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Avth investor presentationredchip-13 Avth investor presentationredchip-13 Presentation Transcript

  • AV THERAPEUTICS A New York Based Biotechnology Company Investor presentation “Treatment and Prevention of Prostate Cancer through Innovation” Except for historical information, the statements made in this presentation are forward looking statements involving significant risks and uncertainties. Confidential - not for distribution 1
  • Safe Harbor Statement All statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for AV Therapeutics, Inc. (The Company) products and services, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited, to statements that contain words such as "will," "believes," "plans," "anticipates," "expects," "estimates") should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights and other risks discussed in the Company’s registration statement on Form S-1 and other reports filed with the Securities and Exchange Commission which is available for review at www.sec.gov. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the Company's business. The Company disclaims any intent or obligation to update these forward-looking statements. Confidential - not for distribution 2
  • AV Therapeutics • Corporate Headquarters 20 East 68th Street New York, NY 10065 Suite 204 • Research Facilities New York Medical College Cancer Institute of New Jersey Confidential - not for distribution 3
  • 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 4
  • 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 5
  • 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 Effective drug based therapy and immunotherapy is an unmet clinical need in prostate cancer Confidential - not for distribution 6
  • Confidential - not for distribution 7
  • The Solution - Capridine • Identified a new class of patent protected nitro-acridine drugs known as Capridines that has specific targeted activity towards prostate, colon and other cancers – Dr. Raj Tiwari and Dr. Jerzy Konopa from Gdansk, Poland are coinventors – Patents are for composition and use and sub-licensed to AVT – Protected in • • • • • USA EU Mexico Canada Israel Confidential - not for distribution 8
  • Capridine-β (C-1748) • Capridines and 200 of their derivatives are patent protected for use as anticancer agents • US patent on combination of capridines with other agents • 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 Data on file AV Therapeutics, Inc. Confidential - not for distribution 9
  • Capridine-β (C-1748) Derivative R1 R2 R3 R4 C-1748 H (CH2)2OH CH3 H Data on file AV Therapeutics, Inc. Confidential - not for distribution 10
  • Capridine-b has Differential IC50 Values in CaP and Leukemic Cells 1 2 Prostate cancer cells are ten to 100 fold more sensitive to capridine-b than leukemic cells (HL-6O) Data on file AV Therapeutics, Inc. Confidential - not for distribution 11
  • Capridine-β is a more potent anticancer drug than Mitoxantrone in several cancers Data on file AV Therapeutics, Inc. Confidential - not for distribution 12
  • Capridine - b Inhibits Hormone-Responsive and Non-Responsive CaP Xenografts in Nude Mice 4 3 6 5 Treatment started week 1, once weekly for 7 – 9 weeks Data on file AV Therapeutics, Inc. Confidential - not for distribution 13
  • Cell lines IC50 Values (nM) Taxane Capridine LnCaP >100nM 15nM PC3 16-20nM 5nM DU145 15-20nM 5nM Confidential - not for distribution 14
  • 80 cross-linked [%] 60 HeLa S3 LnCaP CEM HT-29 40 20 0 0.01 0.1 1 10 Drug concentration [ mM] 100 DNA cross-linking induced by Capridine b in different tumor cells incubated with compounds for 14 h Confidential - not for distribution 15
  • Prostate cancer Hormone dependant 1. 2. 3. Hormone independent Loss of androgen receptor Upregulation of ER-β Upregulation of CDC25 group of proteins Confidential - not for distribution 16
  • Capridine-β induces the androgen receptor in hormone independent DU-145 cells C 6h 5 nM 10 nM 12 h 5 nM 10 nM Actin Androgen receptor Series1 Confidential - not for distribution 17
  • Salient Features of Capridine-β • Capridine- β is active on hormone dependent and independent Prostate cancer (CaP) xenografts • Anti cancer doses of Capridine-β in animals and MTD values in dogs (1.84mg/Kg) extrapolated to humans has a wide human therapeutic dose range • Specificity towards CaP and high differential IC50 values for hematopoietic cells making Capridine-β a non-myelosuppressive chemotherapeutic agent Data on file AV Therapeutics, Inc. Confidential - not for distribution 18
  • Salient Features of Capridine-β • Capridine-β is active against taxane resistant prostate cancer cells, hormone dependent and hormone independent prostate cancer xenografts and is non-myelosuppressive • Capridine- β renders aggressive hormone independent CaP cells hormone sensitive and thus can synergize with antiandrogen therapy in Cap • The cell cycle kinase cdk-4 and the tumor suppressor gene p16 are the specific targets of capridine-β in prostate cancer Data on file AV Therapeutics, Inc. Confidential - not for distribution 19
  • Capridine Confidential - not for distribution 20
  • 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 Data on file AV Therapeutics, Inc. Confidential - not for distribution 21
  • 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 22
  • 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 disease and hence prevent recurrence Confidential - not for distribution and residual 23
  • 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 24
  • Peptide vaccine Capridine Confidential - not for distribution 25
  • 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 26
  • 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 27
  • Clinical Research Partner The Prostate Cancer Clinical Trials Consortium Howard Scher MD, Head of Clinical Consortium Confidential - not for distribution 28
  • Use of proceeds for development of Capridine months 0-6 Months 6-12 Clinical product synthesis and testing IND application & FDA approval for Phase I Activities • GMP synthesis •Stability •Toxicology •Formulation Output • Capridine IND Activities • • • • Contractual services for IND Data analysis and compilation Chem manufacture write up Comp lab mechanism studies Output • Approval for Phase I months 12-18 Initiation and completion of Phase I Overall development Activities Output • Multicenter Phase I • Consortium lead •60 patients • Clinical development of Capridine Output Strategy • • Phase I/ II trial • Licensing of Capridine to strategic partner Continue development Cost ($000) 2,500 1,000 1,600 Confidential - not for distribution 5.1 million 29
  • Development of peptide vaccines for prostate cancer Months 1-12 Peptide vaccines for prostate cancer Activities • Peptide identification • Tox testing • Tech Assessment Output • therapeutic Peptides ready For clinical trial Months 12-24 Peptide vaccines Activities • Peptides human Pca antigens • Preclinical testing •I Output • Limited Phase I/II trial months 12-24 Pilot clinical trial Activities • peptide synthesis • IND submission Output • Phase I/ II trial Cost ($000) 1,000,000 Confidential - not for distribution 1,500,000 Marketing and other strategies 1,500,000 Activities • Adjuvant development •Acquisition of other synergistic products •cost of capital Exit strategy • Licensing of peptide products to big pharma • marketing collaboration with peptides and acquired products •Adjuvant marketing 4,000,000 30
  • 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 31
  • 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 2.5 m raise by PPM @ $0.20/share : 12,500,000 • Proposed reverse merger with a PUBCO with Barry Honig as lead investor Confidential - not for distribution 32
  • Clinical Research Partner The Prostate Cancer Clinical Trials Consortium Howard I. Scher, MD, Head of Clinical Consortium – – –     Memorial Sloan-Kettering Cancer Center Chief, Genitourinary Oncology Service D. Wayne Calloway Chair in Urologic Oncology Education: MD Degree New York University School of Medicine Fellowships: MSKCC, NY Hospital - Cornell Medical Center Board Certifications: Internal Medicine, Medical Oncology Clinical Expertise: Prostate Cancer, Genitourinary Malignancies, Immunotherapy Confidential - not for distribution 33