Her2neu Breast Cancer - Mayo Clinic Rochester MN

Report
At the Forefront of Immunotherapy
OTCQB: TPIV
1551 Eastlake Ave E
Suite 100
Seattle, WA
www.TapImmune.com
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.
TAPIMMUNE INC.
A New Frontier in Immunotherapy
TapImmune is an Immunotherapy company specializing in the
development of the most comprehensive and innovative
immunotherapeutics in cancer and infectious diseases.
Opportunity & Milestones
Why invest in TapImmune now?
• Unique and Broad product opportunities in cancer & infectious disease
• Two Phase I Clinical Trials ready to progress to Phase II
• HER2/neu breast cancer vaccine potential blockbuster
• Ovarian Cancer Urgently Needed Therapeutic with blockbuster potential
• HUGE market opportunities in multiple therapeutic indications
• PolyStart™ expression vector is a significant advance in vaccine
technologies
• Strong management & advisory team
• Leverage of key collaborations with leading institutions
• Series of preclinical and clinical value inflexion points
• Significantly undervalued and poised for significant growth
An approach with the potential to change lives and excellent entry level valuation
TAPIMMUNE
Harnessing the Power of Immune System
Leading Immunotherapy Approach:
CANCER
• Making tumors visible to T-cells
• Stimulating T-killer cells AND T-helper cells
• Applicable to broad patient populations
INFECTIOUS DISEASE
• Up-regulation of Antigen Presentation
• Stimulating T-killer cells & T-helper cells
• Applicable Multiple Infectious Diseases and Biothreats
The Immunotherapy Space
New Frontier in Treatment of Cancer
Immunotherapies
• Immune Checkpoint Blocade, Monoclonal antibodies (Roche) T-cell
Therapies
T-Cell Therapies
• Ex-Vivo: Adoptive T-cell transfer (LBIO;Juno); Dendritic cell transfer
(NWBIO;DNDN; PBMD)
• In Vivo: Antigen stimulation (ONTY;GALE;IMUC)
TapImmune is Unique:
Platforms to stimulate BOTH Antigen presentation & T Cell stimulation
(TPIV)
GOAL: To Stimulate the Immune System to Effectively KILL
Tumors
The TapImmune Approach
Why we are different!
Prime BOTH sides of the tumor Killing equation
Proprietary peptide antigens used to stimulate a broad based
• T - Helper cell response (CD4) LONG-LIVED
• KILLER T-cells to actually KILL the tumor (CD8)
These Proprietary Antigens allow us to treat:
• Wider patient populations (EG: +50% Vs Roche Herceptin 15%)
• Multiple Indications
• Multiple Therapeutic Areas (Cancer and Infectious Disease)
SOLUTION: Most COMPREHENSIVE immunotherapeutic in development
Product Pipeline
Clincal Trial - Breast
TPIV100/110
Trial 1: Her2neu Breast Cancer - Mayo Clinic Rochester MN
• HER2/neu positive breast cancer is one of most aggressive forms
• HER2/neu is overexpressed in ~ 30% breast cancer patients (total
220,000 /yr)
• 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
• In Contrast: We believe TapImmune’s comprehensive combination of
Killers and Helpers has the potential to provide Long Lasting Immune
Response in upto 84% of the HER2/neu positive patient population.
• A $ Multi-Billion product potential meeting an UNSATISFIED CLINICAL
NEED in a very LARGE Market
Herceptin Facts:
Late Stage Survival improved by 4.5 Months.
Early stage treatment resulted in a 9.5% improvement on recurrence.
70% of Her2neu+ patients do NOT respond to treatment
HER2/neu Clinical Status
Her2neu Breast Cancer - Mayo Clinic Rochester MN
Phase l
• Class II antigens (4 epitopes NPE) discovered in breast
cancer patients - Clin. Cancer Res. (2010) 16, 825-83
• 22 Patients post Herceptin
• 6 x monthly intradermal + GMCSF
 Interim safety chectkpoint completed
 Positive Immune responses on first 6 patients (interim
data)
• Excellent Results – Support progression to Phase ll
Phase lb/ll
Class II + Class I (p373-382) antigens (4+1)
• To start Q4, 2014
• Small safety study
• 100-150 patient multicenter phase II
ImmunoTherapeutic TPIV110
Most Comprehensive Her2neu Breast Cancer Immunotherapeutic
Leading HER2/neu Vaccine Candidate in Development
Peptide Antigens to stimulate BOTH:
• T-helper cells – Long Lasting
•
•
Antigens discovered in breast cancer patients
Naturally Processed Epitopes (NPE’s)
• Killer T-cells (p373-382) - Kills Tumor Cells
Compared to NeuVax by Galena:
4-5x greater KILLING activity against human tumor cell targets
See: J.Immonol. (2013) 190, 479-488
Clinical Trial Ovarian
TPIV200
Trial 2: Stage II/IIl Ovarian & Breast Cancer - Mayo Clinic MN
• Folate Receptor Alpha is expressed over 95% of ovarian cancers, for which
the only treatment options are surgery and chemotherapy
• Very important and urgent clinical need for a new therapeutic.
• Time to recurrence is relatively short for this type of cancer and survival
prognosis is extremely poor after recurrence.
• US alone, approximately 30,000 ovarian cancer patients newly diagnosed
every year.
• Phase lb/2 advancement expected in late 2014.
• Orphan Drug Application – Pending FDA
• Another $ Multi-Billion product potential with an UNSATISFIED CLINICAL
NEED
URGENT CLINICAL NEED – LARGE MARKET – ORPHAN DRUG – FAST TRACK?
Clinical Trial Ovarian
TPIV200
Trial 2: Stage II/IIl Ovarian & Breast Cancer - Mayo Clinic MN
23 patients with Stage II-III Breast, Ovarian, Peritoneal, Fallopian
Tube Cancer
 Interim safety checkpoint completed
 Positive Immune responses observed
Promising Interim Results – Support progression to Phase ll
Phase ll Expected to Start in 2014 with Orphan Drug Application - FDA Pending
These Folate Alpha Antigens Also Applicable to Triple Negative Breast Cancer
Collaborators & Scientific Advisors
World Class Team
Dr Keith Knutson (Vaccine & Gene Therapy Institute of Florida/Mayo Clinic):
Director, Cancer Immunology and Immunotherapy Program, VGTI;
Adjunct Faculty - Immunology, Mayo Clinic
Dr Greg Poland: (Mayo Clinic)
Head of Vaccines; Infectious disease/biodefense
Dr Mac Cheever (Fred Hutchinson Cancer Research Center)
Director Solid Tumor Research; Professor of Medicine/Oncology at the University of
Washington (Seattle) & Director of the NCI-funded Cancer Immunotherapy Trials
Network (CITN)
Mark Reddish Advisor: Development , Board
Product Development: Cancer vaccines and Biodefense: Biomira, ID Biomedical, Baxter,
Bayer AG
Management And Advisors
Glynn Wilson, PhD
CEO
25 years experience in
product & corporate
development
Bob Florkiewicz,
PhD
Head of Research
25 years experience,
academic and biotech
SmithKline Beecham,
Ciba-Geigy, Tacora
Synergen, TSRI, UW, GSK,
Seed IP Law Group
Denis Corin
Mark Reddish
Corporate Finance
Advisor: Development,
Board
25 years experience in
cancer vaccines and
biodefense
Beckman Coulter,
Novartis, MIV
Therapeutics, Business
Objects (PeopleSoft)
Biomira, ID Biomedical, Baxter,
Bayer AG
Cap Structure and Comps
Reorganized Feb 2014
TPIV - TAPIMMUNE INC
Capital Structure
Shares Outstanding
Public Float
Market cap
Stock Price
19,000,000
6,000,000
~$25,000,000
$1.25
Comparrisons in Immunotherapy and Biotech
GALE (Galena)
LBIO (Lion Bio)
INO (Inovio)
DNDN (Dendreon)
NWBO (Nothwest Bio)
Shares Out
105,240,000
26,000,000
60,000,000
160,000,000
53,400,000
Market Cap
$ 250,000,000
$ 180,000,000
$ 565,550,000
$ 636,560,000
$ 355,730,000
Stock Price
$2.50
$6.50
$10.30
$1.40
$5.95
Opportunity & Milestones
Why invest in TapImmune now?
• Unique and Broad product opportunities in cancer & infectious disease
• Two Phase I Clinical Trials ready to progress to Phase II
• HER2/neu breast cancer vaccine potential blockbuster
• Ovarian Cancer Urgently Needed Therapeutic with blockbuster potential
• HUGE market opportunities in multiple therapeutic indications
• PolyStart™ expression vector is a significant advance in vaccine
technologies
• Strong management & advisory team
• Leverage of key collaborations with leading institutions
• Series of preclinical and clinical value inflexion points
• Significantly undervalued and poised for significant growth
An approach with the potential to change lives and excellent entry level valuation
THANK YOU
CONTACT:
GLYNN WILSON
Chief Executive Officer
[email protected]
DENIS CORIN
Corporate Finance
[email protected]
OTCBB: TPIV

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