Presentation Transcript

1. MakingImmunotherapy more Effective OTCQB: TPIV(D) 1551 Eastlake Ave E Seattle, WA www.TapImmune.com
2. CAUTIONARY STATEMENT REGARDING FORWARD LOOKING STATEMENTS Certain statements contained herein are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements in this document include, but are not limited to, statements relating to long-term stability, the Company's plan of operations and finances, the potential for the Company's vaccines and proposed clinical trials. The reader is cautioned that any such forward-looking statements are not guarantees of future performance and that actual results may differ materially from estimates in the forward-looking statements. The Company undertakes no obligation to revise these forward-looking statements to reflect events or circumstances after the date hereof.
3. Immunotherapy New Frontier in Treatment of Cancer Uses Patient’s Immune System Traditional Approaches Chemotherapy, Radiation, Surgery, Small Molecules Immunotherapy Adoptive T-Cell Transfer (DNDN;LBIO;Juno) Immune Checkpoint Blockade (BMS) Monoclonal antibodies (Roche) T-cell Vaccines (TPIV;ONTY;GALE;NWBIO;GSK) Challenge to stimulate Immune System to effectively kill Tumors
4. TapImmune Mission: Most Comprehensive T-Cell Immunotherapeutic Vaccines in Development Proprietary set of peptide antigens to illicit production of BOTH: Killer T-cells (CD8) Helper T-cells (CD4) Unique combination separates the TPIV approach from others These Platforms allow us to treat: Wider patient populations Multiple Indications Multiple Therapeutic Areas (Cancer and Infectious Disease) TWO Phase 2 Clinical Trials Q4 2014 Comprehensive Strategy Addressing Deficiencies in Earlier Approaches
5. TapImmune: Technology Portfolio Peptide Antigens To stimulate Helper T-cells (CD4) & Killer T-cells (CD8) Positive Phase I clinical data in HER2/neu+ breast cancer Applicable to ovarian & colorectal cancer Most Comprehensive Approach to Stimulate Killer T-cells to Kill Tumors
6. Corporate Presentation July 2012 TapImmune: Pipeline of Products
7. TapImmune Lead Clinical Program –HER2/neu+ Breast Cancer - HER2/neu+breast cancer is one of most aggressive forms of the disease and is overexpressed in ~ 30% breast cancer patients - Roche’s monoclonal antibody, Herceptin (current standard of care) can only treat ~ 20% of these patients (+$6 billion sales in 2013) - Herceptin does not stimulate Killer T-cells – it slows/retards tumor growth. One-year dosing due to cardiotoxicity - In Contrast: TapImmune’s comprehensive combination of Helper T-Cell PLUS Killer T-Cell Vaccine approach provides long-term Killing and has $ Billion Product Potential Unsatisfied Clinical Need – Large Market Opportunity
8. TapImmune Clinical Studies Mayo Clinic Rochester MN Phase I: Design 22 breast cancer patients previously on Herceptin Class II antigens (4 epitopes) discovered in breast cancer patients - Clin. Cancer Res. (2010) 16, 825-83 6 x monthly intradermal + GMCSF Antigens Applicable to Colorectal and Ovarian Cancer
9. Phase Ib/II Strategy Includes new Class I Antigen Far more Potent than Neuvax Phase Ib/II (4+1) Strategy: Class II antigens (4 epitopes) Class I antigen (p373-382): Superior Killer T Cell Epitope Naturally processed killer T-cell epitope (p373-382)* Log order increased binding to HLA-A2* Higher class I expression on human A2 cells* 4-5x killing efficacy of human breast cancer cells* * Compared to E-75 (Neuvax): J. Immunol. (2013) 190, 479-488 The most comprehensive multi-antigen HER2/neu T-cell vaccine currently in development
10. Clinical Program: Ovarian/Breast Cancer Mayo Clinic Rochester MN Phase I: Design 24 patients with Stage II-III Breast, Ovarian, Peritoneal, Fallopian Tube Cancer Multiple epitope Folate Receptor Alpha peptide vaccine used in combination with Cyclophosphamide Cyclophosphamide 100mg orally Vaccine: 6 x monthly intradermally 7-10 days after last dose of cyclophosphamide Endpoints: Safety Specific T-cell responses Time to disease recurrence Antigens Applicable to Ovarian and Triple –ve Breast
11. TapImmune: 2014 Upcoming Milestones Q1 Q2 Q3 Q4 TPIV Restructure NASDAQ Global HER2/neu+ breast cancer FDA meeting for Phase Ib/II Start Phase Ib/II Folate Alpha Breast/Ovarian Licensing of Phase I program Start Phase II PolyStart™ PolyStart IP Finish Preclinical FDA meeting Viral Disease Smallpox Partnership Burn Rate: ~ $7.5 million 2014; ~ $7.5 million 2015
12. TapImmune: Peptide Expression Technology DNA Expression Vector Platforms Enhance the visibility of cancer or infected cells so that they can be killed by Killer T-cells Polystart™ 4x T-Cell Targets TAP New Approaches to Stimulate Killer T-cells to Kill Tumors
13. TapImmune: PolyStart Delivery and Expression Killer T-cell mediated destruction of PolyStart/PAA transiently transfected human cells Controls PolyStart Transfected PolyStart works, providing antigen for T-cell stimulation and killing
14. Management Team & Board Product & Technology Development: SmithKline Beecham, Ciba-Geigy, Tacora Glynn Wilson, Ph.D Chairman & CEO Academic and Biotech: Synergen, Ciblex, TSRI, UW, IDB/GSK, Seed IP Law Group Bob Florkiewicz, Ph.D. Head of Research Product Development: Cancer vaccines and Biodefense: Biomira, ID Biomedical, Baxter, Bayer AG Mark Reddish Development Advisor, BOD Denis Corin Corporate Finance Advisor Marketing and financial background at Beckman, Novartis, Lindsay Capital Sherry Griswood BOD Investment banking, advisory and research at Dawson James, Tripoint Global Equities & Jesup & Lamont Experience, Credibility, Enthusiasm
15. TapImmune: Scientific Advisory Group Keith Knutson, Ph.D. Research Program Director in Oncology, Vaccine & Gene Therapy Institute of Florida, Port St Lucie, FL Fred Hutchinson Cancer Research Center (FHCRC), Seattle, WA, Professor of Medicine and Director of the NCI-funded Cancer Immunotherapy Trials Network (CITN) Martin Cheever, Ph.D. Director Vaccine Research Group, Professor of Medicine & Director of Program in Translational Immunovirology and Biodefense at Mayo Clinic, Rochester, MN Gregory Poland, MD Leaders in Cancer Immunotherapy & Infectious Disease
16. TapImmune: Investment Highlights Two Phase I Clinical Trials ready to progress to Phase II HUGE market opportunities in multiple therapeutic indications Blockbuster potential, platform for HER2/neu+ breast cancer vaccine PolyStart™ expression, a significant advance in vaccine technologies Strong management & advisory team Leveraging key collaborations with leading institutions Significant near term value catalysts Significantly undervalued and poised for significant growth Price Shares Out Market Cap Stock TPIV (TapImmune) 16,000,000 $ 59,000,000 $3.70 (close 3/18) GALE (Galena) 105,240,000 $ 338,000,000 $3.22 LBIO (Lion Bio) 18,890,000 $ 150,000,000 $7.90 DNDN (Dendreon) 157,490,000 $ 453,560,000 $2.88 ONTY (Oncothyreon) 70,000,000 $ 261,000,000 $3.69 NWBO (Nothwest Bio) 43,400,000 $ 307,730,000 $7.09 Competitive - Broad Applicability - Cancer & infectious Disease
17. Contact Glynn Wilson, Ph.D. Chairman & CEO gwilson@tapimmune.com 206.504.7267
18. TapImmune Appendix Further Details and Insights
19. TapImmune: Viral Disease Platform Proprietary smallpox antigens in animal testing at Mayo Clinic - Protects animals against lethal challenge with virus - Efficacy of plasmid PolyStart expressing antigens plus TAP demonstrated - Business development opportunity Platform for viral pandemics and biodefense - New vaccine can be produced in a few weeks Antiviral Therapeutics and Biodefense
20. Huge Technology Potential – Present & Future State of the Art in: Creating Targets: Multiple antigens – Class I and Class II PolyStart™ PAA four fold increase in T-cell targets TAP expression – enhances target cell visibility to T-cells Applicable to multiple cancer and viral targets Killing Targets: Antigens to stimulate both T-killer and T-helper cells Natural intracellular processing Multiple Technology Platforms
21. PolyStartTM Technology: Innovative Boost Strategy Poly-Antigen Array (PAA) Portion PolyStart Portion A. 3’ 5’ Promoter Xba1 sites multiple translation start sites TAP1 portion IRES portion TAP2 portion 5’ 3’ SV40 Late Promoter AUG TAA AUG TAA B. - Confirmed PolyStart mediated four fold enhanced expression of T-cell antigenic epitopes encoded by PAA portion - Confirmed processing and functional cell surface presentation, and CD8+ T-cell recognition/killing Administration - Plasmid or Viral
22. Natural Processing of Antigens Expressed from PolyStart: More Antigen on Cell Surface Corporate Presentation July 2012
23. Prime & Boost Strategy TapImmune: Vaccine Administration PRIME: - Proprietary naturally processed Class I peptide antigens stimulate killer (CD8+) T-cells; plus - Proprietary naturally processed Class II peptide antigens stimulate helper (CD4+) T-cells; followed by BOOST: - PolyStartTMmediated nucleic acid-dependent intracellular expression of the same Class I and/or Class II antigens with or without co-expression of TAP (Transporter Associated with Antigen Presentation) Straightforward - Can be Combined With Existing Technologies