tap immune presentation
TRANSCRIPT
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New Generation of T-cell Therapeutics
April, 2017
NASDAQ: TPIV
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Certain statements contained herein are forward-looking statements withinthe meaning of the safe harbor provisions of the Private Securities LitigationReform Act of 1995. Forward-looking statements in this document include, butare not limited to, statements relating to long-term stability, the Company'splan of operations and finances, the potential for the Company's vaccines andproposed clinical trials.
The reader is cautioned that any such forward-looking statements are notguarantees of future performance and that actual results may differ materiallyfrom estimates in the forward-looking statements. The Company undertakesno obligation to revise these forward-looking statements to reflect events orcircumstances after the date hereof.
Safe Harbor Statement
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• Lead Vaccine Candidate in Four Phase 2 Clinical Studies Focused on Women’s Cancers: Breast, Ovarian
• Robust, sustained immune responses in Phase 1• FDA Fast Track and Orphan Disease Designation
• T-Cell Vaccines Overcome Deficiencies of Earlier Approaches• Carefully selected antigens generate memory T-cell response
against tumor-overexpressed self-antigens
• Addresses Tumors Resistant to Other Immunotherapies• T-cell impermeable, immunologically inert tumors with high recurrence• Standalone or in combination: chemotherapy and/or immunotherapy
Emerging Leader in T-Cell Immunotherapy
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• Initially Focused on Ovarian and Breast Cancers• Resistant to most immunotherapies• Time to recurrence is relatively short • Survival prognosis is extremely poor after recurrence
• Large U.S. Market (newly diagnosed patients per year): • Ovarian Cancer: ~30,000 • Breast Cancer: 40,000 triple-negative; ~220,000 HER2/neu
• Addressing Treatment- Patients in Need• Prevent recurrence (consolidation therapy)• Improve outcomes for patients resistant to first-line therapies
• Phase 2 Collaborations with Industry & Clinical Leaders:
Significant Opportunity in Women’s Cancers
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Multi-epitope peptide vaccines:• TPIV 200 against Folate Receptor Alpha
• Ovarian; TNBC; NSCLC• TPIV 100/110 against HER2neu
• Her2neu; ovarian; colorectal
PolyStart™:• DNA vector for multiple antigens
• Self antigens/neo-antigens
Technologies & Targets
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• Target-driven: Does Not Rely on Exposing Neo-Antigens • Molecules over-expressed by majority of cancer cells (90% ovarian) ;
correlate with disease prognosis
• Discovered through translational medicine• Naturally processed antigens derived from patient immune responses• MHC class I and II antigens activate CD4+ (helper) and CD8+ (Killer) T cells
• Elicits durable “memory” anti-tumor response• Targets primary tumor and metastases/circulating tumor cells
• Off-the-Shelf Product • Easy, low-cost manufacturing
TPIV 200
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• TPIV 200
Clinical Pipeline – Phase I Results
Ovarian and Breast Cancer patients at
Safe and well tolerated
95% evaluable patients generated robust T-cell responses
100% demonstrated T-cell responses lasting >6 months
Abstract published – ASCO 2015
Led to significant collaborations, multiple Phase II studies
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Indication Design Preclin. Phase 1 Phase 2 Sponsors/Collaborators
TPIV 200
Ovarian Cancer(platinum-resistant)
Combo with durvalumab(anti PD-L1)
Triple-NegativeBreast Cancer
Dose & BoostSafety
Ovarian Cancer(platinum-sensitive)
Time to progression
Triple-NegativeBreast Cancer
Time to progression
TPIV 110 Her2/neu Breast Cancer
Preparing Phase 1/2
Enrolling Phase 2
Mid-Stage Pipeline - Multiple Shots on Goal
Enrolling Phase 2
Phase 2-Ready
Enrolling Phase 2
IND filing in 2017
Fully Funded
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Phase 2 Study Design: TPIV 200 + Durvalumab
Currently Enrolling Platinum-Resistant Ovarian Cancer Patients:• Disease progression within six months of recent platinum-based therapy• Progression while receiving platinum-based therapy• No prior treatment with PD-1 or PD-L1 inhibitors
TPIV 200 + GM-CSF (1x / cycle I.D.; day 1; cycles 1-6)
Durvalumab (2x / cycle I.V.; day 1 and day 15; cycles 1-12)
Cycle Follow UpUntil Progression
1 2 3 4 5 6 7 8 9 10 11 12
Radiographic Tumor Assessment(every 12 weeks)
Patients: 40 total: over 50% recruited; MSKCC plus 6 satellite sitesPrimary Endpoint: Overall Response Rate (RECIST*)Upcoming Milestones: Interim analysis & Go/No Go decision September 2017
* Pre-defined deviations from RECIST will be permitted to allow select patients deemed to be benefitting from treatment to receive continued therapy
Sponsor: MSKCC
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Phase 2 Study Design: TPIV 200 Maintenance Therapy
Currently Enrolling Recurrent Platinum-Sensitive Ovarian Cancer Patients:• Confirmed sensitivity (CR/PR or SD after last platinum regimen)• Start study treatment within 12 weeks of last platinum-based dose
Treatment Period(I.D. at 4-week intervals)
Month
18-month Follow Up
1 2 3 4 5 6
Radiographic Tumor Assessment(every ~12 weeks; up to two years)
Patients: 100: up to 15 sitesPrimary Endpoint: Time to disease progression/recurrence (RESIST)Secondary Endpoints: Overall Survival, Response Rate (CRs+PRs; CRs+PRs+SDs; irRESIST), CA 125 response, Progression-Free Rate at 6 months (PFR)Upcoming Milestones: Interim analysis Q3 2018
Sponsor: TapImmune
< 12 weeks
Platinum Therapy
Randomize 1:1
TPIV 200 + GM-CSF (Active)
GM-CSF Alone (Control)
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Sponsor: TapImmune
Phase 2 Study Design: TPIV 200 for Triple-Negative Breast
Currently Enrolling Stage IIb-III Triple-Negative Breast Cancer Patients:• Completed surgery and radio/chemotherapy <360 days from consent• 4-arm study: High/Low dose TPIV 200 +/- cyclophosphamide (CP)
CP: 300 mg/m2
60min infusionTPIV 200: I.D. injection500µg (high) and 165µg (low)/peptide
>60 days
Radio/Chemotherapy
Randomize 1:1:1:1
Arm 1: TPIV 200 + GM-CSF ( + CP)
Arm 4: TPIV 200 + GM-CSF ( - CP)
Arm 3: TPIV 200 + GM-CSF ( + CP)
Arm 2: TPIV 200 + GM-CSF ( - CP)
+ CP
- CP
+ CP
- CP
Patients 80: Positive DSMB recommendation after 25%; full recruitment by end of 2017 at 12 sitesUpcoming Milestone : interim analysis Q4, 2017
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TPIV 110 Clinical Development Plan
Sponsor/IND Holder
Collaborators N Status Indication Study Design
n/a TBD Planned2017 start Breast Cancer Phase 1b/2a
TBD 2017 start DCIS Breast Cancer Phase 1b/2a
TapImmune
TapImmune
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Combination Immunotherapy is the Future in Oncology
SOC = standard of care
SOC
Ipilimumab
Ipilimumab +Anti-PD-1
Time
%Su
rviv
al
0
100Combination Therapy:• Vaccines• Checkpoint Inhibitors• Adjuvants• Oncolytic Viruses• CAR T Cells
Checkpoint Inhibitors
Chemotherapy
TapImmune Opportunity: Unlock Promise of Immunotherapy for Certain Cancers That Do Not Respond to Checkpoint Inhibitors
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PolyStart™ - Proprietary Protein Expression System
• Unique Protein Expression Technology that Increases Potency of DNA-based Immunotherapies
• Driving incremental value for TapImmune• Proprietary technology invented and owned by TPIV• Applications for oncology and infectious diseases• Application to self-antigens and neo-antigens in cancer• High potential to monetize via out-license to partners
• Advancing in preclinical studies• Recent patent approvals• New constructs for breast and ovarian cancer synthesized
Enhanced Immune Response
Enhanced Antigen Presentation to Killer T-cells
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PolyStart™ and Poly-Antigen Array (PAA)
Modular Design: PAA portion designed for rapid, straight forward replacement
5’……….CUG….CUG…CUG……..AUG………..(PAA)…..TAA…3’
PolyStart Portion PAA Portion(T-Cell Epitopes)
NH2
mRNA
Translation NH2 NH2 NH2
PAA COOHPAAPAAPAA
COOHCOOHCOOH
(one mole)
(four moles)
4 aa
kDa3525
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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
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Experienced Management TeamGlynn 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., MBAPresident 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 LoiaconoCFO & 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 DonnellyDirector of Administration• 20 years of experience in Human Resources and Administration with APL Logistics, System Designs,
Ability Network, and Interline Brands.
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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
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Clinical and Partnership Strategies in 2017
Initiative
Complete Phase 2 proof-of-concept studies
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
Status
Four Phase 2’s Ongoing~$17 million in non-dilutive funding
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
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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
Internally developed Next Generation Vaccine Technology -PolyStart
Capital efficient development strategy
Experienced management and advisory team
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Equity Overview
Capital Structure Shares Outstanding 8.4MPublic Float 6.7MMarket cap 40M (03/06/17)Stock Price $4.73 (03/23/17)Volume (3m): ~48 K
2016 FinancingWarrant exercise ($6.0M)Private Placement ($3.1M)
TapImmune trades on NASDAQ (TPIV)
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CONTACT:
GLYNN WILSON
Chief Executive Officer
NASDAQ: TPIV