New Generation of T-cell Therapeutics

Transcription

1 New Generation of T-cell Therapeutics Corporate Overview January 2017 NASDAQ: TPIV 1

2 Safe Harbor Statement Certain statements contained herein are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 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. 2

3 Leader in T-Cell Therapeutics T-Cell Vaccine Technology Derived from Advances in Cancer Immunology Overcomes deficiencies of earlier vaccine approaches Standalone vaccine or in combination with other treatments and immunotherapies Lead Vaccine Candidate in Four Phase 2 Clinical Studies Focused on Women s Cancers: Breast, Ovarian Robust immune responses in Phase I FDA Fast Track and Orphan Disease Designation 3

4 Combination Immunotherapy is the Future in Oncology % Survival 100 Vaccines - Checkpoint Inh.- Adjuvants - Oncolytic Viruses - CAR T Cells Ipilimumab + Anti-PD-1 Ipilimumab Checkpoint Inhibitors 0 Time SOC SOC = standard of care Chemotherapy 4

5 Significant Opportunity in Women s Cancers Off-the-shelf Vaccine activates helper AND killer T-cells Robust, sustained immune responses against primary tumor and metastatic disease Lead Vaccine Candidate focused on Ovarian and Breast Cancers Collaborations with industry & clinical leaders: AstraZeneca, Mayo Clinic, and Memorial Sloan Kettering Cancer Center Significant non-dilutive funding Second Vaccine focused Her2/neu Breast Cancer Successful Phase 1 clinical study; Preparing to start Phase 1/2 studies in

6 Unique Focus on Women s Cancers Large U.S. Market (newly diagnosed per year): ~30,000 ovarian cancer 40,000 triple negative breast cancer ~220,000 Her2/neu breast cancer Current treatment options are surgery, radiation, and chemotherapy Time to recurrence is relatively short and survival prognosis is extremely poor after recurrence 6

7 Mid-Stage Pipeline - Multiple Shots on Goal Indication Design Preclin. Phase 1 Phase 2 Sponsors/ Collaborators Ovarian Cancer (platinum-resistant) Combo with durvalumab (anti PD-L1) Enrolling Phase 2 TPIV 200 Triple-Negative Breast Cancer Ovarian Cancer (platinum-sensitive) Dose & Boost Safety Time to progression Enrolling Phase 2 Enrolling Phase 2 Triple-Negative Breast Cancer Time to progression Phase 2-Ready Fully Funded TPIV 110 Her2/neu Breast Cancer Preparing Phase 1/2 IND filing in

8 Approach to New Generation of T-Cell Therapeutics Discovered through Translational Medicine Molecular targets correlate with disease prognosis Vaccines directed against specific surface proteins on the majority of target tumor cells TPIV 200: Folate Receptor Alpha overexpressed by ~90% of ovarian cancer cells; 80% of triple-negative breast cancer cells TPIV 110: Her2/neu - ~ 30% breast cancer patients Immune system recognizes antigens in cancer patients Naturally processed antigens derived from patient immune responses MHC class I and II antigens broadly stimulate CD4+ and CD8+ T cells Cover ~85% of human genotypes world wide Off the shelf product easy, low cost manufacturing 8

9 Eliciting Robust and Durable Immune Responses B cells Antibodies Signaling ADCC Complement CD4 and CD8 T-cell Immune responses against tumor associated antigens Selected for binding to MHC Class I and Class II CD4 helper T cells (Class II peptides) Inflammation (macrophages and neutrophils) Antibodies Induce/Enhance cytotoxic T cells CD8 cytolytic T cells (Class I peptides) Tumor lysis 9

10 Lead Phase 2 Vaccine TPIV 200 Consists of naturally processed peptide antigens of Folate Receptor Alpha (FRa) Five Class II peptides with embedded Class I Four T-cell epitopes, one antibody epitope FRa overexpressed in: ~ 90% of ovarian cancer cells >80% of triple negative breast cancers 80% of NSCLC Spontaneous immunity to FRa in cancer patients 10

11 FRa Associated with Cancer Recurrence Proportion Free of Recurrence (%) Weak FRa expression Average Staining Intensity Strong FRa expression Years Hartmann et al. Int J Cancer 2007; 121:

12 TPIV 200 Phase I Ovarian and Breast Cancer patients at Safe and well tolerated 95% evaluable patients generated immune responses 100% demonstrated T-cell responses lasting >6 months Published in Journal of Clinical Oncology Led to significant collaborations, multiple Phase 2 studies 12

13 TPIV Active Phase 2 Clinical Programs Ovarian Cancer Sponsor/ IND Holder MSKCC TapImmune Triple Negative Breast Cancer Sponsor/ IND Holder TapImmune Collaborators N Status Study Design and Objectives TapImmune 40 Recruiting 80 Recruiting Collaborators N Status Study Design and Objectives n/a 80 Recruiting Platinum-resistant patients TPIV durvalumab Time to disease progression Platinum-sensitive patients Multi-center Time to disease progression Multi-center Dose & Boost Safety & Immune Responses TapImmune 280 Planned 2017 Time to disease progression Fully Funded by DoD grant 13

14 TPIV 110 Breast Cancer Vaccine TPIV 110: Five peptides targeting HER2/neu Overexpressed in ~30% breast cancer patients 220,000 cases per year Roche s monoclonal antibodies generated >$6 billion (2013) Herceptin /Parjeta : treat only ~ 20% of HER2/neu+ patients TPIV 110 more effective at killing breast cancer cells in culture than NeuVax (both type 1 antigens) Published in: J Immunol :

15 TPIV 100 generates robust T-Cell Responses in Phase I In Phase I TPIV 100 was well-tolerated and safe in Her2/neu+ patients (Stage II-III, n=22) 95% patients showed robust T-cell responses to two antigens 75% patients responded to all four antigens Class I antigen added for Phase II studies (TPIV 110) 15 San Antonio Breast Cancer Symposium, 2016

16 TPIV 110 Clinical Development Plan Sponsor/ IND Holder TapImmune Collaborators N Status Indication Study Design n/a TapImmune TBD Planned 2017 start TBD 2017 start Breast Cancer DCIS Breast Cancer Phase 1b/2a Phase 1b/2a Completed manufacturing and CMC Completed Pre-IND meeting with FDA Upcoming Milestones: 1. File new IND with FDA Mayo Clinic to initiate Phase 1/2 study in DCIS breast cancer

17 PolyStart - Proprietary Protein Expression System Unique Protein Expression Technology that Increases Potency of DNA-based Immunotherapies Enhanced Antigen Presentation to Killer T-cells Enhanced Immune Response Driving incremental value for TapImmune Proprietary technology invented and owned by TPIV Applications for oncology and infectious diseases High potential to monetize via out-license to partners Advancing in preclinical studies Recent patent approvals New constructs for breast and ovarian cancer synthesized 17

18 PolyStart and Poly-Antigen Array (PAA) Protein antigens are a key component of most cancer immunotherapy DNA approach is attractive, but protein expression is variable to poor Normally : 1 DNA 1 RNA 1 Protein PolyStart : 1 DNA + PolyStart 4 or more Proteins mrna (one mole) PolyStart Portion PAA Portion (T-Cell Epitopes) 5.CUG.CUG CUG..AUG..(PAA)..TAA 3 4 aa NH 2 PAA COOH Translation NH 2 PAA COOH (four moles) NH 2 PAA COOH NH 2 PAA COOH kda Modular Design: PAA portion designed for rapid, straight forward replacement 18

19 Experienced Management Team Glynn Wilson, Ph.D. Founder, Chairman & CEO Extensive track record of success in corporate management and product development at major multinational pharmaceutical companies and startups. Former Worldwide Head of Drug Delivery at SmithKline Beecham and Research Area Head in Advanced Drug Delivery at Ciba-Geigy. John Bonfiglio, Ph.D., MBA President and COO 30 plus years in development and executive roles in pharmaceutical/biotechnology large and small companies. C-level roles at Peregrine Pharmaceuticals, Cypress Biosciences, the Immune Response Corporation, Argos Therapeutics, Oragenics. Michael Loiacono CFO & Chief Accounting Officer 25 plus years of financial management experience and executive roles in private and publicly traded organizations such as Global Axcess. Robert Florkiewicz, Ph.D. Director of Research Extensive experience in molecular biology research and intellectual property development at Scripps Institute, Synergen, ID Bio Medical and Seed Intellectual Law Group. Elizabeth Donnelly Director of Administration 20 years of experience in Human Resources and Administration with APL Logistics, System Designs, Ability Network, and Interline Brands. 19

20 Medical and Scientific Advisors Keith Knutson, Ph.D. Director, Immunotherapy and Cancer Vaccine Program, Mayo Clinic, Jacksonville, FL Discoverer of current HER2/neu and FRA peptide antigens Edith A. Perez, M.D. Deputy Director at Large for Mayo Clinic Cancer Center in Jacksonville, FL Professor at Mayo Clinic College of Medicine and Chair of the Mayo Clinic Breast Cancer Translational Genomics Program Mark Pegram, M.D. Director of the Breast Cancer Oncology Program at Stanford Women s Cancer Center Co-director of Stanford s Molecular Therapeutics Program 20

21 Executing on Clinical and Partnership Strategies in 2017 Initiative Status Complete Phase 2 proof-of-concept studies Four Phase 2 s Ongoing Seek Pharma/Biotech partners for late-stage development and commercialization Explore combination regimens Seek synergistic technologies for acquisition, licensing or joint R&D, e.g. antigens; checkpoint inhibitors Seek to monetize PolyStart expression platform Ongoing Ongoing Phase 2 vaccine + AZ s anti-pd-l1 (durvalumab) Focusing on cancer immunity cycle and women s cancers Working to establish collaborations in cancer & viral disease 21

22 Why Invest in TapImmune Now? Potential to be dominant player in T-cell cancer vaccines Highly vetted technology: Mayo Clinic, DoD, AstraZeneca, Sloan Kettering Evaluating cancer vaccines in four Phase 2 studies FDA Fast Track, Orphan Disease Status Compelling Phase 1 data show durable immune response against vaccine targets Multiple upcoming clinical value inflection points Capital efficient development strategy Experienced management and advisory team 22

23 Equity Overview Capital Structure Shares Outstanding 8.4M Public Float 0.68M Market cap $42.0M (as of 10/31/16) Stock Price $5.00 (as of 10/31/16) Volume (3m): 15.9K Cash Balance: $9.6M as of 9/30/ Financing Warrant exercise ($6.0M) Private Placement ($3.1M) TapImmune is now trading on NASDAQ (TPIV) 23

24 CONTACT: GLYNN WILSON Chief Executive Officer NASDAQ: TPIV 24