Upload
redchip-companies-inc
View
406
Download
1
Embed Size (px)
DESCRIPTION
Citation preview
AV THERAPEUTICS
Investor presentation 2013
Confidential - not for distribution
Except for historical information, the statements made in this presentation are forward looking statements involving significant risks and uncertainties.
“Treatment and Prevention of Prostate Cancer through Innovation”
A New York Based Biotechnology Company
1
• Corporate Headquarters 20 East 68th Street
New York, NY 10065 Suite 204
• Research Facilities New York Medical College
Cancer Institute of New Jersey
AV Therapeutics
Confidential - not for distribution 2
Professional Advisors
Corporate Counsel Sichenzia Ross Friedman Ference
LLP, 61 Broadway, New York, NY
Darrin Ocasio
Consultants Objective Equity
Red Chip
Confidential - not for distribution 3
Management Team • Abraham Mittelman , M.D., Chief Executive Officer and Chairman of the
Board Oncologist and professor at New York Medical College (NYMC) with over 30 years of experience in patient treatment and clinical trials.
Over 200 peer reviewed publications and presentations, trained at Memorial Sloan Kettering Cancer Center (Memorial).
• Raj Tiwari, Ph.D., Chief Scientific Officer Professor of Microbiology & Immunology and Graduate Program Director at NYMC. Over 30 years of research experience with over 150
peer reviewed publications and presentations. Trained at Memorial, inventor of several patents involving Capridine and Peptide based Cancer Vaccine Technology.
• Morton Coleman, M.D., Vice President, Director of Clinical Development Clinical Professor at Weill Medical College of Cornell University and Director of the Center for Lymphoma and Myeloma at New York
Presbyterian Hospital – Weill Cornell. Chairman, Medical Affiliate Board of Lymphoma Research Foundation, over 400 publications and designated one of the “Best Doctors in America”
• Robert Pollock, President Over 40 years business experience. Founder and managing partner of Continuum Partners, a global network security and business
development consulting firm.
• Jan Geliebter, Ph.D., Secretary, VP Genomic Platforms Professor of Microbiology & Immunology at NYMC with over 30 years of cancer research experience and over 100 peer reviewed
publications. Holder of multiple patents, including a BCG-based prostate cancer vaccine
• Debabrata Banerjee, Ph.D., VP Preclinical Development Associate Professor of Medicine and Pharmacology, The Cancer Institute of New Jersey. Over 25 years of experience in preclinical and
experimental therapeutics with over 125 publications and presentations. Inventor of several patents.
Confidential - not for distribution 4
AV Therapeutics - Overview
• AVT is a Biotechnology company focused on: • Targeted drug based cancer therapies that are safer and
more effective than current chemotherapeutic agents • Proprietary peptide based immunotherapeutic vaccine
technology platform
• Scientists at AVT have developed Capridine: • A patented drug having specific activity against prostate
cancer
• Outstanding physicians and clinical researchers
Confidential - not for distribution 5
IP position of AV Therapeutics • Two patents on Capridine : Dr. Raj Tiwari and Dr. Jerzy Konopa from
Gdansk, Poland are co-inventors. US, EU (19 countries], Mexico, Canada, Israel, valid till 2021 with 6 years extension possibility – One Patent are for synthesis and 200 other substituted
derivatives and sub-licensed to AVT – Composition of matter patent on capridine in combination with
other therapeutics
• Third US patent on a novel technology using synthetic off the shelf easily synthesizable peptides with a broad application “ Immunogens for treatment of neoplastic and infectious diseases”
• Fourth US patent on the delivery of immunogens “ Immunotherapy for prostate cancer using Bacille-Calmette-Guerin expressing prostate specific antigens”.
Confidential - not for distribution Data on file AV Therapeutics, Inc. 6
The Problem - Prostate Cancer
• Prostate Cancer is the most common type of cancer in men in the USA
• Annual expenditures exceed $15 billion • Current therapies have limited efficacy for metastatic disease • Current chemotherapeutic regimens are associated with
severe bone marrow toxicity and poor tolerance • Current immunotherapy (Provenge) is expensive and has
minimal efficacy • Radiation, hormonal and chemotherapy remain palliative
Confidential - not for distribution
Effective drug based therapy and immunotherapy is an unmet clinical need in prostate cancer
7
The Solution - Capridine • Identified a new class of patent protected nitro-acridine drugs
known as Capridines • NCI tested prostate cancer specific drug • Over 6 million dollars invested in development (pre-AVT) • Limited side affects
– Low blood and bone marrow toxicity
• High therapeutic index for prostate – Low amount of drug, high efficacy
Confidential - not for distribution 8
Confidential - not for distribution 9
Prostate cancer cells are ten to 100 fold more sensitive to capridine-β than leukemic cells (HL-6O)
1 2
Data on file AV Therapeutics, Inc.
Capridine-β has Differential IC50 Values in CaP and Leukemic Cells
10 Confidential - not for distribution
Capridine-β is a more potent anticancer drug than Mitoxantrone in several cancers
Confidential - not for distribution Data on file AV Therapeutics, Inc. 11
Treatment started week 1, once weekly for 7 – 9 weeks
3 4
5 6
Data on file AV Therapeutics, Inc.
Capridine - β Inhibits Hormone-Responsive and Non-Responsive CaP Xenografts in Nude Mice
12 Confidential - not for distribution
Cell lines IC50 Values (nM)
Taxane Capridine
LnCaP >100nM 15nM
PC3 16-20nM 5nM
DU145 15-20nM 5nM
Confidential - not for distribution 13
Capridine is superior to taxane and is effective on taxane resistant prostate cancer
6 h 12 h C 5 nM 10 nM 5 nM 10 nM
Actin
Androgen receptor
Capridine-β induces the androgen receptor in hormone independent DU-145 cells
Confidential - not for distribution 14
Unique Features of Capridine
• Capridine is active against taxane resistant prostate cancer cells, hormone dependent and hormone independent prostate cancer xenografts and is non-myelosuppressive
• Capridine renders aggressive hormone independent CaP cells hormone sensitive and thus can synergize with anti-androgen therapy in Cap
Confidential - not for distribution Data on file AV Therapeutics, Inc. 15
Capridine-β Advantage
• Based on the results of Pre-Clinical Studies, Capridine-β has minimal bone marrow toxicity with a wide therapeutic range active against taxane resistant CaP cells
• Capridine-β can be added to other drugs thus lowering chemotherapy associated toxicities
Confidential - not for distribution Data on file AV Therapeutics, Inc. 17
Development Plan for Capridine – Next Steps
• Drug manufacture and formulation under GMP conditions
• Stability testing of the formulated product
• Limited rodent and dog toxicology with formulated product
• Pharmacokinetics and pharmacodynamics
• IND application
• Phase I/II clinical trials
Confidential - not for distribution 18
Summary • Preclinical studies complete for Capridine. Unique properties include no
blood toxicity and wide therapeutic dose range with specificity towards prostate cancer - ready to commence phase I and II human trials
• A world-class, internationally recognized, well published scientists and
clinicians (PhD’s and MDs) from A+ institutions
• World class medical research collaborators and Scientific Advisory Board
• All IPs patent protected
Confidential - not for distribution 19
Scientific Advisory Board • Joseph Bertino, MD, Associate Director and Chief Scientific Officer, The Cancer Institute of
New Jersey and past President of the American Association for Cancer Research and The American Association of Clinical Oncologists, organizations of over 50,000 researchers, worldwide. He is the founding Editor of the Journal of Clinical Oncology.
• Charles Cantor, PhD, is Director of the Center for Advanced Biotechnology at Boston
University and Chief Scientific Officer at Sequenom, Inc. in La Jolla (a publicly traded company). He has published more than 400 articles, and has been awarded more than sixty (60) patents. He is most known for his authoring of the book, Genomics: The Science and Technology Behind the Human Genome Project.
• Roy G. Smith, PhD, is the Director of then Huffington Center on Aging, Professor in the
Department of Molecular and Cellular Biology, and Professor in the Department of Medicine at Baylor College of Medicine. He was previously Vice President of Basic Research at Merck and was responsible for identifying new drug targets for metabolic diseases
• Pramod Srivastava, PhD, is a Professor of immunology at the University of Connecticut,
where he holds an Endowed Chair in Cancer Immunology and is the Director of the Cancer Center and the Scientific Founder of Antigenics. He is among the founding members of the Academy of Cancer Immunology.
Confidential - not for distribution 20
Medical Advisors/Collaborators • Dan Petrylak, M.D. - Director of the Prostate Cancer Program, Yale
University
• Ashutosh Tewari, M.D., - Director of the Prostate Cancer Institute and the LeFrak Robotic Surgery Center at Weil Cornell Medical College [Tentative]
• Derek Raghavan, M.D. – President of the Levine Cancer Institute at the Carolinas Healthcare System, formerly, Chairman and Director of the Taussig Cancer Center at the Cleveland Clinic
• Christopher Logothetis, M.D. – Department Chair, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, The University of Texas MD Anderson Cancer Center
Confidential - not for distribution 21
Clinical Research Partner
Confidential - not for distribution
The Prostate Cancer Clinical Trials Consortium Howard Scher MD, Head of Clinical Consortium
22
IP position of AV Therapeutics • Two patents on Capridine : Dr. Raj Tiwari and Dr. Jerzy Konopa from
Gdansk, Poland are co-inventors. US, EU (19 countries], Mexico, Canada, Israel, valid till 2021 with 6 years extension possibility – One Patent are for synthesis and 200 other substituted
derivatives and sub-licensed to AVT – Composition of matter patent on capridine in combination with
other therapeutics
• Third US patent on a novel technology using synthetic off the shelf easily synthesizable peptides with a broad application “ Immunogens for treatment of neoplastic and infectious diseases”
• Fourth US patent on the delivery of immunogens “ Immunotherapy for prostate cancer using Bacille-Calmette-Guerin expressing prostate specific antigens”.
Confidential - not for distribution Data on file AV Therapeutics, Inc. 23
Pros-Vax Peptide Therapeutic Vaccine
• Synthetic peptide vaccine (Pros-Vax) that mimics cancer proteins, induces the host’s immune response directed against multiple cancer-specific proteins
• Easily manufactured, small molecule drug
• Preclinical studies complete • Expected to eliminate micrometasatic and residual
disease and hence prevent recurrence
Confidential - not for distribution 24
Immunization with peptide vaccines prevents metastatic prostate cancer growth
Unimmunized rat Immunized rats
BTE6-LX-8b ProVac 1
BTE6-X-15-7 ProVac 2
Confidential - not for distribution 25
Capridine
Peptide vaccine
Confidential - not for distribution 26
Business Strategy, Use of Capital and Time Line PRIVATE PLACEMENT MEMORANDUM • 12 Million Units Each Consisting of One Share of Common Stock (0.50
cents a share) and One Warrant (0.75 cents). Shares of Common Stock Maximum $6,000,000 Public offering by reverse merger or S1 filing after the IND application [6-9 months]
• Clinical product synthesis and testing [months,0-6] 2,500,000 • IND application for phase I [months 6-9] 1,000,000 • Initiation and completion phase I [months 9-15] 1,600,000 • Vaccine development [months 0-15] 4,000,000 • Operation and Expense 900,000
• Total Expenses $10,000,000
Confidential - not for distribution 27
Current Capital Structure
• Authorized Common shares: 50,000,000 • Issued & outstanding: 17,739,561 • Number of shareholders: 32 • Management ownership: 86%* *may change based on consultant agreement (s)
Total Capital invested to date : 7 million Grants, NIH, Department of Defense and other: 6 million Friends and Family: 1 million
Confidential - not for distribution 28