GHIT Fund Advancing Portfolio · advancements. For the semi-annual progress report, partners...

AcquireLibrary/Strains

Develop TargetResearch

Report

ValidateAssays

Prepare AssayValidation

Plan

DevelopAssays

Prepare AssayDevelopment

Plan

IdentifyTarget(s)

ConductTarget

Research

PrepareTarget

Research Plan

SCREENGO

TARGETRESEARCH

GO

ScreenLibrary/Strains

EvaluateHits

Prepare LeadOptimization

Plan

OptimizeLead(s)

EvaluateOptimized

Lead(s)

DevelopOptimized

Lead Report

PreparePreclinical

Plan

ConductPreclinical

Study

AnalyzePreclinical

Data

Prepare INDAddressIND Q&A

AddressIND Q&A

DevelopTPP

DevelopProduct

DevelopmentPlan

Plan Ph1Program

Enroll Ph1Study

Plan Ph2aProgram

Enroll Ph2aStudy

ConductPh2a Study

AnalyzePh2a Data

Prepare Ph2aStudy Report

Plan Ph2bProgram

Enroll Ph2bStudy

Conduct Ph2bStudy

Plan Ph2Program

Enroll Ph2Study

Conduct Ph2Study

Ph2 DataAnalyzed

Plan Ph3Program

Enroll Ph3Study

Conduct Ph3Study

Analyze Ph3Data

PrepareDossier

AddressDossier Q&A

PrepareSupplemental

Lic/PQ Dossiers

AddressSupp Lic/

PQ Dossier Q&A

ScreenInitiated

AssayValidationCompleted

AssayValidationInitiated

Assay Dev.Completed

Assay Dev.Initiated

Target(s)Identified

TargetResearch

Completed

TargetResearchInitiated

ScreenCompleted

DevelopScreenReport

Prepare HTL Plan

HitsIdentified

GenerateLead(s)

Lead GenInitiated

EvaluateLead(s)

Lead GenCompleted

DevelopHTL Report

LeadsIdentified

LEAD OPT.GO

HIT TOLEAD GO

Lead OptInitiated

Lead OptCompleted

Candidate(s)Identified

PRECLINICALGO

PreclinInitiated

PreclinCompleted

PreparePreclinical

Report

Preclin DataAnalyzed

INDGO

INDFiled

INDApproved

TPPDeveloped

PHASE 1GO

Ph1FPI

Conduct Ph1Study

Ph1LPI

Analyze Ph1Data

Ph1LPO

Prepare Ph1Study Report

Ph1 DataAnalyzed

PHASE 2a /PHASE 2 GO

Ph2aFPI

Ph2a LPI /Ph2 FPI

Ph2aLPO

Ph2a DataAnalyzed /

Ph2 LPIPHASE 2b

GOPh2b FPI /Ph2 LPO

Ph2bLPI

AnalyzePh2b Data

Prepare Ph2bStudy Report

Prepare Ph2Study Report

Ph2b LPO /Ph2 DataAnalyzed

Ph2b DataAnalyzed

PHASE 3GO

Ph3FPI

Ph3LPI

Ph3LPO

Prepare Ph3Study Report

Ph3 DataAnalyzed

LICENSEGO

DossierFiled

DevelopSupplementalLic./PQ Plan

1st LicensureGranted

SUPP. LIC /PQ GO

Supp. Lic/PQ Submitted

Prepare forDelivery

Add’ l Lic/PQ Granted

LAUNCHGO

DRUG DEVELOPMENT

TargetDisease

CollaborationPartners 1

Investment (USD)

2.3

Malaria

10,352,089

11,286

570

1,849,333

75,582

31,000

7,558

-

75,582

1,043,531

1,105,170

1,959,774

Malaria

Malaria

Malaria

Malaria

Malaria

Chagas disease,Leishmaniasis

Malaria, Chagas Disease,Cryptosporidium,Leishmaniasis

Chagas disease,Leishmaniasis

Malaria

Malaria

Malaria

Malaria

Malaria

Chagas disease,Leishmaniasis

Chagas disease,Leishmaniasis

5,308,616

119,000

Chagas disease,Leishmaniasis

Chagas disease,Leishmaniasis

150,000Chagas disease,Leishmaniasis

Tuberculosis

204,990Tuberculosis

Tuberculosis

Tuberculosis

500,000

982,436

Chagas disease

882,350Chagas disease

Malaria

207,754

Malaria 1,284,520

Malaria 1,016,129

560,000

5,428,979

3,840,893

8,268,923

10,365,743

6,034,137

Malaria

7,499,822

60,000

Malaria 68,400

Malaria 150,000

Malaria 49,500

Malaria 65,836

Malaria 5,590,092

Malaria 1,290,883

Malaria 150,000

Malaria 41,963

Tuberculosis

Tuberculosis

Tuberculosis

Leishmaniasis

Leishmaniasis

Lymphatic filariasis,Onchocerciasis

Soil-transmittedhelminthiasis

583,383

2,727,117

2,639,622

150,000

1,342,440

10,070,310

Dengue 10,241,632

2,843,214

Malaria

Malaria

132,000

Tuberculosis 79,200

Tuberculosis 1,103,160

Tuberculosis 150,000

Tuberculosis 99,986

Tuberculosis 2,003,324

Chagas disease

Chagas disease

Schistosomiasis

1,002,996

15,924,407

5,606,388Leishmaniasis

2,526,217Mycetoma

4,214,187Malaria

Tuberculosis 110,000

750,000

ID

T5-134(3)

H9-104

S3-113

S3-112(4)

S3-114

S3-115(4)

S4-211(2)

S4-212(3)

S3-111(3)

H4-101

S5-111

S5-112

S7-111

S7-112

S8-111

S9-111

G4-107(3)

G3-113

G9-215

G4-105(2)

G3-112(3)

G4-108

G5-120

G18-112

G6-108

S3-131(2)

T6-101

S3-132(2)

S3-133(3)

S4-231

S4-232(2)

S5-131

S5-132

S5-232(2)

S5-231

S7-131

G3-109

T6-203

G3-218

S3-121

S5-222

S3-122

S3-123

S3-124

G6-217(2)

S5-221(3)

H4-201(3)

G4-208(2)

G3-209(2)

G3-212(4)

G5-205

G5-211(2)

G7-106

S7-221

S9-121

T7-278

G7-101

S8-131

H6-201

Screening Platform

Target IdentificationTarget Identification Target Validation Target Validation Hit IdentificationHit Identification Lead IdentificationLead Identification Lead OptimizationLead Optimization Preclinical DevelopmentPreclinical Development Phase 1 Clinical DevelopmentPhase 1 Clinical Development Phase 2 Clinical Development Phase 2 Clinical Development Phase 3 Clinical Development Phase 3 Clinical Development RegistrationRegistration

Hit-to-Lead Platform Product Development PlatformTarget Research Platform

DISCOVERY PRECLINICAL CLINICAL REG

Note: 1 includes past and present Collaboration Partners' logos　 2 The awarded amount refers to the conditional investment figure agreed at the initiation of each project.　 3 GHIT invests using Japanese yen. US dollar amounts represent conversions from Japanese yen, solely for the reader’s convenience, at JPY 100 = USD 1.ver6.4 2020.3.31

Copyright © 2013 - 2020 Global Health Innovative Technology Fund

GHIT Fund Advancing PortfolioPlan Ph2Program

Enroll Ph2Study

Conduct Ph2Study

Analyze Ph2Data

Prepare Ph2Study Report

Plan Ph3Program

Enroll Ph3Study

PHASE 2GO

PHASE 3GOPh2 FPI

Ph2a DataAnalyzedPh2 LPI Ph2 LPO Ph3 FPI Ph3 LPI

CURRENT STATUS

For example, a successful investment in a Phase 2 clinical trial would yield one stage gate and five milestone advancements. For the semi-annual progress report, partners designate the current state of the project by specifying the project’s current activity. For example, completing the study portion of the Phase 2 clinical trial by the second reporting period would credit the project with one stage gate and four milestone advancements. A green triangle represents a continued investment.

Project Scope vs Current Reporting Period Status

1st PROJECT SCOPE 2nd PROJECT SCOPE

CONTINUATIONLegend

STAGE ACTIVITYMILESTONESTAGE-GATE

DiscontinuedSuccessfully completedCurrent Status

Develop DevFeasibility

Report Report

ConductDevelopment

Feasibility

PrepareDevelopment

Feasibility Plan

Develop TechFeasibility

Report

ConductTechnicalFeasibility

Prepare TechFeasibility Plan

DevelopConcept

Dev Report

DevelopConcept

Prepare ConceptDevelopment Plan

DevelopmentFeasibilityCompleted

TARGETRESEARCH

GO

Prepare ProductDesign Plan

DesignProduct

Develop ProductDesign Report

Prepare ProductDevelopment Plan

DevelopProduct

Prepare OperationalEvaluation Plan

Conduct OperationalEvaluation

Prepare OperationalEvaluation Report

Analyze EvaluationData

PrepareDossier

AddressDossier Q&A

PrepareSupplemental

Lic/PQ Dossiers

AddressSupp Lic/

PQ Dossier Q&A

DevelopmentFeasibilityInitiated

DEVELOPMENTFEASIBILITY

GO

TechnicalFeasibilityCompleted

TechnicalFeasibilityInitiated

TECHNICALFEASIBILITY

GO

ConceptDevelopmentCompleted

ConceptDevelopment

InitiatedPRODUCT

DESIGN GOProduct Design

InitiatedProduct Design

CompletedPRODUCT

DEVELOPMENT GOProduct Development

Initiated

Develop ProductDevelopment Report

Product DevelopmentCompleted

Prepare AnalyticalEvaluation Plan

ANALYTICALEVALUATION GO

Prepare AnalytiocalEvaluation Report

Conduct AnalyticalEvaluation

Analytical EvaluationInitiated

Operational EvaluationInitiated

OPERATIONALEVALUATION GO

Analytical EvaluationCompleted

Operational EvaluationCompleted

Evaluation DataAnalysis Initiated

Develop EvaluationReport

Evaluation DataAnalysis Completed

LICENSEGO

DossierFiled

DevelopSupplementalLic./PQ Plan

1st LicensureGranted

SUPP. LIC /PQ GO

Supp. Lic/PQ Submitted

Prepare forDelivery

Add’ l Lic/PQ Granted

LAUNCHGO

ValidateAssays

Prepare AssayValidation

Plan

DevelopAssays

Prepare AssayDevelopment

Plan

DevelopConcept

Prepare ConceptDevelopment

Plan

IdentifyAntigen(s)

ConductAntigen

Research

PrepareAntigen

Research Plan

AssayValidationInitiated

TARGETRESEARCH

GO

Prepare TechPlatform ID

Plan

Identify TechPlatform

PreparePreclinical

Plan

ConductPreclinical

Study

AnalyzePreclinical

Data

PreparePreclinical

Report

PrepareIND

AddressIND Q&A

DevelopTPP

Plan Ph1Program

Enroll Ph1Study

Plan Ph2aProgram

Enroll Ph2aStudy

ConductPh2a Study

AnalyzePh2a Data

Prepare Ph2aStudy Report

Plan Ph2bProgram

Enroll Ph2bStudy

Conduct Ph2bStudy

Plan Ph2Program

Enroll Ph2Study

Conduct Ph2Study

Ph2 DataAnalyzed

Plan Ph3Program

Enroll Ph3Study

Conduct Ph3Study

Analyze Ph3Data

PrepareDossier

AddressDossier Q&A

PrepareSupplemental

Lic/PQ Dossiers

AddressSupp Lic/

PQ Dossier Q&A

AssayValidationCompleted

AssayDevelopmentCompleted

AssayDevelopment

InitiatedConcept Dev.

CompletedConcept Dev.

InitiatedAntigen(s)Identified

AntigenResearch

Completed

AntigenResearchInitiated

TechPlatfrom ID

Initiated

Develop TargetResearch

Report

Prepare LeadAntigen

Optimization Plan

TechPlatform IDCompleted

OptimizeAntigen Lead(s)

Antigen LeadOpt Initiated

EvaluateOptimized

Antigen Lead(s)

Develop LeadAntigen Opt

Report

Antigen LeadOpt Completed

OptimizedAntigen(s)Selected

PRECLINICALGO

LEADANTIGENOPT GO

PreclinInitiated

PreclinCompleted

PreclinData

AnalyzedINDGO

INDFiled

INDApproved

Develop ProductDevelopment

Plan

TPPDeveloped

PHASE 1GO

Ph1FPI

Conduct Ph1Study

Ph1LPI

Analyze Ph1Data

Ph1LPO

Prepare Ph1Study Report

Ph1 DataAnalyzed

PHASE 2a /PHASE 2 GO

Ph2aFPI

Ph2a LPI /Ph2 FPI

Ph2aLPO

Ph2a DataAnalyzed /

Ph2 LPIPHASE 2b

GOPh2b FPI /Ph2 LPO

Ph2bLPI

AnalyzePh2b Data

Prepare Ph2bStudy Report

Prepare Ph2Study Report

Ph2b LPO /Ph2 DataAnalyzed

Ph2b DataAnalyzed

PHASE 3GO

Ph3FPI

Ph3LPI

Ph3LPO

Prepare Ph3Study Report

Ph3 DataAnalyzed

LICENSEGO

DossierFiled

DevelopSupplementalLic./PQ Plan

1st LicensureGranted

SUPP. LIC /PQ GO

Supp. Lic/PQ Submitted

Prepare forDelivery

Add’ l Lic/PQ Granted

LAUNCHGO

VACCINE DEVELOPMENT

DIAGNOSTIC DEVELOPMENT

CollaborationPartners

TargetDisease

CollaborationPartners

TargetDisease

Investment (USD)

Investment (USD)

2.3

2.3

Tuberculosis

Tuberculosis

Malaria

Schistosomiasis 779,036

Schistosomiasis 763,890

Tuberculosis 6,377,747

Malaria 993,031

Malaria 1,382,697

Malaria $728,831

Malaria 964,500

591,397

714,500

Malaria 3,903,504

Malaria 5,602,934

Malaria 972,951

6,349,620

Tuberculosis 373,561

1,423,590

3,450,277

612,902

5,831,957

5,652,366

766,099

2,000,000

Malaria

Malaria

881,900Malaria

Malaria

Dengue

Leishmaniasis

558,316Leishmaniasis

5,408,632Dengue

Dengue

Chagas disease

1,097,928Chagas disease

Malaria 930,571

Tuberculosis 1,000,000

4,096,664Leishmaniasis

Leishmaniasis 2,257,700

Mycetoma 285,938

Malaria 526,900

Malaria 960,772

ID

T5-142

G9-105

T7-105

G5-210

G5-201(2)

T18-157

G4-201

T7-272

G9-213

T9-260

ID

G3-118

G4-110

T7-274

G4-109(3)

G3-105

G5-214(2)

T6-207(2)

G9-111

T18-151

T9-252

T9-254

G3-102(2)

T6-110

G5-147

G4-111

G9-102

G4-102

G5-121

G6-109(2)

G5-115(2)

G8-111

G6-203

DISCOVERY PRECLINICAL CLINICAL REG

Concept DevelopmentConcept Development Technical FeasibilityTechnical Feasibility Development FeasibilityDevelopment Feasibility Product DesignProduct Design Product Development Product Development Product ValidationProduct Validation RegistrationRegistration

Product Development PlatformTarget Research Platform

Antigen IdentificationAntigen Identification Vaccine ConceptDevelopment

Vaccine ConceptDevelopment

Technology PlatformIdentification

Technology PlatformIdentification Lead OptimizationLead Optimization Preclinical DevelopmentPreclinical Development Phase 1 Clinical DevelopmentPhase 1 Clinical Development Phase 2 Clinical Development Phase 2 Clinical Development Phase 3 Clinical Development Phase 3 Clinical Development RegistrationRegistration

Product Development PlatformTarget Research Platform

Note: 1 includes past and present Collaboration Partners' logos　 2 The awarded amount refers to the conditional investment figure agreed at the initiation of each project.　 3 GHIT invests using Japanese yen. US dollar amounts represent conversions from Japanese yen, solely for the reader’s convenience, at JPY 100 = USD 1.ver6.4 2020.3.31

Copyright © 2013 - 2020 Global Health Innovative Technology Fund

GHIT Fund Advancing PortfolioPlan Ph2Program

Enroll Ph2Study

Conduct Ph2Study

Analyze Ph2Data

Prepare Ph2Study Report

Plan Ph3Program

Enroll Ph3Study

PHASE 2GO

PHASE 3GOPh2 FPI

Ph2a DataAnalyzedPh2 LPI Ph2 LPO Ph3 FPI Ph3 LPI

CURRENT STATUS

For example, a successful investment in a Phase 2 clinical trial would yield one stage gate and five milestone advancements. For the semi-annual progress report, partners designate the current state of the project by specifying the project’s current activity. For example, completing the study portion of the Phase 2 clinical trial by the second reporting period would credit the project with one stage gate and four milestone advancements. A green triangle represents a continued investment.

Project Scope vs Current Reporting Period Status

1st PROJECT SCOPE 2nd PROJECT SCOPE

CONTINUATIONLegend

STAGE ACTIVITYMILESTONESTAGE-GATE

DiscontinuedSuccessfully completedCurrent Status