiGel™ UroGen Pharma bladder cancer (Fast Track) Phase II

mitomycin intravesicular New York, NY www.urogen.com

ORPHAN DRUG

Medicines in Development: Cancer ǀ 2018 4

Page 5: 2018 Medicines in Development for Cancer...Vicinium Eleven Biotherapeutics BCG-refractory high-grade non-muscle Phase III recombinant fusion protein Cambridge, MA invasive bladder

Bladder CancerProduct Name Sponsor Indication Development Phase

Vesimune™ UroGen Pharma high-grade non-muscle invasive Phase II

imiquimod intravesicular New York, NY bladder cancer www.urogen.com

ORPHAN DRUG

Vicinium™ Eleven Biotherapeutics BCG-refractory high-grade non-muscle Phase III

recombinant fusion protein Cambridge, MA invasive bladder cancer www.elevenbio.com

BCG-refractory high-grade non-muscle Phase I

invasive bladder cancer (+durvalumab) www.elevenbio.com

Brain CancerProduct Name Sponsor Indication Development Phase

2X-111 2X Oncology brain metastases from breast cancer, Phase I completed

(liposomal doxorubicin) Cambridge, MA recurrent glioblastoma www.2xoncology.com

ORPHAN DRUG

abexinostat Xynomic Pharmaceuticals brain Phase I

(HDAC inhibitor) Cheyenne, WY www.xynomicpharma.com

Ad-RTS-hIL12 ZIOPHARM Oncology glioblastoma Phase II

(DNA-based therapy) Boston, MA www.ziopharm.com

ORPHAN DRUG

glioblastoma (+nivolumab), Phase I

glioblastoma (stereotactic treatment), www.ziopharm.com

pediatric brain tumors

Medicines in Development: Cancer ǀ 2018 5

Page 6: 2018 Medicines in Development for Cancer...Vicinium Eleven Biotherapeutics BCG-refractory high-grade non-muscle Phase III recombinant fusion protein Cambridge, MA invasive bladder

Brain CancerProduct Name Sponsor Indication Development Phase

AG-881 Agios Pharmaceuticals glioma Phase I

(pan-IDH inhibitor) Cambridge, MA www.celgene.com

Celgene

Summit, NJ

aglatimagene besadenovec Advantagene glioma, pediatric glioma Phase II

(gene therapy) Auburndale, MA www.advantagene.com

ORPHAN DRUG

pediatric brain tumors Phase I

www.advantagene.com

AMG 596 Amgen glioblastoma Phase I

(anti-EGFRvIII x anti-CD3 Thousand Oaks, CA www.amgen.com

bispecific T-cell engager)

ANG1005 AngioChem brain metastases from breast cancer, Phase II

(peptide-paclitaxel conjugate) Montreal, Canada glioblastoma (Fast Track) www.angiochem.com

ORPHAN DRUG

antineoplaston therapy Burzynski Research Institute diffuse intrinsic pontine glioma Phase II

ORPHAN DRUG Houston, TX www.burzynskiresearch.com

APX005M Apexigen recurrent refractory brain tumors Phase I

(CD40 agonistic antibody) San Carlos, CA www.apexigen.com

AU101 Aurora BioPharma recurrent glioblastoma Phase I/II

(HER2-CD28 CAR-T cell therapy) Cambridge, MA www.aurora-biopharma.com

Medicines in Development: Cancer ǀ 2018 6

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Brain CancerProduct Name Sponsor Indication Development Phase

AU105 Aurora BioPharma newly-diagnosed glioblastoma Phase I/II

(HER2-CMV CAR-T cell therapy) Cambridge, MA www.aurora-biopharma.com

Avastin® Genentech brain metastases Phase II

bevacizumab South San Francisco, CA www.gene.com

AZD1390 AstraZeneca glioblastoma (+radiation) Phase I

(ATM kinase inhibitor) Wilmington, DE www.astrazeneca.com

Azixa® Cytovia glioblastoma Phase II

verubulin Englewood Cliffs, NJ www.immunepharma.com

ORPHAN DRUG

BAL101553 Basilea Pharmaceutica newly-diagnosed glioblastoma Phase I

(tumor checkpoint inhibitor) Basel, Switzerland www.basilea.com

Adult Brain Tumor Consortium

Baltimore, MD

bavituximab Oncologie newly-diagnosed glioblastoma Phase II

Boston, MA www.oncologie.international

BMX-001 BioMimetix glioma Phase I/II

(mangano porphyrin antioxidant Greenwood Village, CO www.biomimetix.com

mimetic)

BXQ-350 Bexion Pharmaceuticals glioblastoma Phase I

(apoptosis stimulant) Covington, KY www.bexionpharma.com

ORPHAN DRUG

Medicines in Development: Cancer ǀ 2018 7

Page 8: 2018 Medicines in Development for Cancer...Vicinium Eleven Biotherapeutics BCG-refractory high-grade non-muscle Phase III recombinant fusion protein Cambridge, MA invasive bladder

Brain CancerProduct Name Sponsor Indication Development Phase

capmatinib (INC280) Novartis Oncology glioblastoma (combination therapy) Phase I completed

(c-Met inhibitor) East Hanover, NJ www.novartis.com

Incyte

Wilmington, DE

CC-122 (avadomide) Celgene glioblastoma Phase I

(pleiotropic pathway modulator) Summit, NJ www.celgene.com

Cerebral EDV™ EnGeneIC glioblastoma Phase I

doxorubicin encapsulated nanocells New York, NY www.engeneic.com

ORPHAN DRUG

DCC-2618 Deciphera Pharmaceuticals glioblastoma, glioma Phase I

(PDGFR-alpha kinase switch Waltham, MA www.deciphera.com

control inhibitor)

ORPHAN DRUG

DCVax®-L Northwest Biotherapeutics glioblastoma Phase III

cancer vaccine Bethesda, MD www.nwbio.com

ORPHAN DRUG

depatuxizumab mafodotin AbbVie glioblastoma Phase III

(anti-EGFR antibody-drug conjugate) North Chicago, IL www.abbvie.com

ORPHAN DRUG

pediatric brain tumors Phase I

www.abbvie.com

Medicines in Development: Cancer ǀ 2018 8

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Brain CancerProduct Name Sponsor Indication Development Phase

Dicopp™ Cantex Pharmaceuticals recurrent glioblastoma Phase II

copper gluconate/disulfiram Weston, FL www.cantex.com

ORPHAN DRUG

DM-CHOC-PEN Dekk-Tec primary brain cancer, Phase II

New Orleans, LA brain metastases www.dekk-tec.com

DSP-7888 Sumitomo Dainippon Pharma recurrent glioblastoma Phase II

(adegramotide/nelatimotide) Osaka, Japan (combination therapy) www.ds-pharma.com

ORPHAN DRUG

eflornithine oral Orbus Therapeutics anaplastic astrocytoma Phase III

(ornithine decarboxylase inhibitor) Palo Alto, CA www.orbustherapeutics.com

ORPHAN DRUG

epacadostat Incyte glioblastoma Phase I

(IDO1 inhibitor) Wilmington, DE www.incyte.com

ERC1671 Epitopoietic Research glioblastoma Phase II

(therapeutic cancer vaccine) Pasadena, CA www.erc-immunotherapy.com

ORPHAN DRUG

fimepinostat (CUDC-907) Curis brain tumor Phase I

(HDAC/PI3K inhibitor) Lexington, MA www.curis.com

Medicines in Development: Cancer ǀ 2018 9

Page 10: 2018 Medicines in Development for Cancer...Vicinium Eleven Biotherapeutics BCG-refractory high-grade non-muscle Phase III recombinant fusion protein Cambridge, MA invasive bladder

Brain CancerProduct Name Sponsor Indication Development Phase

GBM-Lamp-Vax Immunomic Therapeutics glioblastoma Phase II

(dendritic cell vaccine comprising Rockville, MD www.immunomix.com

CMV antigen pp65 expressed as Duke University

fusion protein with LAMP) Durham, NC

University of Florida

Gainesville, FL

GDC-0084 Kazia Therapeutics glioblastoma Phase I

(PI3K inhibitor) Sydney, Australia www.kaziatherapeutics.com

ORPHAN DRUG

Gilotrif® Boehringer Ingelheim Pharmaceuticals glioma Phase II

afatinib Ridgefield, CT www.boehringer-ingelheim.com

HER2.taNK NantKwest recurrent HER2-positive glioblastoma Phase I

(CAR-T cell therapy) Culver City, CA www.nantkwest.com

ICT-121 ImmunoCellular Therapeutics glioblastoma Phase I

(dendritic cell vaccine) Westlake Village, CA www.imuc.com

ifabotuzumab Humanigen glioblastoma Phase I

(anti-EphA3 mAb) Brisbane, CA www.humanigen.com

Olivia Newton-John Cancer

Research Institute

Heidelberg, Australia

indoximod NewLink Genetics pediatric malignant brain tumors Phase I

(IDO inhibitor) Ames, IA (+temozolomide) www.newlinkgenetics.com

Medicines in Development: Cancer ǀ 2018 10

Page 11: 2018 Medicines in Development for Cancer...Vicinium Eleven Biotherapeutics BCG-refractory high-grade non-muscle Phase III recombinant fusion protein Cambridge, MA invasive bladder

Brain CancerProduct Name Sponsor Indication Development Phase

INO-5401 Inovio Pharmaceuticals glioblastoma Phase II

(T-cell activating DNA immunotherapy) Plymouth Meeting, PA www.inovio.com

ivosidenib Agios Pharmaceuticals glioma Phase I

(IDH1 inhibitor) Cambridge, MA www.agios.com

marizomib Celgene glioblastoma Phase II

(proteasome inhibitor) Summit, NJ www.celgene.com

ORPHAN DRUG

MB-101 Mustang Bio glioblastoma Phase I

(CAR-T cell therapy) New York, NY www.mustangbio.com

MDNA55 Medicenna Therapeutics glioblastoma (Fast Track) Phase II

(interleukin-4 superkine) Toronto, Canada www.medicenna.com

ORPHAN DRUG

MNX-100 MetronomX medulloblastoma Phase II

(nifurtimox) Houston, TX www.metronomx.com

MTX110 Midatech Pharma US diffuse interstitial pontine glioma Phase I

(nano-inclusion product) Raleigh, NC www.midatechpharma.com

MV-NIS Vyriad medulloblastoma Phase I

(oncolytic virus cancer vaccine) Rochester, MN www.vyriad.com

Medicines in Development: Cancer ǀ 2018 11

Page 12: 2018 Medicines in Development for Cancer...Vicinium Eleven Biotherapeutics BCG-refractory high-grade non-muscle Phase III recombinant fusion protein Cambridge, MA invasive bladder

Brain CancerProduct Name Sponsor Indication Development Phase

napabucasin Boston Biomedical recurrent or progressed glioblastoma Phase I/II

(STAT3 inhibitor) Cambridge, MA (+temozolomide) www.bostonbiomedical.com

NEO100 NEONC Technologies recurrent malignant glioma Phase I/II

(perillyl alcohol intranasal) Los Angeles, CA www.neonctech.com

ORPHAN DRUG

NVX-108 NuvOx Pharma glioblastoma (combination therapy) Phase II

(perflenapent nanoparticles) Tucson, AZ www.nuvoxpharma.com

ORPHAN DRUG

Odomzo® Novartis Oncology medulloblastoma Phase II completed

sonidegib East Hanover, NJ www.novartis.com

OKN007 Oblato (GtreeBNT) glioblastoma Phase I

(disufenton sodium) Oklahoma City, OK www.gtreebnt.com

ORPHAN DRUG

omburtamab I-124 Y-mAbs Therapeutics diffuse intrinsic pontine glioma Phase I/II

(B7-H3 inhibitor) New York, NY www.ymabs.com

Medicines in Development: Cancer ǀ 2018 12

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Brain CancerProduct Name Sponsor Indication Development Phase

ONC201 Oncoceutics recurrent H3-mutation high-grade Phase II

(dopamine receptor D2/3 antagonist) Philadelphia, PA glioma, recurrent glioblastoma www.oncoceutics.com

ORPHAN DRUG

newly-diagnosed diffuse intrinsic Phase I

pontine glioma (pediatric), www.oncoceutics.com

recurrent H3-mutation

high-grade glioma (pediatric)

Onzeald™ Nektar Therapeutics brain metastases from breast cancer Phase III

etirinotecan pegol San Francisco, CA (Fast Track) www.nektar.com

Opdivo® Bristol-Myers Squibb glioblastoma Phase III

nivolumab Princeton, NJ www.bms.com

OT-101 Autotelic glioblastoma Phase II/III

(TGF-beta antisense) Costa Mesa, CA www.oncotelic.com

ORPHAN DRUG Oncotelic

Agoura Hills, CA

PAC-1 (VO-100) Vanquish Oncology anaplastic astrocytoma, Phase I

(procaspase activating compound-1) Campaign, IL glioblastoma www.vanquishoncology.com

pamiparib (BGB-290) BeiGene USA glioblastoma (combination therapy) Phase I/II

(PARP inhibitor) Cambridge, MA www.beigene.com

PDT with Photofrin® Pinnacle Biologics brain cancer Phase II

porfimer sodium Chicago, IL www.pinnaclebiologics.com

Medicines in Development: Cancer ǀ 2018 13

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Brain CancerProduct Name Sponsor Indication Development Phase

PEPIDH1M Annias Immunotherapeutics glioblastoma Phase I/II

(dendritic cell vaccine) Chapel Hill, NC www.aniasimmuno.com

Poly-ICLC Oncovir glioblastoma Phase I/II completed

(biological response modifier) Washington, DC www.oncovir.com

ORPHAN DRUG

Pomalyst® Celgene recurrent or progressive primary Phase II

pomalidomide Summit, NJ brain tumors (ages 1 to < 21 years) www.celgene.com

pritumumab Nascent Biotech glioma Phase II

(human IgG antibody) Vero Beach, FL www.nascentbiotech.com

ORPHAN DRUG

Prophage™ Agenus newly-diagnosed glioblastoma Phase II

vitespen Lexington, MA www.agenusbio.com

ORPHAN DRUG

PT2385 Peloton Therapeutics recurrent glioblastoma Phase II

(HIF-1 alpha inhibitor) Dallas, TX www.pelotontherapeutics.com

relatlimab Bristol-Myers Squibb glioblastoma Phase I

(anti-LAG3 mAb) Princeton, NJ www.bms.com

RRx-001 EpicentRx anaplastic glioma, newly-diagnosed Phase I

(free radical stimulant) La Jolla, CA glioblastoma (combination therapy) www.epicentrx.com

Medicines in Development: Cancer ǀ 2018 14

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Brain CancerProduct Name Sponsor Indication Development Phase

selinexor Karyopharm Therapeutics glioblastoma Phase II

(nuclear export inhibitor) Newton, MA www.karyopharm.com

SGT-53 SynerGene Therapeutics recurrent glioblastoma Phase II

(gene therapy) Rockville, MD (+temozolomide)

SL-701 Stemline Therapeutics adult glioblastoma Phase I/II

(brain cancer vaccine) New York, NY www.stemline.com

ORPHAN DRUG

SurVaxM MimiVax glioblastoma Phase II

BIRC5 protein inhibitor vaccine Buffalo, NY www.mimivax.com

Sym004 Symphogen glioblastoma Phase II

(EGFR antagonist mAb) Somerville, NJ www.symphogen.com

Tafinlar® + Mekinist® Novartis Oncology BRAF V600+ relapsed/refractory Phase II

dabrafenib + trametinib East Hanover, NJ high-grade glioma www.novartis.com

tasadenoturev (DNA-2401) DNAtrix recurrent glioblastoma (Fast Track) Phase II

(oncolytic virus immunotherapy) Houston, TX (monotherapy and combination) www.dnatrix.com

ORPHAN DRUG

newly-diagnosed diffuse intrinsic Phase I

pontine glioma www.dnatrix.com

Medicines in Development: Cancer ǀ 2018 15

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Brain CancerProduct Name Sponsor Indication Development Phase

TB-403 BioInvent International medulloblastoma Phase I/II

(anti-PIGF mAb) Lund, Sweden www.bioinvent.com

Oncurious

Leuven, Belgium

tesevatinib Kadmon Pharmaceuticals brain metastases, Phase II

(protein tyrosine kinase inhibitor) New York, NY leptomeningeal metastases, www.kadmon.com

recurrent glioblastoma

TG02 Tragara Pharmaceuticals anaplastic astrocytoma, Phase I/II

(CDK inhibitor) Carlsbad, CA glioblastoma www.tragarapharma.com

Toca 511 + Toca Fc Tocagen recurrent high-grade glioma Phase III

(vocimagene amiretrorepvec- San Diego, CA (Fast Track) www.tocagen.com

flucytosine gene therapy)

ORPHAN DRUG

TPI-287 Cortice Biosciences recurrent glioblastoma (+bevacizumab) Phase II

(next generation taxane) New York, NY www.corticebiosciences.com

secondary brain metastases (+radiation) Phase I

www.corticebiosciences.com

trans sodium crocetinate (TSC) Diffusion Pharmaceuticals glioblastoma Phase II

ORPHAN DRUG Charlottesville, VA www.diffusionpharma.com

brain metastases Phase I

www.diffusionpharma.com

Medicines in Development: Cancer ǀ 2018 16

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Brain CancerProduct Name Sponsor Indication Development Phase

TRC-102 TRACON Pharmaceuticals glioblastoma Phase II

(methoxyamine hydrochloride) San Diego, CA www.traconpharma.com

TRC-105 TRACON Pharmaceuticals glioblastoma (combination therapy) Phase II

(carotuximab) San Diego, CA www.traconpharma.com

TVB-2640 3-V Biosciences astrocytoma Phase II

(FASN inhibitor) Menlo Park, CA www.3vbio.com

TVI-Brain-1 cancer vaccine TVAX Biomedical astrocytoma, glioblastoma, glioma Phase II completed

ORPHAN DRUG Olathe, KS www.tvaxmedical.com

USL311 Upsher-Smith relapsed/recurrent glioblastoma Phase I/II

(CXCR4 antagonist) Maple Grove, MN www.upsher-smith.com

ORPHAN DRUG

VAL-083 DelMar Pharmaceuticals refractory glioblastoma (Fast Track) Phase III

(dianhydrogalactitol) Menlo Park, CA www.delmarpharma.com

ORPHAN DRUG

varlilumab Celldex Therapeutics glioblastoma Phase II

(anti-CD28 mAb) Hampton, NJ www.celldex.com

VB-111 VBL Therapeutics glioblastoma (Fast Track) Phase III

(ofranergene obadenovec) Modi'in, Israel www.vblrx.com

ORPHAN DRUG

Medicines in Development: Cancer ǀ 2018 17

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Brain CancerProduct Name Sponsor Indication Development Phase

VBI-1901 VBI Vaccines glioblastoma Phase I/II

(bivalent cancer vaccine) Cambridge, MA www.vbivaccines.com

WP1066 Moleculin Biotech glioblastoma, melanoma Phase I/II

(STAT3 transcription factor inhibitor) Houston, TX metastases to the brain www.moleculin.com

Breast CancerProduct Name Sponsor Indication Development Phase

2X-121 2X Oncology breast cancer Phase II

(PARP/tankyrase inhibitor) Cambridge, MA www.2xoncology.com

abexinostat Xynomic Pharmaceuticals breast cancer (combination therapy) Phase II

(HDAC inhibitor) Cheyenne, WY www.xynomicpharma.com

adagloxad simolenin OBI Pharma metastatic breast cancer Phase II

(cancer immunotherapy vaccine) Taipei, Taiwan www.obipharma.com

AE37 (HER2.neu) Antigen Express newly-diagnosed breast cancer Phase II

(Li-key hybrid cancer vaccine) Wellesley, MA www.antigenexpress.com

AE37/GP2 peptide vaccine Antigen Express breast cancer Phase II

(Li-key hybrid cancer vaccine) Wellesley, MA www.antigenexpress.com

afimoxifene (4-OHT) BHR Pharma ductal carcinoma in situ of the breast Phase II

(percutaneous gel formulation) Herndon, VA www.bhr-pharma.com

Medicines in Development: Cancer ǀ 2018 18

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Breast CancerProduct Name Sponsor Indication Development Phase

alpelisib Novartis Oncology hormone receptor-positive Phase III

(PI3K-alpha inhibitor) East Hanover, NJ HER2-negative advanced breast cancer www.novartis.com

(postmenopausal women),

2L breast cancer (+ fulvestrant)

metastatic or locally-advanced Phase I

breast cancer (premenopausal) www.novartis.com

Apristor™  Context Therapeutics progesterone receptor-positive Phase II

onapristone Philadelphia, PA metastatic breast cancer www.contexttherapeutics.com

ARX788 Ambrx HER2-positive breast cancer Phase I

(HER2 antibody-drug conjugate) La Jolla, CA www.ambrx.com

AZD5363 (capivasertib) AstraZeneca breast cancer Phase II

(Akt inhibitor) Wilmington, DE www.astrazeneca.com

AZD9496 AstraZeneca estrogen receptor-positive Phase I

(estrogen receptor antagonist) Wilmington, DE breast cancer www.astrazeneca.com

balixafortide (POL6326) Polyphor metastatic breast cancer Phase I

(CXCR4 antagonist) Allschwil, Switzerland (combination therapy) (Fast Track) www.polyphor.com

Bavencio® EMD Serono triple negative breast cancer (+4-1BB) Phase II

avelumab Rockland, MA www.emdserono.com

(anti-PD-L1 inhibitor) Pfizer www.pfizer.com

New York, NY

Medicines in Development: Cancer ǀ 2018 19

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Breast CancerProduct Name Sponsor Indication Development Phase

bemcentinib (BGB324) BerGenBio triple negative breast cancer Phase II

(AXL kinase inhibitor) Bergen, Norway (+pembrolizumab) www.bergenbio.com

Bria-IMT™ BriaCell Therapeutics metastatic breast cancer, Phase I/II

SV-BR-1 GM cancer vaccine Berkeley, CA breast cancer (combination therapy) www.briacell.com

CB-839 Calithera Biosciences triple negative breast cancer Phase II

(glutaminase inhibitor) South San Francisco, CA (+paclitaxel) www.calithera.com

Cotellic® Genentech triple negative breast cancer Phase II

cobimetinib South San Francisco, CA (+atezolizumab +/- taxane) www.gene.com

DEBIO 1347 Debiopharm breast cancer Phase I/II

(FGFR 1/2/3 inhibitor) Lausanne, Switzerland www.debiopharm.com

DHES0815A Genentech breast cancer Phase I

South San Francisco, CA www.gene.com

eFT508 eFFECTOR Therapeutics triple negative breast cancer Phase II

(MKNK1/MKNK2 protein inhibitor) San Diego, CA www.effector.com

endoxifen Jina Pharmaceuticals breast cancer Phase II

(estrogen receptor antagonist) Libertyville, IL www.jinapharma.com

endoxifen (topical) Atossa Genetics breast cancer prevention in women Phase II

Seattle, WA with mammographic breast density www.atossagenetics.com

Medicines in Development: Cancer ǀ 2018 20

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Breast CancerProduct Name Sponsor Indication Development Phase

ENMD-2076 CASI Pharmaceuticals triple negative breast cancer Phase II

(mulitple kinase inhibitor) Rockville, MD www.casipharmaceuticals.com

enobosarm GTx breast cancer Phase II completed

(SARM) Memphis, TN www.gtxinc.com

entinostat Syndax Pharmaceuticals advanced hormone receptor-positive Phase III

(HDAC inhibitor) Waltham, MA HER2-breast cancer (+exemestane) www.syndax.com

triple negative breast cancer Phase II

(+atezolizumab) www.syndax.com

EP-101 EpiThany breast cancer Phase I

(multi-antigen vaccine) Seattle, WA www.epithany.com

EP-301 EpiThany breast cancer Phase I

(HER2 ICD vaccine) Seattle, WA www.epithany.com

EP-302 EpiThany breast cancer Phase I

(multi-antigen vaccine) Seattle, WA www.epithany.com

ETBX-021 Etubics HER2-expressing breast cancer Phase I

(HER2/neu targeted cancer vaccine) Seattle, WA www.etubics.com

NantBioScience www.nantworks.com

Culver City, CA

Medicines in Development: Cancer ǀ 2018 21

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Breast CancerProduct Name Sponsor Indication Development Phase

fulvestrant for injectable Eagle Pharmaceuticals hormone receptor-positive Phase I

suspension Woodcliff Lake, NJ breast cancer www.eagleus.com

fulvestrant intraductal Atossa Genetics breast cancer (neoadjuvant) Phase II

microcatheter delivery Seattle, WA www.atossagenetics.com

G1T38 G1 Therapeutics estrogen receptor-positive Phase II

(CDK4/6 inhibitor) Research Tringle Park, NC HER2-negative breast cancer www.g1therapeutics.com

GDC-0077 (RG6114) Genentech hormone receptor-positive Phase I

(PI3K inhibitor) South San Francisco, CA breast cancer www.gene.com

GDC-9545 (RG6171) Genentech estrogen receptor-positive Phase I

(SERD) South San Francisco, CA HER2-negative metastatic www.gene.com

breast cancer

Gilotrif® Boehringer Ingelheim Pharmaceuticals breast cancer Phase III

afatinib Ridgefield, CT www.boehringer-ingelheim.com

H3B-6545 Eisai estrogen receptor-positive HER2- Phase I

(estrogen receptor alpha antagonist) Woodcliff Lake, NJ negative metastatic breast cancer www.h3biomedicine.com

H3 Biomedicine

Cambridge, MA

Halaven® Eisai breast cancer (+pembrolizumab), Phase I/II

eribulin Woodcliff Lake, NJ breast cancer (+PEGPH20) www.eisai.com

Medicines in Development: Cancer ǀ 2018 22

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Breast CancerProduct Name Sponsor Indication Development Phase

Ibrance® Pfizer high risk early breast cancer, Phase III

palbociclib New York, NY HER2-positive breast cancer (adjuvant), www.pfizer.com

early breast cancer (adjuvant)

Imlygic® Amgen triple-negative breast cancer Phase I

talimogene laherparepvec Thousand Oaks, CA (+atezolizumab) www.amgen.com

(oncolytic virus therapy)

Imprime PGG® Biothera Pharmaceuticals triple-negative breast cancer Phase II

immunostimulant PGG glucan Eagan, MN (+pembrolizumab) www.biothera.com

IMT-1012 Immunotope breast cancer Phase I completed

(immunotherapeutic vaccine) Doylestown, PA www.immunotope.com

ipatasertib Array BioPharma 1L triple negative hormone receptor- Phase III

(pan-Akt inhibitor) Boulder, CO positive breast cancer (+chemotherapy) www.arraybiopharma.com

Genentech www.gene.com

South San Francisco, CA

triple negative breast cancer Phase II

(neoadjuvant) www.arraybiopharma.com

www.gene.com

triple negative breast cancer Phase I

(+atezolizumab +taxane) www.arraybiopharma.com

www.gene.com

IPI-549 Infinity Pharmaceuticals triple negative breast cancer Phase I

(PI3K-gamma inhibitor) Cambridge, MA (+nivolumab) www.infi.com

Medicines in Development: Cancer ǀ 2018 23

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Breast CancerProduct Name Sponsor Indication Development Phase

IRX4204 Io Therapeutics breast cancer Phase I

(RXR agonist) Santa Ana, CA www.io-therapeutics.com

Kadcyla® Genentech 1L HER2-positive metastatic Phase III

trastuzumab emtansine South San Francisco, CA breast cancer, 3L HER2-positive www.gene.com

metastatic breast cancer

Kanjinti™ Allergan HER2-postive breast cancer application submitted

trastuzumab biosimilar Madison, NJ www.allergan.com

(ABP 980) Amgen www.amgen.com

Thousand Oaks, CA

Keytruda® Merck breast cancer Phase III

pembrolizumab Kenilworth, NJ www.merck.com

Kisqali® Novartis Oncology hormone-receptor positive HER2- Phase III

ribociclib East Hanover, NJ negative breast cancer (adjuvant), www.novartis.com

(CDK4/6 inhibitor) 1L hormone-receptor positive

HER2-negative advanced breast cancer

(premenopausal women),

1L/2L hormone-receptor positive

HER2-negative advanced breast cancer

(postmenopausal women)

Korlym® Corcept Therapeutics triple negative breast cancer (+eribulin) Phase I

mifepristone Menlo Park, CA www.corcept.com

Medicines in Development: Cancer ǀ 2018 24

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Breast CancerProduct Name Sponsor Indication Development Phase

ladiratuzumab vedotin Seattle Genetics HER2-negative breast cancer, Phase II

(LIV-1 antibody-drug conjugate) Bothell, WA triple negative breast cancer www.seattlegenetics.com

(+pembrolizumab), triple negative

breast cancer (+atezolizumab)

breast cancer Phase I

www.seattlegenetics.com

lasofoxifene Sermonix Pharmaceuticals estrogen receptor-positive Phase II

(SERM) Columbus, OH metastatic breast cancer www.sermonixpharma.com

LCL161 Novartis Oncology breast cancer (+PDR001) Phase I

(apoptosis protein inhibitor) East Hanover, NJ www.novartis.com

LSZ102 Novartis Oncology estrogen receptor-positive metastatic Phase I

(SERM) East Hanover, NJ breast cancer (monotherapy and www.novartis.com

combination therapy)

Lynparza® AstraZeneca gBRCA-mutated adjuvant breast cancer, Phase III

olaparib Wilmington, DE gBRCA-mutated metastatic breast cancer www.astrazeneca.com

margetuximab MacroGenics HER2-positive breast cancer (Fast Track) Phase III

(anti-HER2 mAb) Rockville, MD www.macrogenics.com

MCLA-128 Merus breast cancer Phase II

(ERBB2/3 receptor antagonist) Utrecht, Netherlands www.merus.nl

Medicines in Development: Cancer ǀ 2018 25

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Breast CancerProduct Name Sponsor Indication Development Phase

MCS110 Novartis Oncology triple negative breast cancer Phase II

(CSF-1 mAb) East Hanover, NJ www.novartis.com

ME-344 MEI Pharma HER2-negative breast cancer Phase I/II

(MTORC1/2 protein inhibitor) San Diego, CA (+bevacizumab) www.meipharma.com

MM-121 (seribantumab) Merrimack Pharmaceuticals metastatic breast cancer Phase II

(anti-HER3 mAb) Cambridge, MA www.merrimack.com

MSI-1436 DepYmed HER2-postive breast cancer Phase I

(trodusquemine) Farmingdale, NY www.depymedinc.com

Nerlynx® Puma Biotechnology 3L metastatic HER2-positive breast Phase III

neratinib Los Angeles, CA cancer www.pumabiotechnology.com

(pan-ErbB inhibitor)

HER2-positive breast cancer with brain Phase II

metastases, HER2-positive breast www.pumabiotechnology.com

cancer (neoadjuvant therapy),

metastatic HER2-positive breast cancer,

metastatic ER2-mutant breast cancer

Neuvax™ Sellas Life Sciences HER2-positive breast cancer Phase II

nelipepimut-S New York, NY (Fast Track) www.sellaslifesciences.com

Onivyde® Ipsen Biopharmaceuticals breast cancer Phase I

irinotecan liposome injection Basking Ridge, NJ www.ipsen.com

Medicines in Development: Cancer ǀ 2018 26

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Breast CancerProduct Name Sponsor Indication Development Phase

Onzeald™ Nektar Therapeutics metastatic breast cancer (Fast Track) Phase III

etirinotecan pegol San Francisco, CA www.nektar.com

Opdivo® Bristol-Myers Squibb triple negative breast cancer Phase I/II

nivolumab Princeton, NJ www.bms.com

Oraxol Athenex breast cancer Phase III

paclitaxel oral Buffalo, NY www.athenex.com

OTS-167 OncoTherapy Science advanced breast cancer, Phase I

(MELK inhibitor) Kanagawa, China triple-negative breast cancer www.oncotherapy.co.jp

PCA062 Novartis Oncology pCAD-positive triple negative Phase I

(p-cadherin modulator) East Hanover, NJ breast cancer www.novartis.com

pertuzumab subcutaneous + Genentech early breast cancer Phase II

trastuzumab fixed-dose combination South San Francisco, CA www.gene.com

PF-06873600 Pfizer metastatic breast cancer Phase I

(CDK inhibitor) New York, NY www.pfizer.com

poziotinib Spectrum Pharmaceuticals HER2-positive breast cancer Phase II

(pan-HER/tyrosine kinase inhibitor) Henderson, NV www.sppirx.com

Medicines in Development: Cancer ǀ 2018 27

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Breast CancerProduct Name Sponsor Indication Development Phase

PTX-200 Prescient Therapeutics HER2-negative breast cancer Phase II

(Akt inhibitor) South Melbourne, Australia www.ptxtherapeutics.com

stage IIB-IV breast cancer Phase I/II

www.ptxtherapeutics.com

PU-H71 Samus Therapeutics metastatic breast cancer Phase I

(HSP90 inhibitor) Topsfield, MA www.samustherapeutics.com

PVX-410 OncoPep metastatic triple negative breast Phase I

(multi-peptide cancer vaccine) Boston, MA cancer (+pembrolizumab), www.oncopep.com

metastatic triple negative breast

cancer (+ durvalumab)

RAD140 Radius Health metastatic breast cancer Phase I

(SARM) Waltham, MA www.radiuspharm.com

rebastinib Deciphera Pharmaceuticals breast cancer (+chemotherapy) Phase I

(TIE2 immunokinase inhibitor) Waltham, MA www.deciphera.com

REM-001 (rostaporfin) Adgero Biopharmaceuticals cutaneous metastatic breast cancer Phase II

(photosensitizer) Princeton, NJ www.adgerobiopharm.com

RG6264 Roche/Genentech HER2-positive breast cancer Phase I

(pertuzumab/trastuzumab Basel, Switzerland www.roche.com

fixed-dose combination)

Medicines in Development: Cancer ǀ 2018 28

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Breast CancerProduct Name Sponsor Indication Development Phase

RX-5902 (supinoxin) Rexahn Pharmaceuticals triple negative breast cancer Phase II

(P-p68 inhibitor) Rockville, MD www.rexahn.com

sacituzumab govitecan Immunomedics metastatic triple-negative breast Phase III

(anti-TROP-2-SN-38 ADC) Morris Plains, NJ cancer (Fast Track) www.immunomedics.com

(Breakthrough Therapy)

sapacitabine Cyclacel Pharmaceuticals breast cancer (+seliciclib) Phase II

(nucleoside analogue) Berkeley Heights, NJ www.cyclacel.com

sapanisertib Takeda Oncology breast cancer Phase II

(MTOR protein inhibitor) Deerfield, IL www.takeda.com

SAR439859 Sanofi metastatic breast cancer (+palbociclib) Phase I

(SERD) Bridgewater, NJ www.sanofi.com

SAR566658 Sanofi triple negative breast cancer Phase II

(anti-CA6 antibody-drug conjugate) Bridgewater, NJ www.sanofi.com

SC-005 AbbVie triple negative breast cancer Phase I

(antibody-drug conjugate) North Chicago, IL www.abbvie.com

seviteronel (INO-464) Innocrin Pharmaceuticals triple-negative breast cancer Phase II

(CYP17 lyase inhibitor) Durham, NC (Fast Track), estrogen receptor- www.innocrinpharma.com

positive breast cancer,

male breast cancer

Medicines in Development: Cancer ǀ 2018 29

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Breast CancerProduct Name Sponsor Indication Development Phase

talazoparib Pfizer germline BRCA-mutated Phase III

(PARP inhibitor) New York, NY metastatic breast cancer www.pfizer.com

taselisib Genentech estrogen receptor-positive Phase III

(PI3K inhibitor) South San Francisco, CA HER2-negative breast cancer www.gene.com

HER2-negative metastatic breast Phase II

cancer (neoadjuvant) www.gene.com

tavokinogene telsaplasmid Oncosec Medical triple negative breast cancer Phase II

(interleukin-12 gene therapy) San Diego, CA www.oncosec.com

Tecentriq® Genentech 1L triple negative breast cancer Phase III

atezolizumab South San Francisco, CA (+paclitaxel), 1L triple negative breast www.gene.com

cancer (+nab-paclitaxel), triple negative

breast cancer (+nab-paclitaxel)

HER2-positive breast cancer (+K/HP) Phase I

www.gene.com

tesetaxel Odonate Therapeutics HER2-negative hormone receptor- Phase III

(taxane derivative) San Diego, CA positive metastatic breast cancer www.odonate.com

ThermoDox® Celsion recurrent chest wall breast cancer Phase I/II

doxorubicin liposomal Lawrenceville, NJ www.celsion.com

Medicines in Development: Cancer ǀ 2018 30

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Breast CancerProduct Name Sponsor Indication Development Phase

TPIV100/110 TapImmune HER2/neu-positive breast cancer Phase I

(T-cell cancer vaccine) Jacksonville, FL www.tapimmune.com

TPIV200 TapImmune triple negative breast cancer Phase II

(folate receptor-alpha vaccine) Jacksonville, FL www.tapimmune.com

trastuzumab biosimilar Celltrion HER2-positive breast cancer application submitted

Incheon, South Korea www.celltrion.com

trastuzumab biosimilar Pfizer metastatic breast cancer application submitted

(PF-05280014) New York, NY www.pfizer.com

trastuzumab biosimilar Samsung Bioepis HER2-postive breast cancer application submitted

(SB3) Incheon, South Korea www.samsungbioepis.com

trastuzumab deruxtecan (DS-8201) Daiichi Sankyo breast cancer (Fast Track) Phase II

(anti-HER2 antibody-drug conjugate) Basking Ridge, NJ www.dsi.com

trastuzumab duocarmazine Synthon Pharmaceuticals pre-treated HER2-positive metastatic Phase III

(anti-HER2 antibody-drug conjugate) Durham, NC breast cancer (Fast Track) www.synthon.com

TRC-105 TRACON Pharmaceuticals breast cancer Phase I

(carotuximab) San Diego, CA www.traconpharma.com

trilaciclib G1 Therapeutics triple negative breast cancer Phase II

(CDK4/CDK6 inhibitor) Research Triangle Park, NC www.g1therapeutics.com

Medicines in Development: Cancer ǀ 2018 31

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Breast CancerProduct Name Sponsor Indication Development Phase

TTC-352 TTC Oncology metastatic breast cancer Phase I

(estrogen receptor alpha agonist) Edina, MN

tucatinib Seattle Genetics HER2-postive breast cancer Phase II

(HER2 inhibitor) Bothell, WA (combination therapy) (Fast Track) www.seattlegenetics.com

ORPHAN DRUG

veliparib AbbVie breast cancer Phase III

(PARP inhibitor) North Chicago, IL www.abbvie.com

ORPHAN DRUG

Verzenio® Eli Lilly breast cancer (adjuvant) Phase III

abemaciclib Indianapolis, IN www.lilly.com

hormone receptor-positive/HER2- Phase II

positive metastatic breast cancer www.lilly.com

XMT-1522 Mersana Therapeutics HER2-expressing breast cancer Phase I

(anti-HER2 antibody-drug conjugate) Cambridge, MA www.mersana.com

Zejula® TESARO triple negative breast cancer Phase II

niraparib Waltham, MA (+pembrolizumab) www.tesarobio.com

ZW25 Zymeworks HER2-expressing breast cancer Phase I

(bispecific antibody) Vancouver, Canada www.zymeworks.com

Medicines in Development: Cancer ǀ 2018 32

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Colorectal CancerProduct Name Sponsor Indication Development Phase

AbGn-107 AbGenomics colorectal cancer Phase I

(antibody-drug conjugate) Los Altos, CA www.abgenomics.com

ADXS-NEO Advaxis metastatic colon cancer Phase I

(neoepitope-based Princeton, NJ www.advaxis.com

immunotherapy vaccine) Amgen

Thousand Oaks, CA

AlloStim® Immunovative Therapies metastatic colorectal cancer Phase II

cancer vaccine Jerusalem, Israel (+cryoablation) www.immunovative.com

bevacizumab biosimilar Boehringer Ingelheim Pharmaceuticals colorectal cancer Phase III

(BI 695502) Ridgefield, CT www.boehringer-ingelheim.com

bevacizumab biosimilar Tanvex BioPharma metastatic colorectal cancer Phase I

(TX16) San Diego, CA www.tanvex.com

binimetinib Array BioPharma BRAF-mutant colorectal cancer Phase III

(MEK inhibitor) Boulder, CO www.arraybiopharma.com

microsatellite-stable metastatic Phase I/II

colorectal cancer with RAS mutation www.arraybiopharma.com

(+nivolumab +/-ipilimumab)

Medicines in Development: Cancer ǀ 2018 33

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Colorectal CancerProduct Name Sponsor Indication Development Phase

colorectal cancer vaccine Targeted Diagnostics and Therapeutics colorectal cancer Phase I

Exton, PA www.viralgeneinc.com

Viral Gene

Exton, PA

CPI-613 Rafael Pharmaceuticals relapsed/refractory metastatic Phase I

(altered energy metabolism- Newark, NJ colorectal cancer www.rafaelpharma.com

derived medicine)

CPP-1X/sul Cancer Prevention Pharmaceuticals colon cancer risk reduction Phase III

(eflornithine + sulindac) Tucson, AZ www.canprevent.com

eFT508 eFFECTOR Therapeutics microsatellite stable colorectal cancer Phase II

(MKNK1/MKNK2 protein inhibitor) San Diego, CA (+avelumab) www.effector.com

eltanexor oral (KPT-8602) Karyopharm Therapeutics colorectal cancer Phase I/II

(nuclear export inhibitor) Newton, MA www.karyopharm.com

encorafenib Array BioPharma colorectal cancer Phase III

(BRAF inhibitor) Boulder, CO www.arraybiopharma.com

ensituximab Precision Biologics advanced colorectal cancer Phase II

(neoplasm antigen inhibitor) Rockville, MD www.precision-biologics.com

entinostat Syndax Pharmaceuticals colorectal cancer (+pembrolizumab) Phase II

(HDAC inhibitor) Waltham, MA www.syndax.com

Medicines in Development: Cancer ǀ 2018 34

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Colorectal CancerProduct Name Sponsor Indication Development Phase

entolimod Cleveland BioLabs colorectal cancer (neoadjuvant) Phase I

(TLR5 agonist) Buffalo, N Y www.cbiolabs.com

epacadostat Incyte colorectal cancer Phase I

(IDO1 inhibitor) Wilmington, DE www.incyte.com

ETBX-011 Etubics colorectal cancer Phase I/II completed

(CEA targeted cancer vaccine) Seattle, WA www.etubics.com

NantKWest www.nantkwest.com

Culver City, CA

Hu5F9-G4 Forty Seven advanced colorectal cancer Phase I/II

(CD47 antigen inhibitor mAb) Menlo Park, CA (+cetixumab) www.fortyseveninc.com

Imlygic® Amgen colorectal cancer with liver metastases Phase I

talimogene laherparepvec Thousand Oaks, CA (+atezolizumab) www.amgen.com

(oncolytic virus therapy)

Imprime PGG® Biothera Pharmaceuticals colorectal cancer Phase I/II

immunostimulant PGG glucan Eagan, MN (+atezolizumab +bevacizumab) www.biothera.com

ipatasertib Array BioPharma 1L colorectal cancer (+abiratorone) Phase III

(pan-Akt inhibitor) Boulder, CO www.arraybiopharma.com

Genentech www.gene.com

South San Francisco, CA

Medicines in Development: Cancer ǀ 2018 35

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Colorectal CancerProduct Name Sponsor Indication Development Phase

Keytruda® Merck colorectal cancer Phase III

pembrolizumab Kenilworth, NJ www.merck.com

MABp1 XBiotech advanced colorectal cancer (Fast Track), Phase III

Austin, TX symptomatic colorectal cancer www.xbiotech.com

MGD007 MacroGenics colorectal cancer Phase I

(gpA33 x CD3 bispecific antibody) Rockville, MD www.macrogenics.com

napabucasin Boston Biomedical colorectal cancer (+FOLFIRI ) Phase III

(STAT3 inhibitor) Cambridge, MA www.bostonbiomedical.com

ORPHAN DRUG

colorectal cancer Phase II

(combination therapy) www.bostonbiomedical.com

navicixizumab OncoMed Pharmaceuticals metastatic colorectal cancer Phase I

(anti-DLL4/VEGF bispecific mAb) Redwood City, CA www.oncomed.com

ONCOS-102 Targovax colorectal cancer Phase I/II

(oncolytic virus therapy) Oslo, Norway www.targovax.com

OncoVax® Vaccinogen colorectal cancer (Fast Track) Phase III

autologous cancer vaccine Baltimore, MD www.vaccinogeninc.com

Opdivo® + Yervoy® Bristol-Myers Squibb colorectal cancer Phase II

nivolumab + ipilimumab Princeton, NJ www.bms.com

Medicines in Development: Cancer ǀ 2018 36

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Colorectal CancerProduct Name Sponsor Indication Development Phase

pLADD Aduro BioTech microsatellite stable colorectal cancer Phase I

(personalised LADD immunotherapy) Berkeley, CA www.aduro.com

PM184 PharmaMar advanced colorectal cancer Phase II

(tubulin polymerisation inhibitor) Madrid, Spain www.pharmamar.com

polyclonal antibody stimulator Cancer Advances colorectal cancer Phase II

(fusion peptide) Durham, NC www.canceradvancesinc.com

PolyPEPI1018 Treos Bio colorectal cancer Phase I

(immunotherapy cancer vaccine) London, United Kingdom www.treosbio.com

SC-006 AbbVie colorectal cancer Phase I

(antibody-drug conjugate) North Chicago, IL www.abbvie.com

Sym004 Symphogen 3L/4L metastatic colorectal cancer Phase III

(EGFR antagonist mAb) Somerville, NJ www.symphogen.com

Tecentriq® Genentech 2L/3L colorectal cancer Phase I

atezolizumab South San Francisco, CA (+bevacizumab +cobimetinib) www.gene.com

trastuzumab deruxtecan (DS-8201) Daiichi Sankyo colorectal cancer Phase II

(anti-HER2 antibody-drug conjugate) Basking Ridge, NJ www.dsi.com

TVB-2640 3-V Biosciences colon cancer Phase II

(FASN inhibitor) Menlo Park, CA www.3vbio.com

Medicines in Development: Cancer ǀ 2018 37

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Colorectal CancerProduct Name Sponsor Indication Development Phase

varlilumab Celldex Therapeutics colorectal cancer (+nivolumab) Phase II

(anti-CD28 mAb) Hampton, NJ www.celldex.com

Gastric CancerProduct Name Sponsor Indication Development Phase

AbGn-107 AbGenomics gastric cancer Phase I

(antibody-drug conjugate) Los Altos, CA www.abgenomics.com

andecaliximab Gilead Sciences gastric cancer Phase III

(MMP9 inhibitor mAb) Foster City, CA www.gilead.com

APR-246 Aprea Therapeutics esophageal cancer Phase I

(tumor suppressor protein Boston, MA www.aprea.com

p53 stimulant)

avapritinib Blueprint Medicines unresectable, treatment-resistant Phase I

(PDGFRa/KIT inhibitor) Cambridge, MA gastrointestinal stromal tumors (GIST) www.blueprintmedicines.com

ORPHAN DRUG (Fast Track) (Breakthrough Therapy)

Bavencio® EMD Serono 1L gastric cancer Phase III

avelumab Rockland, MA www.emdserono.com

(anti-PD-L1 inhibitor) Pfizer www.pfizer.com

New York, NY

Medicines in Development: Cancer ǀ 2018 38

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Gastric CancerProduct Name Sponsor Indication Development Phase

bemarituzumab Five Prime Therapeutics gastric/gastroesophageal junction Phase I

(FGFR2b receptor antagonist) South San Francisco, CA cancer www.fiveprime.com

ORPHAN DRUG

BMS-986205 Bristol-Myers Squibb advanced gastric cancer Phase II

(IDO1 inhibitor) Princeton, NJ (+nivolumab +ipilimumab +relatlimab) www.bms.com

cellspan esophageal implant  Biostage esophageal cancer in clinical trials

ORPHAN DRUG Holliston, MA www.biostage.com

CPP-1X Cancer Prevention Pharmaceuticals gastric cancer Phase II

(eflornithine + high dose powder sachet) Tucson, AZ www.canprevent.cpom

ORPHAN DRUG

crenolanib AROG Pharmaceuticals GIST (Fast Track) Phase III

(tyrosine kinase inhibitor) Dallas, TX www.arogpharmaceuticals.com

DCC-2618 Deciphera Pharmaceuticals GIST Phase III

(PDGFR-alpha kinase switch Waltham, MA www.deciphera.com

control inhibitor)

ORPHAN DRUG

DKN-01 Leap Therapeutics esophagogastric cancer (+/-paclitaxel), Phase I/II

(anti-DKK1 mAb) Cambridge, MA esophagogastric cancer www.leaptx.com

(+pembrolizumab), gastric cancer

(+/-paclitaxel)

Medicines in Development: Cancer ǀ 2018 39

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Gastric CancerProduct Name Sponsor Indication Development Phase

IMAB362 (zolbetuximab) Astellas gastric cancer, gastroesophageal Phase III

(anti-claudin 18.2 mAb) Northbrook, IL junction adenocarcinoma www.astellas.com

ORPHAN DRUG

Imfinzi® MedImmune gastric cancer (+tremelimumab), Phase II

durvalumab Gaithersburg, MD esophageal cancer (+tremelimumab) www.medimmune.com

1L esophageal cancer Phase I

(+tremelimumab +chemotherapy) www.medimmune.com

Kanjinti™ Allergan HER2-positive gastric cancer application submitted

trastuzumab biosimilar Madison, NJ www.allergan.com

(ABP 980) Amgen www.amgen.com

Thousand Oaks, CA

Keytruda® Merck esophageal cancer Phase III

pembrolizumab Kenilworth, NJ www.merck.com

Lonsurf® Taiho Oncology gastric cancer Phase III

tipiracil/trifluridine Princeton, NJ www.taihooncology.com

Lynparza® AstraZeneca gastric cancer (+AZD6738) Phase II

olaparib Wilmington, DE www.astrazeneca.com

margetuximab MacroGenics gastric cancer (+anti-PD-1) Phase II

(anti-HER2 mAb) Rockville, MD www.macrogenics.com

Medicines in Development: Cancer ǀ 2018 40

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Gastric CancerProduct Name Sponsor Indication Development Phase

masitinib AB Science 1L GIST Phase III

(protein tyrosine kinase inhibitor) Paris, France www.ab-science.com

ORPHAN DRUG

napabucasin Boston Biomedical gastrointestinal cancer Phase I/II

(STAT3 inhibitor) Cambridge, MA (+chemotherapy) www.bostonbiomedical.com

ORPHAN DRUG

Opdivo® Bristol-Myers Squibb esophageal cancer, gastric cancer, Phase III

nivolumab Princeton, NJ gastroesophageal junction www.bms.com

adenocarcinoma

Opdivo® + Yervoy® Bristol-Myers Squibb gastric cancer, esophageal cancer Phase III

nivolumab + ipilimumab Princeton, NJ www.bms.com

Oraxol Athenex gastric cancer (+ramucirumab) Phase I

paclitaxel oral Buffalo, NY www.athenex.com

PCA062 Novartis Oncology pCAD-positive esophageal cancer Phase I

(p-cadherin modulator) East Hanover, NJ www.novartis.com

pegargiminase Polaris Pharmaceuticals gastrointestinal cancer (+FOLFOX) Phase I/II

(ADI-PEG-20) San Diego, CA www.polarispharma.com

PEGPH20 Halozyme Therapeutics gastric cancer (+pembrolizumab), Phase I

(pegylated recombinant San Diego, CA gastric cancer (+atezolizumab) www.halozyme.com

human hyalurinodase)

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Gastric CancerProduct Name Sponsor Indication Development Phase

PLX9486 Plexxikon GIST Phase I

(c-kit inhibitor) Berkeley, CA www.plexxikon.com

polyclonal antibody stimulator Cancer Advances gastric cancer Phase III

(fusion peptide) Durham, NC www.canceradvancesinc.com

ORPHAN DRUG

rivoceranib LSK Biopharma advanced or metastatic gastric cancer Phase III

(VEGFr-2 antagonist) Salt Lake City, UT www.lskbiopharma.com

ORPHAN DRUG

ropidoxuridine Shuttle Pharmaceuticals gastrointestinal cancer Phase I

(radiation sensitizer) Rockville, MD www.shuttlepharma.com

Sutent® Pfizer GIST (pediatric) Phase II completed

sunitinib New York, NY www.pfizer.com

Tecentriq® Genentech gastric cancer Phase I

atezolizumab South San Francisco, CA (+bevacizumab +chemotherapy) www.gene.com

tislelizumab (BGB-A317) BeiGene USA esophageal squamous cell carcinoma Phase III

(anti-PD-1 mAb) Cambridge, MA www.beigene.com

Celgene www.celgene.com

Summit, NJ

trastuzumab biosimilar Celltrion HER2-positive gastric cancer application submitted

Incheon, South Korea www.celltrion.com

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Gastric CancerProduct Name Sponsor Indication Development Phase

XmAb18087 Xencor GIST Phase I

(SSTR2 x CD3 bispecific mAb) Monrovia, CA www.xencor.com

XMT-1522 Mersana Therapeutics HER2-expressing gastric cancer Phase I

(anti-HER2 antibody-drug conjugate) Cambridge, MA www.mersana.com

ZW25 Zymeworks HER2-expressing gastric cancer Phase I

(bispecific antibody) Vancouver, Canada www.zymeworks.com

ORPHAN DRUG

Head and Neck CancerProduct Name Sponsor Indication Development Phase

ADXS-NEO Advaxis metastatic head and neck cancer Phase I

(neoepitope-based Princeton, NJ www.advaxis.com

immunotherapy vaccine) Amgen

Thousand Oaks, CA

axalimogene filolisbac (AXAL) Advaxis metastatic head and neck cancer Phase II

(cancer immunotherapy vaccine) Princeton, NJ (+durvalumab) www.advaxis.com

ORPHAN DRUG

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Head and Neck CancerProduct Name Sponsor Indication Development Phase

Bavencio® EMD Serono locally advanced head and neck cancer, Phase III

avelumab Rockland, MA locally-advanced squamous cell www.emdserono.com

(anti-PD-L1 inhibitor) Pfizer carcinoma of the head and neck www.pfizer.com

New York, NY

squamous cell carcinoma of the Phase II

head and neck (+OX40 or 4-1BBB) www.emdserono.com

www.pfizer.com

biropepimut-S (GL-0817) Gliknik squamous cell carcinoma of the Phase II

(MAGEA 3 immunomodulator) Baltimore, MD oral cavity www.gliknik.com

ORPHAN DRUG

BMX-001 BioMimetix head and neck cancer Phase I

(mangano porphyrin antioxidant Greenwood Village, CO www.biomimetix.com

mimetic)

CDX-3379 Celldex Therapeutics squamous cell carcinoma of the Phase II

(anti-ErbB3 mAb) Hampton, NJ head and neck www.celldex.com

Cotellic® Genentech head and neck cancer (+atezolizumab) Phase I

cobimetinib South San Francisco, CA www.gene.com

COTI-2 Cotinga Pharmaceuticals head and neck cancer Phase I

(p53 gene modulator) London, Canada www.cotingapharma.com

DPX-E7 Immunovaccine HPV-related head and neck cancer Phase I/II

(peptide cancer vaccine) Halifax, Canada www.imvaccine.com

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Head and Neck CancerProduct Name Sponsor Indication Development Phase

epacadostat Incyte head and neck cancer Phase I

(IDO1 inhibitor) Wilmington, DE www.incyte.com

evofosfamide Molecular Templates squamous cell carcinoma of the Phase I

Austin, TX head and neck (+ipilimumab) www.mtem.com

ficlatuzumab AVEO Oncology squamous cell carcinoma of the Phase II

(HGF/c-Met inhibitor) Cambridge, MA head and neck www.aveooncology.com

Gilotrif® Boehringer Ingelheim Pharmaceuticals squamous cell carcinoma of the Phase III completed

afatinib Ridgefield, CT head and neck www.boehringer-ingelheim.com

IMA201 Immatics US squamous cell carcinoma of the Phase I

(adoptive T-cell therapy) Houston, TX head and neck www.immatics.com

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Head and Neck CancerProduct Name Sponsor Indication Development Phase

Imfinzi® MedImmune 1L squamous cell carcinoma of the Phase III

durvalumab Gaithersburg, MD head and neck (+tremelimumab), www.medimmune.com

2L squamous cell carcinoma of the

head and neck (+tremelimumab)

squamous cell carcinoma of the Phase II

head and neck (+AZD5069), www.medimmune.com

squamous cell carcinoma of the

head and neck (+AZD9150),

squamous cell carcinoma of the

head and neck (+MEDI0457)

locally-advanced squamous cell Phase I

carcinoma of the head and neck (+ RT) www.medimmune.com

Imlygic® Amgen squamous cell carcinoma of the Phase I

talimogene laherparepvec Thousand Oaks, CA head and neck (+permbrolizumab) www.amgen.com

(oncolytic virus therapy)

Imprime PGG® Biothera Pharmaceuticals head and neck cancer Phase II

immunostimulant PGG glucan Eagan, MN (+pembrolizumab) www.biothera.com

IPI-549 Infinity Pharmaceuticals head and neck cancer (+nivolumab) Phase I

(PI3K-gamma inhibitor) Cambridge, MA www.infi.com

IRX-2 IRX Therapeutics squamous cell carcinoma of the Phase II

(citoplurikin) New York, NY head and neck (Fast Track) www.irxtherapeutics.com

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Head and Neck CancerProduct Name Sponsor Indication Development Phase

LN-145 Iovance Biotherapeutics squamous cell carcinoma of the Phase II

(tumor-infiltrating lymphocyte) San Carlos, CA head and neck www.iovance.com

MAGE-A10 TCR Adaptimmune head and neck cancer Phase I/II

(T-cell receptor therapy) Philadelphia, PA www.adaptimmune.com

monalizumab Innate Pharma head and neck cancer (+cetuximab), Phase II

(NKG2A checkpoint receptor Marseille, France head and neck cancer (+cetuximab) www.innate-pharma.com

antagonist)

Multikine® CEL-SCI head and neck cancer Phase III

leukocyte interleukin Vienna, VA www.cel-sci.com

ORPHAN DRUG

NC-6004 NanoCarrier head and neck cancer Phase I

(cisplatin micellar nanoparticle) Chiba, Japan (combination therapy) www.nanocarrier.com

Opdivo® + Yervoy® Bristol-Myers Squibb head and neck cancer Phase III

nivolumab + ipilimumab Princeton, NJ www.bms.com

PCA062 Novartis Oncology pCAD-positive head and neck cancer Phase I

(p-cadherin modulator) East Hanover, NJ www.novartis.com

prexasertib Eli Lilly head and neck cancer Phase I

(CHK1 inhibitor) Indianapolis, IN www.lilly.com

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Head and Neck CancerProduct Name Sponsor Indication Development Phase

Proxinium™ Eleven Biotherapeutics squamous cell carcinoma of the Phase I

recombinant fusion protein Cambridge, MA head and neck (Fast Track) www.elevenbio.com

ORPHAN DRUG

RM-1929 Aspyrian Therapeutics head and neck cancer (Fast Track) Phase II

(EGFR antagonist) San Diego, CA www.aspyriantherapeutics.com

SD-101 Dynavax Technologies squamous cell carcinoma of the Phase I/II

(TLR9 agonist) Berkeley, CA head and neck (+pembrolizumab) www.dynavax.com

SF1126 SignalRx Pharmaceuticals head and neck cancer Phase II

(PI3K/mTOR inhibitor) San Diego, CA www.signalrx.com

Tecentriq® Genentech squamous cell carcinoma of the Phase III

atezolizumab South San Francisco, CA head and neck (+/- chemotherapy) www.gene.com

tipifarnib Kura Oncology HRAS-mutant head and neck cancer Phase II

(farnesyltranstransferase inhibitor) San Diego, CA www.kuraoncology.com

TT10 (EBVST) Tessa Therapeutics nasopharyngeal cancer (Fast Track) Phase III

(EBV antigen-specific CTL) Singapore www.tessatherapeutics.com

ORPHAN DRUG

TT12 (armoured HPVST) Tessa Therapeutics oropharyngeal cancer Phase I

(HPV-specific T-cell therapy) Singapore www.tessatherapeutics.com

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Head and Neck CancerProduct Name Sponsor Indication Development Phase

varlilumab Celldex Therapeutics head and neck cancer (+nivolumab) Phase II

(anti-CD28 mAb) Hampton, NJ www.celldex.com

Hematologic MalignanciesProduct Name Sponsor Indication Development Phase

ABBV-621 AbbVie hematologic malignancies Phase I

(TRAIL receptor agonist) North Chicago, IL www.abbvie.com

AEB1102 Aeglea Biotherapeutics myelodysplastic syndromes Phase I

(pegzilarginase) Austin, TX www.aegleabio.com

ALRN-6924 Aileron Therapeutics hematologic malignancies Phase II

(MDM2/MDMX antagonist) Cambridge, MA www.aileronrx.com

myelodysplastic syndromes Phase I

www.aileronrx.com

anagrelide controlled-release Sellas Life Sciences essential thrombocythemia Phase II

New York, NY www.sellaslifesciences.com

APG-1387 Ascentage Pharma hematologic malignancies Phase I

(IAP protein inhibitor) Rockville, MD en.ascentagepharma.com

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Hematologic MalignanciesProduct Name Sponsor Indication Development Phase

APR-246 Aprea Therapeutics myelodysplastic syndromes Phase I

(tumor suppressor protein Boston, MA www.aprea.com

p53 stimulant)

ARQ 531 ArQule hematologic malignancies Phase I

(BTK inhibitor) Burlington, MA www.arqule.com

ASTX727 Astex Pharmaceuticals myelodysplastic syndromes Phase III

(DNMT inhibitor) Pleasanton, CA www.astx.com

ATA520 Atara Biotherapeutics hematologic malignancies Phase I

(WT1-specific T-cell therapy) South San Francisco, CA www.atarabio.com

AZD4573 AstraZeneca hematologic malignancies Phase I

(CDK9 inhibitor) Wilmington, DE www.astrazeneca.com

AZD5991 AstraZeneca hematologic malignancies Phase I

(MCL-1 protein inhibitor) Wilmington, DE www.astrazeneca.com

Bavencio® EMD Serono hematologic malignancies Phase I

avelumab Rockland, MA www.emdserono.com

(anti-PD-L1 inhibitor) Pfizer www.pfizer.com

New York, NY

BAY1251152 Bayer Pharmaceuticals hematologic malignancies Phase I

(PTEFb inhibitor) Whippany, NJ www.pharma.bayer.com

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Hematologic MalignanciesProduct Name Sponsor Indication Development Phase

Beleodaq® Spectrum Pharmaceuticals UGT1A1 wild type gene hematologic Phase I

belinostat Henderson, NV malignancies, UGT1A1*28 genotype www.sppirx.com

hematologic malignancies

bemcentinib (BGB324) BerGenBio myelodysplastic syndromes Phase I/II

(AXL kinase inhibitor) Bergen, Norway www.bergenbio.com

BI 836858 Boehringer Ingelheim Pharmaceuticals myelodysplastic syndromes Phase II

(anti-CD33 mAb) Ridgefield, CT www.boehringer-ingelheim.com

ORPHAN DRUG

BL-8040 BioLineRx hypoplastic myelodysplastic syndromes Phase II

(CXCR4 chemokine receptor antagonist) Modi’in, Israel (combination therapy) www.biolinerx.com

BPX-701 Bellicum Pharmaceuticals myelodysplastic syndromes Phase I

(T-cell receptor therapy) Houston, TX www.belicum.com

BSK01™ Kiromic relapsed/refractory hematologic Phase I/II

(tumor-associated peptide antigen Houston, TX malignancies www.kiromic.com

pulsed dendritic cell vaccine)

BXCL702 BioXcel Therapeutics hematologic malignancies Phase I

(enzyme inhibitor) Branford, CT www.bioxceltherapeutics.com

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Hematologic MalignanciesProduct Name Sponsor Indication Development Phase

Calquence® Acerta Pharma B-cell malignancies Phase III

acalabrutinib South San Francisco, CA www.astrazeneca.com

AstraZeneca

Wilmington, DE

hematologic malignancies (+AZD6738), Phase I

hematologic malignancies (+vistusertib) www.astrazeneca.com

CBLC137 Incuron hematologic malignancies Phase I

(curaxin) Buffalo, NY www.incuron.com

CC-486 Celgene lower-risk myelodysplastic syndromes Phase III

(oral azacitidine) Summit, NJ www.celgene.com

myelodysplastic syndromes Phase II

(post-hypomethylating agent failure) www.celgene.com

CC-90002 Celgene myelodysplastic syndromes Phase I

(anti-CD47 antibody) Summit, NJ www.celgene.com

cerdulatinib Portola Pharmaceuticals relapsed/refractory B-cell malignancies Phase II

(Syk/JAK inhibitor) South San Francisco, CA www.portola.com

CLR-131 Cellectar Biosciences hematologic malignancies Phase II

(phospholipid-drug conjugate) Madison, WI www.cellectar.com

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Hematologic MalignanciesProduct Name Sponsor Indication Development Phase

CNDO-109 Fortress Biotech myelodysplastic syndromes Phase I

(natural killer cell stimulant) New York, NY www.fortressbiotech.com

CPI-0610 Constellation Pharmaceuticals acute myelodysplastic syndromes, Phase I/II

(BET protein inhibitor) Cambridge, MA myelofibrosis, myelodysplastic/ www.constellationpharma.com

myeloproliferative neoplasms

CPI-613 Rafael Pharmaceuticals relapsed/refractory myelodysplastic Phase II

(altered energy metabolism- Newark, NJ syndromes www.rafaelpharma.com

derived medicine)

Cresemba® Astellas hematologic malignancies (pediatric) Phase I

isavuconazonium Northbrook, IL www.astellas.com

Basilea Pharmaceutica

Basel, Switzerland

CX-01 Cantex Pharmaceuticals myelodysplastic syndromes Phase II

(dociparstat sodium) Weston, FL www.cantex.com

CYAD-01 Celyad hematologic malignancies Phase I

(NKG2D CAR-T cell therapy) New York, NY www.celyad.com

DCC-3014 Deciphera Pharmaceuticals hematologic malignancies Phase I

(CSF1R inhibitor) Waltham, MA www.deciphera.com

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Hematologic MalignanciesProduct Name Sponsor Indication Development Phase

DS-3032 Daiichi Sankyo hematologic malignancies Phase I

(MDM2 inhibitor) Basking Ridge, NJ www.dsi.com

DSP-7888 Sumitomo Dainippon Pharma hematologic malignancies Phase I

(adegramotide/nelatimotide) Osaka, Japan www.ds-pharma.com

eltanexor oral (KPT-8602) Karyopharm Therapeutics high-risk myelodysplastic syndromes Phase I/II

(nuclear export inhibitor) Newton, MA www.karyopharm.com

entospletinib Gilead Sciences hematologic malignancies Phase II

(Syk inhibitor) Foster City, CA www.gilead.com

epacadostat Incyte B-cell malignancies Phase I

(IDO1 inhibitor) Wilmington, DE www.incyte.com

ET190 Eureka Therapeutics hematologic malignancies Phase I

(anti-CD19 CAR-T cell therapy) Emeryville, CA www.eurekatherapeutics.com

fedratinib Celgene myelofibrosis Phase III

(JAK2 inhibitor) Summit, NJ www.celgene.com

Impact Biomedicines

San Diego, CA

FF-10501-01 FUJIFILM Pharmaceuticals U.S.A myelodysplastic syndromes Phase I/II

(cell differentiation stimulant) Valhalla, NJ www.fujifilmusa.com

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Hematologic MalignanciesProduct Name Sponsor Indication Development Phase

flotetuzumab Macrogenics myelodysplastic syndromes Phase I

(CD123 and CD3 bispecific antibody) Rockville, MD www.macrogenics.com

Servier

Paris, France

FT-1101 FORMA Therapeutics relapsed/refractory hematologic Phase I

(BET inhibitor) Watertown, MA malignancies www.formatherapeutics.com

FT-2102 FORMA Therapeutics myelodysplastic syndromes with Phase I

Watertown, MA IDH1-mutation www.formatherapeutics.com

Gazyva® Genentech hematologic malignancies Phase I

obinutuzumab South San Francisco, CA (anti-CD20 combination therapy) www.gene.com

GSK3174998 GlaxoSmithKline hematologic malignancies Phase I

(anti-OX40 mAb) Research Triangle Park, NC www.gsk.com

GSK525762 (molibresib) GlaxoSmithKline hematologic malignancies Phase I

(BET inhibitor) Research Triangle Park, NC www.gsk.com

guadecitabine (SGI-110) Astex Pharmaceuticals myelodysplastic syndromes Phase III

(DNMT1 inhibitor) Pleasanton, CA www.astx.com

H3B-8800 Eisai myelodysplastic syndromes Phase I

(SF3B1 protein modulator) Woodcliff Lake, NJ www.eisai.com

H3 Biomedicine

Cambridge, MA

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Hematologic MalignanciesProduct Name Sponsor Indication Development Phase

HDM201 Novartis Oncology hematologic malignancies Phase I

(p53-HDM2 inhibitor) East Hanover, NJ www.novartis.com

Hu5F9-G4 Forty Seven myelodysplastic syndromes, Phase I

(CD47 antigen inhibitor mAb) Menlo Park, CA myelodysplastic syndromes www.fortyseveninc.com

(+azacitidine)

idasanutlin (RG7388) Roche/Genentech polycythemia vera Phase II

(MDM2 antagonist) South San Francisco, CA www.gene.com

IGF-MTX IGF Oncology myelodysplastic syndromes Phase I/II

(IGF-methotrexate conjugate) St. Paul, MN www.igfoncology.com

Imbruvica® Janssen Research & Development hematologic malignancies Phase I/II

ibrutinib Raritan, NJ (+nivolumab) www.jansen.com

Pharmacyclics www.pharmacyclics.com

Sunnyvale, CA

Imfinzi® MedImmune myelodysplastic syndromes Phase I

durvalumab Gaithersburg, MD (+azacitidine) www.medimmne.com

Celgene myelodysplastic syndromes Phase II

Summit, NJ (post-hypomethylating agent failure) www.celgene.com

MedImmune

Gaithersburg, MD

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Hematologic MalignanciesProduct Name Sponsor Indication Development Phase

IMG-7289 Imago BioSciences  myelodysplastic syndromes Phase II

(LSD1 inhibitor) San Carlos, CA www.imagobio.com

myelofibrosis Phase I/II

www.imagobio.com

IMGN632 ImmunoGen hematologic malignancies Phase I

(anti-CD123 antibody-drug conjugate) Waltham, MA www.immunogen.com

IMMU-114 Immunomedics hematologic malignancies Phase I

(anti-HLA-DR) Morris Plains, NJ www.immunomedics.com

INCB54828 Incyte 8p11 myeloproliferative syndrome Phase II

(FGFR1/2/3 inhibitor) Wilmington, DE www.incyte.com

Jakafi® Incyte essential thrombocythemia Phase III

ruxolitinib Wilmington, DE www.incyte.com

ORPHAN DRUG

LCL161 Novartis Oncology post-essential thrombocytosis Phase II

(apoptosis protein inhibitor) East Hanover, NJ myelofibrosis, post-polycythemia www.novartis.com

myelofibrosis, primary myelofibrosis

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Hematologic MalignanciesProduct Name Sponsor Indication Development Phase

luspatercept (ACE-536) Acceleron Pharma myelodysplastic syndromes Phase III

Cambridge, MA www.acceleron.com

Celgene www.celgene.com

Summit, NJ

myelofibrosis Phase II

www.acceleron.com

www.celgene.com

M7583 EMD Serono hematologic malignancies Phase I

(BTK inhibitor) Rockland, MA www.emdserono.com

MEDI7247 MedImmune hematologic malignancies Phase I

(immunomodulator) Gaithersburg, MD www.medimmune.com

MGD013 MacroGenics hematologic malignancies Phase I

(anti-PD-1 mAb x LAG-3) Rockville, MD www.macrogenics.com

MK-8628 Merck hematologic malignancies Phase I

(BET protein inhibitor) Kenilworth, NJ www.merck.com

momelotinib Gilead Sciences myelofibrosis, post-polycythemia vera, Phase II

(JAK 1/2 inhibitor) Foster City, CA post-essential thrombocythemia www.gilead.com

ORPHAN DRUG

napabucasin Boston Biomedical hematologic malignancies Phase I

(STAT3 inhibitor) Cambridge, MA (combination therapy) www.bostonbiomedical.com

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Hematologic MalignanciesProduct Name Sponsor Indication Development Phase

navitoclax AbbVie myelofibrosis Phase II

(Bcl-1 inhibitor) North Chicago, IL www.abbvie.com

NiCord® Gamida-Cell high-risk hematologic malignancies Phase III

cord blood stem cell therapy Jerusalem, Israel www.gamida-cell.com

ORPHAN DRUG

NS-018 NS Pharma myelofibrosis Phase I/II

(JAK2 inhibitor) Paramus, NJ www.nspharma.com

OPB-111077 Otsuka Pharmaceutical hematologic malignancies Phase I

(signal transduction pathway inhibitor) Rockville, MD www.otsuka.com

OTS-167 OncoTherapy Science advanced myelodysplastic syndromes, Phase I/II

(MELK inhibitor) Kanagawa, China advanced myeloproliferative www.oncotherapy.co.jp

neoplastic disorders

OXi4503 Mateon Therapeutics myelodysplastic malignancies Phase I/II

(combretastatin A1 phosphate) South San Francisco, CA (+ cytarabine) www.mateon.com

pacritinib CTI BioPharma myelofibrosis (Fast Track) Phase III

(JAK2 inhibitor) Seattle, WA www.ctibiopharma.com

ORPHAN DRUG

pevonedistat Takeda Oncology high-risk myelodysplastic syndromes Phase III

(Nedd-activating enzyme inhibior) Deerfield, IL www.takeda.com

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Hematologic MalignanciesProduct Name Sponsor Indication Development Phase

PIM447 Novartis Oncology myelofibrosis Phase I

(Pan-PIM inhibitor) East Hanover, NJ www.novartis.com

PLX51107 Plexxikon hematologic malignancies Phase I

(BET inhibitor) Berkeley, CA www.plexxikon.com

pracinostat MEI Pharma myelodysplastic syndromes Phase II

(hydroxamic inhibitor) San Diego, CA (+azacitidine) www.meipharma.com

PRM-151 Promedior myelofibrosis (Fast Track), Phase II

(cell differentiation modulator) Lexington, MA essential thrombocythemia, www.promedior.com

ORPHAN DRUG polycythemia vera

PU-H71 Samus Therapeutics myelofibrosis Phase I

(HSP90 inhibitor) Topsfield, MA www.samustherapeutics.com

relatlimab Bristol-Myers Squibb relapsed/refractory hematologic Phase II/III

(anti-LAG3 mAb) Princeton, NJ malignancies www.bms.com

RG6146 Roche/Genentech hematologic malignancies Phase I

(BET inhibitor) South San Francisco, CA www.gene.com

RG7828 Genentech hematologic malignancies Phase I

(anti-CD20/CD3 mAb) South San Francisco, CA (+/-atezolizumab) www.gene.com

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Hematologic MalignanciesProduct Name Sponsor Indication Development Phase

rigosertib Onconova Therapeutics 2L higher-risk myelodysplastic Phase III

(PI3K/Plk1 inhibitor) Newtown, PA syndromes (intravenous) (Fast Track) www.onconova.com

ORPHAN DRUG

1L higher-risk myelodysplastic Phase II

syndromes (oral) www.onconova.com

ropeginterferon alfa-2b PharmaEssentia polycythemia vera Phase III

ORPHAN DRUG Taipei, Taiwan www.pharmaessentia.com

SL-401 Stemline Therapeutics blastic plasmacytoid dendritic cell application submitted

(recombinant fusion protein) New York, NY neoplasm (Breakthrough Therapy) www.stemline.com

ORPHAN DRUG

advanced, high-risk myeloproliferative Phase I/II

neoplasms www.stemline.com

SNX-5422 Esanex hematologic malignancies Phase I/II

(Hsp90 inhibitor) Indianapolis, IN www.esanexpharma.com

SRF231 Surface Oncology hematologic malignancies Phase I

(anti-CD47 mAb) Cambridge, MA www.surfaceoncology.com

SY-1425 Syros Pharmaceuticals myelodysplastic syndromes Phase I

(RAR-alpha agonist) Cambridge, MA (+ daratumumab) www.syros.com

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Hematologic MalignanciesProduct Name Sponsor Indication Development Phase

Tecentriq® Genentech hematologic malignancies Phase I

atezolizumab South San Francisco, CA (+anti-CD20 combinations), www.gene.com

myelodysplastic syndromes

(+post-hypomethylating agent)

TEW-7197 MedPacto myelodysplastic syndromes Phase I/II

(TGF-beta antagonist) Suwon, South Korea www.medpacto.com

tinostamustine (EDO-S101) Mundipharma relapsed/refractory Phase I

(histone deacetylase inhibitor) Cambridge, United Kingdom hematologic malignancies www.mundipharma.com

tipifarnib Kura Oncology myelodysplastic syndromes Phase II

(farnesyltranstransferase inhibitor) San Diego, CA www.kuraoncology.com

tosedostat CTI BioPharma myelodysplastic syndromes Phase II

(aminopeptidases inhibitor) Seattle, WA www.ctibiopharma.com

TTI-621 Trillium Therapeutics hematologic malignancies Phase I

(CD47 inhibitors/SIRPA stimulant) Mississauga, Canada www.trilliumtherapeutics.com

UCART123 Cellectis blastic plasmacytoid Phase I

(CAR-T cell therapy) New York, NY dendritic cell neoplasm www.cellectis.com

vecabrutinib Sunesis Pharmaceuticals B-cell hematologic malignancies Phase I/II

(BTK inhibitor) South San Francisco, CA www.sunesis.com

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Hematologic MalignanciesProduct Name Sponsor Indication Development Phase

Venclexta™ AbbVie myelodysplastic syndromes, Phase II

venetoclax North Chicago, IL 1L myelodysplastic syndromes www.abbvie.com

ORPHAN DRUG Genentech (+azacitidine) www.gene.com

South San Francisco, CA

relapsed/refractory myelodysplastic Phase I

syndromes (+azacitidine) www.abbvie.com

www.gene.com

Vyxeos® Jazz Pharmaceuticals myelodysplastic syndromes Phase II

daunorubicin and cytarabine Dublin, Ireland www.jazzpharma.com

WT-2725 Sunovion Pharmaceuticals hematologic malignancies Phase I

(peptide cancer vaccine) Marlborough, MA www.sunovion.com

XmAb13676 Xencor B-cell hematologic malignancies Phase I

(CD20 x CD3bispecific mAb) Monrovia, CA www.xencor.com

zanubrutinib (BGB-3111) BeiGene Waldenström's macroglobulinemia Phase III

(BTK inhibitor) Cambridge, MA www.beigene.com

ORPHAN DRUG

relapsed/refractory B-cell malignancies Phase I

www.beigene.com

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Kidney CancerProduct Name Sponsor Indication Development Phase

abexinostat Xynomic Pharmaceuticals kidney cancer (+pazopanib) Phase III

(HDAC inhibitor) Cheyenne, WY www.xynomicpharma.com

AGS-16C3F Astellas renal cell carcinoma Phase II

(anti-ENPP3 antibody-drug conjugate) Northbrook, IL www.astellas.com

AM0010 ARMO Biosciences renal cell carcinoma (+PD-1) Phase I

(PEG-IL-10) Redwood City, CA www.armobio.com

Archexin® (RX-0201) Rexahn Pharmaceuticals metastatic renal cell carcinoma Phase II

Akt inhibitor Rockville, MD www.rexahn.com

ORPHAN DRUG

Bavencio® EMD Serono 1L renal cell carcinoma (+axitinib) Phase III

avelumab Rockland, MA (Breakthrough Therapy) www.emdserono.com

(anti-PD-L1 inhibitor) Pfizer www.pfizer.com

New York, NY

BMS-986205 Bristol-Myers Squibb advanced renal cell carcinoma Phase II

(IDO1 inhibitor) Princeton, NJ (+nivolumab +ipilimumab +relatlimab) www.bms.com

Cabometyx™ Exelixis 1L renal call carcinoma (+nivolumab) Phase III

cabozantinib South San Francisco, CA www.exelixis.com

1L or 2L papillary renal cell carcinoma Phase II

www.exelixis.com

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Kidney CancerProduct Name Sponsor Indication Development Phase

camptothecin (CRLX101) BlueLink Pharmaceuticals metastatic renal cell carcinoma Phase II completed

ORPHAN DRUG Ames, IA (Fast Track)

CB-839 Calithera Biosciences renal cell carcinoma Phase II

(glutaminase inhibitor) South San Francisco, CA (+cabozantinib) (Fast Track), www.calithera.com

renal cell carcinoma

(+everolimus) (Fast Track)

CDX-014 Celldex Therapeutics renal cell carcinoma Phase I

(TIM-1 antibody-drug conjugate) Hampton, NJ www.celldex.com

Cotellic® Genentech renal cell carcinoma (+atezolizumab) Phase I

cobimetinib South San Francisco, CA www.gene.com

HBI-8000 HUYA Bioscience renal cell carcinoma Phase I/II

(HDAC inhibitor) San Diego, CA www.huyabio.com

ilixadencel Immunicum renal cell carcinoma Phase II

(dendritic cell vaccine) Gothenburg, Sweden www.immunicum.com

Keytruda® Merck renal cell carcinoma Phase III

pembrolizumab Kenilworth, NJ www.merck.com

LAG525 Novartis Oncology renal cell carcinoma (+PDR-001) Phase I/II

(anti-LAG3 mAb) East Hanover, NJ www.novartis.com

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Kidney CancerProduct Name Sponsor Indication Development Phase

Lenvima® Eisai

lenvatinib Woodcliff Lake, NJ 1L renal cell carcinoma Phase III

www.eisai.com

Opdivo® Bristol-Myers Squibb 1L renal cell carcinoma (Fast Track) application submitted

nivolumab Princeton, NJ www.bms.com

PT2385 Peloton Therapeutics von Hippel-Landau disease Phase II

(HIF-1 alpha inhibitor) Dallas, TX associated renal cell carcinoma www.pelotontherapeutics.com

PT2977 Peloton Therapeutics von Hippel-Lindau disease Phase II

(HIF-2α inhibitor) Dallas, TX associated renal cell carcinoma www.pelotontherapeutics.com

rocapuldencel-T Argos Therapeutics 1L metastatic renal cell carcinoma Phase III

(personalised dendritic cell vaccine) Durham, NC (Fast Track) www.argostherapeutics.com

savolitinib AstraZeneca papillary renal cell carcinoma Phase III

(c-Met inhibitor) Wilmington, DE www.astrazeneca.com

Tecentriq® Genentech renal cell carcinoma (adjuvant), Phase III

atezolizumab South San Francisco, CA renal cell carcinoma (+bevacizumab) www.gene.com

tivozanib AVEO Oncology renal cell carcinoma Phase III

(VEGR antagonist) Cambridge, MA www.aveooncology.com

renal cell carcinoma (+nivolumab) Phase II

www.aveooncology.com

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Kidney CancerProduct Name Sponsor Indication Development Phase

TRC-105 TRACON Pharmaceuticals renal cell carcinoma (Fast Track) Phase II

(carotuximab) San Diego, CA www.traconpharma.com

varlilumab Celldex Therapeutics renal cell carcinoma (+nivolumab) Phase II

(anti-CD28 mAb) Hampton, NJ www.celldex.com

X4P-001-IO X4 Pharmaceuticals refractory clear cell renal cell Phase I/II

(CXCR4 inhibitor) Cambridge, MA carcinoma www.x4pharma.com

LeukemiaProduct Name Sponsor Indication Development Phase

ABBV-744 AbbVie relapsed/refractory acute myeloid Phase I

(BRD2/3/4 inhibitor) North Chicago, IL leukemia (AML) www.abbvie.com

abexinostat Xynomic Pharmaceuticals AML (+ibrutinib) Phase II

(HDAC inhibitor) Cheyenne, WY www.xynomicpharma.com

ABL001 (asciminib) Novartis Oncology 3L chronic myeloid leukemia (CML) Phase III

(BCR-ABL inhibitor) East Hanover, NJ www.novartis.com

1L CML Phase II

www.novartis.com

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LeukemiaProduct Name Sponsor Indication Development Phase

Actimab-A Actinium Pharmaceuticals newly-diagnosed AML in patients Phase II

lintuzumab Ac-225 New York, NY over age 60 www.actiniumpharma.com

ORPHAN DRUG

ADCT-301 (camidanlumab tesirine) ADC Therapeutics ALL, AML Phase I

(antibody-drug conjugate) Murray Hill, NJ www.adctherapeutics.com

ADCT-402 ADC Therapeutics B-cell ALL Phase I

(loncastuximab tesirine) Murray Hill, NJ www.adctherapeutics.com

AEB1102 Aeglea Biotherapeutics AML Phase I

(pegzilarginase) Austin, TX www.aegleabio.com

AG-881 Agios Pharmaceuticals AML Phase I

(pan-IDH inhibitor) Cambridge, MA www.celgene.com

Celgene

Summit, NJ

AGS62P1 Astellas AML Phase I

(anti-FLT3 antibody-drug conjugate) Northbrook, IL www.astellas.com

ALRN-6924 Aileron Therapeutics AML Phase I

(MDM2/MDMX antagonist) Cambridge, MA www.aileronrx.com

ORPHAN DRUG

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LeukemiaProduct Name Sponsor Indication Development Phase

alvocidib (DSP-2033) Tolero Pharmaceuticals MCL-1 dependent relapsed/refractory Phase II

(CDK9 inhibitor) Lehi, UT AML www.toleropharma.com

ORPHAN DRUG

newly-diagnosed AML Phase I

(combination therapy) www.toleropharma.com

AMG 176 Amgen relapsed/refractory AML Phase I

(MCL1 protein inhibitor) Thousand Oaks, CA www.amgen.com

AMG 330 Amgen relapsed/refractory AML Phase I

(anti-CD33 x anti-CD3 Thousand Oaks, CA www.amgen.com

bispecific T-cell engager)

AMG 673 Amgen relapsed/refractory AML Phase I

(anti-CD33 x anti-CD3 Thousand Oaks, CA www.amgen.com

bispecific T-cell engager)

AMV564 Amphivena Therapeutics relapsed/refractory AML Phase I

(anti-CD33 x anti-CD3 South San Francisco, CA www.amphivena.com

bispecific T-cell engager)

ORPHAN DRUG

annamycin liposomal Moleculin Biotech relapsed/refractory AML Phase I/II

(type II DNA topoisomerase inhibitor) Houston, TX www.moleculin.com

ORPHAN DRUG

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LeukemiaProduct Name Sponsor Indication Development Phase

anti-CD19 CAR-T cell therapy Intrexon leukemia Phase I

Germantown, MD www.intrexon.com

ZIOPHARM Oncology www.ziopharm.com

Boston, MA

anti-CD33 CAR-T cell therapy Intrexon AML Phase I

Germantown, MD www.ziopharm.com

ZIOPHARM Oncology

Boston, MA

AST-VAC1 Asterias Biotherapeutics AML Phase II

(telomerase-based cancer vaccine) Fremont, CA www.asteriasbiotherapeutics.com

ASTX727 Astex Pharmaceuticals chronic myelomonocytic leukemia Phase III

(DNMT inhibitor) Pleasanton, CA (CMML) www.astx.com

avapritinib Blueprint Medicines mast cell leukemia Phase I

(PDGFRa/KIT inhibitor) Cambridge, MA www.blueprintmedicines.com

ORPHAN DRUG

AVB-S6-500 Aravive Biologics AML Phase I

(GAS6-AXL pathway inhibitor) Houston, TX www.aravive.com

BAY1436032 Bayer Pharmaceuticals IDH1-mutant AML Phase I

(mutant-IDH1 inhibitor) Whippany, NJ www.pharma.bayer.com

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LeukemiaProduct Name Sponsor Indication Development Phase

bemcentinib (BGB324) BerGenBio AML Phase I/II

(AXL kinase inhibitor) Bergen, Norway www.bergenbio.com

BI 836826 Boehringer Ingelheim Pharmaceuticals CLL Phase I/II

(anti-CD37 mAb) Ridgefield, CT www.boehringer-ingelheim.com

BI 836858 Boehringer Ingelheim Pharmaceuticals AML Phase II

(anti-CD33 mAb) Ridgefield, CT www.boehringer-ingelheim.com

ORPHAN DRUG

BNZ-1 Bioniz T-cell leukemia (large granular Phase II

(IL-2/IL-9/IL-15 receptor antagonist) Irvine, CA leukemia, cutaneous T-cell leukemia) www.bioniz.com

BPX-501 Bellicum Pharmaceuticals ALL (pediatric), AML Phase I/II

(rivogenlecleucel) Houston, TX www.bellicum.com

BPX-701 Bellicum Pharmaceuticals AML Phase I

(T-cell receptor therapy) Houston, TX www.bellicum.com

calaspargase pegol (SHP-633) Shire ALL application submitted

(pegylated L-asparaginase) Cambridge, MA www.shire.com

ORPHAN DRUG

Calquence® Acerta Pharma 1L chronic lymphocytic leukemia (CLL), Phase III

acalabrutinib South San Francisco, CA relapsed/refractory high-risk CLL www.astrazeneca.com

AstraZeneca

Wilmington, DE

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LeukemiaProduct Name Sponsor Indication Development Phase

CC-122 (avadomide) Celgene CLL Phase I

(pleiotropic pathway modulator) Summit, NJ www.celgene.com

CC-486 Celgene post-induction AML (maintenance) Phase III

(oral azacitidine) Summit, NJ www.celgene.com

CC-90002 Celgene AML Phase I

(anti-CD47 antibody) Summit, NJ www.celgene.com

CC-90009 Celgene AML Phase I

(CELMoD) Summit, NJ www.celgene.com

CIK-CAR.CD19 Formula Pharmaceuticals relapsed or refractory ALL Phase I/II

(CIK-CAR-T cell therapy) Berwyn, PA www.formulapharma.com

cirmtuzumab Oncternal Therapeutics CLL Phase I/II

(ROR1 antagonist) San Diego, CA www.oncternal.com

CNDO-109 Fortress Biotech AML Phase I

(natural killer cell stimulant) New York, NY www.fortressbiotech.com

ORPHAN DRUG

cobomarsen miRagen Therapeutics CLL, T-cell lymphoma/leukemia Phase I

(microRNA inhibitor) Boulder, CO www.miragen.com

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LeukemiaProduct Name Sponsor Indication Development Phase

CPI-0610 Constellation Pharmaceuticals AML Phase I/II

(BET protein inhibitor) Cambridge, MA www.constellationpharma.com

CPI-613 Rafael Pharmaceuticals relapsed/refractory AML Phase III

(altered energy metabolism- Newark, NJ (combination therapy) www.rafaelpharma.com

derived medicine)

ORPHAN DRUG

crenolanib AROG Pharmaceuticals AML (Fast Track) Phase II

(tyrosine kinase inhibitor) Dallas, TX www.arogpharmaceuticals.com

ORPHAN DRUG

CTL119 Novartis Oncology B-cell prolymphocytic leukemia, Phase I

(anti-CD19 CAR-T cell therapy) East Hanover, NJ precursor cell lymphoblastic www.novartis.com

University of Pennsylvania leukemia-lymphoma

Philadelphia, PA

CX-01 Cantex Pharmaceuticals AML Phase II

(dociparstat sodium) Weston, FL www.cantex.com

ORPHAN DRUG

DCLL9718S (RG6109) Genentech AML Phase I

South San Francisco, CA www.gene.com

DFP-10917 Delta-Fly Pharma ALL, AML Phase I/II

(cell cycle inhibitor) Tokushima, Japan www.delta-flypharma.co.jp

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LeukemiaProduct Name Sponsor Indication Development Phase

DS-3201 Daiichi Sankyo ALL, AML Phase I

(EZH1/2 inhibitor) Basking Ridge, NJ www.dsi.com

DSP-7888 Sumitomo Dainippon Pharma relapsed/refractory AML Phase II

(adegramotide/nelatimotide) Osaka, Japan www.ds-pharma.com

DTRMWXHS 12 Zhejiang DTRM Biopharma CLL Phase I

(BTK inhibitor) Hangzhou, China

duvelisib Verastem relapsed/refractory CLL (Fast Track), application submitted

(PI3K delta/PI3K gamma inhibitor) Needham, MA relapsed/refractory small lymphocytic www.verastem.com

ORPHAN DRUG leukemia

relapsed/refractory CLL (post-BTK), Phase II

relapsed/refractory small lymphocytic www.verastem.com

(post-BTK)

entospletinib Gilead Sciences AML Phase II

(Syk inhibitor) Foster City, CA www.gilead.com

epratuzumab Immunomedics ALL (pediatric) Phase III

(anti-CD22 mAb) Morris Plains, NJ www.immunomedics.com

ORPHAN DRUG

eryaspase Erytech Pharma AML Phase II

(L-asparaginase ) Cambridge, MA www.erytech.com

ORPHAN DRUG

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LeukemiaProduct Name Sponsor Indication Development Phase

FATE-NK100 Fate Therapeutics AML Phase I

(natural killer cell stimulant) La Jolla, CA www.fatetherapeutics.com

FF-10101-01 FUJIFILM Pharmaceuticals U.S.A. AML Phase I

(FLT3 inhibitor) Cambridge, MA www.fujifilmusa.com

FF-10501-01 FUJIFILM Pharmaceuticals U.S.A. AML, CMML Phase I/II

(cell differentiation stimulant) Cambridge, MA www.fujifilmusa.com

ficlatuzumab AVEO Oncology AML Phase I

(HGF/c-Met inhibitor) Cambridge, MA www.aveooncology.com

flotetuzumab Macrogenics AML Phase I

(CD123 and CD3 bispecific antibody) Rockville, MD www.macrogenics.com

ORPHAN DRUG Servier

Paris, France

FT-2102 FORMA Therapeutics relapsed/refractory AML with Phase I

Watertown, MA IDH1-mutation www.formatherapeutics.com

galinpepimut-S Sellas Life Sciences AML (Fast Track) Phase II

(anti-WT1 peptide cancer vaccine) New York, NY www.sellaslifesciences.com

ORPHAN DRUG

CML, AML (+hypomethylating agent) Phase I

www.sellaslifesciences.com

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LeukemiaProduct Name Sponsor Indication Development Phase

gilteritinib Astellas relapsed/refractory AML with application submitted

(FLT3/AXL inhibitor) Northbrook, IL FLT3-mutation (Fast Track) www.astellas.com

ORPHAN DRUG

relapsed/refractory AML, Phase III

AML (post-chemotherapy maintenance), www.astellas.com

AML (post-HSCT maintenance)

newly-diagnosed AML Phase II/III

(low-intensity chemotherapy) www.astellas.com

newly-diagnosed AML Phase I

(high-intensity chemotherapy) www.astellas.com

glasdegib Pfizer AML Phase II

(SMO antagonist) New York, NY www.pfizer.com

ORHAN DRUG

GLG-801 GLG Pharma CLL Phase I/II

(STAT3 inhibitor) Jupiter, FL www.glgpharma.com

GMI-1271 GlycoMimetics AML (Fast Track) Phase II

(uproleselan sodium) Rockville, MD www.glycomimetics.com

ORPHAN DRUG

GO-203-2c Genus Oncology AML Phase II

(MUC1-C inhibitor) Boston, MA www.genusoncology.com

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LeukemiaProduct Name Sponsor Indication Development Phase

guadecitabine (SGI-110) Astex Pharmaceuticals AML, CMML Phase III

(DNMT1 inhibitor) Pleasanton, CA www.astx.com

ORPHAN DRUG

H3B-8800 Eisai AML, CMML Phase I

(SF3B1 protein modulator) Woodcliff Lake, NJ www.eisai.com

ORPHAN DRUG H3 Biomedicine

Cambridge, MA

HSV-Tk MolMed high risk acute leukemia Phase III

(nalotimagene carmaleucel)  Milan, Italy www.molmed.com

ORPHAN DRUG

Hu5F9-G4 Forty Seven AML, AML (+azacitidine) Phase I

(CD47 antigen inhibitor mAb) Menlo Park, CA www.fortyseveninc.com

iC9/CAR.19/IL15-transduced CB-NK cells Bellicum Pharmaceuticals ALL, CLL Phase I/II

Houston, TX www.bellicum.com

M.D. Anderson Cancer Center

Houston, TX

idasanutlin (RG7388) Roche/Genentech AML (+chemotherapy) Phase III

(MDM2 antagonist) South San Francisco, CA www.gene.com

Idhifa® Agios Pharmaceuticals newly-diagnosed AML with Phase I

enasidenib Cambridge, MA IDH2-mutation www.celgene.com

Celgene

Summit, NJ

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LeukemiaProduct Name Sponsor Indication Development Phase

IGF-MTX IGF Oncology CMML Phase I/II

(IGF-methotrexate conjugate) St. Paul, MN www.igfoncology.com

Imbruvica® Janssen Research & Development 1L CLL Phase III

ibrutinib Raritan, NJ www.janssen.com

Pharmacyclics www.pharmacyclics.com

Sunnyvale, CA

Imfinzi® Celgene AML Phase II

durvalumab Summit, NJ www.celgene.com

MedImmune

Gaithersburg, MD

IMG-7289 Imago BioSciences  AML Phase II

(LSD1 inhibitor) San Carlos, CA www.imagobio.com

IMGN779 ImmunoGen AML Phase I

(anti-CD33 antibody-drug conjugate) Waltham, MA www.immunogen.com

INCB59872 Incyte AML Phase I/II

(LSD1 inhibitor) Wilmington, DE www.incyte.com

indoximod NewLink Genetics newly-diagnosed AML Phase I

(IDO inhibitor) Ames, IA www.newlinkgenetics.com

inecalcitol Hybrigenics AML Phase II

(calcitriol receptor agonist) Paris, France www.hybrigenics.com

ORPHAN DRUG

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LeukemiaProduct Name Sponsor Indication Development Phase

Iomab-B CD45 Actinium Pharmaceuticals induction and conditioning agent Phase III

(I-131-apamistamab) New York, NY prior to a bone marrow transplant www.actiniumpharma.com

ORPHAN DRUG for AML in patients over age 56

ivosidenib Agios Pharmaceuticals AML application submitted

(IDH1 inhibitor) Cambridge, MA www.agios.com

ORPHAN DRUG

JNJ-63709178 Janssen Research & Development relapsed/refractory AML Phase I

(CD123 x CD3 DuoBody® protein) Raritan, NJ www.janssen.com

KTE-C19 CAR-T cell therapy Kite Pharma ALL (pediatric and adult) Phase I

(second generation anti-CD19) Santa Monica, CA www.kitepharma.com

Kymriah™ Novartis Oncology ALL (pediatric/young adult) application submitted

tisagenlecleucel-T East Hanover, NJ www.novartis.com

(anti-CD19 CAT-T cell therapy)

CLL Phase III

www.novartis.com

LAM-003 LAM Therapeutics AML Phase I

(immunmodulator) Guilford, CT www.lamtherapeutics.com

lenzilumab Humanigen CMML Phase I

(anti-GM-CSF mAb) Brisbane, CA www.humanigen.com

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LeukemiaProduct Name Sponsor Indication Development Phase

LY3039478 Eli Lilly T-cell ALL (combination therapy) Phase I/II

(NOTCH inhibitor) Indianapolis, IN www.lilly.com

MB-102 Mustang Bio AML Phase I

(CAR-T cell therapy) New York, NY www.mustangbio.com

ME-401 MEI Pharma CLL Phase I

(PI3K delta inhibitor) San Diego, CA www.meipharma.com

mivebresib (ABBV-075) AbbVie AML Phase I

(BET inhibitor) North Chicago, IL www.abbvie.com

monalizumab Innate Pharma CLL (combination therapy) Phase I/II

(NKG2A checkpoint receptor Marseille, France www.innate-pharma.com

antagonist)

MOR-208 (XmAb5574) MorphoSys B-cell CLL, CLL Phase II

(B-cell inhibitor mAb) Planegg, Germany www.morphosys.com

ORPHAN DRUG

moxetumomab pasudotox MedImmune hairy cell leukemia application submitted

(CD22 antigen inhibitor) Gaithersburg, MD www.medimmune.com

ORPHAN DRUG

3L hairy cell leukemia Phase III

www.medimmune.com

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LeukemiaProduct Name Sponsor Indication Development Phase

MT-3724 Molecular Templates B-cell CLL Phase I

(engineered toxin bodies [ETB] Austin, TX www.mtem.com

targeting CD20)

ONC201 Oncoceutics leukemia Phase I/II

(dopamine receptor D2/3 antagonist) Philadelphia, PA www.oncoceutics.com

ONO-7475 Ono Pharmaceutical AML Phase I

(Axl/Mer inhibitor) Osaka, Japan www.ono.co.jp

Opdivo® Bristol-Myers Squibb CML Phase I

nivolumab Princeton, NJ www.bms.com

otlertuzumab Aptevo Therapeutics CLL (combination therapy) Phase II

(CD37 protein inhibitor) Seattle, WA www.aptevotherapeutics.com

ORPHAN DRUG

OTS-167 OncoTherapy Science ALL, refractory/relapsed AML, Phase I/II

(MELK inhibitor) Kanagawa, China advanced CML www.oncotherapy.co.jp

OXi4503 Mateon Therapeutics AML (+cytarabine) (Fast Track) Phase I/II

(combretastatin A1 phosphate) South San Francisco, CA www.mateon.com

ORPHAN DRUG

OXS-1550 GT Biopharma relapsed/refractory B-lineage leukemia Phase I/II

(bispecific scFv recombinant Washington, DC www.gtbiopharma.com

fusion protein-drug conjugate)

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LeukemiaProduct Name Sponsor Indication Development Phase

PCM-075 TrovaGene AML Phase II

(PLK1 inhibitor) San Diego, CA www.trovagene.com

ORPHAN DRUG

pegargiminase Polaris Pharmaceuticals AML (+low-dose cytarabine) Phase I

(ADI-PEG-20) San Diego, CA www.polarispharma.com

pinometostat Epizyme MLL-R (rearranged) ALL, MLL-R AML Phase I

(DOT1L protein inhibitor) Cambridge, MA www.epizyme.com

ORPHAN DRUG

pracinostat MEI Pharma AML (+azacitidine) Phase III

(hydroxamic inhibitor) San Diego, CA www.meipharma.com

ORPHAN DRUG

prexigebersen Bio-Path Holdings AML, CML Phase II

(antisense cancer therapy) Houston, TX www.biopathholdings.com

ORPHAN DRUG

PTX-200 Prescient Therapeutics relapsed/refractory AML Phase I

(Akt inhibitor) South Melbourne, Australia www.ptxtherapeutics.com

quizartinib Daiichi Sankyo 1L/2L AML (Fast Track) Phase III

(FLT3 inhibitor) Basking Ridge, NJ www.dsi.com

ORPHAN DRUG

REGN1979 Regeneron Pharmaceuticals CLL Phase I

(anti-CD20/CD3 bispecific mAb)  Tarrytown, NY www.regeneron.com

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LeukemiaProduct Name Sponsor Indication Development Phase

rituximab biosimilar Allergan CLL Phase III

(ABP 798) Parsippany, NJ www.amgen.com

Amgen

Thousand Oaks, CA

rituximab biosimilar Celltrion CLL application submitted

Incheon, South Korea www.celltrion.com

rituximab biosimilar Sandoz CLL application submitted

(GP2013) Princeton, NJ www.sandoz.com

Rydapt® Novartis Oncology FLT3 wild type AML Phase III

midostaurin East Hanover, NJ www.novartis.com

sapacitabine Cyclacel Pharmaceuticals AML Phase III

(nucleoside analogue) Berkeley Heights, NJ www.cyclacel.com

ORPHAN DRUG

SEL24 Selvita AML Phase I/II

(PIM/FLT3 inhibitor) Krakow, Poland www.selvita.com

SGN-CD123A Seattle Genetics relapsed/refractory AML Phase I

(anti-CD123 antibody-drug conjugate) Bothell, WA www.seattlegenetics.com

SL-401 Stemline Therapeutics AML Phase I/II

(recombinant fusion protein) New York, NY www.stemline.com

ORPHAN DRUG

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LeukemiaProduct Name Sponsor Indication Development Phase

SNX-5422 Esanex CLL (+ibrutinib) Phase I

(Hsp90 inhibitor) Indianapolis, IN www.esanexpharma.com

Sprycel® Bristol-Myers Squibb CML (+nivolumab) Phase I

dasatinib Princeton, NJ www.bms.com

SUN-K0706 Sun Pharma Advanced Research CML Phase I

(tyrosine kinase inhibitor) Mumbai, India www.sparc.life

SY-1425 Syros Pharmaceuticals 1L AML (+ azacitidine), relapsed/ Phase I

(RAR-alpha agonist) Cambridge, MA refractory AML (+ daratumumab) www.syros.com

ORPHAN DRUG

Tecentriq® Genentech AML (+guadecitabine) Phase I

atezolizumab South San Francisco, CA www.gene.com

tipifarnib Kura Oncology CMML Phase II

(farnesyltranstransferase inhibitor) San Diego, CA www.kuraoncology.com

tosedostat CTI BioPharma AML Phase II

(aminopeptidases inhibitor) Seattle, WA www.ctibiopharma.com

ORPHAN DRUG

TPA Rich Pharmaceuticals AML Phase II

(tetradecanoylphorbol acetate) Beverly Hills, CA www.richpharmaceuticals.com

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LeukemiaProduct Name Sponsor Indication Development Phase

ublituximab (TG-1101) TG Therapeutics high-risk CLL Phase III

(anti-CD20 mAb) New York, NY www.tgtherapeutics.com

ORPHAN DRUG

ublituximab + umbralisib TG Therapeutics CLL Phase III

(anti-CD20 mAb.PI3K inhibitor) New York, NY www.tgtherapeutics.com

UCART123 Cellectis AML Phase I

(CAR-T cell therapy) New York, NY www.cellectis.com

UCART19 Allogene Therapeutics B-cell ALL Phase I

(CAR-T cell therapy) South San Francisco, CA www.allogene.com

Servier

Paris, France

ulocuplumab Bristol-Myers Squibb newly-diagnosed AML Phase I/II

(anti-CXCR4 mAb) Princeton, NJ www.bms.com

umbralisib (TGR-1202) TG Therapeutics relapsed/refractory CLL Phase II

(PI3K inhibitor) New York, NY www.tgtherapeutics.com

ORPHAN DRUG

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LeukemiaProduct Name Sponsor Indication Development Phase

Venclexta™ AbbVie 1L CLL application submitted

venetoclax North Chicago, IL www.abbvie.com

ORPHAN DRUG Genentech www.gene.com

South San Francisco, CA

AML, relapsed/refractory CLL Phase III

www.abbvie.com

www.gene.com

AML (+ cobimetinib/idasanutlin) Phase I

www.abbvie.com

www.gene.com

vosaroxin Sunesis Pharmaceuticals AML (Fast Track) Phase II

(quinolone derivative) South San Francisco, CA www.sunesis.com

ORPHAN DRUG

XmAb14045 Xencor AML Phase I

(CD123 x CD3 bispecific mAb) Monrovia, CA www.xencor.com

zanubrutinib (BGB-3111) BeiGene 1L CLL Phase III

(BTK inhibitor) Cambridge, MA www.beigene.com

ORPHAN DRUG

Zydelig® Gilead Sciences relapsed/refractory CLL Phase III

idelalisib Foster City, CA www.gilead.com

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Liver CancerProduct Name Sponsor Indication Development Phase

ABC294640 (Yeliva®) RedHill Biopharma advanced hepatocellular carcinoma, Phase II

(sphingosine kinase-2 inhibitor) Raleigh, NC cholangiocarcinoma www.redhillbio.com

ORPHAN DRUG

Ad-p53 MultiVir liver metastases Phase I

(gene therapy) Houston, TX www.multivir.com

AFP TCR Adaptimmune hepatocellular carcinoma Phase I

(alpha fetoprotein targeted Philadelphia, PA www.adaptimmune.com

T-cell therapy)

amcasertib (BBI503) Boston Biomedical hepatocellular carcinoma Phase I/II

(cancer cel [stemness] inhibitor) Cambridge, MA (combination therapy) www.bostonbiomedical.com

anti-CEA CAR-T cell therapy Sorrento Therapeutics metastatic liver cancer Phase I

San Diego, CA www.sorrentotherapeutics.com

BLU-554 Blueprint Medicines advanced hepatocellular carcinoma Phase I

(FGFR4 kinase inhibitor) Cambridge, MA www.blueprintmedicines.com

ORPHAN DRUG

BMS-986183 Bristol-Myers Squibb hepatocellular carcinoma Phase I/II

Princeton, NJ www.bms.com

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Liver CancerProduct Name Sponsor Indication Development Phase

Cabometyx™ Exelixis 2L and later-line advanced application submitted

cabozantinib South San Francisco, CA hepatocellular carcinoma www.exelixis.com

ORPHAN DRUG

1L and previously treated advanced Phase I/II

hepatocellular carcinoma www.exelixis.com

(+nivolumab +/-ipilimumab)

capmatinib (INC280) Novartis Oncology hepatocellular carcinoma Phase I/II

(c-Met inhibitor) East Hanover, NJ www.novartis.com

Incyte

Wilmington, DE

Cavatak® Viralytics uveal melanoma metastatic Phase I

coxsackievirus Sydney, Australia to the liver (+ipilimumab) www.viralytics.com

CC-122 (avadomide) Celgene hepatocellular carcinoma Phase I

(pleiotropic pathway modulator) Summit, NJ www.celgene.com

codrituzumab (RG7686) Roche/Genentech hepatocellular carcinoma Phase II

(glypican 3 inhibitor) South San Francisco, CA www.roche.com

Cyramza® Eli Lilly hepatocellular carcinoma Phase III

ramucirumab Indianapolis, IN www.lilly.com

ORPHAN DRUG

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Liver CancerProduct Name Sponsor Indication Development Phase

derazantinib (ARQ 087) ArQule intrahepatic cholangiocarcinoma Phase III

(FGFR antagonist) Burlington, MA www.arqule.com

ORPHAN DRUG Basilea Pharmaceutica

Basel, Switzerland

DKN-01 Leap Therapeutics biliary tract cancer Phase I/II

(anti-DKK1 mAb) Cambridge, MA (combination therapy) www.leaptx.com

eFT508 eFFECTOR Therapeutics hepatocellular carcinoma Phase II

(MKNK1/MKNK2 protein inhibitor) San Diego, CA www.effector.com

ENMD-2076 CASI Pharmaceuticals fibrolamellar liver cancer Phase II

(mulitple kinase inhibitor) Rockville, MD www.casipharmaceuticals.com

ORPHAN DRUG

FGF401 Novartis Oncology hepatocellular carcinoma Phase I/II

(FGFR4 antagonist) East Hanover, NJ www.novartis.com

galunisertib Eli Lilly recurrent/refractory hepatocellular Phase I/II

(TGF-beta 1 inhibitor) Indianapolis, IN carcinoma (+nivolumab) www.lilly.com

H3B-6527 Eisai advanced hepatocellular carcinoma Phase I

(FGFR4 inhibitor) Woodcliff Lake, NJ www.h3biomedicine.com

ORPHAN DRUG H3 Biomedicine

Cambridge, MA

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Liver CancerProduct Name Sponsor Indication Development Phase

Imfinzi® MedImmune 1L hepatocellular carcinoma Phase III

durvalumab Gaithersburg, MD (+tremelimumab) www.medimmune.com

biliary tract cancer (+tremelimumab) Phase II

www.medimmune.com

Imlygic® Amgen hepatocellular carcinoma Phase I

talimogene laherparepvec Thousand Oaks, CA (+pembrolizumab) www.amgen.com

(oncolytic virus therapy)

INCB54828 Incyte cholangiocarcinoma Phase II

(FGFR1/2/3 inhibitor) Wilmington, DE www.incyte.com

INCB62079 Incyte liver cancer Phase I/II

(FGFR4 inhibitor) Wilmington, DE www.incyte.com

infigratinib (BGJ398) QED Therapeutics chemo-refractory cholangiocarcinoma Phase II

(FGFR inhibitor) Palo Alto, CA with FGFR-fusions www.qedtx.com

ivosidenib Agios Pharmaceuticals cholangiocarcinoma (Fast Track) Phase III

(IDH1 inhibitor) Cambridge, MA www.agios.com

ORPHAN DRUG

Keytruda® Merck hepatocellular carcinoma Phase III

pembrolizumab Kenilworth, NJ www.merck.com

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Liver CancerProduct Name Sponsor Indication Development Phase

Lenvima® Eisai hepatocellular carcinoma application submitted

lenvatinib Woodcliff Lake, NJ www.eisai.com

ORPHAN DRUG

hepatocellular (+pembrolizumab) Phase I

www.eisai.com

melphalan drug delivery system Delcath Systems hepatic-dominant ocular melanoma Phase III

ORPHAN DRUG New York, NY (liver metastases) (Fast Track), www.delcath.com

intrahepatic cholangiocarcinoma

merestinib Eli Lilly biliary tract cancer Phase II

(type II multikinase inhibitor) Indianapolis, IN www.lilly.com

namodenoson (CF102) Can-Fite BioPharma hepatocellular carcinoma (Fast Track) Phase II

(A3AR agonist) Petah-Tikva, Israel www.canfite.com

ORPHAN DRUG

napabucasin Boston Biomedical hepatocellular carcinoma (+sorafenib) Phase I/II

(STAT3 inhibitor) Cambridge, MA www.bostonbiomedical.com

NC-6004 NanoCarrier biliary tract liver (+gemcitabine) Phase II

(cisplatin micellar nanoparticle) Chiba, Japan www.nanocarrier.co.jp

ORPHAN DRUG

pegargiminase Polaris Pharmaceuticals hepatocellular carcinoma (+FOLFOX) Phase I/II

(ADI-PEG-20) San Diego, CA www.polarispharma.com

ORPHAN DRUG

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Liver CancerProduct Name Sponsor Indication Development Phase

pexastimogene devacirepvec (Pexa-Vec) SillaJen Biotherapeutics hepatocellular carcinoma Phase III

(genetically-engineered Busan, South Korea www.sillajen.com

oncolytic vaccinia poxvirus)

ORPHAN DRUG

PV-10 Provectus Biopharmaceuticals cancer metastatic to the liver Phase I

(rose bengal sodium) Knoxville, TN www.provectusbio.com

ORPHAN DRUG

SF1126 SignalRx Pharmaceuticals hepatocellular carcinoma Phase I

(PI3K/mTOR inhibitor) San Diego, CA www.signalrx.com

silmitasertib (CX-4945) Senhwa Biosciences cholangiocarcinoma Phase I/II

(casein kinase II inhibitor) New Taipei City, Taiwan (combination therapy) www.senhwabiosciences.com

ORPHAN DRUG

Tecentriq® Genentech 1L hepatocellular carcinoma Phase III

atezolizumab South San Francisco, CA (+bevacizumab) www.gene.com

hepatocellular carcinoma Phase I

(+bevacizumab +chemotherapy) www.gene.com

tepotinib EMD Serono hepatocellular carcinoma Phase II

(c-Met kinase inhibitor) Rockland, MA www.emdserono.com

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Liver CancerProduct Name Sponsor Indication Development Phase

ThermoDox® Celsion hepatocellular carcinoma (Fast Track) Phase III

doxorubicin liposomal Lawrenceville, NJ www.celsion.com

ORPHAN DRUG

tirapazamine (TPZ) Teclison hepatocellular carcinoma Phase II

(type II DNA topoisomerase inhibitor) Taipei, Taiwan www.teclison.com

tislelizumab (BGB-A317) BeiGene USA hepatocellular carcinoma Phase III

(anti-PD-1 mAb) Cambridge, MA www.beigene.com

Celgene www.celgene.com

Summit, NJ

TRC-105 TRACON Pharmaceuticals hepatocellular carcinoma Phase II

(carotuximab) San Diego, CA www.traconpharma.com

varlitinib ASLAN Pharmaceuticals metastatic biliary tract cancer Phase II/III

(pan-HER inhibitor) Singapore www.aslanpharma.com

ORPHAN DRUG

VT-122 Vicus Therapeutics hepatocellular carcinoma Phase II

(propranolol/etodolac combination) Morristown, NJ www.vicusrx.com

Lung CancerProduct Name Sponsor Indication Development Phase

AC0010 ACEA Biosciences mutant-EGFR non-small cell Phase I

(EGFR inhibitor) San Diego, CA lung cancer (NSCLC) www.aceabio.com

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Lung CancerProduct Name Sponsor Indication Development Phase

ADXS-NEO Advaxis metastatic NSCLC Phase I

(neoepitope-based Princeton, NJ www.advaxis.com

immunotherapy vaccine) Amgen

Thousand Oaks, CA

AEB1102 Aeglea Biotherapeutics SCLC (+pembrolizumab) Phase I/II

(pegzilarginase) Austin, TX www.aegleabio.com

AGEN1884 Agenus NSCLC (+pembrolizumab) Phase II

(CTLA-4 antagonist) Lexington, MA www.agenus.com

aglatimagene besadenovec Advantagene NSCLC (combination therapy) Phase I

(gene therapy) Auburndale, MA www.advantagene.com

aldoxorubicin CytRx 2L small cell lung cancer (SCLC) Phase II

ORPHAN DRUG Los Angeles, CA www.cytrx.com

NantKwest

Culver City, CA

ALT-803 Altor BioScience NSCLC (combination therapy) Phase II

(IL-15 superagonist protein complex) Miramar, FL www.altorbioscience.com

NantKwest

Culver City, CA

Alunbrig® Takeda 1L ALK-positive NSCLC Phase III

brigatinib Northbrook, IL www.takeda.com

ORPHAN DRUG

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Lung CancerProduct Name Sponsor Indication Development Phase

AM0010 ARMO Biosciences NSCLC (+PD-1) Phase I

(PEG-IL-10) Redwood City, CA www.armobio.com

amatuximab (MORAb-009) Eisai mesothelioma Phase II

(IgG1 mAb) Woodcliff Lake, NJ www.eisai.com

ORPHAN DRUG

AMG 757 Amgen SCLC Phase I

bispecific T-cell engager) Thousand Oaks, CA www.amgen.com

anetumab ravtansine Bayer Pharmaceuticals 2L malignant pleural mesothelioma Phase II

(antibody-drug conjugate) Whippany, NJ www.pharma.bayer.com

ORPHAN DRUG

antroquinonol Golden Biotechnology NSCLC Phase II

ORPHAN DRUG New Taipei City, Taiwan www.goldenbiotech.com

APG-1252 Ascentage Pharma SCLC Phase I

(Bcl-2/Bcl-xl inhibitor) Rockville, MD en.ascentagepharma.com

APX005M Apexigen NSCLC (+nivolumab) Phase I/II

(CD40 agonistic antibody) San Carlos, CA www.apexigen.com

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Lung CancerProduct Name Sponsor Indication Development Phase

Bavencio® EMD Serono 1L NSCLC, 2L NSCLC Phase III

avelumab Rockland, MA www.emdserono.com

(anti-PD-L1 inhibitor) Pfizer www.pfizer.com

New York, NY

NSCLC (+4-1BB), SCLC (+4-1BB) Phase II

www.emdserono.com

www.pfizer.com

bemcentinib (BGB324) BerGenBio NSCLC (+pembrolizumab) Phase II

(AXL kinase inhibitor) Bergen, Norway www.bergenbio.com

NSCLC Phase I/II

www.bergenbio.com

bevacizumab biosimilar Boehringer Ingelheim Pharmaceuticals NSCLC Phase III

(BI 695502) Ridgefield, CT www.boehringer-ingelheim.com

bevacizumab biosimilar Pfizer NSCLC Phase III

(PF-06439536) New York, NY www.pfizer.com

BI 1361849 (CV-9202) Boehringer Ingelheim Pharmaceuticals NSCLC Phase II

(RNA cancer vaccine) Ridgefield, CT www.boehringer-ingelheim.com

BIO-11006 BioMarck Pharmaceuticals NSCLC Phase II

(MARCKS inhibitor) Durham, NC www.biomarck.com

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Lung CancerProduct Name Sponsor Indication Development Phase

BLU-667 Blueprint Medicines NSCLC Phase I

(RET inhibitor) Cambridge, MA www.blueprintmedicines.com

BMS-986012 Bristol-Myers Squibb SCLC Phase I/II

(anti-fucosyl-GM1 mAb) Princeton, NJ www.bms.com

BMS-986205 Bristol-Myers Squibb advanced NSCLC Phase II

(IDO1 inhibitor) Princeton, NJ (immunotherapy combinations) www.bms.com

Cabometyx™ Exelixis EGFR wild type NSCLC Phase II

cabozantinib South San Francisco, CA www.exelixis.com

NSCLC (+atezolizumab) Phase I

www.exelixis.com

camptothecin (CRLX101) BlueLink Pharmaceuticals NSCLC Phase II completed

ORPHAN DRUG Ames, IA

canakinumab Novartis Oncology 1L NSCLC, 2L NSCLC, NSCLC (adjuvant) Phase III

East Hanover, NJ www.novartis.com

capmatinib (INC280) Novartis Oncology NSCLC Phase III

(c-Met inhibitor) East Hanover, NJ www.novartis.com

Incyte

Wilmington, DE

EGFR-mutated NSCLC Phase II

www.novartis.com

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Lung CancerProduct Name Sponsor Indication Development Phase

Cavatak® Viralytics NSCLC (+pembrolizumab) Phase I

coxsackievirus Sydney, Australia www.viralytics.com

CD40LGVAX  Cellular Biomedicine advanced NSCLC Phase II

Cupertino, CA www.cellbiomedgroup.com

cemiplimab Regeneron Pharmaceuticals 1L NSCLC Phase III

(anti-PD-1 mAb) Tarrytown, NY www.sanofi.com

Sanofi

Bridgewater, NJ

CK-101 Checkpoint Therapeutics NSCLC Phase I/II

(EGFR inhibitor) New York, NY www.checkpointtx.com

ORPHAN DRUG

CMP-001 Checkmate Pharmaceuticals NSCLC (+atezolizumab) Phase I

(TLR9 agonist cancer vaccine) Cambridge, MA www.checkmatepharma.com

CV-301 Bavarian Nordic NSCLC (+ anti-PD-1) Phase II

(CEA-MUC-1-TRICOM cancer vaccine) Morrisville, NC www.bavarian-nordic.com

Cyramza® Eli Lilly NSCLC Phase III

ramucirumab Indianapolis, IN www.lilly.com

dacomitinib Pfizer 1L EGFR-activating mutant NSCLC application submitted

(pan-HER inhibitor) New York, NY www.pfizer.com

ORPHAN DRUG

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Lung CancerProduct Name Sponsor Indication Development Phase

defactinib Verastem NSCLC (+pembrolizumab) Phase II

(FAK inhibitor) Needham, MA www.verastem.com

ORPHAN DRUG

mesothelioma (+pembrolizumab) Phase I

www.verastem.com

DKN-01 Leap Therapeutics NSCLC Phase I

(anti-DKK1 mAb) Cambridge, MA www.leaptx.com

DPV-001 UbiVac NSCLC (adjuvant therapy) Phase II

(autophagosome-enriched vaccine) Portland, OR www.ubivac.com

DS-1062 Daiichi Sankyo NSCLC Phase I

(anti-TROP2 antibody-drug conjugate) Basking Ridge, NJ www.dsi.com

DS-1205 Daiichi Sankyo EGFR-mutant NSCLC Phase I

(AXL inhibitor) Parsippany, NJ www.dsi.com

DV281 Dynavax NSCLC Phase I

(TLT9 agonist) Berkeley, CA www.dynavax.com

ensartinib Xcovery ALK-positive NSCLC Phase III

(ALK inhibitor) Palm Beach Gardens, FL www.xcovery.com

entinostat Syndax Pharmaceuticals NSCLC (+pembrolizumab) Phase II

(HDAC inhibitor) Waltham, MA www.syndax.com

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Lung CancerProduct Name Sponsor Indication Development Phase

entrectinib Ignyta ROS1-positive NSCLC Phase II

(panTRK/ROS1 inhibitor) San Diego, CA www.ignta.com

ORPHAN DRUG

epacadostat Incyte NSCLC (+pembrolizumab) Phase III

(IDO1 inhibitor) Wilmington, DE www.incyte.com

lung cancer Phase I

www.incyte.com

G1T38 G1 Therapeutics EGFR metastatic NSCLC Phase II

(CDK4/6 inhibitor) Research Tringle Park, NC www.g1therapeutics.com

galinpepimut-S Sellas Life Sciences malignant pleural mesothelioma Phase II

(anti-WT1 peptide cancer vaccine) New York, NY (Fast Track) www.sellaslifesciences.com

ORPHAN DRUG

galunisertib Eli Lilly recurrent/refractory NSCLC Phase I/II

(TGF-beta 1 inhibitor) Indianapolis, IN (+nivolumab) www.lilly.com

Gilotrif® Boehringer Ingelheim Pharmaceuticals squamous cell of the lung Phase II

afatinib Ridgefield, CT (+pembrolizumab) www.boehringer-ingelheim.com

glesatinib (MGCD265) Mirati Therapeutics NSCLC Phase II

(multi-kinase inhibitor) San Diego, CA www.mirati.com

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Lung CancerProduct Name Sponsor Indication Development Phase

GRN-1201 BrightPath Biotherapeutics NSCLC (+checkpoint inhibitor) Phase II

(cancer peptide vaccine) Tokyo, Japan www.nrightpathbio.com

GSK3377794 GlaxoSmithKline NSCLC Phase II

(NY-ESO-autologous engineered Research Triangle Park, NC www.gsk.com

T-cell receptor therapy)

HBI-8000 HUYA Bioscience NSCLC Phase I/II

(HDAC inhibitor) San Diego, CA www.huyabio.com

HS-10296 Jiangsu Hansoh Pharmaceutical NSCLC Phase I/II

Jiangsi, China www.hansoh.cn

IMA201 Immatics US squamous cell NSCLC Phase I

(adoptive T-cell therapy) Houston, TX www.immatics.com

Imfinzi® MedImmune 1L NSCLC (+tremelimumab), Phase III

durvalumab Gaithersburg, MD 1L NSCLC (+tremelimumab +chemo), www.medimmune.com

stage III NSCLC (monotherapy),

1L SCLC (+tremelimumab +SoC)

NSCLC (+RT), SCLC (+RT), Phase I

1L SCLC (+tremelimumab +chemo) www.medimmune.com

NSCLC (+gefitinib)

Imprime PGG® Biothera Pharmaceuticals NSCLC (+pembrolizumab) Phase I/II

immunostimulant PGG glucan Eagan, MN www.biothera.com

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Lung CancerProduct Name Sponsor Indication Development Phase

INCB59872 Incyte SCLC Phase I/II

(LSD1 inhibitor) Wilmington, DE www.incyte.com

IPI-549 Infinity Pharmaceuticals mesothelioma (+nivolumab), Phase I

(PI3K-gamma inhibitor) Cambridge, MA NSCLC (+nivolumab) www.infi.com

IRX4204 Io Therapeutics NSCLC Phase II

(RXR agonist) Santa Ana, CA www.io-therapeutics.com

itacitinib Incyte NSCLC (+ osimertinib) Phase II

(JAK1 inhibitor) Wilmington, DE www.incyte.com

JNJ-61186372 Janssen Research & Development NSCLC Phase I

(EGFR/c-Met DuoBody® protein) Raritan, NJ www.janssen.com

JNJ-64041757 (ADU-214) Aduro Biotech adenocarcinoma of the lung Phase I/II

(Listeria monocytogenes Berkeley, CA www.aduro.com

immunotherapy vaccine) Janssen Research & Development www.janssen.com

Raritan, NJ

Keytruda® Merck SCLC Phase III

pembrolizumab Kenilworth, NJ www.merck.com

Kyprolis® Amgen SCLC Phase I/II

carfilzomib Thousand Oaks, CA www.amgen.com

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Lung CancerProduct Name Sponsor Indication Development Phase

LAG525 Novartis Oncology NSCLC (+PDR001) Phase I/II

(anti-LAG3 mAb) East Hanover, NJ www.novartis.com

L-DOS47 Helix BioPharma recurrent or metastatic squamous Phase II

(tumor defense breaker) Toronto, Canada NSCLC www.helixbiopharma.com

Lenvima® Eisai NSCLC (RET translocations) Phase II

lenvatinib Woodcliff Lake, NJ www.eisai.com

LMB-100 Selecta Biosciences mesothelioma Phase I

(recombinant immunotoxin) Watertown, MA www.selectabio.com

LN-145 Iovance Biotherapeutics NSCLC (+/-durvalumab) Phase II

(tumor-infiltrating lymphocyte) San Carlos, CA www.iovance.com

lorlatinib (PF-06463922) Pfizer 1L ALK NSCLC Phase III

(ALK inhibitor) New York, NY www.pfizer.com

ORPHAN DRUG

2L ALK NSCLC (Breakthrough Therapy) Phase II

www.pfizer.com

lurbinectedin (PM1183) PharmaMar 2L SCLC Phase III

(RNA polymerase II inhibitor) Madrid, Spain www.pharmamar.com

LXH254 Novartis Oncology NSCLC (+LTT462), Phase I

(Raf kinase inhibitor) East Hanover, NJ NSCLC (+trametinib) www.novartis.com

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Lung CancerProduct Name Sponsor Indication Development Phase

LYC-55716 Lycera NSCLC Phase I

(ROR-gamma agonist) Ann Arbor, MI www.lycera.com

MABp1 XBiotech NSCLC Phase II

Austin, TX www.xbiotech.com

MAGE-A10 TCR Adaptimmune NSCLC Phase I/II

(T-cell receptor therapy) Philadelphia, PA www.adaptimmune.com

MM-121 (seribantumab) Merrimack Pharmaceuticals NSCLC (Fast Track) Phase II

(anti-HER3 mAb) Cambridge, MA www.merrimack.com

ORPHAN DRUG

mocetinostat Mirati Therapeutics NSCLC (+durvalumab), Phase II

(HDAC inhibitor) San Diego, CA NSCLC (+pembrolizumab www.mirati.com

+guadecitabine)

MORAb-009 Eisai mesothelioma Phase II

Woodcliff Lake, NJ www.eisai.com

MP0250 Molecular Partners EGFR-mutated NSCLC (+osimertinib) Phase I/II

(angiogenesis / VEGF-A / HGF inhibitor) Zurich, Switzerland www.molecularpartners.com

MV-NIS Vyriad NSCLC (+atezolizumab) Phase I

(oncolytic viruse cancer vaccine) Rochester, MN www.vyriad.com

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Lung CancerProduct Name Sponsor Indication Development Phase

nazartinib (EGF816) Novartis Oncology NSCLC Phase III

(EGFR mutation modulator) East Hanover, NJ www.novartis.com

NC-6004 NanoCarrier NSCLC (+ gemcitabine) Phase II

(cisplatin micellar nanoparticle) Chiba, Japan www.nanocarrier.co.jp

NEO-PV-01 Neon Therapeutics NSCLC Phase I

(personal neoantigen vaccine) Cambridge, MA www.neontherapeutics.com

NGR-hTNF MolMed malignant pleural mesothelioma Phase III completed

(recombinant fusion protein) Milan, Italy www.molmed.com

ORPHAN DRUG

Ofev® Boehringer Ingelheim Pharmaceuticals mesothelioma Phase III

nintedanib Ridgefield, CT www.boehringer-ingelheim.com

ORPHAN DRUG

Oncoprex™ Genprex NSCLC (+ erlotinib) Phase II

gene therapy Austin, TX www.genprex.com

Onivyde® Ipsen Biopharmaceuticals 2L SCLC Phase II

irinotecan liposome injection Basking Ridge, NJ www.ipsen.com

Opdivo® Bristol-Myers Squibb 1L NSCLC (Fast Track), SCLC, Phase III

nivolumab Princeton, NJ malignant pleural mesothelioma www.bms.com

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Lung CancerProduct Name Sponsor Indication Development Phase

Opdivo® + Yervoy® Bristol-Myers Squibb NSCLC, SCLC, malignant pleural Phase III

nivolumab + ipilimumab Princeton, NJ mesothelioma www.bms.com

OSE-2101 OSE Immunotherapeutics NSCLC Phase III

(neo-epitopes cancer vaccine) Nantes, France www.ose-immuno.com

ORPHAN DRUG

PBF-1129 Palobiofarma NSCLC Phase I

(adenosine A2B receptor antagonist) Barcelona, Spain www.palobiofarma.com

PBF509 Novartis Oncology NSCLC (+PDR001) Phase I/II

(adenosine A2A receptor antagonist) East Hanover, NJ www.novartis.com

Palobiofarma

Barcelona, Spain

PDT with Photofrin® Pinnacle Biologics NSCLC Phase I

porfimer sodium Chicago, IL www.pinnaclebiologics.com

pegargiminase Polaris Pharmaceuticals mesothelioma (+pemetrexed +cisplatin) Phase II/III

(ADI-PEG-20) San Diego, CA www.polarispharma.com

ORPHAN DRUG

PEGPH20 Halozyme Therapeutics NSCLC (+pembrolizumab) Phase I

(pegylated recombinant San Diego, CA cholangiocarcinoma (+atezolizumab) www.halozyme.com

human hyalurinodase)

pemetrexed Apotex mesothelioma, NSCLC application submitted

Weston, FL www.apotex.com

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Lung CancerProduct Name Sponsor Indication Development Phase

Pemfexy™ Eagle Pharmaceuticals mesothelioma (+cisplatin), NSCLC application submitted

pemetrexed injection Woodcliff Lake, NJ www.eagleus.com

PEN-221 Tarveda Therapeutics SCLC Phase I/II

(somatostatin receptor 2 modulator) Watertown, MA www.tarveda.com

plinabulin BeyondSpring Pharmaceuticals 2L/3L NSCLC (+docetaxel) Phase III

(guanine nucleotide exchange New York, NY www.beyondspringpharma.com

factor stimulant)

poziotinib Spectrum Pharmaceuticals NSCLC Phase II

(pan-HER/tyrosine kinase inhibitor) Henderson, NV www.sppirx.com

prexasertib Eli Lilly SCLC Phase II

(CHK1 inhibitor) Indianapolis, IN www.lilly.com

PT 107 Pique Therapeutics NSCLC Phase II

(allogeneic B7.1/HLA-A1 Durham, NC www.piquetherapeutics.com

cancer vaccine)

Rova-T AbbVie 1L SCLC, 2L SCLC Phase III

(rovalpituzumab tesirine) North Chicago, IL www.abbvie.com

ORPHAN DRUG

3L SCLC Phase II

www.abbvie.com

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Lung CancerProduct Name Sponsor Indication Development Phase

RRx-001 EpicentRx NSCLC, SCLC Phase II

(free radical stimulant) La Jolla, CA www.epicentrx.com

sacituzumab govitecan Immunomedics metastatic lung cancer Phase II

(anti-TROP-2-SN-38 ADC) Morris Plains, NJ www.immunomedics.com

SC-002 AbbVie SCLC Phase I

(antibody-drug conjugate) North Chicago, IL www.abbvie.com

SEL-403 Selecta Biosciences mesothelioma Phase I

(recombinant immunotoxin + Watertown, MA www.selectabio.com

SVP-rapamycin)

sitravatinib (MGCD516) Mirati Therapeutics NSCLC (+nivolumab) Phase II

(multi kinase inhibitor) San Diego, CA www.mirati.com

SNX-5422 Esanex NSCLC Phase I

(Hsp90 inhibitor) Indianapolis, IN www.esanexpharma.com

Tagrisso® AstraZeneca 1L advanced EGFR-mutated NSCLC, Phase III

osimertinib Wilmington, DE EGFR-mutated NSCLC (adjuvant) www.astrazeneca.com

CNS metastases in advanced Phase II

EGFR-mutant NSCLC, www.astrazeneca.com

advanced EGFR-mutated NSCLC

(+selumetinib or savolitinib)

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Lung CancerProduct Name Sponsor Indication Development Phase

TAK-788 (AP32788) Takeda Oncology NSCLC Phase I

(EGFR/HER2 inhibitor) Cambridge, MA www.takeda.com

TAS-114 Taiho Oncology NSCLC Phase II

(dUTPase inhibitor) Princeton, NJ www.taihooncology.com

Tavocept® BioNumerik Pharmaceuticals primary adenocarcinoma of the lung Phase III completed

dimesna San Antonio, TX www.bionumerik.com

tazemetostat Epizyme relapsed/refractory mesothelioma Phase II

(EZH2 enzyme inhibitor) Cambridge, MA www.epizyme.com

ORPHAN DRUG

NSCLC (+atezolizumab) Phase I

www.epizyme.com

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Lung CancerProduct Name Sponsor Indication Development Phase

Tecentriq® Genentech ALK-positive NSCLC, NSCLC (adjuvant), Phase III

atezolizumab South San Francisco, CA 1L non-squamous NSCLC www.gene.com

(+nab-paclitaxel), 1L non-squamous

NSCLC (+bevacizumab +chemotherapy),

1L non-squamous NSCLC (+pemetrexed),

1L squamous NSCLC (+nab-paclitaxel),

1L squamous/non-squamous SCLC (+Dx),

1L extensive stage SCLC (+chemotherapy),

metastatic NSCLC Phase II

www.gene.com

NSCLC (+erlotinib +alectinib) Phase I

www.gene.com

tepotinib EMD Serono NSCLC Phase II

(c-Met kinase inhibitor) Rockland, MA www.emdserono.com

tesevatinib Kadmon Pharmaceuticals NSCLC Phase II

(protein tyrosine kinase inhibitor) New York, NY www.kadmon.com

TG-4010 Transgene NSCLC (+nivolumab) Phase II

(MVA-MUC1-IL2 cancer vaccine) Cambridge, MA www.transgene.fr

tislelizumab (BGB-A317) BeiGene USA NSCLC Phase III

(anti-PD-1 mAb) Cambridge, MA www.beigene.com

Celgene www.celgene.com

Summit, NJ

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Lung CancerProduct Name Sponsor Indication Development Phase

trastuzumab deruxtecan (DS-8201) Daiichi Sankyo NSCLC Phase I

(anti-HER2 antibody-drug conjugate) Basking Ridge, NJ www.dsi.com

TRC-102 TRACON Pharmaceuticals mesothelioma Phase II

(methoxyamine hydrochloride) San Diego, CA www.traconpharma.com

NSCLC Phase I

www.traconpharma.com

TRC-105 TRACON Pharmaceuticals lung cancer Phase I

(carotuximab) San Diego, CA www.traconpharma.com

trilaciclib G1 Therapeutics 1L SCLC (combination therapy), Phase II

(CDK4/CDK6 inhibitor) Research Triangle Park, NC 2L/3L SCLC (combination therapy) www.g1therapeutics.com

U3-1402 Daiichi Sankyo NSCLC Phase I

(anti-HER3 antibody-drug conjugate) Basking Ridge, NJ www.dsi.com

Unituxin® United Therapeutics SCLC Phase II/III

dinutuximab Silver Spring, MD www.unither.con

veliparib AbbVie NSCLC Phase III

(PARP inhibitor) North Chicago, IL www.abbvie.com

ORPHAN DRUG

viagenpumatucel-L (HS-110) Heat Biologics NSCLC Phase II

(HSP cancer vaccine) Durham, NC www.heatbio.com

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Lung CancerProduct Name Sponsor Indication Development Phase

VX15 Vaccinex NSCLC Phase I/II

(SEMA4D mAb) Rochester, NY www.vaccinex.com

XMT-1522 Mersana Therapeutics HER2-expressing NSCLC Phase I

(anti-HER2 antibody-drug conjugate) Cambridge, MA www.mersana.com

Zejula® TESARO advanced NSCLC (+/- anti-PD-1), Phase II

niraparib Waltham, MA squamous call carcinoma of the www.tesarobio.com

ORPHAN DRUG lung (+/- anti-PD-1)

LymphomaProduct Name Sponsor Indication Development Phase

abexinostat Xynomic Pharmaceuticals follicular lymphoma Phase III

(HDAC inhibitor) Cheyenne, WY www.xynomicpharma.com

peripheral T-cell lymphoma, diffuse Phase II

large B-cell lymphoma (DLBCL) www.xynomicpharma.com

(+ibrutinib)

ACTR087 Unum Therapeutics non-Hodgkin lymphoma (NHL) Phase I

(antibody-coupled T-cell receptor Cambridge, MA (+rituximab) www.unumrx.com

immunotherapy)

ACTR707 Unum Therapeutics NHL (+rituximab) Phase I

(ACTR immunotherpay) Cambridge, MA www.unumrx.com

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LymphomaProduct Name Sponsor Indication Development Phase

Adcetris® Seattle Genetics 1L CD30-expressing mature T-cell Phase III

brentuximab vedotin Bothell, WA lymphoma, relapsed NHL (+nivolumab), www.seattlegenetics.com

ORPHAN DRUG Takeda Oncology mature T-cell lymphoma (Fast Track)

Northbrook, IL

1L Hodgkin lymphoma (60 years and Phase II

older), 2L Hodgkin lymphoma, www.seattlegenetics.com

relapsed NHL (+nivolumab)

ADCT-301 (camidanlumab tesirine) ADC Therapeutics Hodgkin lymphoma, NHL Phase I

(antibody-drug conjugate) Murray Hill, NJ www.adctherapeutics.com

ADCT-402 ADC Therapeutics B-cell NHL Phase I

(loncastuximab tesirine) Murray Hill, NJ www.adctherapeutics.com

AFM11 Affimed Therapeutics NHL Phase I

(CD19/CD3 antigen modulator) Heidelberg, Germany www.affimed.com

AFM13 Affimed Therapeutics CD30-positive lymphoma including Phase I/II

(CD30/CD16A antigen modulator) Heidelberg, Germany T-cell lymphoma www.affimed.com

ORPHAN DRUG

Hodgkin lymphoma Phase I

www.affimed.com

AG-270 Agios Pharmaceuticals lymphoma Phase I

(MAT2A inhibitor) Cambridge, MA www.agios.com

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LymphomaProduct Name Sponsor Indication Development Phase

AGS67E Astellas lymphoid malignancies Phase I

(anti-CD37 antibody-drug conjugate) Northbrook, IL www.astellas.com

ALT-803 Altor BioScience relapsed/refractory indolent NHL Phase I/II

(IL-15 superagonist protein Miramar, FL www.altorbioscience.com

complex) NantKWest

Culver City, CA

ALX148 Alexo Therapeutics NHL Phase I

(CD47 checkpoint inhibitor) South San Francisco, CA www.alexotherapeutics.com

anti-CD19 CAR-T cell therapy Intrexon lymphoma Phase I

Germantown, MD www.intrexon.com

ZIOPHARM Oncology www.ziopharm.com

Boston, MA

APG-115 Ascentage Pharma lymphoma Phase I

(MDM2-P53 inhibitor) Rockville, MD en.ascentagepharma.com

apilimod dimesylate (LAM-002) LAM Therapeutics NHL Phase II

(PIKfyve kinase inhibitor) Guilford, CT www.lamtherapeutics.om

Aplidin PharmaMar relapsed/refractory angioimmuno- Phase II

plitidepsin Madrid, Spain blastic T-cell lymphoma www.pharmamar.com

Arzerra® Novartis Oncology refractory indolent NHL Phase III

ofatumumab East Hanover, NJ www.novartis.com

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LymphomaProduct Name Sponsor Indication Development Phase

ASN002 Asana BioSciences relapsed/refractory lymphoma Phase I/II

(JAK/Syk inhibitor) Lawrenceville, NJ www.asanabiosciences.com

ASTX660 Astex Pharmaceuticals lymphoma Phase II

(IAP inhibitor) Pleasanton, CA www.astx.com

AvidinOx Alfasigma inoperable lymphomas Phase I

(177Lu-ST2210) Bologna, Italy www.alfasigma.com

axicabtagene ciloleucel Kite Pharma DLBCL, primary mediastinal B-cell Phase II

(CAR-T cell therapy) Santa Monica, CA lymphoma, transformed follicular www.kitepharma.com

ORPHAN DRUG lymphoma, indolent NHL

DLBCL (+PD-L1) Phase I

www.kitepharma.com

baltaleucel-T (CMD-003) Cell Medica extranodal natural killer T-cell Phase II

(T-lymphocyte cell therapy) Houston, TX lymphoma, DLBCL, Hodgkin lymphoma, www.cellmedica.com

ORPHAN DRUG post-transplant lymphoproliferative

disease (Fast Track)

BAY1862864 Bayer Pharmaceuticals NHL Phase I

(CD22-thorium conjugate) Whippany, NJ www.pharma.bayer.com

BAY1895344 Bayer Pharmaceuticals lymphoma Phase I

(ATR protein inhibitor) Whippany, NJ www.pharma.bayer.com

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LymphomaProduct Name Sponsor Indication Development Phase

BCL201 Novartis Oncology follicular lymphoma (+idelalisib), Phase I

(Bcl-2 inhibitor) East Hanover, NJ mantle cell lymphoma (+idelalisib) www.novartis.com

Beleodaq® Spectrum Pharmaceuticals 1L peripheral T-cell lymphoma Phase I

belinostat Henderson, NV www.sppirx.com

Betalutin® Nordic Nanovector DLBCL Phase I

lilotomab satetraxetan Oslo, Norway www.nordicnanovector.com

ORPHAN DRUG

BI 836826 Boehringer Ingelheim Pharmaceuticals DLBCL Phase II

(anti-CD37 mAb) Ridgefield, CT www.boehringer-ingelheim.com

NHL Phase I

www.boehringer-ingelheim.com

Blincyto® Amgen relapsed/refractory DLBCL (adults) Phase II/III

blinatumomab Thousand Oaks, CA www.amgen.com

CA-170 Curis lymphoma Phase I

(PD-L1 checkpoint inhibitor) Lexington, MA www.curis.com

CA-4948 Curis MYD88-altered lymphoma Phase I

(IRAK4 kinase inhibitor) Lexington, MA www.curis.com

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LymphomaProduct Name Sponsor Indication Development Phase

Calquence® Acerta Pharma 1L mantle cell lymphoma Phase III

acalabrutinib South San Francisco, CA www.astrazeneca.com

AstraZeneca

Wilmington, DE

CC-122 (avadomide) Celgene DLBCL, relapsed/refractory indolent Phase I

(pleiotropic pathway modulator) Summit, NJ lymphoma www.celgene.com

CC-486 Celgene DLBCL Phase I

(oral azacitidine) Summit, NJ www.celgene.com

CC-90002 Celgene NHL Phase I

(anti-CD47 antibody) Summit, NJ www.celgene.com

CC-90010 Celgene NHL Phase I

(BET inhibitor) Summit, NJ www.celgene.com

CC-90011 Celgene NHL Phase I

(LSD1 inhibitor) Summit, NJ www.celgene.com

CD11301 Galderma cutaneous T-cell lymphoma Phase II

(topical gel) Fort Worth, TX www.galdermausa.com

cirmtuzumab Oncternal Therapeutics mantel cell lymphoma, Phase I/II

(ROR1 antagonist) San Diego, CA small lymphocytic lymphoma www.oncternal.com

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LymphomaProduct Name Sponsor Indication Development Phase

cobomarsen miRagen Therapeutics cutaneous T-cell lymphoma, DLBCL Phase I

(microRNA inhibitor) Boulder, CO www.miragen.com

ORPHAN DRUG

coltuximab ravtansine ImmunoGen DLBCL Phase II

(CD19-targeting antibody drug Waltham, MA www.immunogen.com

conjugate)

copanlisib Bayer Pharmaceuticals NHL Phase III

(PI3K inhibitor) Whippany, NJ www.pharma.bayer.com

ORPHAN DRUG

CPI-613 Rafael Pharmaceuticals high-grade B-cell lymphoma, Phase II

(altered energy metabolism- Newark, NJ relapsed/refractory Burkitt's www.rafaelpharma.com

derived medicine) lymphoma

ORPHAN DRUG

relapsed/refractory T-cell lymphoma Phase I

(combination therapy) www.rafaelpharma.com

CPI-1205 Constellation Pharmaceuticals B-cell lymphoma Phase I

(EZH2 enzyme inhibitor) Cambridge, MA www.constellationpharma.com

CX-072 CytomX Therapeutics lymphoma Phase I/II

(PD-L1 targeting probody) South San Francisco, CA www.cytomix.com

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LymphomaProduct Name Sponsor Indication Development Phase

CYC065 Cyclacel Pharmaceuticals lymphoma Phase I

(CDK2/CDK9 inhibitor) Berkeley Heights, NJ www.cyclacel.com

CZ48 Cao Pharmaceuticals lymphoma Phase I

(DNA topoisomerase I inhibitor) Webster, TX www.caopharmaceuticals.com

NMT Pharmaceuticals

Webster, TX

darinaparsin (SP-02) Solasia Pharma peripheral T-cell lymphoma Phase II

ORPHAN DRUG Tokyo, Japan www.solasia.co.jp

DCDS0780A Roche/Genentech NHL Phase I

(anti-CD79b Thiomab™-drug conjugate) South San Francisco, CA www.roche.com

DEBIO 1562 (MGN529) Debiopharm B-cell NHL, DLBCL Phase II

(anti-CD37 antibody-drug conjugate) Lausanne, Switzerland www.immunogen.com

ORPHAN DRUG ImmunoGen

Waltham, MA

denintuzumab mafodotin Seattle Genetics DLBCL Phase II

(anti-CD19 antibody-drug conjugate) Bothell, WA www.seattlegenetics.com

DI-Leu16-IL2 Alopexx Oncology NHL Phase II

(immunocytokine fusion protein) Concord, MA www.alopexx.com

DTRMWXHS 12 Zhejiang DTRM Biopharma B-cell lymphoma Phase I

(BTK inhibitor) Hangzhou, China

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LymphomaProduct Name Sponsor Indication Development Phase

duvelisib Verastem refractory indolent NHL, Phase II

(PI3K delta/PI3K gamma inhibitor) Needham, MA relapsed/refractory peripheral www.verastem.com

T-cell lymphoma

eFT508 eFFECTOR Therapeutics lymphoma Phase I/II

(MKNK1/MKNK2 protein inhibitor) San Diego, CA www.effector.com

enzastaurin (DB 102) Denovo Biopharma 1L DLBCL Phase III

(PKC-β and PI3K/AKT inhibitor) San Diego, CA www.denovobiopharma.com

ORPHAN DRUG

epacadostat Incyte lymphoma Phase I

(IDO1 inhibitor) Wilmington, DE www.incyte.com

fenretinide intravenous CerRx lymphoma (adults) Phase II

Lubbock, TX www.cerrx.com

FF-10502-01 FUJIFILM Pharmaceuticals U.S.A lymphoma Phase I

(DNA synthesis inhibitor) Valhalla, NJ www.fujifilmusa.com

fimepinostat (CUDC-907) Curis MYC-altered DLBCL Phase II

(HDAC/PI3K inhibitor) Lexington, MA www.curis.com

ORPHAN DRUG

Folotyn® Spectrum Pharmaceuticals 1L peripheral T-cell lymphoma Phase II

pralatrexate Henderson, NV www.sppirx.com

ORPHAN DRUG

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LymphomaProduct Name Sponsor Indication Development Phase

G100 Immune Design NHL (+pembrolizumab) Phase II

(TLR4 antagonist) Seattle, WA www.immunedesign.com

ORPHAN DRUG

GSK3326595 GlaxoSmithKline NHL Phase I

(PRMT5 inhibitor) Research Triangle Park, NC www.gsk.com

GWN323 Novartis Oncology lymphoma (+PDR001) Phase I

(anti-C+GITR mAb) East Hanover, NJ www.novartis.com

Hu5F9-G4 Forty Seven relapsed/refractory B-cell NHL Phase I/II

(CD47 antigen inhibitor mAb) Menlo Park, CA (+rituximab) www.fortyseveninc.com

iC9/CAR.19/IL15-transduced Bellicum Pharmaceuticals B-lymphoid malignancies, NHL Phase I/II

CB-NK cells Houston, TX www.bellicum.com

M.D. Anderson Cancer Center

Houston, TX

IGN002 ImmunGene relapsed/refractory NHL Phase I

(anti-CD20/interferon-alpha) Camarillo, CA

Imbruvica® Janssen Research & Development DLBCL, follicular lymphoma, Phase III

ibrutinib Raritan, NJ relapsed/refractory mature www.janssen.com

Pharmacyclics B-cell NHL (pediatric), treatment- www.pharmacyclics.com

Sunnyvale, CA naïve mantle cell lymphoma

(combination therapy), indolent NHL

(combination therapy)

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LymphomaProduct Name Sponsor Indication Development Phase

Imfinzi® MedImmune DLBCL (monotherapy), Phase I

durvalumab Gaithersburg, MD DLBCL (+ tremelimumab or AZD9150) www.medimmune.com

INCB50465 Incyte DLBCL, follicular lymphoma, Phase II

(PI3K-delta inhibitor) Wilmington, DE mantle cell lymphoma, www.incyte.com

marginal zone lymphoma

IPH4102 Innate Pharma cutaneous T-cell lymphoma Phase I

(KIR3DL2 receptor antagonist) Marseille, France www.innate-pharma.com

ORPHAN DRUG

Istodax® Celgene 1L peripheral T-cell lymphoma Phase III

romidepsin Summit, NJ www.celgene.com

JCAR014 Juno Therapeutics relapsed/refractory B-cell NHL Phase I

(CD19 CAR-T cell therapy) Seattle, WA (+ durvalumab) www.junotherapeutics.com

KA2237 Karus Therapeutics B-cell lymphoma Phase I

(PI3K selective inhibitor) Oxfordshire, United Kingdom www.karustherapeutics.com

Keytruda® Merck relapsed/refractory primary application submitted

pembrolizumab Kenilworth, NJ mediastinal B-cell lymphoma www.merck.com

KPT-9274 Karyopharm Therapeutics NHL Phase I

(PAK4/NAMPT oral inhibitor) Newton, MA www.karyopharm.com

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LymphomaProduct Name Sponsor Indication Development Phase

KTE-C19 CAR-T cell therapy Kite Pharma mantle cell lymphoma Phase II

(second generation anti-CD19) Santa Monica, CA www.kitepharma.com

ORPHAN DRUG

Kymriah™ Novartis Oncology relapsed/refractory DLBCL application submitted

tisagenlecleucel-T East Hanover, NJ www.novartis.com

(anti-CD19 CAT-T cell therapy)

relapsed/refractory DLBCL Phase III

(+pembrolizumab) www.novartis.com

relapsed/refractory DLBCL in 1st relapse, Phase II

relapsed/refractory follicular lymphoma www.novartis.com

LAM-002 LAM Therapeutics relapsed/refractory B-cell NHL Phase I

(PIKfyve kinase inhibitor) Guilford, CT www.lamtherapeutics.com

LAM-003 LAM Therapeutics NHL Phase I

(immunmodulator) Guilford, CT www.lamtherapeutics.com

lisocabtagene maraleucel (JCAR017) Juno Therapeutics relapsed/refractory aggressive Phase I

(CD19 CAR-T cell therapy) Seattle, WA large B-cell NHL www.junotherapeutics.com

ORPHAN DRUG

LY3039478 Eli Lilly T-cell ALL Phase I/II

(NOTCH inhibitor) Indianapolis, IN www.lilly.com

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LymphomaProduct Name Sponsor Indication Development Phase

MAK683 Novartis Oncology DLBCL Phase I/II

(EED inhibitor) East Hanover, NJ www.novartis.com

MB-106 Mustang Bio relapsed/refractory B-cell NHL Phase I

(CAR-T cell therapy) New York, NY www.mustangbio.com

ME-401 MEI Pharma DLBCL (+rituximab), Phase I

(PI3K delta inhibitor) San Diego, CA follicular lymphoma, www.meipharma.com

indolent lymphoma (+rituximab)

mitoxantrone liposomal CSPC ZhongQi Pharmaceutical NHL Phase I/II

Shijiazhuang, China www.cspc.com.hk

MK-1454 Merck lymphoma Phase I

(STING agonist) Kenilworth, NJ www.merck.com

MK-2118 Merck lymphoma (+/-pembrolizumab) Phase I

Kenilworth, NJ www.merck.com

mogamulizumab Kyowa Hakko Kirin cutaneous T-cell lymphoma application submitted

(CCR4 receptor antagonist) Princeton, NJ www.kyowa-kirin.com

ORPHAN DRUG

adult T-cell leukemia/lymphoma Phase II

www.kyowa-kirin.com

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LymphomaProduct Name Sponsor Indication Development Phase

MOR-208 (XmAb5574) MorphoSys

(B-cell inhibitor mAb) Planegg, Germany relapsed/refractory DLBCL (Fast Track) Phase II/III

ORPHAN DRUG www.morphosys.com

NHL, small lymphocytic lymphoma Phase II

www.morphosys.com

mRNA-2416 Moderna Therapeutics lymphoma Phase I

(OX40L protein modulator) Cambridge, MA www.modernatx.com

MT-3724 Molecular Templates relapsed B-cell NHL Phase I

(engineered toxin bodies [ETB] Austin, TX www.mtem.com

targeting CD20)

NAM-NK cells + IL-2 Gamida Cell NHL Phase I

(natural killer cells) Jerusalem, Israel www.gamida-cell.com

NBT-011 (ABI-011) NantBioScience lymphoma Phase I

(angiogenesis inhibitor) Culver City, CA www.nantworks.com

NIR178 Novartis Oncology NHL (+ PDR001) Phase II

(adenosine receptor antagonist) East Hanover, NJ www.novartis.com

NM-IL-12 Neumedicines cutaneous T-cell lymphoma Phase II

(recombinant interleukin-12) Pasadena, CA (radio-immunotherapy), www.neumedicines.com

DLBCL (chemo-immunotherapy)

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LymphomaProduct Name Sponsor Indication Development Phase

ONC201 Oncoceutics lymphoma Phase I/II

(dopamine receptor D2/3 antagonist) Philadelphia, PA www.oncoceutics.com

Oncoquest™-L XEME Biopharma follicular lymphoma Phase I

non-Hodgkin lymphoma vaccine Lombard, IL www.xemebiopharma.com

Opdivo® Bristol-Myers Squibb CNS lymphoma, DLBCL Phase II

nivolumab Princeton, NJ primary testicular lymphoma, www.bms.com

follicular lymphoma

otlertuzumab Aptevo Therapeutics peripheral T-cell lymphoma Phase II

(CD37 protein inhibitor) Seattle, WA www.aptevotherapeutics.com

OXS-1550 GT Biopharma relapsed/refractory B-lineage Phase I/II

(bispecific scFv recombinant Washington, DC lymphoma www.gtbiopharma.com

fusion protein-drug conjugate)

Pixuvri® CTI BioPharma 2L aggressive NHL Phase III

pixantrone Seattle, WA (+rituximab) (Fast Track) www.ctibiopharma.com

polatuzumab vedotin Genentech 1L DLBCL Phase III

(anti-CD79b antibody-drug conjugate) South San Francisco, CA www.gene.com

relapsed/refractory DLBCL, Phase II

follicular lymphoma www.gene.com

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LymphomaProduct Name Sponsor Indication Development Phase

REGN1979 Regeneron Pharmaceuticals NHL Phase I

(anti-CD20/CD3 bispecific mAb)  Tarrytown, NY www.regeneron.com

remetinostat Medivir cutaneous T-cell lymphoma Phase II

(HDAC inhibitor) Huddinge, Sweden www.medivir.se

ORPHAN DRUG

Resimmune® Angimmune cutaneous T-cell lymphoma Phase I/II

anti-CD3 immunotoxin Rockville, MD www.angimmune.com

Revlimid® Celgene 1L DLBCL (ABC subtype), 1L follicular Phase III

lenalidomide Summit, NJ lymphoma, relapsed/refractory www.celgene.com

indolent lymphoma

RGX-104 Rgenix lymphoma Phase I

(LXR agonist) New York, NY www.rgenix.com

rituximab biosimilar Allergan NHL Phase III

(ABP 798) Parsippany, NJ www.amgen.com

Amgen

Thousand Oaks, CA

rituximab biosimilar Celltrion NHL application submitted

Incheon, South Korea www.celltrion.com

rituximab biosimilar Sandoz DLBCL, follicular lymphoma application submitted

(GP2013) Princeton, NJ www.sandoz.com

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LymphomaProduct Name Sponsor Indication Development Phase

rituximab biosimilar Pfizer follicular lymphoma Phase III

(PF-052805860) New York, NY www.pfizer.com

rituximab biosimilar Archigen Biotech follicular lymphoma Phase III

(SAIT101) Cambridge, United Kingdom www.archigenbio.com

RO7082859 Roche/Genentech NHL Phase I

(T-cell bispecific antibody) South San Francisco, CA www.roche.com

RP4010 Rhizen Pharmaceuticals NHL Phase I

(ORAI1 protein inhibitor) La Chaux-de-Fonds, Switzerland www.rhizen.com

SEA-CD40 Seattle Genetics lymphoma (+/-checkpoint inhibitor) Phase I

(anti-CD40 mAb) Bothell, WA www.seattlegenetics.com

selinexor Karyopharm Therapeutics DLBCL Phase II

(nuclear export inhibitor) Newton, MA www.karyopharm.com

ORPHAN DRUG

SGN-CD19B Seattle Genetics relapsed/refractory aggressive Phase I

(anti-CD19 antibody-drug conjugate) Bothell, WA B-cell NHL www.seattlegenetics.com

SGX-301 ointment Soligenix cutaneous T-cell lymphoma (Fast Track) Phase III

(hypericin photodynamic therapy) Princeton, NJ www.soligenix.com

ORPHAN DRUG

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LymphomaProduct Name Sponsor Indication Development Phase

STRO-001 Sutro Biopharma B-cell lymphoma Phase I

(anti-CD74 antibody-drug conjugate) South San Francisco, CA www.sutrobio.com

Sym021 Symphogen lymphoma Phase I

(anti-PD-1 mAb) Somerville, NJ www.symphogen.com

TAK-659 Takeda Oncology DLBCL Phase II

(SYK/FLT3 inhibitor) Deerfield, IL www.takeda.com

tazemetostat Epizyme B-cell lymphoma, relapsed/refractory Phase I/II

(EZH2 enzyme inhibitor) Cambridge, MA DLBCL (+prednisolone) www.epizyme.com

1L DLBCL (+R-CHOP), Phase I

relapsed/refractory DLBCL www.epizyme.com

(+atezolizumab)

Tecentriq® Genentech relapsed/refractory DLBCL Phase I

atezolizumab South San Francisco, CA (+obinutuzumab/tazemetostat) www.gene.com

follicular lymphoma

(+obinutuzumab/tazemetostat)

tenalisib (RP6530) Rhizen Pharmaceuticals cutaneous T-cell lymphoma (Fast Track), Phase I

(PI3K-delta/gamma inhibitor) La Chaux-de-Fonds, Switzerland peripheral T-cell lymphoma (Fast Track) www.rhizen.com

ORPHAN DRUG

tipifarnib Kura Oncology peripheral T-cell lymphoma Phase II

(farnesyltranstransferase inhibitor) San Diego, CA www.kuraoncology.com

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LymphomaProduct Name Sponsor Indication Development Phase

Toca 511 + Toca Fc Tocagen lymphoma Phase I

(vocimagene amiretrorepvec- San Diego, CA www.tocagen.com

flucytosine gene therapy)

TPA Rich Pharmaceuticals Hodgkin lymphoma Phase II

(tetradecanoylphorbol acetate) Beverly Hills, CA www.richpharmaceuticals.com

tractinostat Viracta Therapeutics EBV-positive lymphoma Phase I/II

(HDAC inhibitor) Cardiff, CA (+valganciclovir) www.viracta.com

TTI-621 Trillium Therapeutics mycosis fungoides Phase I

(CD47 inhibitors/SIRPA stimulant) Mississauga, Canada (cutaneous T-cell lymphoma) www.trilliumtherapeutics.com

ORPHAN DRUG

ublituximab + umbralisib TG Therapeutics NHL Phase II/III

(anti-CD20 mAb/PI3K inhibitor) New York, NY www.tgtherapeutics.com

umbralisib (TGR-1202) TG Therapeutics non-follicular NHL Phase II

(PI3K inhibitor) New York, NY www.tgtherapeutics.com

urelumab Bristol-Myers Squibb B-cell NHL Phase I/II

(anti-CD137 mAb) Princeton, NJ www.bms.com

Venclexta™ AbbVie DLBCL (+rituximab), follicular lymphoma, Phase II

venetoclax North Chicago, IL relapsed/refractory follicular lymphoma www.abbvie.com

ORPHAN DRUG Genentech (+rituximab) www.gene.com

South San Francisco, CA

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LymphomaProduct Name Sponsor Indication Development Phase

zanubrutinib (BGB-3111) BeiGene 1L small lymphocytic lymphoma Phase III

(BTK inhibitor) Cambridge, MA www.beigene.com

relapsed/refractory follicular lymphoma Phase II

(+ obinutuzumab) www.beigene.com

B-cell lymphoid malignancies Phase I

www.beigene.com

Multiple MyelomaProduct Name Sponsor Indication Development Phase

ABC294640 (Yeliva®) RedHill Biopharma multiple myeloma Phase I/II

(sphingosine kinase-2 inhibitor) Raleigh, NC www.redhillbio.com

ACTR-BCMA Unum Therapeutics multiple myeloma Phase I

(ACTR087 + SEA-BCMA) Cambridge, MA www.unumrx.com

Seattle Genetics www.seattlegenetics.com

Bothell, WA

ALT-803 Altor BioScience relapsed/refractory multiple myeloma Phase I

(IL-15 superagonist protein Miramar, FL www.altorbioscience.com

complex)

AMG 176 Amgen relapsed/refractory multiple myeloma Phase I

(MCL1 protein inhibitor) Thousand Oaks, CA www.amgen.com

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Multiple MyelomaProduct Name Sponsor Indication Development Phase

AMG 224 Amgen relapsed/refractory multiple myeloma Phase I

(antibody-drug conjugate) Thousand Oaks, CA www.amgen.com

AMG 420 Amgen multiple myeloma Phase I

(anti-BCMA x anti-CD3 Thousand Oaks, CA www.amgen.com

bispecific T-cell engager)

AMG 701 Amgen multiple myeloma Phase I

(anti-BCMA x anti-CD3 Thousand Oaks, CA www.amgen.com

bispecific T-cell engager)

anti-CD38 CAR-T cell therapy Sorrento Therapeutics relapsed/refractory multiple myeloma Phase I

San Diego, CA www.sorrentotherapeutics.com

BAY2402234 Bayer Pharmaceuticals myeloid leukemia Phase I

(DHODH inhibitor) Whippany, NJ www.pharma.bayer.com

bb2121 bluebird bio relapsed/refractory multiple myeloma Phase II

(anti-BCMA CAR-T cell therapy) Cambridge, MA www.bluebirdbio.com

ORPHAN DRUG Celgene www.celgene.com

Summit, NJ

bb21217 bluebird bio multiple myeloma Phase I

(anti-BCMA CAR-T cell therapy) Cambridge, MA www.bluebirdbio.com

ORPHAN DRUG Celgene www.celgene.com

Summit, NJ

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Multiple MyelomaProduct Name Sponsor Indication Development Phase

BFCR4350A (RG6160) Genentech relapsed/refractory multiple myeloma Phase I

South San Francisco, CA www.gene.com

BION-1301 Aduro BioTech multiple myeloma Phase I/II

(anti-APRIL mAb) Berkeley, CA www.aduro.com

BL-8040 BioLineRx multiple myeloma (combination therapy) Phase III

(CXCR4 chemokine receptor antagonist) Modi’in, Israel www.biolinerx.com

bortezomib intravenous Allergan multiple myeloma application submitted

Parsippany, NJ www.allergan.com

CB-5083 Cleave Biosciences multiple myeloma Phase I

(p97 inhibitor) Burlingame, CA www.cleavebio.com

ORPHAN DRUG

CC-122 (avadomide) Celgene multiple myeloma Phase I

(pleiotropic pathway modulator) Summit, NJ www.celgene.com

CC-220 Celgene relapsed/refractory multiple myeloma Phase I

(CRBN protein inhibitor) Summit, NJ www.celgene.com

CC-92480 Celgene relapsed/refractory multiple myeloma Phase I

(CELMoD) Summit, NJ www.celgene.com

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Multiple MyelomaProduct Name Sponsor Indication Development Phase

CC-93269 Celgene relapsed/refractory multiple myeloma Phase I

(T-cell bispecific antibody) Summit, NJ www.celgene.com

CDX-301 Celldex Therapeutics multiple myeloma Phase I

(recombinant Flt-3 ligand) Hampton, NJ www.celldex.com

citarinostat (ACY-241) Celgene relapsed/refractory multiple myeloma Phase I

(HDAC6 protein inhibitor) Summit, NJ www.celgene.com

CJM112 Novartis Oncology multiple myeloma Phase I

(IL17A protein inhibitor) East Hanover, NJ www.novartis.com

CLR-131 Cellectar Biosciences multiple myeloma Phase II

(phospholipid-drug conjugate) Madison, WI www.cellectar.com

ORPHAN DRUG

CWP 232291 JW Pharmaceutical relapsed/refractory multiple myeloma Phase I

(Wnt signalling pathway inhibitor) Seoul, South Korea www.jw-pharma.co.kr

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Multiple MyelomaProduct Name Sponsor Indication Development Phase

Darzalex® Janssen Research & Development 1L multiple myeloma application submitted

daratumumab Raritan, NJ (transplant ineligible) www.janssen.com

1st-line multiple myeloma (transplant Phase III

eligible), relapsed/refractory multiple www.janssen.com

myeloma, smoldering multiple

myeloma

multiple myeloma Phase III

(subcutaneous formulation) www.janssen.com

Empliciti® AbbVie 1L multiple myeloma Phase III

elotuzumab North Chicago, IL www.abbvie.com

Bristol-Myers Squibb www.bms.com

Princeton, NJ

galinpepimut-S Sellas Life Sciences multiple myeloma Phase II

(anti-WT1 peptide cancer vaccine) New York, NY www.sellaslifesciences.com

GBR 1342 Glenmark Pharmaceuticals multiple myeloma Phase I

(CD38/CD3 bispecific antibody) Mumbai, India www.glenmarkpharma.com

GMI-1271 GlycoMimetics multiple myeloma Phase I

(uproleselan sodium) Rockville, MD www.tgtherapeutics.com

GSK2857916 GlaxoSmithKline multiple myeloma Phase II

(antibody-drug conjugate) Research Triangle Park, NC www.gsk.com

ORPHAN DRUG

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Multiple MyelomaProduct Name Sponsor Indication Development Phase

GSK3377794 GlaxoSmithKline multiple myeloma Phase II

(NY-ESO-autologous engineered Research Triangle Park, NC www.gsk.com

T-cell receptor therapy)

indatuximab ravtansine (BT-062) Biotest multiple myeloma Phase II

(anti-CD138/DM4 immunoconjugte) Dreieich, Germany www.biotest.com

ORPHAN DRUG ImmunoGen www.immunogen.com

Waltham, MA

isatuximab Sanofi relapsing/refractory multiple myeloma, Phase III

(anti-CD38 mAb) Bridgewater, NJ 1L newly-diagnosed multiple myeloma www.sanofi.com

ORPHAN DRUG

newly-diagnosed multiple myeloma Phase I

(+ combination therapy), relapsed/ www.sanofi.com

refractory multiple myeloma

(+ cemiplimab)

JCARH125 Juno Therapeutics multiple myeloma Phase I

(anti-BCMA CAR-T cell therapy) Seattle, WA www.junotherapeutics.com

JNJ-63723283 Janssen Research & Development multiple myeloma (+daratumumab) Phase I

(anti-PD-1 mAb) Raritan, NJ www.janssen.com

JNJ-64007957 Janssen Research & Development relapsed/refractory multiple myeloma Phase I

(BCMA CD3 DuoBody® antibody) Raritan, NJ www.janssen.com

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Multiple MyelomaProduct Name Sponsor Indication Development Phase

JNJ-64407564 Janssen Research & Development relapsed/refractory multiple myeloma Phase I

(bispecific antibody) Raritan, NJ www.janssen.com

KITE-585 Kite Pharma multiple myeloma Phase I

(anti-BCMA CAR-T cell therapy) Santa Monica, CA www.kitepharma.com

LCL161 Novartis Oncology relapsed/refractory multiple myeloma Phase II

(apoptosis protein inhibitor) East Hanover, NJ www.novartis.com

mivebresib (ABBV-075) AbbVie multiple myeloma Phase I

(BET inhibitor) North Chicago, IL www.abbvie.com

MTV273 Novartis Oncology multiple myeloma Phase I

(BCMA-targeted CAR-T cell therapy) East Hanover, NJ www.novartis.com

NAM-NK cells + IL-2 Gamida Cell multiple myeloma Phase I

(nicotinamide expanded Jerusalem, Israel www.gamida-cell.com

(haploidentical or mismatched

related donor natural killer cells)

Ninlaro® Takeda Oncology 1L multiple myeloma, Phase III

ixazomib Deerfield, IL multiple myeloma (maintenance), www.takeda.com

relapsed/refractory multiple myeloma

(doublet regimen)

ONC201 Oncoceutics multiple myeloma Phase II

(dopamine receptor D2/3 antagonist) Philadelphia, PA www.oncoceutics.com

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Multiple MyelomaProduct Name Sponsor Indication Development Phase

Opdivo® Bristol-Myers Squibb multiple myeloma Phase III

nivolumab Princeton, NJ www.bms.com

oprozomib Amgen relapsed/refractory multiple myeloma Phase I

(oral proteasome inhibitor) Thousand Oaks, CA www.amgen.com

ORPHAN DRUG

P-BCMA-101 Poseida Therapeutics multiple myeloma Phase I

(CAR-T cell therapy) San Diego, CA www.poseida.com

PF-06863135 Pfizer multiple myeloma Phase I

(bispecific protein) New York, NY www.pfizer.com

PNK-007 Celularity multiple myeloma Phase I

(natural killer cell therapy) Warren, NJ www.celularity.com

PT-112 Phosplatin Therapeutics relapsed/refractory multiple myeloma Phase I

phosphaplatin New York, NY www.phosplatin.com

ORPHAN DRUG

PVX-410 OncoPep smoldering multiple myeloma, Phase I

(multi-peptide cancer vaccine) Boston, MA smoldering multiple myeloma www.oncopep.com

ORPHAN DRUG (+durvalumab)

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Multiple MyelomaProduct Name Sponsor Indication Development Phase

selinexor Karyopharm Therapeutics multiple myeloma (+bortezomib) Phase III

(nuclear export inhibitor) Newton, MA (Fast Track) www.karyopharm.com

ORPHAN DRUG

multiple myeloma (+dexamethasone) Phase II

(Fast Track), multiple myeloma www.karyopharm.com

(+backbone therapies) (Fast Track)

SGN-CD48A Seattle Genetics relapsed/refractory multiple myeloma Phase I

(antiCD48 antibody-drug conjugate) Bothell, WA www.seattlegenetics.com

SGN-CD352A Seattle Genetics relapsed/refractory multiple myeloma Phase I

(anti-CD351 antibody-drug conjugate) Bothell, WA www.seattlegenetics.com

SL-401 Stemline Therapeutics relapsed/refractory multiple myeloma Phase I/II

(recombinant fusion protein) New York, NY (+pomalidomide) www.stemline.com

STRO-001 Sutro Biopharma multiple myeloma Phase I

(anti-CD74 antibody-drug conjugate) South San Francisco, CA www.sutrobio.com

Sylvant® Janssen Research & Development high-risk smoldering multiple myeloma Phase II

siltuximab Raritan, NJ www.janssen.com

TAK-573 Takeda Oncology refractory multiple myeloma Phase I

(anti-CD38 attenukine) Deerfield, IL www.takeda.com

Tecentriq® Genentech multiple myeloma Phase I

atezolizumab South San Francisco, CA (+/-lenalidomide +/-daratumumab) www.gene.com

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Multiple MyelomaProduct Name Sponsor Indication Development Phase

Venclexta™ AbbVie multiple myeloma Phase III

venetoclax North Chicago, IL www.abbvie.com

ORPHAN DRUG Genentech www.gene.com

South San Francisco, CA

Ygalo® Oncopeptides multiple myeloma Phase II

peptidase-potentiated alkylator Stockholm, Sweden www.oncopeptides.com

ORPHAN DRUG

Ovarian CancerProduct Name Sponsor Indication Development Phase

AL3818 Advenchen Laboratories ovarian cancer Phase I/II

(tyrosine kinase inhibitor) Moorpark, CA www.advenchen.com

amcasertib (BBI503) Boston Biomedical ovarian cancer Phase II

(cancer cel [stemness] inhibitor) Cambridge, MA www.bostonbiomedical.com

anetumab ravtansine Bayer Pharmaceuticals recurrent mesothelin-expressing Phase I

(antibody-drug conjugate) Whippany, NJ platinum-resistant ovarian cancer www.pharma.bayer.com

APR-246 Aprea Therapeutics platinum-sensitive high grade serous Phase II

(tumor suppressor protein Boston, MA ovarian cancer www.aprea.com

p53 stimulant)

platinum-resistant high grade serous Phase I

ovarian cancer www.aprea.com

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Ovarian CancerProduct Name Sponsor Indication Development Phase

Avastin® Genentech relapsed platinum-sensitive application submitted

bevacizumab South San Francisco, CA ovarian cancer www.gene.com

ORPHAN DRUG

AZD1775 (adavosertib) AstraZeneca ovarian cancer (+chemotherapy) Phase II

(WEE1 kinase inhibitor) Wilmington, DE www.astrazeneca.com

Bavencio® EMD Serono 1L ovarian, platinum-resistant/refractory Phase III

avelumab Rockland, MA ovarian cancer www.emdserono.com

(anti-PD-L1 inhibitor) Pfizer www.pfizer.com

New York, NY

camptothecin (CRLX101) BlueLink Pharmaceuticals ovarian cancer (Fast Track) Phase II

ORPHAN DRUG Ames, IA

cantrixil Kazia Therapeutics ovarian cancer Phase I

(SMETI inhibitor) Sydney, Australia www.kaziatherapeutics.com

ORPHAN DRUG

CDX-014 Celldex Therapeutics ovarian cancer Phase I

(TIM-1 antibody-drug conjugate) Hampton, NJ www.celldex.com

CDX-1401 Celldex Therapeutics ovarian cancer Phase II

(NY-ESO-1) Hampton, NJ (combination therapy) www.celldex.com

COTI-2 Cotinga Pharmaceuticals ovarian cancer Phase I

(p53 gene modulator) London, Canada www.cotingapharma.com

ORPHAN DRUG

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Ovarian CancerProduct Name Sponsor Indication Development Phase

DCVax®-L Northwest Biotherapeutics ovarian cancer Phase I completed

cancer vaccine Bethesda, MD www.nwbio.com

defactinib Verastem ovarian cancer (+avelumab) Phase II

(FAK inhibitor) Needham, MA www.verastem.com

ORPHAN DRUG

DKN-01 Leap Therapeutics endometroid ovarian cancer Phase II

(anti-DKK1 mAb) Cambridge, MA (combination therapy) www.leaptx.com

DPX-Survivac Immunovaccine advanced ovarian cancer (Fast Track) Phase I

(cancer vaccine) Halifax, Canada www.imvaccine.com

ORPHAN DRUG

entinostat Syndax Pharmaceuticals ovarian cancer (+avelumab) Phase II

(HDAC inhibitor) Waltham, MA www.syndax.com

EP-100 Esperance Pharmaceuticals ovarian cancer Phase II

(precision targeted membrane- Houston, TX www.esperancepharma.com

disrupting peptide)

EP-201 EpiThany ovarian cancer Phase I

(IGFBP-2 vaccine) Seattle, WA www.epithany.com

epacadostat Incyte ovarian cancer Phase I

(IDO1 inhibitor) Wilmington, DE www.incyte.com

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Ovarian CancerProduct Name Sponsor Indication Development Phase

farletuzumab (MORAb-003) Eisai platinum-sensitive ovarian cancer Phase II

(IgG1 mAb) Woodcliff Lake, NJ www.eisai.com

ORPHAN DRUG

FATE-NK100 Fate Therapeutics ovarian cancer Phase I

(natural killer cell stimulant) La Jolla, CA www.fatetherapeutics.com

GALE-301 Sellas Life Sciences ovarian cancer Phase I/II

(E39 peptide vaccine) New York, NY www.sellalifesciences.com

ORPHAN DRUG

GALE-302 Sellas Life Sciences ovarian cancer Phase I/II

(E39 peptide vaccine) New York, NY www.sellalifesciences.com

ORPHAN DRUG

galinpepimut-S Sellas Life Sciences ovarian cancer (+nivolumab) Phase I/II

(anti-WT1 peptide cancer vaccine) New York, NY www.sellaslifesciences.com

GEN-1 Celsion ovarian cancer Phase I/II

(IL-2 plasmid vector nanoparticles) Lawrenceville, NJ www.celsion.com

ORPHAN DRUG

GSK3377794 GlaxoSmithKline ovarian cancer Phase II

(NY-ESO-autologous engineered Research Triangle Park, NC www.gsk.com

T-cell receptor therapy)

IMT-1012 Immunotope ovarian cancer Phase I completed

(immunotherapeutic vaccine) Doylestown, PA www.immunotope.com

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Ovarian CancerProduct Name Sponsor Indication Development Phase

karenitecin BioNumerik Pharmaceuticals advanced ovarian cancer Phase III completed

(DNA topoisomerase inhibitor) San Antonio, TX www.bionumerick.com

Kevetrin™ Innovation Pharmaceuticals ovarian cancer Phase II

p53 protein stimulant Beverly, MA www.ipharminc.com

ORPHAN DRUG

Keytruda® Merck ovarian cancer Phase II

pembrolizumab Kenilworth, NJ www.merck.com

Lynparza® AstraZeneca 1L BRCA-mutated ovarian cancer, Phase III

olaparib Wilmington, DE 2L or greater BRCA-mutation www.astrazeneca.com

platinum-sensitive recurrent

ovarian cancer (maintenance),

gBRCA-mutated platinum-sensitive

recurrent ovarian cancer

recurrent platinum-resistant ovarian Phase II

cancer (+cediranib) www.astrazeneca.com

masitinib AB Science relapsed metastatic ovarian cancer Phase III

(protein tyrosine kinase inhibitor) Paris, France www.ab-science.com

mirvetuximab soravtansine ImmunoGen FOLR1-positive ovarian cancer Phase III

(folate receptor 1 antagonist) Waltham, MA www.immunogen.com

ORPHAN DRUG

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Ovarian CancerProduct Name Sponsor Indication Development Phase

NanoPac® NanOlogy ovarian cancer Phase II

paclitaxel nanoformulation Fort Worth, TX www.nanology.us

ORPHAN DRUG

navicixizumab OncoMed Pharmaceuticals ovarian cancer Phase I

(anti-DLL4/VEGF bispecific mAb) Redwood City, CA www.oncomed.com

NUC-1031 NuCana platinum-resistant ovarian cancer Phase II

(DNA synthesis inhibitor) Newton, MA www.nucana.com

ONCOS-102 Targovax platinum-resistant ovarian cancer Phase I/II

(oncolytic virus therapy) Oslo, Norway www.targovax.com

ORPHAN DRUG

Opdivo® Bristol-Myers Squibb ovarian cancer Phase I/II

nivolumab Princeton, NJ www.bms.com

Opdivo® + Yervoy® Bristol-Myers Squibb ovarian cancer Phase I/II

nivolumab + ipilimumab Princeton, NJ www.bms.com

oregovomab OncoQuest ovarian cancer (+chemotherapy) Phase II

(MUC16 protein mAb) Edmonton, Canada www.oncoquestinc.com

ORPHAN DRUG

ovarian cancer (+poly ICLC) Phase I

www.oncoquestinc.com

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Ovarian CancerProduct Name Sponsor Indication Development Phase

ovapuldencel-T AiVita Biomedical advanced ovarian cancer Phase II

(dendritic cell cancer vaccine) Irvine, CA www.aivitabiomedical.com

prexasertib Eli Lilly platinum-resistant or refractory Phase II

(CHK1 inhibitor) Indianapolis, IN ovarian cancer www.lilly.com

Prolanta™ Oncolix ovarian cancer Phase I

prolactin receptor antagonist Houston, TX www.oncolixbio.com

ORPHAN DRUG

PTC596 PTC Therapeutics ovarian cancer Phase I

(tumor stem cell targeting) South Plainfield, NJ www.ptcbio.com

PTX-200 Prescient Therapeutics relapsed/refractory ovarian cancer Phase I

(Akt inhibitor) South Melbourne, Australia www.ptxtherapeutics.com

RG7882 Genentech ovarian cancer Phase I

(anti-MUC16 THIOMAB drug conjugate) South San Francisco, CA www.gene.com

RRx-001 EpicentRx ovarian epithelial cancer Phase II

(free radical stimulant) La Jolla, CA www.epicentrx.com

Rubraca® Clovis Oncology ovarian cancer (+nivolumab) Phase III

rucaparib Boulder, CO www.clovisoncology.com

(PARP inhibitor)

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Ovarian CancerProduct Name Sponsor Indication Development Phase

sapacitabine Cyclacel Pharmaceuticals ovarian cancer (+seliciclib) Phase II

(nucleoside analogue) Berkeley Heights, NJ www.cyclacel.com

SC-003 AbbVie ovarian cancer Phase I

(antibody-drug conjugate) North Chicago, IL www.abbvie.com

SPL-108 Splash Pharmaceuticals ovarian epithelial cancer Phase II

(anti-CD44) San Diego, CA www.splashpharma.com

platinum-resistant ovarian cancer Phase I

www.splashpharma.com

taladegib Ignyta ovarian cancer (combination therapy) Phase I

(hedgehog pathway/SMO inhibitor) San Diego, CA www.ignyta.com

Tecentriq® Genentech 1L ovarian cancer Phase III

atezolizumab South San Francisco, CA (+bevacizumab +chemotherapy) www.gene.com

ovarian cancer (+rucaparib) Phase I

www.gene.com

TPIV200 TapImmune platinum-sensitive ovarian cancer Phase II

(folate receptor-alpha vaccine) Jacksonville, FL (Fast Track) www.tapimmune.com

ORPHAN DRUG

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Ovarian CancerProduct Name Sponsor Indication Development Phase

varlilumab Celldex Therapeutics ovarian cancer (+nivolumab) Phase II

(anti-CD28 mAb) Hampton, NJ www.celldex.com

VB-111 VBL Therapeutics recurrent platinum-resistant Phase III

(ofranergene obadenovec) Modi'in, Israel ovarian cancer www.vblrx.com

ORPHAN DRUG

veliparib AbbVie ovarian cancer Phase III

(PARP inhibitor) North Chicago, IL www.abbvie.com

Vigil™ Gradalis ovarian cancer Phase II

autologous tumor cell vaccine Carrolton, TX www.gradalisinc.com

Yondelis® Janssen Research & Development relapsed ovarian cancer Phase III

trabectedin Raritan, NJ www.janssen.com

ORPHAN DRUG

Zejula® TESARO advanced ovarian cancer following Phase III

niraparib Waltham, MA response on 1L platinum-based www.tesarobio.com

ORPHAN DRUG chemotherapy

1L ovarian cancer (+bevacizumab), Phase II

ovarian cancer (+bevacizumab), www.tesarobio.com

ovarian cancer (+pembrolizumab),

ovarian cancer (monotherapy)

Medicines in Development: Cancer ǀ 2018 148

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Ovarian CancerProduct Name Sponsor Indication Development Phase

ZW25 Zymeworks HER2-expressing ovarian cancer Phase I

(bispecific antibody) Vancouver, Canada www.zymeworks.com

ORPHAN DRUG

Pancreatic CancerProduct Name Sponsor Indication Development Phase

AbGn-107 AbGenomics pancreatic cancer Phase I

(antibody-drug conjugate) Los Altos, CA www.abgenomics.com

Abraxane® Celgene pancreatic cancer (adjuvant therapy) Phase III

paclitaxel protein-bound particles Summit, NJ www.celgene.com

for injectable suspension

(albumin-bound)

aglatimagene besadenovec Advantagene pancreatic cancer Phase I/II

(gene therapy) Auburndale, MA www.advantagene.com

AM0010 ARMO Biosciences pancreatic ductal adenocarcinoma Phase III

(PEG-IL-10) Redwood City, CA (Fast Track) www.armobio.com

ORPHAN DRUG

antroquinonol Golden Biotechnology pancreatic cancer Phase I/II

(rare medicinal fungus) New Taipei City, Taiwan www.goldenbiotech.com

ORPHAN DRUG

Medicines in Development: Cancer ǀ 2018 149

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Pancreatic CancerProduct Name Sponsor Indication Development Phase

AR20.5 OncoQuest pancreatic cancer Phase I/II

(anti-MUC1 mAb) Edmonton, Canada www.oncoquestinc.com

ARQ 761 ArQule pancreatic cancer Phase II

(NQO1 inhibitor) Burlington, MA www.arqule.com

BL-8040 BioLineRx metastatic pancreatic cancer Phase II

(CXCR4 chemokine receptor antagonist) Modi’in, Israel (+pembrolizumab) www.biolinerx.com

BPM31510 Berg advanced pancreatic cancer Phase II

(cancer cell metabolism restorer) Framingham, MA (+/- gemcitabine) www.berghealth.com

ORPHAN DRUG

BPX-601 Bellicum Pharmaceuticals non-resectable pancreatic cancer Phase I

(anti-PSCA CAR-T cell therapy) Houston, TX www.bellicum.com

BVD-523 BioMed Valley Discoveries metastatic pancreatic cancer Phase I

(ERK inhibitor) Kanas City, MO (+nab-paclitaxel +gemcitabine) www.biomed-valley.com

cabiralizumab Five Prime Therapeutics pancreatic cancer (+nivolumab) Phase II

(anti-CSF1R) South San Francisco, CA www.fiveprime.com

Bristol-Myers Squibb

Princeton, NJ

Cabometyx™ Exelixis pancreatic neuroendocrine tumors Phase II

cabozantinib South San Francisco, CA www.exelixis.com

Medicines in Development: Cancer ǀ 2018 150

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Pancreatic CancerProduct Name Sponsor Indication Development Phase

CCX872 ChemoCentryx advanced pancreatic cancer Phase II

(CCR2 receptor antagonist) Mountain View, CA www.chemocentryx.com

CPI-613 Rafael Pharmaceuticals 1L metastatic pancreatic cancer Phase III

(altered energy metabolism- Newark, NJ (+modified FOLFIRINOX) www.rafaelpharma.com

derived medicine)

ORPHAN DRUG

1L locally advanced pancreatic cancer Phase II

(+modified FOLFIRINOX) www.rafaelpharma.com

1L advanced or metastatic Phase I

pancreatic cancer www.rafaelpharma.com

(+gemcitabine +nab-paclitaxel)

defactinib Verastem pancreatic cancer (+pembrolizumab), Phase I

(FAK inhibitor) Needham, MA relapsed pancreatic cancer www.verastem.com

ORPHAN DRUG (+pembrolizumab +gemcitabine)

encapsulated live cells PharmaCyte Biotech pancreatic cancer Phase II

converting ifosfamide Laguna Hills, CA www.pharmacyte.com

(genetically engineered live human cells)

ORPHAN DRUG

ensituximab Precision Biologics advanced pancreatic cancer Phase II

(neoplasm antigen inhibitor) Rockville, MD www.precision-biologics.com

ORPHAN DRUG

evofosfamide Molecular Templates pancreatic cancer (+ipilimumab) Phase I

ORPHAN DRUG Austin, TX www.mtem.com

Medicines in Development: Cancer ǀ 2018 151

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Pancreatic CancerProduct Name Sponsor Indication Development Phase

ficlatuzumab AVEO Oncology pancreatic cancer Phase II

(HGF/c-Met inhibitor) Cambridge, MA www.aveooncology.com

galunisertib Eli Lilly metastatic pancreatic cancer Phase I

(TGF-beta 1 inhibitor) Indianapolis, IN (+ durvalumab) www.lilly.com

GC4419 Galera Therapeutics pancreatic cancer Phase I/II

(superoxide dismutase modulator) Malvern, PA (+ stereotactic body radiation therapy) www.galeratx.com

glufosfamide Eleison Pharmaceuticals 2L metastatic pancreatic cancer Phase III

(DNA synthesis inhibitor) Princeton, NJ (Fast Track) www.eleision-pharma.com

ORHAN DRUG

Imbruvica® Janssen Research & Development pancreatic cancer Phase III

ibrutinib Raritan, NJ www.janssen.com

Pharmacyclics www.pharmacyclics.com

Sunnyvale, CA

Imfinzi® MedImmune pancreatic ductal adenocarcinoma Phase II

durvalumab Gaithersburg, MD (+AZD5069) www.medimmune.com

1L pancreatic ductal adenocarcinoma Phase I

(+tremelimumab +chemotherapy) www.medimmune.com

indoximod NewLink Genetics metastatic pancreatic cancer Phase II

(IDO inhibitor) Ames, IA (combination therapy) www.newlinkgenetics.com

Medicines in Development: Cancer ǀ 2018 152

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Pancreatic CancerProduct Name Sponsor Indication Development Phase

IRX4204 Io Therapeutics pancreatic cancer Phase I

(RXR agonist) Santa Ana, CA www.io-therapeutics.com

istiratumab (MM-141) Merrimack Pharmaceuticals pancreatic cancer Phase II

(PI3K/AKT/mTOR inhibitor) Cambridge, MA www.merrimack.com

ORPHAN DRUG

LMB-100 Selecta Biosciences pancreatic cancer Phase I/II

(recombinant immunotoxin) Watertown, MA www.selectabio.com

LOAd703 Lokon Pharma pancreatic cancer Phase I/II

(oncolytic virus therapy) Uppsala, Sweden www.lokonpharma.com

ORPHAN DRUG

Lynparza® AstraZeneca pancreatic cancer Phase III

olaparib Wilmington, DE www.astrazeneca.com

Merck pancreatic cancer Phase III

Kenilworth, NJ (combination therapy) www.merck.com

masitinib AB Science pancreatic cancer Phase III

(protein tyrosine kinase inhibitor) Paris, France www.ab-science.com

ORPHAN DRUG

MENK (IRT-101) Cytocom advanced pancreatic cancer Phase II

(opioid growth factor) Orlando, FL www.cytocom.com

Medicines in Development: Cancer ǀ 2018 153

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Pancreatic CancerProduct Name Sponsor Indication Development Phase

MVT-1075 MabVax Therapeutics pancreatic cancer Phase I

(177Lu mAB 5B1/radio- San Diego, CA www.mabvax.com

imunotherapy)

MVT-5873 MabVax Therapeutics pancreatic cancer, metastatic prostate Phase I

(5B1 mAb) San Diego, CA (+chemotherapy) www.mabvax.com

NanoPac® NanOlogy pancreatic cancer Phase II

paclitaxel nanoformulation Fort Worth, TX www.nanology.us

NANT pancreatic cancer vaccine NantKwest pancreatic cancer (combination therapy) Phase I/II

(activated natural killer cells - Culver City, CA www.nantkwest.com

haNK for infusion)

napabucasin Boston Biomedical pancreatic cancer Phase III

(STAT3 inhibitor) Cambridge, MA (+nab-paclitaxel +gemcitabine) www.bostonbiomedical.com

ORPHAN DRUG

pancreatic cancer (+chemotherapy) Phase I

www.bostonbiomedical.com

Onivyde® Ipsen Biopharmaceuticals 1L pancreatic ductal adenocarcinoma Phase II

irinotecan liposome injection Basking Ridge, NJ www.ipsen.com

Opdivo® Bristol-Myers Squibb pancreatic cancer Phase I/II

nivolumab Princeton, NJ www.bms.com

Medicines in Development: Cancer ǀ 2018 154

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Pancreatic CancerProduct Name Sponsor Indication Development Phase

OT-101 Autotelic pancreatic cancer Phase II/III

(TGF-beta antisense) Costa Mesa, CA www.oncotelic.com

ORPHAN DRUG Oncotelic

Agoura Hills, CA

pamrevlumab FibroGen pancreatic cancer (Fast Track) Phase II

(anti-CTGF antibody) San Francisco, CA www.fibrogen.com

ORPHAN DRUG

PBI-05204 Phoenix Biotechnology pancreatic cancer Phase II

(Nerium oleander herbal extract) San Antonio, TX www.phoenixbiotechnology.com

PEGPH20 Halozyme Therapeutics pancreatic cancer (Fast Track) Phase III

(pegylated recombinant San Diego, CA (+nab-paclitaxel +gemcitabine) www.halozyme.com

human hyalurinodase)

ORPHAN DRUGpancreatic cancer (+atezolizumab) Phase I

www.halozyme.com

polyclonal antibody stimulator Cancer Advances pancreatic cancer Phase III

(fusion peptide) Durham, NC www.canceradvancesinc.com

ORPHAN DRUG

Medicines in Development: Cancer ǀ 2018 155

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Pancreatic CancerProduct Name Sponsor Indication Development Phase

Reolysin® Oncolytics Biotech

pelareorep Calgary, Canada pancreatic cancer (+gemcitabine), Phase II

ORPHAN DRUG metastatic pancreatic cancer www.oncolyticsbiotech.com

(+paclitaxel +carboplatin)

advanced or metastatic pancreatic Phase I

cancer (+pembrolizumab) www.oncolyticsbiotech.com

RX-3117 Rexahn Pharmaceuticals 3L metastatic pancreatic cancer, Phase II

(DNA and RNA synthesis inhibitor) Rockville, MD 1L metastatic pancreatic cancer www.rexahn.com

ORPHAN DRUG (+palbociclib)

sapacitabine Cyclacel Pharmaceuticals pancreatic cancer (+seliciclib) Phase II

(nucleoside analogue) Berkeley Heights, NJ www.cyclacel.com

SBP-101 Sun BioPharma pancreatic ductal adenocarcinoma Phase I

(polyamine analogue) Waconia, MN www.sunbiopharma.com

ORPHAN DRUG

SEL-403 Selecta Biosciences pancreatic cancer Phase I

(recombinant immunotoxin + Watertown, MA www.selectabio.com

SVP-rapamycin)

SGT-53 SynerGene Therapeutics metastatic pancreatic cancer Phase II

(gene therapy) Rockville, MD (+gemcitabine +nab-paclitaxel)

Medicines in Development: Cancer ǀ 2018 156

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Pancreatic CancerProduct Name Sponsor Indication Development Phase

siG12D-LODER Silenseed pancreatic cancer Phase II

(antisense K-ras RNA gene therapy) Modi’in, Israel www.silenseed.com

SM-88 Tyme Technologies metastatic pancreatic cancer Phase II

(free radical stimulant) New York, NY www.tymeinc.com

Tecentriq® Genentech pancreatic cancer Phase I

atezolizumab South San Francisco, CA (+bevacizumab +chemotherapy) www.gene.com

Prostate CancerProduct Name Sponsor Indication Development Phase

ABBV-744 AbbVie advanced prostate cancer Phase I

(BRD2/3/4 inhibitor) North Chicago, IL www.abbvie.com

ADXS-PSA Advaxis metastatic castration-resistant Phase I/II

(cancer immunotherapy vaccine) Princeton, NJ prostate cancer, metastatic www.advaxis.com

castration-resistant prostate cancer

(+pembrolizumab)

AE37 (HER2.neu) Antigen Express metastatic prostate cancer Phase I

(Li-key hybrid cancer vaccine) Wellesley, MA www.antigenexpress.com

Medicines in Development: Cancer ǀ 2018 157

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Prostate CancerProduct Name Sponsor Indication Development Phase

aglatimagene besadenovec Advantagene intermediate and high-risk prostate Phase III

(gene therapy) Auburndale, MA cancer (Fast Track) www.advantagene.com

prostate cancer (proactive surveillance) Phase II/III

www.advantagene.com

APVO414 Aptevo Therapeutics metastatic castration-resistant Phase I

(bispecific immunotherapeutic) Seattle, WA prostate cancer www.aptevotherapeutics.com

cabazitaxel injection Accord Healthcare hormone-refractory metastatic application submitted

Durham, NC prostate cancer (+prednisone) www.accordhealthcare.us

cabazitaxel injection Allergan hormone-refractory metastatic application submitted

Parsippany, NJ prostate cancer www.allergan.com

CORT125281 Corcept Therapeutics metastatic castration-resistant Phase I

(glucocorticoid receptor antagonist) Menlo Park, CA prostate cancer www.corcept.com

CPI-1205 Constellation Pharmaceuticals metastatic castration-resistant Phase I/II

(EZH2 enzyme inhibitor) Cambridge, MA prostate cancer www.constellationpharma.com

darolutamide Bayer Pharmaceuticals non-metastatic castration-resistant Phase III

(androgen receptor antagonist) Whippany, NJ prostate cancer, metastatic www.pharma.bayer.com

hormone-sensitive prostate cancer

Medicines in Development: Cancer ǀ 2018 158

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Prostate CancerProduct Name Sponsor Indication Development Phase

DCVax®-Prostate Northwest Biotherapeutics prostate cancer Phase II completed

cancer vaccine Bethesda, MD www.nwbio.com

Dicopp™ Cantex Pharmaceuticals metastatic castration-resistant Phase I

copper gluconate/disulfiram Weston, FL prostate cancer www.cantex.com

DPV-001 UbiVac prostate cancer Phase I

(autophagosome-enriched vaccine) Portland, OR www.ubivac.com

eltanexor oral (KPT-8602) Karyopharm Therapeutics metastatic castration-resistant Phase I/II

(nuclear export inhibitor) Newton, MA prostate cancer www.karyopharm.com

enoblituzumab MacroGenics prostate cancer (neoadjuvant) Phase I

(anti-B7-H3 IgG1/κ mAb) Rockville, MD www.macrogenics.com

Erleada® Janssen Research & Development metastatic hormone-sensitive prostate Phase III

apalutamide Raritan, NJ cancer, localized prostate cancer www.janssen.com

evofosfamide Molecular Templates prostate cancer (+ipilimumab) Phase I

Austin, TX www.mtem.com

fexapotide Nymox Pharmaceutical low-risk localized (T1c) prostate Phase II completed

Hasbrouck Heights, NJ cancer www.nymox.com

FP-001 Foresee Pharmaceuticals prostate cancer Phase III

(leuprorelin depot) Newark, DE www.foreseepharma.com

Medicines in Development: Cancer ǀ 2018 159

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Prostate CancerProduct Name Sponsor Indication Development Phase

GSK2636771 GlaxoSmithKline castration-resistant prostate cancer Phase I

(PI3K beta inhibitor) Research Triangle Park, NC www.gsk.com

GT0918 Suzhou Kintor Pharmaceuticals metastatic castration-resistant Phase I/II

(proxalutamide) Suzhou, China prostate cancer

indoximod NewLink Genetics metastatic castration-resistant Phase II

(IDO inhibitor) Ames, IA prostate cancer (+sipuleucel-T) www.newlinkgenetics.com

INO-5150 Inovio Pharmaceuticals prostate cancer Phase I

(PSA/PMSA DNA cancer vaccine) Plymouth Meeting, PA www.inovio.com

IONIS-AR-2.5RX (AZD5312) Ionis Pharmaceuticals prostate cancer Phase II

(olignucleotide antisense drug) Carlsbad, CA www.ionispharma.com

IRX4204 Io Therapeutics prostate cancer Phase II

(RXR agonist) Santa Ana, CA www.io-therapeutics.com

JNJ 63723283 Janssen Research & Development castration-resistant prostate cancer Phase I/II

(anti-PD-1 mAb) Raritan, NJ (+niraparib) www.janssen.com

JNJ-64041809 (ADU-741) Aduro Biotech castration-resistant prostate cancer Phase I

(live attenuated double-deleted Berkeley, CA www.aduro.com

Listeria immunotherapy) Janssen Research & Development www.janssen.com

Raritan, NJ

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Prostate CancerProduct Name Sponsor Indication Development Phase

Keytruda® Merck prostate cancer Phase II

pembrolizumab Kenilworth, NJ www.merck.com

LY01005 Luye Pharma prostate cancer Phase I

(goserelin extended release) Shanghai, China www.luye-pharm.com

LY3023414 Eli Lilly prostate cancer (combination therapy) Phase II

(PI3K/mTOR inhibitor) Indianapolis, IN www.lilly.com

Lynparza® AstraZeneca prostate cancer Phase III

olaparib Wilmington, DE www.astrazeneca.com

Merck prostate cancer (combination therapy) Phase III

Kenilworth, NJ www.merck.com

MEDI3726 MedImmune prostate cancer Phase I

(antibody-drug conjugate) Gaithersburg, MD www.medimmune.com

MIP-1095 I-131 Progenics Pharmaceuticals prostate cancer Phase I

(small molecule thernostic) New York, NY www.progenics.com

MVI-118 Madison Vaccines metastatic prostate cancer Phase I

(plasmid DNA cancer vaccine) Madison, WI www.madisonvaccinesinc.com

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Prostate CancerProduct Name Sponsor Indication Development Phase

MVI-816 Madison Vaccines biochemically recurrent prostate Phase II

(plasmid DNA cancer vaccine) Madison, WI cancer www.madisonvaccinesinc.com

metastatic castration-resistant Phase I

prostate cancer (+pembrolizumab) www.madisonvaccinesinc.com

NanoPac® NanOlogy prostate cancer Phase II

paclitaxel nanoformulation Fort Worth, TX www.nanology.us

NBTXR3 Nanobiotix prostate cancer Phase I/II

(radio-enhancer nanoparticle) Paris, France www.nanobiotix.com

Opdivo® Bristol-Myers Squibb prostate cancer Phase II

nivolumab Princeton, NJ www.bms.com

padeliporfin di-potassium Steba Biotech localized prostate cancer Phase II

(vascular dusrupting agent) Luxembourg City, Luxembourg www.stebabiotech.com

PAN-301-1 Panacea Pharmaceuticals prostate cancer Phase I

(HAAH-directed nanoparticle vaccine) Gaithersburg, MD www.panaceapharma.com

PCM-075 TrovaGene castration-resistant prostate cancer Phase II

(PLK1 inhibitor) San Diego, CA www.trovagene.com

PCUR-101 Pellficure Pharmaceuticals metastatic castration-resistant Phase I

San Diego, CA prostate cancer

Medicines in Development: Cancer ǀ 2018 162

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Prostate CancerProduct Name Sponsor Indication Development Phase

PF-06753512 Pfizer prostate cancer Phase I

(vaccine-based immunotherapy) New York, NY (combination therapy) www.pfizer.com

ProscaVax OncBioMune Pharmaceuticals prostate cancer Phase I

PSA/IL-12/GM-CSF vaccine Baton Rouge, LA www.oncobiomune.com

Prostvac Bavarian Nordic prostate cancer Phase II

rilimogene galvacirepvec- Morrisville, NC (combination therapy) www.bavarian-nordic.com

rilimogene glafolivec Bristol-Myers Squibb www.bms.com

Princeton, NJ

Provenge® Dendreon metastatic castrate-resistant Phase II completed

sipuleucel-T Seal Beach, CA prostate cancer (combination www.dendreon.com

therapy)

PSA/IL-2/GM-CSF vaccine OncBioMune Pharmaceuticals prostate cancer Phase I

Baton Rouge, LA www.oncbiomune.com

PSMA-617 Endocyte metastatic castration-resistant Phase II

(radioligand therapy) West Lafayette, IN prostate cancer www.endocyte.com

Radio Medix

Houston, TX

REIC gene therapy Momotaro-Gene localized prostate cancer Phase I/II

Okayama, Japan www.mt-gene.com

relugolix Myovant Sciences advanced prostate cancer Phase III

(GnRH receptor antagonist) Brisbane, CA www.myovant.com

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Prostate CancerProduct Name Sponsor Indication Development Phase

Rubraca® Clovis Oncology metastatic castration-resistant Phase III

rucaparib Boulder, CO prostate cancer (combination therapy) www.clovisoncology.com

(PARP inhibitor)

metastatic castration-resistant Phase II

prostate cancer www.clovisoncology.com

sacituzumab govitecan Immunomedics metastatic prostate cancer Phase II

(anti-TROP-2-SN-38 ADC) Morris Plains, NJ www.immunomedics.com

seviteronel (INO-464) Innocrin Pharmaceuticals castration-resistant prostate cancer Phase II

(CYP17 lyase inhibitor) Durham, NC (Fast Track) www.innocrinpharma.com

SM-88 Tyme Technologies recurrent non-metastatic Phase II

(free radical stimulant) New York, NY prostate cancer www.tymeinc.com

stapuldencel-T (DCVAC/Pca) SOTIO metastatic castration-resistant Phase III

(autologous immunotherapy) Prague, Czech Republic prostate cancer www.sotio.com

talazoparib Pfizer 1L metastatic castration-resistant Phase III

(PARP inhibitor) New York, NY prostate cancer www.pfizer.com

2L metastatic castration-resistant Phase II

prostate cancer www.pfizer.com

TAS3681 Taiho Oncology metastatic castration-resistant Phase I

(androgen receptor antagonist) Princeton, NJ prostate cancer www.taihooncology.com

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Prostate CancerProduct Name Sponsor Indication Development Phase

Tecentriq® Genentech castration-resistant prostate cancer Phase III

atezolizumab South San Francisco, CA (+enzalutamide) www.gene.com

metastatic castration-resistant Phase I

prostate cancer (+radium 223) www.gene.com

topsalysin (PRX302) Sophiris Bio localized prostate cancer Phase II

(cell membrane modulator) La Jolla, CA www.sophirisbio.com

TRC-253 Janssen Research & Development prostate cancer Phase I

(androgen receptor antagonist) Raritan, NJ www.traconpharma.com

TRACON Pharmaceuticals

San Diego, CA

Xtandi® Astellas non-metastatic castration-resistant application submitted

enzalutamide Northbrook, IL prostate cancer www.astellas.com

Pfizer www.pfizer.com

New York, NY

metastatic hormone-sensitive Phase III

prostate cancer, non-metastatic www.astellas.com

high-risk hormone-sensitive prostate www.pfizer.com

cancer

Yonsa® Churchill Pharmaceuticals metastatic castration-resistant application submitted

abiraterone acetate King of Prussia, PA prostate cancer www.churchhillpharma.com

(submicron particles)

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Prostate CancerProduct Name Sponsor Indication Development Phase

ZEN-3694 Zenith Epigenetics metastatic castration-resistant Phase I/II

(BET inhibitor) San Francisco, CA prostate cancer www.zenithepigenetics.com

Zytiga® Janssen Research & Development castration-resistant metastatic Phase III

abiraterone acetate Raritan, NJ prostate cancer (chemotherapy naïve) www.janssen.com

(+apalutamide)

SarcomaProduct Name Sponsor Indication Development Phase

AL3818 Advenchen Laboratories metastatic or advanced alveolar Phase III

(tyrosine kinase inhibitor) Moorpark, CA soft part sarcoma, leiomyosarcoma, www.advenchen.com

synovial sarcoma

aldoxorubicin CytRx 2L soft tissue sarcoma Phase III

ORPHAN DRUG Los Angeles, CA www.cytrx.com

NantKwest

Culver City, CA

soft tissue sarcoma (+ifosfamide) Phase I/II

www.cytrx.com

AMG 337 NantPharma advanced or metastatic clear cell sarcoma Phase II

(c-Met inhibitor) Culver City, CA www.nantpharma.com

AU101 Aurora BioPharma osteosarcoma Phase I/II

(HER2-CD28 CAR-T cell therapy) Cambridge, MA www.aurora-biopharma.com

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SarcomaProduct Name Sponsor Indication Development Phase

Cabometyx™ Exelixis relapsed osteosarcoma, Ewing sarcoma, Phase II

cabozantinib South San Francisco, CA soft tissue sarcoma www.exelixis.com

CBT-1 CBA Pharma sarcoma Phase I

(tetrandrine) Lexington, KY www.cbapharma.com

CMB305 Immune Design soft tissue sarcoma Phase II

(antigen-specific prime boost) Seattle, WA www.immunedesign.com

ORPHAN DRUG

Gilotrif® Boehringer Ingelheim Pharmaceuticals rhabdomyosarcoma Phase I/II

afatinib Ridgefield, CT www.boehringer-ingelheim.com

GSK3377794 GlaxoSmithKline mixed round cell liposarcoma, Phase II

(NY-ESO-autologous engineered Research Triangle Park, NC synovial sarcoma www.gsk.com

T-cell receptor therapy)

ORPHAN DRUG

HDM201 Novartis Oncology liposarcoma (+LEE011) Phase I

(p53-HDM2 inhibitor) East Hanover, NJ www.novartis.com

inhaled lipid-complexed cisplatin Eleison Pharmaceuticals recurrent pulmonary osteosarcoma Phase II

Princeton, NJ www.eleison-pharma.com

Lartruvo® Eli Lilly soft tissue sarcoma (+pembrolizumab) Phase I

olaratumab Indianapolis, IN www.lilly.com

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SarcomaProduct Name Sponsor Indication Development Phase

MNPR-201 Monopar Therapeutics soft tissue sarcoma Phase II

(GPX-150; 5-imino- Wilmette, IL www.monopartx.com

13-deoxydoxorubicin)

ORPHAN DRUG

naxitamab Y-mAbs Therapeutics osteosarcoma (pediatric) Phase II

(anti-GD2 3F8 mAb) New York, NY www.ymabs.com

ORPHAN DRUG

NC-6300 NanoCarrier soft tissue sarcoma Phase I

(epirubicin micelle) Chiba, Japan www.nanocarrier.co.jp

ORPHAN DRUG

NKTR-214 Nektar Therapeutics sarcoma (+nivolumab) Phase II

(CD122-biased immune- San Francisco, CA www.nektar.com

stimulatory cytokine)

selinexor Karyopharm Therapeutics liposarcoma Phase III

(nuclear export inhibitor) Newton, MA www.karyopharm.com

ORPHAN DRUG

tazemetostat Epizyme synovial sarcoma Phase I

(EZH2 enzyme inhibitor) Cambridge, MA www.epizyme.com

ORPHAN DRUG

TK216 Oncternal Therapeutics Ewing sarcoma (Fast Track) Phase I

(c-ets inhibitor) San Diego, CA www.oncternal.com

ORPHAN DRUG

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SarcomaProduct Name Sponsor Indication Development Phase

TRC-105 TRACON Pharmaceuticals angiosarcoma Phase III

(carotuximab) San Diego, CA www.traconpharma.com

ORPHAN DRUG

Vigil™ Gradalis Ewing's sarcoma Phase III

autologous tumor cell vaccine Carrolton, TX www.gradalisinc.com

Zejula® TESARO Ewing's sarcoma (+chemotherapy) Phase I

niraparib Waltham, MA www.tesarobio.com

Skin CancerProduct Name Sponsor Indication Development Phase

APX005M Apexigen malignant melanoma (+nivolumab) Phase I/II

(CD40 agonistic antibody) San Carlos, CA www.apexigen.com

Bavencio® EMD Serono melanoma (+4-1BB) Phase II

avelumab Rockland, MA www.emdserono.com

(anti-PD-L1 inhibitor) Pfizer www.pfizer.com

New York, NY

binimetinib Array BioPharma BRAF-mutant unresectable or application submitted

(MEK inhibitor) Boulder, CO metastatic melanoma (+encorafenib) www.arraybiopharma.com

BMS-986205 Bristol-Myers Squibb advanced melanoma (+nivolumab) Phase III

(IDO1 inhibitor) Princeton, NJ www.bms.com

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Skin CancerProduct Name Sponsor Indication Development Phase

Cavatak® Viralytics advanced melanoma (+pembrolizumab), Phase I

coxsackievirus Sydney, Australia advanced melanoma (+ipilimumab) www.viralytics.com

ORPHAN DRUG

cemiplimab Regeneron Pharmaceuticals basal cell carcinoma Phase II

(anti-PD-1 mAb) Tarrytown, NY www.sanofi.com

Sanofi

Bridgewater, NJ

CLL442 Novartis Oncology cutaneous squamous cell Phase I/II

East Hanover, NJ carcinoma in situ www.novartis.com

CMP-001 Checkmate Pharmaceuticals malignant melanoma (+pembrolizumab) Phase I

(TLR9 agonist cancer vaccine) Cambridge, MA www.checkmatepharma.com

Cotellic® Genentech 1L BRAF-mutant metastatic melanoma Phase III

cobimetinib South San Francisco, CA (+ atezolizumab + vemurafenib), www.gene.com

ORPHAN DRUG 1L BRAF wild type metastatic melanoma

(+atezolizumab)

2L BRAF wild type metastatic Phase I

melanoma (+atezolizumab), www.gene.com

melanoma (+atezolizumab +vemurafenib)

daromun (darleukin/fibromun) Philogen malignant melanoma Phase III

(L19IL2-L19TNF) Sovicille, Italy www.philogen.com

(recombinant fusion proteins)

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Skin CancerProduct Name Sponsor Indication Development Phase

encorafenib Array BioPharma malignant melanoma application submitted

(BRAF inhibitor) Boulder, CO www.arraybiopharma.com

entinostat Syndax Pharmaceuticals melanoma (+pembrolizumab) Phase II

(HDAC inhibitor) Waltham, MA www.syndax.com

epacadostat Incyte melanoma Phase I

(IDO1 inhibitor) Wilmington, DE www.incyte.com

evofosfamide Molecular Templates melanoma (+ipilimumab) Phase I

Austin, TX www.mtem.com

GR-MD-02 Galectin Therapeutics melanoma (+ipilimumab), Phase I

(galectin 3 inhibitor) Norcross, GA melanoma (+pembrolizumab) www.galectintherapeutics.com

GRN-1201 BrightPath Biotherapeutics melanoma Phase I

(cancer peptide vaccine) Tokyo, Japan www.brightpathbio.com

GSK3377794 GlaxoSmithKline melanoma Phase II

(NY-ESO-autologous engineered Research Triangle Park, NC www.gsk.com

T-cell receptor therapy)

HBI-8000 HUYA Bioscience melanoma Phase I/II

(HDAC inhibitor) San Diego, CA www.huyabio.com

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Skin CancerProduct Name Sponsor Indication Development Phase

HF10 Takara Bio USA malignant melanoma Phase II

(canerpaturev, oncolytic virus therapy) Mountain View, CA www.takara-bio.com

Imfinzi® MedImmune melanoma (+dabrafenib +trametinib) Phase II

durvalumab Gaithersburg, MD www.medimmune.com

Imlygic® Amgen mid- to late-stage metastatic Phase III

talimogene laherparepvec Thousand Oaks, CA melanoma (+pembrolizumab) www.amgen.com

(oncolytic virus therapy)

Imprime PGG® Biothera Pharmaceuticals metastatic melanoma (+pembrolizumab) Phase I/II

immunostimulant PGG glucan Eagan, MN www.biothera.com

indoximod NewLink Genetics advanced melanoma Phase II/III

(IDO inhibitor) Ames, IA (+PD-1 inhibitors) www.newlinkgenetics.com

ORPHAN DRUG

IPI-549 Infinity Pharmaceuticals melanoma (+nivolumab) Phase I

(PI3K-gamma inhibitor) Cambridge, MA www.infi.com

LAG525 Novartis Oncology melanoma (+PDR001) Phase I/II

(anti-LAG3 mAb) East Hanover, NJ www.novartis.com

LN-144 Iovance Biotherapeutics malignant melanoma (Fast Track) Phase II

(tumor-infiltrating lymphocyte) San Carlos, CA www.iovance.com

ORPHAN DRUG

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Skin CancerProduct Name Sponsor Indication Development Phase

MAGE-A10 TCR Adaptimmune melanoma Phase I/II

(T-cell receptor therapy) Philadelphia, PA www.adaptimmune.com

MORAb-004 Eisai melanoma Phase II

(ontuxizumab) Woodcliff Lake, NJ www.eisai.com

NanoPac® NanOlogy cutaneous metastases Phase II

paclitaxel nanoformulation Fort Worth, TX www.nanology.us

NANT merkel cell cancer vaccine NantKwest merkel cell carcinoma Phase II

(activated natural killer cells - Culver City, CA www.nantkwest.com

haNK for infusion)

ORPHAN DRUG

NEO-PV-01 Neon Therapeutics melanoma Phase I

(personal neoantigen vaccine) Cambridge, MA www.neontherapeutics.com

ONCOS-102 Targovax advanced or unresectable melanoma Phase I

(oncolytic virus therapy) Oslo, Norway progressing after PD1 blockade www.targovax.com

OT-101 Autotelic melanoma Phase II/III

(TGF-beta antisense) Costa Mesa, CA www.oncotelic.com

Oncotelic

Agoura Hills, CA

patidegib PellePharm basal cell carcinoma Phase II

(hedgehog signaling inhibitor) San Francisco, CA www.pellepharm.com

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Skin CancerProduct Name Sponsor Indication Development Phase

PV-10 Provectus Biopharmaceuticals locally advanced cutaneous melanoma Phase III

(rose bengal sodium) Knoxville, TN www.provectusbio.com

ORPHAN DRUG

metastatic melanoma (+pembrolizumab) Phase I

www.provectusbio.com

REM-001 (rostaporfin) Adgero Biopharmaceuticals locally advanced basal cell carcinoma Phase I

(photosensitizer) Princeton, NJ www.adgerobiopharm.com

Resimmune® Angimmune malignant melanoma Phase I/II

anti-CD3 immunotoxin Rockville, MD www.angimmune.com

SD-101 Dynavax Technologies malignant melanoma (+pembrolizumab) Phase I/II

(TLR9 agonist) Berkeley, CA www.dynavax.com

seviprotimut-L (POL-103A) Polynoma malignant melanoma Phase III

ORPHAN DRUG San Diego, CA www.polynoma.com

spartalizumab (PDR001) Novartis Oncology malignant melanoma Phase III

(anti-PD-1 mAb) East Hanover, NJ (+dabrafenib +trametinib) www.novartis.com

malignant melanoma Phase II

www.novartis.com

SUBA-itraconazole HedgePath Pharmaceuticals basal cell carcinoma nevus syndrome Phase II

(hedgehog pathway inhibitor) Tampa, FL www.hedgepathpharma.com

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Skin CancerProduct Name Sponsor Indication Development Phase

tavokinogene telsaplasmid Oncosec Medical metastatic melanoma (Fast Track), Phase II

(interleukin-12 gene therapy) San Diego, CA advanced metastatic melanoma www.oncosec.com

ORPHAN DRUG (+pembrolizumab)

telomelysin Oncolys Biopharma metastatic melanoma Phase II

(oncolytic virus immunotherapy) Tokyo, Japan www.oncolys.com

tilsotolimod (IMO-2125) Idera Pharmaceuticals metastatic melanoma (+ipilimumab) Phase III

(TLR9 agonist) Cambridge, MA (Fast Track) www.iderapharma.com

ORPHAN DRUG

metastatic melanoma Phase I/II

(+ipilimumab or pembrolizumab) www.iderapharma.com

TLPLDC Elios Therapeutics metastatic melanoma Phase II

(tumor lysate particle-loaded Austin, TX www.eliostherapeutics.com

dendritic cell vaccine)

X4P-001-IO X4 Pharmaceuticals melanoma Phase I/II

(CXCR4 inhibitor) Cambridge, MA www.4xpharma.com

Solid TumorsProduct Name Sponsor Indication Development Phase

ABBV-085 AbbVie solid tumors Phase I

(antibody-drug conjugate) North Chicago, IL www.abbvie.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

ABBV-176 AbbVie solid tumors Phase I

(antibody-drug conjugate) North Chicago, IL www.abbvie.com

ABBV-181 AbbVie solid tumors Phase I

(immunotherapeutic) North Chicago, IL www.abbvie.com

ABBV-321 AbbVie advanced solid tumors Phase I

North Chicago, IL www.abbvie.com

ABBV-368 AbbVie solid tumors Phase I

(intravenous immunotherapeutic) North Chicago, IL www.abbvie.com

ABBV-428 AbbVie solid tumors Phase I

(anti-CD40 bispecific antibody) North Chicago, IL www.abbvie.com

ABBV-621 AbbVie solid tumors Phase I

(TRAIL receptor agonist) North Chicago, IL www.abbvie.com

ABBV-927 AbbVie solid tumors Phase I

(immunotherapeutic) North Chicago, IL www.abbvie.com

abexinostat Xynomic Pharmaceuticals solid tumors (+pembrolizumab) Phase II

(HDAC inhibitor) Cheyenne, WY www.xynomicpharma.com

ABT-165 AbbVie late-stage solid tumors Phase I

(VEGF and DLL4 inhibitor) North Chicago, IL www.abbvie.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

Actimmune® Horizon Pharma solid tumors (+nivolumab) Phase I

interferon gamma-1b Lake Forest, IL www.horizonpharma.com

ADU-S100 (MIW815) Aduro Biotech solid tumors (+ipilimumab), Phase I

(STING pathway activator) Berkeley, CA solid tumors (monotherapy) www.aduro.com

Novartis Oncology

East Hanover, NJ

ADXS-HER2 Advaxis HER2-expressing solid tumors Phase I/II

(cancer immunotherapy) Princeton, NJ www.advaxis.com

AEB1102 Aeglea Biotherapeutics advanced solid tumors Phase I(pegzilarginase) Austin, TX www.aegleabio.com

AG-270 Agios Pharmaceuticals solid tumors Phase I

(MAT2A inhibitor) Cambridge, MA www.agios.com

AGEN1884 Agenus advanced solid tumors Phase I

(CTLA-4 antagonist) Lexington, MA www.agenus.com

AGEN2034 Agenus solid tumors Phase I/II

(PD-1 protein inhibitor) Lexington, MA www.agenus.com

ALKS 4230 Alkermes solid tumors Phase I

(fusion protein and immuno- Waltham, MA www.alkermes.com

therapeutic based on IL-2)

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Solid TumorsProduct Name Sponsor Indication Development Phase

ALRN-6924 Aileron Therapeutics solid tumors Phase I

(MDM2/MDMX antagonist) Cambridge, MA www.aileronrx.com

ALT-803 Altor BioScience advanced solid tumors Phase I

(IL-15 superagonist protein Miramar, FL www.altorbioscience.com

complex)

ALX148 Alexo Therapeutics solid tumors Phase I

(CD47 checkpoint inhibitor) South San Francisco, CA www.alexotherapeutics.com

AM0010 ARMO Biosciences solid tumors Phase I(PEG-IL-10) Redwood City, CA www.armobio.com

amcasertib (BBI503) Boston Biomedical solid tumors (monotherapy) Phase II

(cancer cell [stemness] inhibitor) Cambridge, MA www.bostonbiomedical.com

solid tumors (combination therapy) Phase I

www.bostonbiomedical.com

AMG 337 NantPharma advanced or metastatic solid tumors Phase II

(c-Met inhibitor) Culver City, CA www.nantpharma.com

Ampligen® Hemispherx Biopharma solid tumors Phase I/II

rintatolimod Philadelphia, PA www.hemispherx.net

andecaliximab Gilead Sciences solid tumors Phase I

(MMP9 inhibitor mAb) Foster City, CA www.gilead.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

Andes-1537 Andes Biotechnologies advanced unresectable solid tumors Phase I

(antisense oligonucleotide) Santiago, Chile www.andesbio.com

anetumab ravtansine Bayer Pharmaceuticals mesothelin-expressing solid tumors Phase I

(antibody-drug conjugate) Whippany, NJ www.pharma.bayer.com

anti-CD27 agonist Aduro Biotech advanced solid tumors Phase I

Berkeley, CA (+/-pembrolizumab) www.aduro.com

Merck www.merck.com

Kenilworth, NJ

APG-115 Ascentage Pharma solid tumors Phase I

(MDM2-P53 inhibitor) Rockville, MD en.ascentagepharma.com

APG-1252 Ascentage Pharma solid tumors Phase I

(Bcl-2/Bcl-xl inhibitor) Rockville, MD en.ascentagepharma.com

APG-1387 Ascentage Pharma solid tumors Phase I

(IAP protein inhibitor) Rockville, MD en.ascentagepharma.com

APN401 Apeiron Biologics solid tumors Phase II

(siRNA-transfected peripheral Vienna, Austria www.apeiron-biologics.com

blood mononuclear cells)

APS001F Anaeropharma Science solid tumors Phase I/II

(cytosine deaminase gene therapy) Tokyo, Japan www.anaeropharma.co.jp

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Solid TumorsProduct Name Sponsor Indication Development Phase

APX005M Apexigen solid tumors Phase I

(CD40 agonistic antibody) San Carlos, CA www.apexigen.com

APX3330 Apexian Pharmaceuticals advanced solid tumors Phase I

(small molecule quinone derivative) Indianapolis, IN www.apexianpharma.com

ARQ 751 ArQule solid tumors Phase I

(pan-AKT inhibitor) Burlington, MA www.arqule.com

ARRY 382 Array BioPharma advanced solid tumors Phase II

(CSF-1R kinase inhibitor)  Boulder, CO (combination therapy) www.arraybiopharma.com

ASN002 Asana BioSciences solid tumors Phase I/II

(JAK/Syk inhibitor) Lawrenceville, NJ www.asanabiosciences.com

ASN003 Asana BioSciences solid tumors Phase I

(B-Raf/PI3K pathway inhibitor) Lawrenceville, NJ www.asanabiosciences.com

ASN007 Asana BioSciences solid tumors Phase I

(ERK 1/2 inhibitor) Lawrenceville, NJ www.asanabiosciences.com

ASP8374 (PTZ-201) Astellas solid tumors Phase I

(TIGIT antagonist) Northbrook, IL www.astellas.com

Potenza Therapeutics

Cambridge, MA

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Solid TumorsProduct Name Sponsor Indication Development Phase

AST-008 Exicure solid tumors Phase I

(TLR9 agonist) Skokie, IL www.exicuretx.com

ASTX660 Astex Pharmaceuticals solid tumors Phase II

(IAP inhibitor) Pleasanton, CA www.astx.com

ATI-1123 Cytori Therapeutics solid tumors Phase I

(docetaxel liposomal) San Diego, CA www.cytori.com

AVB-S6-500 Aravive Biologics solid tumors Phase I

(GAS6-AXL pathway inhibitor) Houston, TX www.aravive.com

AVID100 IV Formation Biologics advanced solid tumors Phase I

(antibody-drug conjugate) Austin, TX www.formationbiologics.com

AvidinOx Alfasigma inoperable solid tumors Phase I

(177Lu-ST2210) Bologna, Italy www.alfasigma.com

AZD0156 AstraZeneca solid tumors Phase I

(ATM kinase inhibitor) Wilmington, DE www.astrazeneca.com

AZD1775 AstraZeneca advanced solid tumors Phase I

(WEE1 kinase inhibitor) Wilmington, DE www.astrazeneca.com

AZD2811 AstraZeneca solid tumors Phase I

(aurora B kinase inhibitor) Wilmington, DE www.astrazeneca.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

AZD4547 AstraZeneca solid tumors Phase II

(FGFR tyrosine kinase inhibitor) Wilmington, DE www.astrazeneca.com

AZD4635 AstraZeneca solid tumors Phase I

(adenosine A2A receptor antagonist) Wilmington, DE www.astrazeneca.com

AZD4785 (IONIS-KRAS-2.5RX) AstraZeneca solid tumors Phase I

(KRAS protein inhibitor) Wilmington, DE www.astrazeneca.com

Ionis Pharmaceuticals www.ionispharma.com

Carlsbad, CA

AZD5153 AstraZeneca solid tumors Phase I

(BRD4 protein inhibitor) Wilmington, DE www.astrazeneca.com

AZD6738 AstraZeneca solid tumors Phase I

(ATR protein inhibitor) Wilmington, DE www.astrazeneca.com

AZD8186 AstraZeneca solid tumors Phase I

(PI3 protein inhibitor) Wilmington, DE www.astrazeneca.com

Bavencio® EMD Serono solid tumors (+talazopanib) Phase I

avelumab Rockland, MA www.emdserono.com

(anti-PD-L1 inhibitor) Pfizer www.pfizer.com

New York, NY

BAY1436032 Bayer Pharmaceuticals IDH1-mutant solid tumors Phase I

(mutant-IDH1 inhibitor) Whippany, NJ www.pharma.bayer.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

BAY1895344 Bayer Pharmaceuticals solid tumors Phase I

(ATR protein inhibitor) Whippany, NJ www.pharma.bayer.com

BDB001 Birdie Biopharmaceuticals solid tumors (+/-pembrolizumab) Phase I

(TLR agonist) Beijing, China 

Beleodaq® Spectrum Pharmaceuticals UGT1A1 wild type gene solid tumors, Phase I

belinostat Henderson, NV UGT1A1*28 genotype solid tumors www.sppirx.com

BI 754091 Boehringer Ingelheim Pharmaceuticals solid tumors Phase I

(anti-PD-1 mAb) Ridgefield, CT www.boehringer-ingelheim.com

BI 754111 Boehringer Ingelheim Pharmaceuticals solid tumors Phase I

(anti-LAG3 mAb) Ridgefield, CT www.boehringer-ingelheim.com

BI 836880 Boehringer Ingelheim Pharmaceuticals solid tumors Phase I

(VEGF/Ang2 bispecific nanobody) Ridgefield, CT www.boehringer-ingelheim.com

BI 891065 Boehringer Ingelheim Pharmaceuticals solid tumors Phase I

(SMAC mimetic) Ridgefield, CT www.boehringer-ingelheim.com

BI 894999 Boehringer Ingelheim Pharmaceuticals solid tumors Phase I

(BET protein inhibitor) Ridgefield, CT www.boehringer-ingelheim.com

birinapant Medivir solid tumors (+pembrolizumab) Phase I/II

(SMAC mimetic) Stockholm, Sweden www.medivir.se

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Solid TumorsProduct Name Sponsor Indication Development Phase

BLU-667 Blueprint Medicines solid tumors Phase I

(RET inhibitor) Cambridge, MA www.blueprintmedicines.com

BLZ945 Novartis Oncology advanced solid tumors Phase I

(CSF-1R antagonist) East Hanover, NJ www.novartis.com

BMS-813160 Bristol-Myers Squibb advanced solid tumors Phase I

(CCR2/5 dual antagonist) Princeton, NJ www.bms.com

BMS-986148 Bristol-Myers Squibb advanced solid tumors (+nivolumab) Phase I

(mesothelin directed antibody Princeton, NJ www.bms.com

drug conjugate)

BMS-986156 Bristol-Myers Squibb solid tumors Phase I/II

(anti-GITR mAb) Princeton, NJ www.bms.com

BMS-986158 Bristol-Myers Squibb solid tumors Phase I

(BET inhibitor) Princeton, NJ www.bms.com

BMS-986178 Bristol-Myers Squibb solid tumors Phase I

(anti-OX40 antibody) Princeton, NJ www.bms.com

BMS-986179 Bristol-Myers Squibb solid tumors Phase I

(anti-CD73 mAb) Princeton, NJ www.bms.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

BMS-986205 Bristol-Myers Squibb solid tumors (+nivolumab), Phase I

(IDO1 inhibitor) Princeton, NJ solid tumors (+nivolumab +ipilimumab) www.bms.com

BMS-986207 Bristol-Myers Squibb solid tumors (+nivolumab) Phase I

(anti-TIGHT mAb) Princeton, NJ www.bms.com

BMS-986218 Bristol-Myers Squibb solid tumors Phase I

(anti-CTLA-4 mAb) Princeton, NJ www.bms.com

BMS-986226 Bristol-Myers Squibb solid tumors Phase I

(anti-ICOS mAb) Princeton, NJ www.bms.com

BMS-986242 Bristol-Myers Squibb solid tumors Phase I

Princeton, NJ www.bms.com

BMS-986249 Bristol-Myers Squibb solid tumors Phase I

(anti-CTLA- 4 probody) Princeton, NJ www.bms.com

BMS-986253 Bristol-Myers Squibb solid tumors (+nivolumab) Phase I/II

(HuMax-IL8 mAb) Princeton, NJ www.bms.com

BMS-986258 Bristol-Myers Squibb advanced solid tumors (+/-nivolumab) Phase I

(immunotherapy) Princeton, NJ www.bms.com

BMS-986299 Bristol-Myers Squibb advanced solid tumors Phase I

(immunotherapy) Princeton, NJ (+/-nivolumab +ipilimumab) www.bms.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

BN-brachyury cancer vaccine Bavarian Nordic solid tumors Phase I

(prime-boost immunotherapy) Morrisville, NC www.bavarian-nordic.com

National Cancer Institute

Bethesda, MD

BOS172722 Boston Pharmaceuticals solid tumors Phase I

(TTK protein inhibitor) Cambridge, MA www.bostonpharmaceuticals.com

BPM31510 Berg solid tumors Phase I

(cancer cell metabolism restorer) Framingham, MA www.berghealth.com

briciclib Onconova Therapeutics solid tumors Phase I

(cyclin D1 inhibitor) Newtown, PA www.onconova.com

BSK01™ Kiromic relapsed/refractory solid tumors Phase I/II

(tumor-associated peptide antigen Houston, TX www.kiromic.com

pulsed dendritic cell vaccine)

BTP-114 Placon Therapeutics solid tumors Phase I

(DNA cross linking agent) Cambridge, MA www.placontx.com

BTRC4017A Genentech HER2-expressing solid tumors Phase I

South San Francisco, CA www.gene.com

BVD-523 BioMed Valley Discoveries advanced solid tumors Phase I/II

(ERK inhibitor) Kanas City, MO www.biomed-valley.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

BXCL701 (talabostat) BioXcel Therapeutics solid tumors Phase I

(DPP 8/9 & FAP Inhibitor) Branford, CT www.bioxcel.com

BXQ-350 Bexion Pharmaceuticals solid tumors Phase I

(apoptosis stimulant) Covington, KY www.bexionpharma.com

C188-9 StemMed solid tumors Phase I

(STAT3 inhibitor) Houston, TX www.stemmedcancer.com

CA-170 Curis solid tumors Phase I

(PD-L1 checkpoint inhibitor) Lexington, MA www.curis.com

CAB-AXL-ADC BioAtla solid tumors Phase I/II

(anti-AXL antibody-drug conjugate) San Diego, CA www.bioatla.com

CAB-ROR2-ADC BioAtla solid tumors Phase I/II

(anti-ROR2 antibody-drug conjugate) San Diego, CA www.bioatla.com

cabiralizumab Five Prime Therapeutics solid tumors (+nivolumab) Phase II

(anti-CSF1R) South San Francisco, CA www.fiveprime.com

Bristol-Myers Squibb

Princeton, NJ

Cabometyx™ Exelixis advanced solid tumors (+atezolizumab) Phase I

cabozantinib South San Francisco, CA www.exelixis.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

camptothecin (CRLX101) BlueLink Pharmaceuticals advanced solid tumors Phase I

Ames, IA

CB-5083 Cleave Biosciences solid tumors Phase I

(p97 inhibitor) Burlingame, CA www.cleavebio.com

CB-839 Calithera Biosciences solid tumors (+nivolumab) Phase II

(glutaminase inhibitor) South San Francisco, CA www.calithera.com

CBLC137 Incuron solid tumors Phase I

(curaxin) Buffalo, NY www.incuron.com

CBP501 CanBas advanced solid tumors Phase I

(peptide mimetic) Numazu, Japan www.canbas.co.jp

CBT-101 CBT Pharmaceuticals solid tumors Phase I

(c-Met inhibitor) Pleasanton, CA www.cbtpharma.com

CBT-101 + CBT-501 CBT Pharmaceuticals solid tumors Phase I

(c-Met + anti-PD-1) Pleasanton, CA www.cbtpharma.com

CBT-501 (genolimzumab) CBT Pharmaceuticals solid tumors Phase I

(anti-PD-1 mAb) Pleasanton, CA www.cbtpharma.com

CBT-501 + CBT-502 CBT Pharmaceuticals solid tumors Phase I

(anti-PD-1 + anti-PD-L1) Pleasanton, CA www.cbtpharma.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

CC-90002 Celgene solid tumors Phase I

(anti-CD47 antibody) Summit, NJ www.celgene.com

CC-90010 Celgene solid tumors Phase I

(BET inhibitor) Summit, NJ www.celgene.com

CC-90011 Celgene solid tumors Phase I

(LSD1 inhibitor) Summit, NJ www.celgene.com

CDX-0158 Celldex Therapeutics solid tumors Phase I

(anti-KIT IgG1 antibody-drug conjugate) Hampton, NJ www.celldex.com

CDX-1140 Celldex Therapeutics advanced solid tumors Phase I

(anti-CD40 mAb) Hampton, NJ www.celldex.com

ceramide nanoliposome Keystone Nano solid tumors Phase I/II

State College, PA www.keystonenano.com

CGX1321 Curegenix solid tumors Phase I

Burlingame, CA

CK-301 Checkpoint Therapeutics solid tumors Phase I

(anti-PD-L1 mAb) New York, NY www.checkpointtx.com

CMB305 Immune Design NY-ESO-1-expressing solid tumors Phase II

(antigen-specific prime boost) Seattle, WA www.immunedesign.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

CNV-NT BioMed Valley Discoveries solid tumors Phase I

(clostridium novyi -NT) Kansas City, MO www.biomed-valley.com

COH29 Novonco Therapeutics solid tumors Phase I

(ribonucleoside reductase inhibitor) Los Angeles, CA www.novoncotherapeutics.com

CPX-POM CicloMed advanced solid tumors Phase I

(ciclopirox prodrug) Kansas City, MO www.ciclomed.com

CRLX301 BlueLink Pharmaceuticals solid tumors Phase I/II

(docetaxel) Ames, IA

Crolibulin™ Cytovia solid tumors Phase I/II

vascular disrupting agent Englewood Cliffs, NJ www.immunepharma.com

CX-072 CytomX Therapeutics solid tumors Phase I/II

(PD-L1 targeting probody) South San Francisco, CA www.cytomix.com

CX-2009 CytomX Therapeutics solid tumors Phase I/II

(CD166-targeting probody- South San Francisco, CA www.cytomx.com

drug conjugate)

CYAD-01 Celyad solid tumors Phase I

(NKG2D CAR-T cell therapy) New York, NY www.celyad.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

CYC065 Cyclacel Pharmaceuticals solid tumors Phase I

(CDK2/CDK9 inhibitor) Berkeley Heights, NJ www.cyclacel.com

CYT-6091 CytImmune Sciences solid tumors Phase I completed

(nanotherapy comprised of cAU Rockville, MD www.cytimmune.com

particles, tumor necrosis factor,

PEG-Thiol)

CZ48 Cao Pharmaceuticals solid tumors Phase I

(DNA topoisomerase I inhibitor) Webster, TX www.caopharmaceuticals.com

NMT Pharmaceuticals

Webster, TX

DCC-2618 Deciphera Pharmaceuticals solid tumors Phase I

(PDGFR-alpha kinase switch Waltham, MA www.deciphera.com

control inhibitor)

DCC-3014 Deciphera Pharmaceuticals solid tumors Phase I

(CSF1R inhibitor) Waltham, MA www.deciphera.com

DCVax®-Direct Northwest Biotherapeutics solid tumors Phase I/II

cancer vaccine Bethesda, MD www.nwbio.com

derazantinib (ARQ 087) ArQule solid tumors Phase I

(FGFR antagonist) Burlington, MA www.arqule.com

Basilea Pharmaceutica

Basel, Switzerland

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Solid TumorsProduct Name Sponsor Indication Development Phase

DFP 13318 Delta-Fly Pharma solid tumors Phase I

(DNA topoisomerase I inhibitor) Tokushima, Japan www.delta-flypharma.co.jp

DSP-0509 Sumitomo Dainippon Pharma solid tumors Phase I

(TLR-7 agonist)  Osaka, Japan www.ds-pharma.com

DSP-7888 Sumitomo Dainippon Pharma solid tumors Phase I

(adegramotide/nelatimotide) Osaka, Japan www.ds-pharma.com

eFT508 eFFECTOR Therapeutics advanced solid tumors Phase I/II

(MKNK1/MKNK2 protein inhibitor) San Diego, CA www.effector.com

Elenagen™ CureLab Oncology solid tumors Phase I/II completed

p62 anti-cancer DNA Vaccine Boston, MA www.curelaboncology.com

emactuzumab (RG7155) Roche/Genentech solid tumors (+atezolizumab), Phase I

(mCS- receptor antagonist) South San Francisco, CA solid tumors (+selicrelumab) www.gene.com

enadenotucirev PsiOxus Therapeutics solid tumors (+nivolumab) Phase I

(oncolytic virus therapeutic) Plymouth Meeting, PA www.psioxus.com

enoblituzumab MacroGenics solid tumors (+anti-PD-1) Phase II

(anti-B7-H3 IgG1/κ mAb) Rockville, MD www.macrogenics.com

entolimod Cleveland BioLabs advanced solid tumors Phase I

(TLR5 agonist) Buffalo, NY www.cbiolabs.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

entrectinib Ignyta NTRK-positive extracranial solid tumors Phase I

(panTRK/ROS1 inhibitor) San Diego, CA www.ignyta.com

ORPHAN DRUG

ERY974 Chugai Pharmaceutical advanced solid tumors Phase I

(anti-glypican3/CD3 bispecific antibody) Tokyo, Japan www.chugai-pharm.co.jp

ETC-1922159 Biomedical Sciences Institute solid tumors Phase I

(PORCN protein inhibitor) Singapore www.a-star.edu.sg/d3

D3 (Drug Product and Development)

Singapore

FATE-NK100 Fate Therapeutics solid tumors (combination therapy) Phase I

(natural killer cell stimulant) La Jolla, CA www.fatetherapeutics.com

FAZ053 Novartis Oncology advanced solid tumors (+/- PDR001) Phase I

(anti-PD-L1 mAb) East Hanover, NJ www.novartis.com

fenretinide intravenous CerRx solid tumors (adults) Phase II

Lubbock, TX www.cerrx.com

mixed tumors (pediatric) Phase I

www.cerx.com

FF-10502-01 FUJIFILM Pharmaceuticals U.S.A. solid tumors Phase I

(DNA synthesis inhibitor) Cambridge, MA www.fujifilmusa.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

FF-21101 FUJIFILM Pharmaceuticals U.S.A. solid tumors Phase I

(Y-90 radiolabeled mAb) Cambridge, MA www.fujifilmusa.com

FGF401 Novartis Oncology solid tumors Phase I/II

(FGFR4 antagonist) East Hanover, NJ www.novartis.com

fimepinostat (CUDC-907) Curis solid tumors Phase I

(HDAC/PI3K inhibitor) Lexington, MA www.curis.com

FLX475 FLX Bio solid tumors Phase I

(CCR4 receptor antagonist) South San Francisco, CA www.flxbio.com

FPA150 Five Prime Therapeutics solid tumors Phase I

(B7-H4 antibody) South San Francisco, CA www.fiveprime.com

fruquintinib Hutchison MediPharma advanced solid tumors Phase I

(VEGFR inhibitor) Shanghai, China www.hmplglobal.com

galinpepimut-S Sellas Life Sciences solid tumors (+pembrolizumab) Phase I

(anti-WT1 peptide cancer vaccine) New York, NY www.sellaslifesciences.com

galunisertib Eli Lilly advanced refractory solid tumors Phase I/II

(TGF-beta 1 inhibitor) Indianapolis, IN (+nivolumab) www.lilly.com

GDC-0077 (RG6114) Genentech solid tumors Phase I

(PI3K inhibitor) South San Francisco, CA www.gene.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

GDC-0575 (RG7741) Array BioPharma solid tumors Phase I

(ChK1 inhibitor) Boulder, CO www.gene.com

Genentech

South San Francisco, CA

GDC-5573 (RG6185) Genentech solid tumors Phase I

(RAF inhibitor) South San Francisco, CA www.gene.com

glesatinib (MGCD265) Mirati Therapeutics advanced solid tumors Phase I

(multi-kinase inhibitor) San Diego, CA www.mirati.com

GL-ONC1 Genelux solid tumors Phase II

(oncolytic virus therapy) San Diego, CA www.genelux.com

GMI-1359 GlycoMimetics solid tumors Phase I

(E-selectin/CXCR4 inhibitor) Rockville, MD www.glycomimetics.com

GS-5829 Gilead Sciences solid tumors Phase I

(BET inhibitor) Foster City, CA www.gilead.com

GSK1795091 GlaxoSmithKline solid tumors Phase I

(TLR4 agonist) Research Triangle Park, NC www.gsk.com

GSK3174998 GlaxoSmithKline solid tumors Phase I

(anti-OX40 mAb) Research Triangle Park, NC www.gsk.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

GSK3326595 GlaxoSmithKline solid tumors Phase I

(PRMT5 inhibitor) Research Triangle Park, NC www.gsk.com

GSK3359609 GlaxoSmithKline solid tumors Phase I

(induced T-cell costimulator Research Triangle Park, NC www.gsk.com

agonist antibody)

GSK525762 (molibresib) GlaxoSmithKline solid tumors Phase I

(BET inhibitor) Research Triangle Park, NC www.gsk.com

guadecitabine (SGI-110) Astex Pharmaceuticals solid tumors Phase II

(DNMT1 inhibitor) Pleasanton, CA www.astx.com

GWN323 Novartis Oncology solid tumors (+PDR001) Phase I

(anti-C+GITR mAb) East Hanover, NJ www.novartis.com

haNK for infusion NantKwest solid tumors Phase I

(nature killer cells) Culver City, CA www.nantkwest.com

HDM201 Novartis Oncology solid tumors Phase I

(p53-HDM2 inhibitor) East Hanover, NJ www.novartis.com

HTI-1066 Jiangsu Hengrui Medicine advanced solid tumors Phase I

(antibody-drug conjugate) Jiangsu, China www.hrs.com.cn

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Solid TumorsProduct Name Sponsor Indication Development Phase

Hu5F9-G4 Forty Seven solid tumors Phase I

(CD47 antigen inhibitor mAb) Menlo Park, CA www.fortyseveninc.com

HuMax-AXL-ADC Genmab solid tumors Phase I/II

(anti-AXL antibody-drug conjugate) Princeton, NJ www.seattlegenetics.com

Seattle Genetics

Bothell, WA

IDO inhibitor(2) Bristol-Myers Squibb solid tumors Phase I

Princeton, NJ www.bms.com

IM156 ImmunoMet solid tumors Phase I

(OXPHOS inhibitor) Houston, TX www.immunomet.com

IMA101 Immatics US solid tumors Phase I

(adoptive T-cell therapy) Houston, TX www.immatics.com

IMA202 Immatics US solid tumors Phase I

(adoptive T-cell therapy) Houston, TX www.immatics.com

Imbruvica® Janssen Research & Development solid tumors Phase II

ibrutinib Raritan, NJ www.janssen.com

Pharmacyclics www.pharmacyclics.com

Sunnyvale, CA

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Solid TumorsProduct Name Sponsor Indication Development Phase

Imfinzi® MedImmune solid tumors (+MEDI0680), Phase II

durvalumab Gaithersburg, MD solid tumors (monotherapy) www.medimmune.com

solid tumors (+AZD1775), Phase I

solid tumors (+MEDI0562), www.medimmune.com

solid tumors (+MEDI9197),

solid tumors (+monalizumab),

solid tumors (+oleclumab),

solid tumors (+selumetinib),

solid tumors (+tremelimumab)

solid tumors (+AZD9150 +chemotherapy)

Imlygic® Amgen pediatric non-CNS tumors Phase I

talimogene laherparepvec Thousand Oaks, CA www.amgen.com

IMX-110 Immix Biopharma solid tumors Phase I/II

(STAT3/NF-kB/poly-tyrosine kinase Los Angeles, CA www.immixbio.com

inhibitor, curcumin and low-dose

doxorubicin nanotherapy)

INCAGN1876 Agenus solid tumors Phase I/II

(anti-GITR antibody) Lexington, MA www.agenus.com

Incyte www.incyte.com

Wilmington, DE

INCAGN1949 Agenus solid tumors Phase I/II

(anti-OX40 antibody) Lexington, MA www.agenus.com

Incyte www.incyte.com

Wilmington, DE

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Solid TumorsProduct Name Sponsor Indication Development Phase

INCB01158 Calithera Biosciences solid tumors (+checkpoint inhibitor), Phase I

(arginase inhibitor) South San Francisco, CA solid tumors (+chemotherapy), www.calithera.com

Incyte solid tumors (+epacadostat)

Wilmington, DE

INO-1400 Inovio Pharmaceuticals solid tumors Phase I

(hTERT DNA cancer vaccine) Plymouth Meeting, PA www.inovio.com

INT230-6 Intensity Therapeutics solid tumors Phase I/II

(cisplatin-based intratumoral Westport, CT www.intensitytherapeutics.com

cancer vaccine)

IPI-549 Infinity Pharmaceuticals solid tumors (monotherapy), Phase I

(PI3K-gamma inhibitor) Cambridge, MA solid tumors (+nivolumab) www.infi.com

IT-139 Intezyne solid tumors Phase I

(cancer resistance pathway inhibitor) Tampa, FL www.intezyne.com

IT-141 Intezyne solid tumors Phase I

(TOP-1 inhibitor) Tampa, FL www.intezyne.com

JNJ 63723283 Janssen Research & Development advanced solid tumors Phase I

(anti-PD-1 mAb) Raritan, NJ www.janssen.com

JNJ-64457107 (ADC-1013) Janssen Research & Development solid tumors Phase I

(IgG1 antibody immunotherapy) Raritan, NJ www.janssen.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

JTX-2011 Jounce Therapeutics solid tumors Phase II

(ICOS agonist) Cambridge, MA www.jouncetx.com

KA2507 Karus Therapeutics solid tumors Phase I

(HDAC6-selective inhibitor) Oxfordshire, United Kingdom www.karustherapeutics.com

Keytruda® Merck advanced solid tumors Phase IIpembrolizumab Kenilworth, NJ www.merck.com

KHK2455 Kyowa Kirin solid tumors Phase I

(IDO-1 inhibitor) Princeton, NJ www.kyowa-kirin.com

KITE-718 Kite Pharma solid tumors Phase I

(MAGE A3/A6 T-cell therapy) Santa Monica, CA www.kitepharma.com

KN035 Alphamab solid tumors Phase I

(anti-PD-L1 mAb) Suzhou, China www.3dmedcare.com

3D Medicines

Shanghai, China

KO-947 Kura Oncology solid tumors Phase I

(ERK inhibitor) San Diego, CA www.kuraoncology.com

KPT-9274 Karyopharm Therapeutics solid tumors Phase I

(PAK4/NAMPT oral inhibitor) Newton, MA www.karyopharm.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

LAG525 Novartis Oncology solid tumors Phase I/II

(anti-LAG3 mAb) East Hanover, NJ www.novartis.com

LB-100 Lixte Biotechnology solid tumors (combination therapy) Phase I

(PP2A inhibitor) East Setauket, NY www.lixte.com

lefitolimod (MGN1703) Mologen advanced solid tumors (+ipilimumab) Phase I

(DNA-based TLR9 agonist) Berlin, Germany www.mologen.com

M.D. Anderson Cancer Center

Houston, TX

Lenvima® Eisai solid tumors (+pembrolizumab) Phase I/II

lenvatinib Woodcliff Lake, NJ www.eisai.com

LGK974 Novartis Oncology Wnt ligand dependent tumors Phase I

(PORCN protein inhibitor) East Hanover, NJ www.novartis.com

lirilumab Bristol-Myers Squibb advanced solid tumors Phase I/II

(anti-KIR mAb) Princeton, NJ (+nivolumab +ipilimumab) www.bms.com

LOXO-292 Loxo Oncology solid tumors Phase I

(RET kinase inhibitor) Stamford, CT www.loxooncology.com

LTT462 Novartis Oncology advanced solid tumors Phase I

(MAP kinase inhibitor) East Hanover, NJ www.novartis.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

lupartumab amadotin Bayer Pharmaceuticals solid tumors Phase I

(C4-4a antibody-drug conjugate) Whippany, NJ www.pharma.bayer.com

lurbinectedin (PM1183) PharmaMar advanced solid tumors Phase II

(RNA polymerase II inhibitor) Madrid, Spain www.pharmamar.com

LY3022855 (IMC-CS4) Eli Lilly solid tumors Phase I

(CSF-1R mAb) Indianapolis, IN www.lilly.com

LY3023414 Eli Lilly advanced solid tumors Phase I

(PI3K/mTOR inhibitor) Indianapolis, IN www.lilly.com

LY3039478 Eli Lilly advanced or metastatic solid tumors Phase I

(NOTCH inhibitor) Indianapolis, IN (combination therapy) www.lilly.com

LY3127804 Eli Lilly solid tumors Phase I

(Ang2 antibody) Indianapolis, IN www.lilly.com

LY3200882 Eli Lilly solid tumors Phase I

(TGF-betaR1 kinase inhibitor) Indianapolis, IN www.lilly.com

LY3214996 Eli Lilly solid tumors Phase I

(ERK1/2 inhibitor) Indianapolis, IN www.lilly.com

LY3300054 Eli Lilly solid tumors Phase I

(PD-L1 antibody) Indianapolis, IN www.lilly.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

LY3321367 Eli Lilly solid tumors (+/-LY3300054) Phase I

(TIM-3 antibody) Indianapolis, IN www.lilly.com

LY3381916 Eli Lilly solid tumors (+/-PD-L1) Phase I

(IDO-1 inhibitor) Indianapolis, IN www.lilly.com

LYC-55716 Lycera solid tumors Phase II

(ROR-gamma agonist) Ann Arbor, MI www.lycera.com

Lynparza® AstraZeneca solid tumors (+durvalumab) Phase II

olaparib Wilmington, DE www.astrazeneca.com

solid tumors (+AZD1775) Phase I

www.astrazeneca.com

LZM009 Livzon Pharmaceutical solid tumors Phase I

(anti-PD-1 mAb) Zhuhai City, China

M2698 EMD Serono solid tumors Phase I

(p70S6K/AKT inhibitor) Rockland, MA www.emdserono.com

M3541 EMD Serono solid tumors Phase I

(ATM inhibitor) Rockland, MA www.emdserono.com

M3814 EMD Serono solid tumors Phase I

(DNA-PK inhibitor) Rockland, MA www.emdserono.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

M4112 EMD Serono solid tumors Phase II

(cancer immunotherapy) Rockland, MA www.emdserono.com

M4344 (VX-803) EMD Serono solid tumors Phase I

(ATR inhibitor) Rockland, MA www.emdserono.com

Vertex Pharmaceuticals

Boston, MA

M6620 (VX-970) EMD Serono solid tumors Phase I

(ATR inhibitor) Rockland, MA www.emdserono.com

Vertex Pharmaceuticals

Boston, MA

M7824 EMD Serono solid tumors Phase II

(PD-L1 / TGF-beta inhibitor) Rockland, MA www.emdserono.com

M8891 EMD Serono solid tumors Phase I

(MetAP2 inhibitor) Rockland, MA www.emdserono.com

M9241 (NHS-IL12) EMD Serono solid tumors Phase I

(IL-12 stimulant) Rockland, MA www.emdserono.com

M9831 EMD Serono solid tumors Phase I

(DNA-PK inhibitor) Rockland, MA www.emdserono.com

MAGE-A4 TCR Adaptimmune solid tumors Phase I

(T-cell receptor cell therapy) Philadelphia, PA www.adaptimmune.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

MBG453 Novartis Oncology solid tumors Phase I/II

(anti-TIM3 antibody) East Hanover, NJ www.novartis.com

MEDI1873 MedImmune solid tumors Phase I

(GITR agonist fusion protein) Gaithersburg, MD www.medimmune.com

MEDI4276 MedImmune solid tumors Phase I

(ERBB 2 receptor modulator) Gaithersburg, MD www.medimmune.com

MEDI5083 MedImmune solid tumors Phase I

(immune activator) Gaithersburg, MD www.medimmune.com

MEDI9197 MedImmune solid tumors Phase I

(TLR7/8 agonist) Gaithersburg, MD www.medimmune.com

MGA012 (INCMGA0012) Incyte solid tumors Phase I

(anti-PD-1 mAb) Wilmington, DE www.incyte.com

MacroGenics www.macrogenics.com

Rockville, MD

MGD009 MacroGenics solid tumors (monotherapy), Phase I

(B7-H3 x CD3 bispecific antibody) Rockville, MD solid tumors (+MGA012) www.macrogenics.com

MGD013 MacroGenics solid tumors Phase I

(anti-PD-1 mAb x LAG-3) Rockville, MD www.macrogenics.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

minnelide Minneamrita Therapeutics advanced solid tumors Phase I

(HSP70 heat shock protein inhibitor) Tampa, FL

miransertib (ARQ-092) ArQule solid tumors Phase I

(pan-AKT inhibitor) Burlington, MA www.arqule.com

mivebresib (ABBV-075) AbbVie solid tumors Phase I

(BET inhibitor) North Chicago, IL www.abbvie.com

MK-1248 Merck advanced solid tumors Phase I

Kenilworth, NJ (+/-pembrolizumab) www.merck.com

MK-1308 Merck solid tumors Phase I

(CTLA-4 antagonist) Kenilworth, NJ www.merck.com

MK-1454 Merck solid tumors Phase I

(STING agonist) Kenilworth, NJ www.merck.com

MK-2118 Merck solid tumors (+/-pembrolizumab) Phase I

Kenilworth, NJ www.merck.com

MK-4166 Merck solid tumors (+/-pembrolizumab) Phase I

(GITR protein stimulant) Kenilworth, NJ www.merck.com

MK-4280 Merck solid tumors (+/-pembrolizumab) Phase I

(anti-LAG3 mAb) Kenilworth, NJ www.merck.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

MK-5890 Merck solid tumors (+/-pembrolizumab) Phase I

Kenilworth, NJ www.merck.com

MK-7123 (navarixin) Merck advanced solid tumors Phase I

(CXCR2/CXCR1 antagonist) Kenilworth, NJ (+pembrolizumab) www.merck.com

MK-7162 Merck solid tumors (+pembrolizumab) Phase I

Kenilworth, NJ www.merck.com

MK-7252 Merck advanced solid tumors Phase I

Kenilworth, NJ www.merck.com

MK-7684 Merck advanced solid tumors Phase I

(anti-TIGIT) Kenilworth, NJ (+/-pembrolizumab) www.merck.com

MK-8353 Merck advanced solid tumors (+pembrolizumab) Phase I

(ERK inhibitor) Kenilworth, NJ www.merck.com

MM-310 Merrimack Pharmaceuticals solid tumors Phase I

(antibody-directed nanotherapeutic Cambridge, MA www.merrimack.com

targeting EphA2 receptor)

mogamulizumab Kyowa Hakko Kirin solid tumors (+ docetaxel), Phase I

(CCR4 receptor antagonist) Princeton, NJ solid tumors (+nivolumab) www.kyowa-kirin.com

solid tumors

(+ durvalumab + tremelimumab)

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Solid TumorsProduct Name Sponsor Indication Development Phase

MORAb-066 Eisai solid tumors Phase I

(anti-TF IgG mAb) Woodcliff Lake, NJ www.eisai.com

MORAb-202 Eisai solid tumors Phase I

(antibody-drug conjugate) Woodcliff Lake, NJ www.eisai.com

mRNA-2416 Moderna Therapeutics solid tumors Phase I

(OX40L protein modulator) Cambridge, MA www.modernatx.com

mRNA-4157 Moderna Therapeutics solid tumors Phase I

(personalized cancer vaccine) Cambridge, MA www.modernatx.com

MS201408-0005A EMD Serono solid tumors Phase I

Rockland, MA www.emdserono.com

MS201408-0005B EMD Serono solid tumors Phase I

Rockland, MA www.emdserono.com

MS201408-0005C EMD Serono solid tumors Phase I

Rockland, MA www.emdserono.com

MSB2311 MabSpace Biosciences solid tumors Phase I

(anti-PD-L1 antibody) Suzhou, China www.mabspacebio.com

MTIG7192A (RG6058) Genentech solid tumors Phase I

(anti-TIGIT mAb) South San Francisco, CA www.gene.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

MVA p53 vaccine Tara Immuno-Oncology solid tumors Phase I

(modified vaccinia virus ankara New York, NY

vaccine expressing p53)

MVT-1075 MabVax Therapeutics CA19-9-expressing solid tumors Phase I

(177Lu mAB 5B1/radio- San Diego, CA www.mabvax.com

imunotherapy)

MVT-5873 MabVax Therapeutics CA19-9-expressing solid tumors, Phase I

(5B1 mAb) San Diego, CA CA19-9-expressing tumors www.mabvax.com

(+ chemotherapy)

napabucasin Boston Biomedical solid tumors Phase I/II

(STAT3 inhibitor) Cambridge, MA (+immune checkpoint inhibitors) www.bostonbiomedical.com

advanced solid tumors (+amcasertib) Phase I

www.bostonbiomedical.com

NBT-011 (ABI-011) NantBioScience solid tumors Phase I

(angiogenesis inhibitor) Culver City, CA www.nantworks.com

NC-6300 NanoCarrier advanced solid tumors Phase I

(epirubicin micelle) Chiba, Japan www.nanocarrier.co.jp

NEV-801 Neovia Oncology solid tumors Phase I

(camptothecin/podophyllotoxin) Bellevue, WA www.neoviaoncology.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

NG-348 Bristol-Myers Squibb solid tumors Phase I

(CD80/CD3 T-SIGn oncolytic virus) Princeton, NJ www.bms.com

PsiOxus Therapeutics www.psioxus.com

Plymouth Meeting, PA

NIR178 Novartis Oncology solid tumors (+ PDR001) Phase II

(adenosine receptor antagonist) East Hanover, NJ www.novartis.com

NIS793 Novartis Oncology solid tumors (+PDR001) Phase I

(TGF-beta inhibitor) East Hanover, NJ www.novartis.com

NIZ985 Novartis Oncology advanced or metastatic Phase I

(heterodimeric IL-15) East Hanover, NJ solid tumors (+ PDR001) www.novartis.com

NKTR-214 Nektar Therapeutics advanced solid tumors, Phase I/II

(CD122-biased immune- San Francisco, CA advanced solid tumors (+NKTR-262), www.nektar.com

stimulatory cytokine) advanced solid tumors (+nivolumab)

advanced solid tumors (+atezolizumab), Phase I

advanced solid tumors (+pembrolizumab) www.nektar.com

NKTR-262 Nektar Therapeutics advanced solid tumors Phase I

(TLR 7/8 agonist) San Francisco, CA www.nektar.com

NLG802 NewLink Genetics advanced solid tumors Phase I

(IDO inhibitor) Ames, IA www.newlinkgenetics.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

NP-G2-044 Novita Pharmaceuticals solid tumors Phase I

(metastasis inhibitor) New York, NY

OBP-801 Oncolys BioPharma solid tumors Phase I

(HDAC inhibitor) Tokyo, Japan www.oncolys.com

oleclumab (MEDI9447) MedImmune solid tumors Phase I

(nucleotidase inhibitor) Gaithersburg, MD www.medimmune.com

OMP-313M32 OncoMed Pharmaceuticals solid tumors Phase I

(anti-TIGIT mAb) Redwood City, CA www.oncomed.com

OMP-336B11 OncoMed Pharmaceuticals solid tumors Phase I

(GITRL-Fc fusion protein) Redwood City, CA www.oncomed.com

ONC201 Oncoceutics solid tumors Phase I

(dopamine receptor D2/3 antagonist) Philadelphia, PA www.oncoceutics.com

ONO-4578 Bristol-Myers Squibb solid tumors Phase I

(EP4 antagonist) Princeton, NJ www.bms.com

ONO-7579 Ono Pharmaceutical solid tumors Phase I/II

(Trk inhibitor) Osaka, Japan www.ono.co.jp

OPB-111077 Otsuka Pharmaceutical solid tumors Phase I

(signal transduction pathway inhibitor) Rockville, MD www.otsuka.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

Opdivo® Bristol-Myers Squibb virus positive/negative solid tumors Phase I/II

nivolumab Princeton, NJ www.bms.com

Opdivo® + Yervoy® Bristol-Myers Squibb virus positive/negative solid tumors Phase I/II

nivolumab + ipilimumab Princeton, NJ www.bms.com

Oradoxel Athenex solid tumors Phase I

docetaxel oral Buffalo, NY www.athenex.com

oral-Vimo-001 Veana Therapeutics solid tumors Phase I

(alpha-tocopheroloxyacetic acid) Portland, OR www.veana-therapeutics.com

Oratecan™ Athenex advanced solid tumors Phase I

irinotecan+HM30181A Buffalo, NY www.athenex.com

Hamni Pharmaceutical

Seoul, South Korea

pamiparib (BGB-290) BeiGene USA solid tumors Phase I/II(PARP inhibitor) Cambridge, MA www.beigene.com

PCM-075 TrovaGene advanced solid tumors Phase I(PLK1 inhibitor) San Diego, CA www.trovagene.com

PD-L1 mAb + LY combo Eli Lilly solid tumors Phase I

Indianapolis, IN www.lilly.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

pegargiminase Polaris Pharmaceuticals advanced solid tumors Phase I(ADI-PEG-20) San Diego, CA (+pembrolizumab) www.polarispharma.com

PEN-866 Tarveda Therapeutics solid tumors Phase I/II(DNA topoisomerase I inhibitor) Watertown, MA www.tarveda.com

PF-06804103 Pfizer solid tumors Phase I(antibody-drug conjugate) New York, NY www.pfizer.com

PIN-2 PIN Pharma solid tumors Phase I

(Immune modulator) New York, NY www.pinpharma.com

PLX51107 Plexxikon solid tumors Phase I(BET inhibitor) Berkeley, CA www.plexxikon.com

PLX73086 Plexxikon solid tumors Phase I(CSR-1R antagonist) Berkeley, CA www.plexxikon.com

PLX7486 Plexxikon solid tumors Phase I(Fms/TRK inhibitor) Berkeley, CA www.plexxikin.com

PLX8394 Plexxikon BRAF-mutant solid tumors Phase II(BRAF inhibitor) Berkeley, CA www.plexxikon.com

PLX9486 Plexxikon KIT-mutant solid tumors Phase I(c-kit inhibitor) Berkeley, CA www.plexxikon.com

Poly-ICLC Oncovir solid tumors Phase II(biological response modifier) Washington, DC www.oncovir.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

PRN1371 Principia Biopharma solid tumors Phase I

(FGFR inhibitor) South San Francisco, CA www.principiabio.com

PRS-343 Pieris Pharmaceuticals solid tumors Phase I

(HER2/41BB bispecific mAb) Boston, MA www.pieris.com

PT-112 Phosplatin Therapeutics advanced solid tumors Phase I

phosphaplatin New York, NY www.phosplatin.com

PT2977 Peloton Therapeutics advanced solid tumors Phase I

(HIF-2α inhibitor) Dallas, TX www.pelotontherapeutics.com

PTX-100 Prescient Therapeutics solid tumors Phase I completed

(geranylgeranyl transferase inhibitor) South Melbourne, Australia www.ptxtherapeutics.com

pyrotinib Hengrui Therapeutics HER2-postive solid tumors Phase I

(EGFR/ErbB2 kinase inhibitor) Princeton, NJ www.hengruitherapeutics.com

relacorilant Corcept Therapeutics solid tumors (+nab-paclitaxel), Phase I/II

(glucocorticoid receptor II antagonist)  Menlo Park, CA www.corcept.com

relatlimab Bristol-Myers Squibb solid tumors (+/-nivolumab) Phase I/II

(anti-LAG3 mAb) Princeton, NJ www.bms.com

RG6146 Roche/Genentech solid tumors Phase I

(BET inhibitor) South San Francisco, CA www.roche.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

RG7386 Roche/Genentech solid tumors Phase I

(FAP-DR5 bispecific mAb) South San Francisco, CA www.roche.com

RG7461 Roche/Genentech solid tumors Phase I

(IL-1 variant fused to FAP antagonist) South San Francisco, CA www.roche.com

RG7802 Roche/Genentech solid tumors (+atezolizumab) Phase I

(CEA T-cell bispecific mAb) South San Francisco, CA www.roche.com

RG7813 Roche/Genentech solid tumors (+atezolizumab) Phase I

(cergutuzumab amunaleukin) South San Francisco, CA www.roche.com

RGX-104 Rgenix solid tumors Phase I

(LXR agonist) New York, NY www.rgenix.com

rivoceranib LSK Biopharma solid tumors (+nivolumab) Phase I

(VEGFr-2 antagonist) Salt Lake City, UT www.lskbiopharma.com

rogaratinib Bayer Pharmaceuticals solid tumors Phase I

(pan-EGFR inhibitor) Whippany, NJ www.pharma.bayer.com

rosmantuzumab OncoMed Pharmaceuticals solid tumors Phase I

(RSPO3 protein inhibitor) Redwood City, CA www.oncomed.com

RP1 Replimmune solid tumors Phase I/II

(oncolytic virus immunotherapy) Woburn, MA www.replimmune.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

RRx-001 EpicentRx advanced or metastatic solid tumors Phase I

(free radical stimulant) La Jolla, CA www.epicentrx.com

rSIFN-co Sichuan Huiyang solid tumors Phase I

(interferon) Chengdu City,  China

RXDX-105 Ignyta solid tumors Phase I

(VEGFR-sparing RET inhibitor) San Diego, CA www.ignyta.com

SAR408701 Sanofi solid tumors Phase I

(maytansin-loaded anti-CEACAM5 mAb) Bridgewater, NJ www.sanofi.com

SAR439459 Sanofi advanced solid tumors Phase I

(anti-TGF-beta mAb) Bridgewater, NJ www.sanofi.com

SAR439859 Sanofi advanced solid tumors (+cemiplimab) Phase I

(SERD) Bridgewater, NJ www.sanofi.com

SC-004 AbbVie solid tumors Phase I

(antibody-drug conjugate) North Chicago, IL www.abbvie.om

SDX-7320 SynDevRx solid tumors Phase I

(MetAP2 inhibitor) Cambridge, MA www.syndevrx.com

SEA-CD40 Seattle Genetics solid tumors (+/-checkpoint inhibitor) Phase I

(anti-CD40 mAb) Bothell, WA www.seattlegenetics.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

selicrelumab Roche/Genentech solid tumors (combination therapy) Phase I

(anti-CD40 mAb) South San Francisco, CA www.roche.com

sEphB4-HSA VasGene Therapeutics solid tumors Phase I

(recombinant fusion protein) Los Angeles, CA

Seprehvir® Sorrento Therapeutics solid tumors Phase I

oncolytic virus immunotherapy San Diego, CA www.sorrentotherapeutics.com

SGN-2FF Seattle Genetics advanced solid tumors Phase I

(fucosylation inhibitor) Bothell, WA www.seattlegenetics.com

SGT-53 SynerGene Therapeutics solid tumors (pediatric) Phase I

(gene therapy) Rockville, MD

sitravatinib (MGCD516) Mirati Therapeutics advanced solid tumors Phase I/II

(multi kinase inhibitor) San Diego, CA www.mirati.com

SL-801 Stemline Therapeutics advanced solid tumors Phase I

(XPO1 inhibitor) New York, NY www.stemline.com

SM08502 Samumed solid tumors Phase I

(Wnt signaling pathway inhibitor) San Diego, CA www.samumed.com

SNDX-6352 Syndax Pharmaceuticals solid tumors Phase I

(CSF-1R antagonist) Waltham, MA www.syndax.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

SOR-C13 Soricimed Biopharma solid tumors Phase I

(TRPV6 protein inhibitor) Moncton, Canada www.soricimed.com

SRF231 Surface Oncology solid tumors Phase I

(anti-CD47 mAb) Cambridge, MA www.surfaceoncology.com

sulfatinib Hutchison MediPharma advanced solid tumors Phase I

(VEGFR/FGFR-1/CSF1R inhibitor) Shanghai, China www.hmplglobal.com

SY-1365 Syros Pharmaceuticals solid tumors Phase I

(CDK7 inhibitor) Cambridge, MA www.syros.com

Sym015 Symphogen met-amplified advanced solid tumors Phase I/II

(MET inhibitor) Somerville, NJ www.symphogen.com

Sym021 Symphogen solid tumors Phase I

(anti-PD-1 mAb) Somerville, NJ www.symphogen.com

SYN004 Synermore Biologics solid tumors Phase I

(anti-EGFR mAb) Taipei City, Taiwan www.synermore.com

Taclantis™ Sun Pharma Advanced Research solid tumors Phase IIpaclitaxel liposomal Mumbai, India www.sparc.life

TAK-202 Takeda Oncology solid tumors Phase I

(CCR2 antagonist) Deerfield, IL www.takeda.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

TAK-243 Takeda Oncology solid tumors Phase I

(ubiquitin-activating enzyme Deerfield, IL www.takeda.com

inhibitor)

TAK-580 Takeda Oncology solid tumors Phase II

(Pan-Raf kinase inhibitor) Deerfield, IL www.takeda.com

TAK-931 Takeda Oncology solid tumors Phase I

(CDC7 inhibitor) Deerfield, IL www.takeda.com

TAS-116 Taiho Oncology solid tumors Phase I

(HSP90 inhibitor) Princeton, NJ www.taihooncology.com

TAS-119 Taiho Oncology advanced solid tumors Phase I

(aurora kinase A inhibitor) Princeton, NJ www.taihooncology.com

TAS-120 Taiho Oncology advanced solid tumors Phase I/II

(FGF/FGFR inhibitor) Princeton, NJ www.taihooncology.com

tavolimab (MEDI0562) MedImmune solid tumors Phase I

(OX40 agonist) Gaithersburg, MD www.medimmune.com

tazemetostat Epizyme INI1-negative solid tumors Phase II

(EZH2 enzyme inhibitor) Cambridge, MA www.epizyme.com

advanced solid tumors Phase I/II

www.epizyme.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

Tecentriq® Genentech solid tumors (monotherapy), Phase I

atezolizumab South San Francisco, CA solid tumors (Morpheus platform), www.gene.com

solid tumors (+cobimetinib),

solid tumors (+ipi/IFN)

telisotuzumab vedotin (ABBV-399) AbbVie solid tumors Phase I

(antibody-drug conjugate) North Chicago, IL www.abbvie.com

TEW-7197 MedPacto advanced solid tumors Phase I

(TGF-beta antagonist) Suwon, South Korea www.medpacto.com

TI-061 Arch Oncology solid tumors Phase I/II

(anti-CD47 mAb) San Francisco, CA www.archoncology.com

tilsotolimod (IMO-2125) Idera Pharmaceuticals refractory solid tumors Phase I

(TLR9 agonist) Cambridge, MA www.iderapharma.com

tinostamustine (EDO-S101) Mundipharma advanced solid tumors Phase I/II

(histone deacetylase inhibitor) Cambridge, United Kingdom www.mundipharma.com

tisotumab vedotin Genmab solid tumors Phase II

(tissue factor antibody-drug conjugate) Princeton, NJ www.seattlegenetics.com

Seattle Genetics

Bothell, WA

TLC178 Taiwan Liposome Company advanced solid tumors Phase I/II

(vinorelbine liposomal) Taipei, Taiwan www.tlcbio.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

TNO155 Novartis Oncology solid tumors Phase I

(SHP2 inhibitor) East Hanover, NJ www.novartis.com

Toca 511 + Toca Fc Tocagen solid tumors Phase I

(vocimagene amiretrorepvec- San Diego, CA www.tocagen.com

flucytosine gene therapy)

TP-0903 Tolero Pharmaceuticals solid tumors Phase I

(Axl kinase inhibitor) Lehi, UT www.toleropharma.com

TPX-0005 (ropotrectinib) TP Therapeutics solid tumors Phase I/II

(ALK/ROS-1/TRK inhibitor) San Diego, CA www.tptherapeutics.com

tractinostat Viracta Therapeutics EBV-positive solid tumors Phase I

(HDAC inhibitor) Cardiff, CA (+valganciclovir) www.viracta.com

TRC-102 TRACON Pharmaceuticals solid tumors Phase I

(methoxyamine hydrochloride) San Diego, CA www.traconpharma.com

tremelimumab MedImmune solid tumors (+MEDI0562) Phase I

(IgG2 monoclonal antibody) Gaithersburg, MD www.medimmune.com

TRK-950 Apexigen solid tumors Phase I

(mAb) San Carlos, CA www.apexigen.com

Toray

Tokyo, Japan

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Solid TumorsProduct Name Sponsor Indication Development Phase

TRX518 Leap Therapeutics solid tumors (+anti-PD-1), Phase I/II

(GITR agonist antibody) Cambridge, MA solid tumors (+chemotherapy) www.leaptx.com

solid tumors (monotherapy) Phase I

www.leaptx.com

TRX-818 (CVM-1118) TaiRx solid tumors Phase I

(angiogenesis inhibitor) Taipei, Taiwan www.tairx.tw

TSR-022 TESARO solid tumors Phase I

(anti-TIM-3 mAb) Waltham, MA www.tesarobio.com

TSR-033 TESARO solid tumors Phase I

(anti-LAG3 mAb) Waltham, MA www.tesarobio.com

TSR-042 TESARO solid tumors Phase I

(anti-PD-1 mAb) Waltham, MA www.tesarobio.com

TTI-621 Trillium Therapeutics solid tumors Phase I

(CD47 inhibitors/SIRPA stimulant) Mississauga, Canada www.trilliumtherapeutics.com

urelumab Bristol-Myers Squibb advanced solid tumors (+nivolumab) Phase I/II

(anti-CD137 mAb) Princeton, NJ www.bms.com

USL311 Upsher-Smith solid tumors Phase I/II

(CXCR4 antagonist) Maple Grove, MN www.upsher-smith.com

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Solid TumorsProduct Name Sponsor Indication Development Phase

Vigil™ Gradalis solid tumors (+PD-1/PD-L1) Phase II

autologous tumor cell vaccine Carrolton, TX www.gradalisinc.com

vistusertib AstraZeneca solid tumors Phase II

(mTORC1/2 inhibitor) Wilmington, DE www.astrazeneca.com

VLX600 Vivolux solid tumors Phase I

(iron chelator) Uppsala, Sweden www.vivolux.com

vorolanib (X-82) Tyrogenex advanced solid tumors Phase I completed

(VEGFR and PDGFR inhibitor) Rockville, MD

VSV-IFN-beta-NIS Vyriad solid tumors Phase I

Rochester, NY www.vyriad.com

VT1021 Vigeo Therapeutics solid tumors Phase I

(peptide immunomodulator) Cambridge, MA www.vigeotherapeutics.com

WT-2725 Sunovion Pharmaceuticals solid tumors Phase I

(peptide cancer vaccine) Marlborough, MA www.sunovion.com

X4P-001-IO X4 Pharmaceuticals solid tumors Phase I/II

(CXCR4 inhibitor) Cambridge, MA www.x4pharma.com

XMT-1536 Mersana Therapeutics NaPi2b-expressing solid tumors Phase I

(anti-NaPi2b immunoconjugate) Cambridge, MA www.mersana.com

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OtherProduct Name Sponsor Indication Development Phase

abexinostat Xynomic Pharmaceuticals gynecologic cancer Phase II

(HDAC inhibitor) Cheyenne, WY www.xynomicpharma.com

ABI-009 AADi Bioscience malignant perivascular Phase II

(nab-rapamycin/mTOR inhibitor) Los Angeles, CA epithelioid cell tumors www.aadibio.com

ADXS-DUAL Advaxis metastatic cervical cancer Phase III

(cancer immunotherapy vaccine) Princeton, NJ (+nivolumab) www.advaxis.com

AGEN1884 Agenus cervical cancer (+AGEN2034) Phase I/II

(CTLA-4 antagonist) Lexington, MA www.agenus.com

aglatimagene besadenovec Advantagene malignant pleural effusion Phase I

(gene therapy) Auburndale, MA www.advantagene.com

AL3818 Advenchen Laboratories cervical cancer, endometrial cancer, Phase I/II

(tyrosine kinase inhibitor) Moorpark, CA fallopian tube cancer, primary www.advenchen.com

peritoneal cancer

AQST-305 Aquestive Therapeutics malignant carcinoid syndrome Phase I

(octreotide oral film) Warren, NJ www.aquestive.com

AU-011 Aura Biosciences uveal melanoma (Fast Track) Phase I/II

(light-activated viral nanoparticles) Cambridge, MA www.aurabiosciences.com

ORPHAN DRUG

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OtherProduct Name Sponsor Indication Development Phase

axalimogene filolisbac (AXAL) Advaxis high-risk locally advanced cervical Phase III

(cancer immunotherapy vaccine) Princeton, NJ cancer (Fast Track) www.advaxis.com

ORPHAN DRUG

metastatic anal cancer, Phase II

metastatic cervical cancer www.advaxis.com

(+durvalumab)

Azedra® Progenics Pharmaceuticals malignant and/or recurrent application submitted

Ultratrace® iobenguane I-131 New York, NY pheochromocytoma and paraganglioma www.progenics.com

ORPHAN DRUG (Fast Track)

BMS-986277 Bristol-Myers Squibb epithelial cancer Phase I/II

Princeton, NJ www.bms.com

Cabometyx™ Exelixis carcinoid tumors, Phase II

cabozantinib South San Francisco, CA endometrial cancer (+nivolumab) www.exelixis.com

genitourinary tumors Phase I

(+nivolumab +/-ipilimumab) www.exelixis.com

CBT-1 CBA Pharma cancer with multiple drug resistance application submitted

(tetrandrine) Lexington, KY (adjunctive therapy) www.cbapharma.com

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OtherProduct Name Sponsor Indication Development Phase

cemiplimab Regeneron Pharmaceuticals squamous cell carcinoma application submitted

(anti-PD-1 mAb) Tarrytown, NY (Breakthrough Therapy) www.sanofi.com

Sanofi

Bridgewater, NJ

2L cervical cancer Phase III

www.sanofi.com

CLR-131 Cellectar Biosciences pediatric cancer Phase I

(phospholipid-drug conjugate) Madison, WI www.cellectar.com

COTI-2 Cotinga Pharmaceuticals cervical cancer, endometrial cancer, Phase I

(p53 gene modulator) London, Canada fallopian tube cancer, peritoneal www.cotingapharma.com

cancer

CPP-1X Cancer Prevention Pharmaceuticals neuroblastoma Phase II

(eflornithine + high dose powder sachet) Tucson, AZ www.canprevent.com

ORPHAN DRUG

DCC-2618 Deciphera Pharmaceuticals advanced systemic mastocytosis Phase I

(PDGFR-alpha kinase switch Waltham, MA www.deciphera.com

control inhibitor)

DKN-01 Leap Therapeutics relapsed/refractory endometroid Phase II

(anti-DKK1 mAb) Cambridge, MA endometrial cancer www.leaptx.com

DP-1038 Dauntless Pharmaceuticals neuroendocrine tumors Phase I

(intranasal octreotide) San Diego, CA www.dauntlessph.com

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OtherProduct Name Sponsor Indication Development Phase

DPX-E7 Immunovaccine HPV-related anal cancer, Phase I/II

(peptide cancer vaccine) Halifax, Canada HPV-related cervical cancer www.imvaccine.com

DPX-Survivac Immunovaccine advanced fallopian cancer (Fast Track), Phase I

(cancer vaccine) Halifax, Canada advanced peritoneal cacner (Fast Track) www.imvaccine.com

E7046 Adlai Nortye rectal cancer Phase I

(EP4 antagonist) Hangzhou, China www.adlainortye.com

erdafitinib Janssen Research & Development urogenital cancer Phase II

(FGFRI kinase inhibitor) Raritan, NJ www.janssen.com

fimepinostat (CUDC-907) Curis neuroblastoma Phase I

(HDAC/PI3K inhibitor) Lexington, MA www.curis.com

Gilotrif® Boehringer Ingelheim Pharmaceuticals neuroectodermal tumors Phase I/II

afatinib Ridgefield, CT www.boehringer-ingelheim.com

ORPHAN DRUG

GL-ONC1 Genelux peritoneal cavity cancer Phase I

(oncolytic virus therapy) San Diego, CA www.genelux.com

IMCgp100 Immunocore uveal melanoma Phase II

(T-cell receptor therapy) Conshohocken, PA www.immunocore.com

ORPHAN DRUG

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OtherProduct Name Sponsor Indication Development Phase

ingenol disoxate LEO Pharma squamous cell carcinoma (prevention) Phase III

(protein kinase C stimulant) Madison, NJ www.leo-pharma.us

iobenguane-I-131 Jubilant DraxImage neuroblastoma Phase II

Kirkland, Canada www.draximage.com

New Approaches to Neuroblastoma

Therapy Consortium

Los Angeles, CA

IPI-549 Infinity Pharmaceuticals adrenocortical carcinoma (+nivolumab) Phase I

(PI3K-gamma inhibitor) Cambridge, MA www.infi.com

Keytruda® Merck nasopharyngeal cancer Phase III

pembrolizumab Kenilworth, NJ www.merck.com

larotrectinib (LOXO-101) Loxo Oncology locally advanced or metastatic solid application submitted

(TRK inhibior) Stamford, CT tumors harboring an NTRK gene fusion www.loxooncology.com

ORPHAN DRUG (Breakthrough Therapy)

solid or primary CNS tumors with Phase II

TRK infusions (adults) www.loxooncology.com

solid or primary CNS tumors with Phase I/II

TRK infusions (pediatric) www.loxooncology.com

LN-145 Iovance Biotherapeutics cervical cancer Phase II

(tumor-infiltrating lymphocyte) San Carlos, CA www.iovance.com

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OtherProduct Name Sponsor Indication Development Phase

lurbinectedin (PM1183) PharmaMar 2L endometrial cancer Phase II

(RNA polymerase II inhibitor) Madrid, Spain www.pharmamar.com

LXS196 Novartis Oncology uveal melanoma Phase I

(protein kinase C inhibitor) East Hanover, NJ www.novartis.com

MCS110 Novartis Oncology giant cell tumor of the tendon sheath Phase II

(CSF-1 mAb) East Hanover, NJ www.novartis.com

mirvetuximab soravtansine ImmunoGen FOLR1-positive endometrial cancer Phase I

(folate receptor 1 antagonist) Waltham, MA www.immunogen.com

navicixizumab OncoMed Pharmaceuticals fallopian tube cancer, Phase I

(anti-DLL4/VEGF bispecific mAb) Redwood City, CA peritoneal cancer www.oncomed.com

naxitamab Y-mAbs Therapeutics relapsed/refractory neuroblastoma Phase III

(anti-GD2 3F8 mAb) New York, NY www.ymabs.com

ORPHAN DRUG

nirogacestat SpringWorks Therapeutics desmoid tumor Phase II

(gamma secretase inhibitor) New York, NY www.springworkstx.com

omburtamab I-131 Y-mAbs Therapeutics CNS/leptomeningeal metastasis Phase II/III

(B7-H3 inhibitor) New York, NY from neuroblastoma www.ymabs.com

ORPHAN DRUG

desmoplastic small round cell tumor Phase I/II

www.ymabs.com

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OtherProduct Name Sponsor Indication Development Phase

ONC201 Oncoceutics endometrial cancer, Phase II

(dopamine receptor D2/3 antagonist) Philadelphia, PA neuroendocrine tumors www.oncoceutics.com

ovapuldencel-T AiVita Biomedical advanced peritoneal cancer Phase II

(dendritic cell cancer vaccine) Irvine, CA advanced fallopian tube cancer www.aivitabiomedical.com

p53 cell pentrating peptide CDG Therapeutics recurrent or progressive CNS tumors Phase I completed

Chicago, IL www.cdgti.com

patidegib PellePharm basal cell nevus syndrome Phase II

(hedgehog signaling inhibitor) San Francisco, CA (Gorlin Syndrome) www.pellepharm.com

ORPHAN DRUG

pegargiminase Polaris Pharmaceuticals ASS1-deficient tumors Phase I

(ADI-PEG-20) San Diego, CA (+pemetrexed +cisplatin) www.polarispharma.com

PEGPH20 Halozyme Therapeutics gallbladder adenocarcinoma Phase I

(pegylated recombinant San Diego, CA (+atezolizumab) www.halozyme.com

human hyalurinodase)

PEN-221 Tarveda Therapeutics neuroendocrine tumors Phase I/II

(somatostatin receptor 2 modulator) Watertown, MA www.tarveda.com

Pixuvri® CTI BioPharma relapsed/refractory cancer (pediatric) Phase I

pixantrone Seattle, WA www.ctibiopharma.com

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OtherProduct Name Sponsor Indication Development Phase

Prolanta™ Oncolix fallopian tube cancer, Phase I

prolactin receptor antagonist Houston, TX peritoneal cancer www.oncolixbio.com

PTC596 PTC Therapeutics fallopian tube cancer, Phase I

(tumor stem cell targeting) South Plainfield, NJ peritoneal cancer www.ptcbio.com

PV-10 Provectus Biopharmaceuticals neuroendocrine tumors Phase I

(rose bengal sodium) Knoxville, TN www.provectusbio.com

REM-001 (rostaporfin) Adgero Biopharmaceuticals cutaneous metastatic recurrent Phase I

(photosensitizer) Princeton, NJ basal cell nevus syndrome www.adgerobiopharm.com

ORPHAN DRUG

Rova-T AbbVie neuroendocrine tumors Phase I

(rovalpituzumab tesirine) North Chicago, IL www.abbvie.com

RRx-001 EpicentRx neuroendocrine tumors Phase II

(free radical stimulant) La Jolla, CA www.epicentrx.com

sacituzumab govitecan Immunomedics metastatic endometrial can cer Phase II

(anti-TROP-2-SN-38 ADC) Morris Plains, NJ www.immunomedics.com

selinexor Karyopharm Therapeutics endometrial cancer Phase III

(nuclear export inhibitor) Newton, MA www.karyopharm.com

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OtherProduct Name Sponsor Indication Development Phase

selumetinib AstraZeneca differentiated thyroid cancer Phase III

(MEK1/2 inhibitor) Wilmington, DE www.astrazeneca.com

ORPHAN DRUG Merck www.merck.com

Kenilworth, NJ

SNX-5422 Esanex neuroendocrine tumors Phase I

(Hsp90 inhibitor) Indianapolis, IN www.esanexpharma.com

Sym013 Symphogen advanced epithelial cancer Phase I/II

(EGFR/HER2/HER3 inhibitor) Somerville, NJ www.symphogen.com

tirabrutinib Gilead Sciences B-cell malignancies Phase II

(Btk inhibitor) Foster City, CA www.gilead.com

TT12 (armoured HPVST) Tessa Therapeutics cervical cancer Phase I

(HPV-specific T-cell therapy) Singapore www.tessatherapeutics.com

VGX-3100 Inovio Pharmaceuticals cervical high-grade squamous Phase III

(DNA cancer vaccine) Plymouth meeting, PA intraepithelial lesions www.inovio.com

vulvar high-grade squamous Phase II

intraepithelial lesions www.inovio.com

XBIO-101 Xenetic Biosciences recurrent or persistent endometrial Phase II

(cridanimod) Lexington, MA cancer www.xeneticbio.com

ORPHAN DRUG

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OtherProduct Name Sponsor Indication Development Phase

XmAb18087 Xencor neuroendocrine tumors Phase I

(SSTR2 x CD3 bispecific mAb) Monrovia, CA www.xencor.com

Xofigo® Bayer Pharmaceuticals bone metastases in breast cancer Phase II

radium Ra 223 dichloride Whippany, NJ www.pharma.bayer.com

UnspecifiedProduct Name Sponsor Indication Development Phase

AB122 Arcus Biosciences cancer Phase I

(anti-PD-1 mAb) Hayward, CA www.arcusbio.com

AB928 Arcus Biosciences cancer Phase I

(adenosine A2A/A2B Hayward, CA www.arcusbio.com

receptor antagonist)

AK107 Akeso Biopharma cancer Phase I

(checkpoint inhibitor) Guangdong, China www.akesobio.com

Merck

Kenilworth, NJ

anti-PD-L1 mAb TG Therapeutics cancer Phase I

New York, NY www.tgtherapeutics.com

autologous stem cell-based StemImmune cancer Phase I completed

cancer immunotherapy San Diego, CA www.stemimmune.com

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UnspecifiedProduct Name Sponsor Indication Development Phase

AutoSynVax® Agenus advanced cancer Phase I

autologous synthetic vaccine Lexington, MA www.agenusbio.com

Bavencio® EMD Serono cancer (+OX40 +4-1BB) Phase I

avelumab Rockland, MA www.emdserono.com

(anti-PD-L1 inhibitor) Pfizer www.pfizer.com

New York, NY

bevacizumab biosimilar Apobiologix cancer in clinical trials

Weston, FL www.apobiologix.com

BMS-986205 Bristol-Myers Squibb advanced cancer (+nivolumab) Phase I

(IDO1 inhibitor) Princeton, NJ www.bms.com

BPX-501 Bellicum Pharmaceuticals cancer (adults) Phase I/II

(rivogenlecleucel) Houston, TX www.bellicum.com

cemiplimab Regeneron Pharmaceuticals advanced cancer (+REGN3767) Phase I

(anti-PD-1 mAb) Tarrytown, NY www.sanofi.com

Sanofi

Bridgewater, NJ

CPI-006 Corvus Pharmaceuticals advanced cancer Phase I

(type 2 humanized IgG1 antibody) Burlingame, CA (+/-CPI-444 +/-pembrolizumab) www.corvuspharma.com

CPI-444 Corvus Pharmaceuticals advanced cancer (+/-atezolizumab) Phase I

(adenosine A2A receptor antagonist) Burlingame, CA www.corvuspharma.com

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UnspecifiedProduct Name Sponsor Indication Development Phase

dendritic cancer vaccine ImmunoRestoration cancer Phase I/II completed

Warminster, PA www.immunorestoration.com

FS118 F-star Biotechnology advanced malignancies Phase I

(anti-LAG-3/anti-PD-L1) Cambridge, United Kingdom www.f-star.com

bispecific antibody)

gedatolisib (PF-05212384) Pfizer cancer Phase I

(PI3K/mTOR inhibitor) New York, NY www.pfizer.com

glasdegib Pfizer cancer Phase I

(SMO antagonist) New York, NY www.pfizer.com

human microbiome modulator Kaleido Biosciences cancer Phase I

Bedford, MA www.kaleido.com

Ibrance® Pfizer cancer Phase I

palbociclib New York, NY www.pfizer.com

IDH305 Novartis Oncology advanced malignancies with Phase I

(IDH1 inhibitor) East Hanover, NJ IDH1R132 mutations www.novartis.com

INCB53914 Incyte advanced malignancies Phase I/II

(pan-PIM kinase inhibitor) Wilmington, DE www.incyte.com

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UnspecifiedProduct Name Sponsor Indication Development Phase

INCB57643 Incyte advanced malignancies Phase I/II

(bromodomain inhibitor) Wilmington, DE www.incyte.com

Inlyta® Pfizer cancer (+pembrolizumab) Phase I

axitinib New York, NY www.pfizer.com

IRX5183 Io Therapeutics cancer Phase I

(RXR agonist) Santa Ana, CA www.io-therapeutics.com

LOXO-195 Bayer Pharmaceuticals cancer Phase I

(TRK inhibitor) Whippany, NJ www.pharma.bayer.com

Loxo Oncology www.loxooncology.com

Stamford, CT

MCS110 Novartis Oncology advanced malignancies (+PDR001) Phase I/II

(CSF-1 mAb) East Hanover, NJ www.novartis.com

napabucasin Boston Biomedical advanced malignancies (+ paclitaxel) Phase I/II

(STAT3 inhibitor) Cambridge, MA www.bostonbiomedical.com

ORB-101 Orbis Biosciences cancer Phase I

(prednisone microencapsulated) Lenexa, KS www.orbisbio.com

ORIC-101 ORIC Pharmaceuticals cancer Phase I

(glucocorticoid receptor antagonist) South San Francisco, CA www.oricpharma.com

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UnspecifiedProduct Name Sponsor Indication Development Phase

PAC-1 (VO-100) Vanquish Oncology advanced malignancies Phase I

(procaspase activating compound-1) Campaign, IL www.vanquishoncology.com

PF-04518600 Pfizer cancer Phase I

(OX40 receptor agonist) New York, NY www.pfizer.com

PF-06647020 (cofetuzumab pelidotin) Pfizer cancer Phase I

(PTK7 targeted cytotoxicity) New York, NY www.pfizer.com

PF-06671008 Pfizer cancer Phase I

(anti-CD3/P-cadherin bispecific New York, NY www.pfizer.com

antibody)

PF-06688992 Pfizer cancer Phase I

(antibody-drug conjugate) New York, NY www.pfizer.com

PF-06747775 (mavelertinib) Pfizer cancer Phase I

(epidermal growth factor receptor) New York, NY www.pfizer.com

PF-06801591 Pfizer cancer Phase I

(PD-1 antagonist immunotherapy) New York, NY www.pfizer.com

PLX2853 Plexxikon cancer Phase I

(BRD4 inhibitor) Berkeley, CA www.plexxikon.com

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UnspecifiedProduct Name Sponsor Indication Development Phase

REGN1979 Regeneron Pharmaceuticals cancer (+cemiplimab) Phase I

(anti-CD20/CD3 bispecific mAb)  Tarrytown, NY www.regeneron.com

REGN3767 Regeneron Pharmaceuticals advanced cancer Phase I

(anti-LAG-3 mab) Tarrytown, NY www.regeneron.com

Sanofi www.sanofi.com

Bridgewater, NJ

RG6180 Genentech cancer Phase I

(personalized cancer vaccine) South San Francisco, CA www.gene.com

rituximab biosimilar Apobiologix cancer in clinical trials

Weston, FL www.apobiologix.com

TAB001 Shanghai Junshi Biosciences advanced malignancies Phase I

(anti-PD-1 mAb) Shanghai, China www.junshipharma.com

TSR-042 TESARO advanced or metastatic Phase I

(anti-PD-1 mAb) Waltham, MA (combination therapy) www.tesarobio.com

veltuzumab Immunomedics cancer Phase II completed

(anti-CD20 mAb) Morris Plains, NJ www.immunomedics.com

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The content of this report has been obtained through public, government and industry sources, and the Springer "Adis Insight” database based on the latest

information. Report current as of May 6, 2018. The medicines in this listing include medicines being developed by U.S.-based companies conducting trials

in the United States abroad, PhRMA-member companies conducting trials in the United States and abroad, and foreign companies conducting clinical trials in

the United States. Some products may not be in active clinical trials. The information may not be comprehensive. For more, specific information about a particular

product, contact the individual company directly or go to www.clinicaltrials.gov. The entire series of Medicines in Development is available on PhRMA's

website: www.phrma.org.

Definitions

Application Submitted—An application for marketing has been submitted by the company to the U.S. Food and Drug Administration (FDA).

Breakthrough Therapy—Upon request by a sponsor, the FDA can grant this designation to expedite the development and review of a drug or biologic intended, alone

or in combination with one or more other drugs, to treat a serious or life threatening disease or condition and preliminary clinical evidence indicates that it may

demonstrate substantial improvement over existing therapies on one or more clinically-significant endpoints, such as substantial treatment effects observed early in

clinical development. If a drug or biologic is designated as a Breakthrough Therapy, the FDA will expedite the development and review. With this designation, all Fast

Track features convey to the medicine.

Fast Track—Upon request by a sponsor, the FDA can grant this designation to facilitate the development and expedite the review of a drug or biologic to treat a

serious condition and fill an unmet medical need. When considering a biopharmaceutical company’s request for Fast Track designation for an investigational

drug or biologic, the FDA evaluates whether it will affect factors such as survival, day-to-day functioning, or the likelihood that the disease, if left untreated, will

progress from a less severe condition to a more serious one, and whether a condition can be adequately addressed by available therapy. With Fast Track designation,

early and frequent communication between the FDA and the biopharmaceutical company is encouraged throughout the entire drug development and review

process to help to quickly resolve any questions or issues that arise, potentially leading to an earlier approval and access by patients.

Orphan Designation—Upon request by a sponsor, the FDA can grant special status (“orphan status”) to a drug or biologic to treat a rare disease or condition.

In order to receive an orphan designation, a qualifying drug or biologic must be intended for the treatment, diagnosis, or prevention of a rare disease or

condition that affects usually fewer than 200,000 people in the United States.

Phase I—Researchers test the investigational drug or biologic in a small group of people, usually between 20 and 100 healthy adult volunteers, to evaluate

its initial safety and tolerability profile, determine a safe dosage range, and identify potential side effects.

Phase II—The investigational drug or biologic is given to volunteer patients, usually between 100 and 500, to determine whether it is effective, identify an

optimal dose, and to further evaluate its short-term safety.

Phase III—The investigational drug or biologic is given to a larger, more diverse patient population, often involving between 1,000 and 5,000 patients

(but sometimes many more), to generate statistically significant evidence to confirm its safety and effectiveness. Phase III studies are the longest studies

and usually take place in multiple sites around the world.

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