Transcript Ovarian & Breast Cancer

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.
Corporate Presentation
TAPIMMUNE
July 2012
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
Corporate Presentation
July 2012
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
Corporate Presentation
July 2012
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 Immune System
Corporate Presentation
July 2012
The body’s immune system is designed to
fight cancer & viral infections
Cancers evade the immune system
allowing tumor growth
Reasons:

The Cancer Markers (antigens) are NOT presented
to the Immune System


Low or Absent T A P (Antigen Transporter)
Epitopes are NOT Naturally Processed (NPE)

T cell response is SHORT lived (No Helper Cells CD4)

T cell response is NOT a KILLER cell response (CD8)
PROBLEM: cancer evades the immune system and current
approaches do not address ALL the reasons adequately
The Immunotherapy Space
Corporate Presentation
July 2012
New Frontier in Treatment of Cancer
Traditional Approaches
Chemotherapy, Radiation, Surgery, Small Molecules
New Immunotherapies
Immune Checkpoint Blockade (BMS; Merck)
Monoclonal antibodies (Roche)
T-Cell Therapies
Ex-Vivo: Adoptive T-cell transfer (LBIO;Juno)
Dendritic cell transfer (NWBIO;DNDN; PBMD)
In Vivo: Antigen stimulation (ONTY;GALE;IMUC)
BOTH Antigen presentation & T Cell stimulation (TPIV)
PROBLEM: To Stimulate the Immunse System to Effectively KILL Tumors
The TapImmune Approach
Corporate Presentation
July 2012
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
• Multiple Indications
• Multiple Therapeutic Areas (Cancer and
Infectious Disease)
SOLUTION: most COMPREHENSIVE immunotherapeutic in development
Product Pipeline
Corporate Presentation
July 2012
Product
Indication
TPIV100
Class II antigens
Her2/neu breast cancer
TPIV110
Class I + II antigens Her2/neu breast cancer
TPIV200
Folate Receptor Alpha Ovarian/breast cancer
Q2 2014
TPIV120
(PolyStart™ Class
I/II antigens)
TPIV 300
(Class I antigens)
Her2/neu breast cancer
Smallpox
Emerging viral threats
Preclinical
Phase I
Phase II
Lead Clinical Programs
Corporate Presentation
July 2012
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
Corporate Presentation
July 2012
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 checkpoint 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
HER2/neu Clinical Program
Corporate Presentation
July 2012
Her2neu Breast Cancer - Mayo Clinic Rochester MN
Leading HER2/neu Vaccine Candidate
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
SOLUTION: most COMPREHENSIVE immunotherapeutic in development
Lead Clinical Programs
Corporate Presentation
July 2012
Trial 2: Stage II/II Ovarian & Breast Cancer - Mayo Clinic
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 llb/2 advancement expected in late 2014.
Orphan Drug Application – Pending FDA
Another $ Multi-Billion product potential with an UNSATISFIED CLINICAL NEED
URGEN CLINCAL NEED - LARGE MARKET OPPORTUNITY
Ovarian Trial Clinical Status
Corporate Presentation
July 2012
T
Trial 2: Ovarian & Breast Cancer (Folate Alpha) - Mayo Clinic Rochester MN
Phase l
22 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
Antigens Applicable to Ovarian and Triple Negative Breast Cancer
TapImmune: 2014 Upcoming Milestones
Q1
Corporate
Trial 1: Breast
Cancer
Trial 2: Ovarian
Cancer
Q2
Restructure
Q3
Q4
NASDAQ
Start
Phase Ib/II
HER2/neu+
breast cancer
Folate Alpha
Licensing of
Breast/Ovarian Phase I program
Pre-Clinical
PolyStart™
Bio-Threat
Viral Disease
Start Phase II
PolyStart IP
Finish Preclinical
FDA meeting
Smallpox Partnership
Multiple Inflection Points and Value Drivers
Corporate Presentation
COLLABORATORS
& ADVISORS
July 2012
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
Denis Corin
Corporate Finance
Management and Advisors
Corporate Presentation
July 2012
Glynn Wilson, PhD
Bob Florkiewicz, PhD
CEO
25 years experience in
product & corporate
development
Head of Research
25 years experience,
academic and biotech
SmithKline Beecham,
Ciba-Geigy, Tacora
Denis Corin
Corporate Finance
Beckman, Novartis
Synergen, TSRI, UW, GSK, Seed
IP Law Group
Mark Reddish
Advisor: Development,
Board
25 years experience in
cancer vaccines and
biodefense
Biomira, ID Biomedical, Baxter,
Bayer AG
Corporate Presentation
CAP STRUCTURE
and COMPS
July 2012
Reorganized Feb 2014
TPIV - TAPIMMUNE INC
Capital Structure
Shares Outstanding
Public Float
Debt Elimination
Market cap
Stock Price
Post Restructure
16,000,000
2,000,000
~$5,000,000
~$30,000,000
$2.00
Comparrisons in Immunotherapy and Biotech
GALE (Galena)
LBIO (Lion Bio)
INO (Inovio)
DNDN (Dendreon)
NWBO (Nothwest Bio)
Shares Out
Market Cap
105,240,000
26,000,000
240,150,000
157,490,000
53,400,000
$
$
$
$
$
250,000,000
180,000,000
565,550,000
453,560,000
317,730,000
Stock Price
$2.50
$6.50
$2.39
$2.88
$5.99
OPPORTUNITY
Corporate Presentation
July 2012
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
CONTACT
Glynn Wilson
Chief Executive Officer
[email protected]
Denis Corin
Corporate Finance
[email protected]