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TRANSCRIPT
AV THERAPEUTICS
Investor presenta6on
Confiden'al -‐ not for distribu'on
Except for historical information, the statements made in this presentation are forward looking statements involving significant risks and uncertainties.
“Be9er Treatment of Cancer through Innova6on”
A New York Based Biotechnology Company
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AV Therapeu6cs: Developing Safer and More Effec6ve Chemotherapeu6c Agents
Capridine: -‐Patented drug
-‐Specific ac'vity against prostate cancer plus an
immuno-‐therapeu'c vaccine
Preliminary efficacy on range
of cancers
World-‐class team of
physicians and clinical
researchers
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Capridine-‐β (C-‐1748)
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Deriva6ve R1 R2 R3 R4
C-‐1748 H (CH2)2OH CH3 H
Data on file AV Therapeu6cs, Inc. 3
Management Team
Abraham Mi9elman , M.D., Chief Execu6ve Officer and Chairman of the Board
• Oncologist and Associate Prof. at New York Medical College (NYMC) with over 30 years of experience in pa'ent treatment and clinical trials.
Raj Tiwari, Ph.D., Chief Scien6fic Officer
• Professor of Microbiology & Immunology and Graduate Program Director at NYMC with over 30 years of Cancer Research, inventor of AVTs IPs related to Capridine and Pep'de Vaccine Technology.
Morton Coleman, M.D., Vice President, Director of Clinical Development
• Clinical Professor at Weill Medical College, Cornell University, Director of the Center for Lymphoma and Myeloma at New York Presbyterian Hospital
Robert Pollock, President
• Over 40 years business experience. Founder and managing partner of Con'nuum Partners, a global network security and business development consul'ng firm.
Jan Geliebter, Ph.D., Secretary, VP Genomic Plaborms • Professor of Microbiology & Immunology at NYMC with over 30 years of Cancer Research experience Holder of mul'ple patents, including AVTs IP BCG-‐based prostate cancer vaccine
Debabrata Banerjee, Ph.D., VP Preclinical Development • Associate Professor of Medicine and Pharmacology, Rutgers University with Over 30 years of experience in preclinical and exptal therapeu'cs and Inventor of several patents.
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The Problem -‐ Prostate Cancer
High Incidence
• Prostate Cancer is the most common type of cancer in men in the USA
• Annual expenditures exceed $15 billion
Limited efficacy for metasta'c disease
• Radia'on, hormonal and chemotherapy remain pallia've
High Toxicity
• Severe bone marrow toxicity and poor tolerance
Confiden'al -‐ not for distribu'on
Effective drug based therapy and immunotherapy is an unmet clinical need in prostate cancer
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• Low amount of drug, high efficacy
• Low blood and bone marrow toxicity • Over 6 million dollars
invested in development (pre-AVT)
• Capridines and 200 of their derivatives are patent protected for use as anticancer agents in US, EU, Mexico, Canada, Israel
The Solu6on: Capridine-‐β (C-‐1748)
NCI tested prostate cancer
specific drug
Limited side affects
High therapeu'c index for prostate
Patent-‐protected
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Prostate cancer cells (DU-145) are ten to 100 fold more sensitive to Capridine-β than leukemic cells (HL-6O)
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Capridine-β Kills Prostate Cancer Preferentially
Confiden'al -‐ not for distribu'on
DU-145 Cells Treated with Capridine-β HL-60 Cells Treated with Capridine-β
Capridine-‐β is a Potent An6cancer Drug in Several Cancers
0"
10"
20"
30"
40"
50"
60"
Uterus" Leuk" Breast" Colon" lymph" Sarc" Prostate"
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Comparisons between the two drugs are based on IC50 values IC50 is the drug concentration required to kill 50% cells
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*
*Mitoxantrane
Treatment started week 1, once weekly for 7 – 9 weeks
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3
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Capridine - β Inhibits Hormone-Responsive and Non-Responsive Xenografts in Nude Mice
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Loss of Androgen Receptor Early Step in Prostate Tumor Progression
Hormone Dependent
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Hormone Independent
Loss of Androgen Receptor
Upregulation of ER-β
Upregulation of CDC25 group
6 h 12 h C 5 nM 10 nM 5 nM 10 nM
Actin
Androgen receptor
Capridine-‐β renders Hormone-‐Independent DU-‐145 CaP Cells Hormone sensi6ve
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0
0.5
1
1.5
Control 5nm (6hr) 10nm (6hr) 5nm (12hr) 10nm (12hr)
Induction of Androgen Receptor in DU-145 Cells
Rel
ativ
e D
ensi
ty
Cell lines IC50 Values (nM)
Taxane Capridine
LnCaP >100nM 15nM
PC3 16-‐20nM 5nM
DU145 15-‐20nM 5nM
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Capridine is superior to taxane and is effec've on taxane resistant prostate cancer
Salient Features of Capridine-‐β
Capridine-‐β is ac've against taxane
resistant prostate cancer cells
Capridine-‐β does not kill bone
marrow cells or white blood cells
Capridine-‐β has a wide predicted
human therapeu'c dose range
Capridine-‐ β is ac've on hormone dependent and independent
Prostate cancer (CaP) xenografs
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Development Plan for Capridine β – Next Steps
Drug manufacture
and formula'on under GMP condi'ons
Stability tes'ng of the formulated product
Limited rodent and dog
toxicology with formulated product
Pharmacokine'cs and pharmacodynamics
IND applica'on
Phase I/II clinical trials
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Confiden'al -‐ not for distribu'on
Howard Scher MD, Head of Clinical Consor6um
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Scien6fic Advisory Board
• Joseph Ber6no, MD, Associate Director and Chief Scien'fic Officer, The Cancer Ins'tute of New Jersey and past President of the American Associa'on for Cancer Research and The American Associa'on of Clinical Oncologists, organiza'ons 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 Scien'fic Officer at Sequenom, Inc. in La Jolla (a publicly traded company). He has published more than 400 ar'cles, 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 iden'fying new drug targets for metabolic diseases
• Pramod Srivastava, PhD, is a Professor of immunology at the University of Connec'cut,
where he holds an Endowed Chair in Cancer Immunology and is the Director of the Cancer Center and the Scien'fic Founder of An'genics. He is among the founding members of the Academy of Cancer Immunology.
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Use of proceeds for development of Capridine
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Clinical product synthesis and testing
IND application & FDA approval for
Phase I
Initiation and completion of Phase I
Overall development
Cost ($000)
Activities
• GMP synthesis • Stability • Toxicology • Formulation
• Contractual services for IND • Data analysis and compilation • Chem manufacture write up • Comp lab mechanism studies
• Multicenter Phase I • Consortium lead • 60 patients
• Clinical development of Capridine
Output
• Capridine IND • Approval for Phase I
• Phase I/ II trial • Licensing of Capridine to
strategic partner • Continue development
1,000 500 1,500 $3 million
months 0-‐6 Months 6-‐12 months 12-‐18
Strategy Output Output
Output
Activities Activities
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Summary
• Preclinical studies complete for Capridine. Unique proper'es include no blood toxicity and wide therapeu6c dose range with specificity towards prostate cancer -‐ ready to commence phase I and II human trials
• A world-‐class, interna'onally recognized, well published scien'sts and
clinicians (PhD’s and MDs) from A+ ins'tu'ons
• World class medical research collaborators and Scien'fic Advisory Board
• All IP is patent protected
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Pros-‐Vax Pep6de Therapeu6c Vaccine
• Synthe'c pep'de vaccine (Pros-‐Vax) that mimics cancer proteins, induces the host’s immune response directed against mul'ple cancer-‐specific proteins
• Easily manufactured, small molecule drug
• Preclinical studies complete • Expected to eliminate micrometasa'c and residual
disease and hence prevent recurrence
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Immunization with peptide vaccines prevents metastatic prostate cancer growth
Unimmunized rat Immunized rats
BTE6-‐LX-‐8b ProVac 1
BTE6-‐X-‐15-‐7 ProVac 2
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Current Capital Structure
• Authorized Common shares : 200,000,000 • Outstanding AVT principals and prior investors: 58,000,000 • Barry Honig and PubCo Group investors : 17,000,000
• Proposed $3.5 million raise by PPM @ $0.20/share and a warrant to purchase one half of a share of the Company’s common stock
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