Corporate Presentation

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.
Opportunity & Milestones
Why invest in TapImmune now?
Immunotherapy is the fastest growing pharmaceutical sector
Unique and broad product opportunities in cancer & infectious disease
Technology platforms:
Comprehensive approach to T-cell stimulation
PolyStart™ is a significant advance in vaccine design
Two Phase I Clinical Trials ready to progress to Phase II
HER2/neu breast cancer vaccine potential blockbuster
Ovarian cancer vaccine addresses urgent therapeutic need
“A” team of management and advisors
Series of preclinical and clinical value inflexion points
Undervalued - poised for significant growth – great buying opportunity
TAPIMMUNE INC.
Immunotherapy is the new frontier in cancer therapy
• Human immune system is largest manufacturer of
therapeutic molecules
• Immunotherapy enhances the immune system to identify,
fight and eradicate disease
• TapImmune has the leading and most comprehensive
approach to stimulate T-cells and enhance antigen
presentation
• Applicable to cancer (including metastatic disease) and
infectious disease across broad patient populations
• Simple injectable products
Immunotherapy Landscape
Monoclonal Antibodies:
Herceptin (tratuzumab); Perjeta (pertuzumab)
Keytruda (pembrolizamab); Yervoy (ipilimumab)
T-cell Stimulation – Ex Vivo:
T-Cell Transfer:
Lion, Juno, Kite
Dendritic Cell Transfer: Dendreon, NW Bio, Prima BioMed
T-cell Stimulation – In Vivo
Antigen Approaches:
ONTY, GALE, IMUC
Antigens + Antigen Presentation: TPIV
Marketed Products:
Provenge; Gardasil; Keytruda; Yervoy, Herceptin
TapImmune Technologies
Stimulate four important functions in the immune system
T-Cell
Function
Technology*
T-killer cells (CTLs;CD8)
Kill non-self cells
Peptide antigens
Polystart™
T-helper cells (CD4)
Release cytokines
Activate and grow T-killer cells
Peptide antigens
Polystart™
T-memory cells
5-10% of activated T-cells have
long-term memory for antigen
Peptide antigens
Antigen Presentation
Transport foreign antigens to
cell surface – inhibited in many
tumor cells
TAP
Polystart™
Peptide antigens & Polystart™ used together as a “Prime” and “Boost” strategy
*Science published in over 20 peer-reviewed publications
Product Pipeline
Lead Product TPIV 100/110:
HER2/neu Breast Cancer
• 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
• Potential for TPIV’s vaccine to:
• provide long lasting immune response in up to 84% of the HER2/neu
positive patient population.
• Ability to kill tumor cells and treat metastatic disease
TPIV 100 Clinical Status
Her2neu Breast Cancer - Mayo Clinic Rochester MN
Phase l
• Class II antigens (TPIV 100: 4 antigens) discovered in breast
cancer patients - Clin. Cancer Res. (2010) 16, 825-83
• 22 Patients post Herceptin
• 6 x monthly intradermal + GMCSF
 Well tolerated
 Safety and Immune responses on all patients
 Trial successful and vaccine stimulates immune system as
predicted
TPIV 100/110 Clinical Status
Phase ll:
Class II + Class I antigens
•
•
•
•
•
•
•
Clinical team & multiple clinical centers identified
150-300 patient study
Manufacturing & formulation underway
Clinical protocol in final review (statistician; breast cancer experts)
Pre IND request ready for submission
PreIND meeting and IND filing in Q1-Q2, 2015
Collaboration with VGTI Florida announced
TPIV 110 +TPIV 100
The leading HER2/neu technology platform in clinical development
• Discovery in lab of Dr Keith Knutson (Mayo)
• T-killer cell antigen (p373-382: TPIV110)
licensed from Mayo Clinic
• 4-5x greater killing activity against human
breast cancer cells than NeuVax (E-75 from
Galena)
• Work published in J. Immunol. (2013) 190,
479-488
TPIV200 – Folate Receptor Alpha Antigens
Ovarian & Breast Cancer
• Folate Receptor Alpha is expressed over 95% of ovarian cancers, for which
the only treatment options are surgery and chemotherapy
• Also expressed in Triple Negative Breast Cancer
• Urgent clinical need for a new therapeutics.
• 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.
• Orphan Drug Application
• $ Multi-Billion product potential
TPIV 200 Clinical Status
Stage II/IIl Ovarian & Breast Cancer - Mayo Clinic MN
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
Pre-IND Phase ll meeting Q1 2015
Phase ll Expected to Start in Q1-Q2 2015 with Orphan Drug Application
PolyStart™ DNA Expression Vector
• Enhanced synthesis of a peptide antigen array (PAA)
comprising multiple proprietary T-cell peptide epitopes
• Up to 4x conventional protein expression
• Vaccine technology - rapid plug-and-play design
• Used with T-cell peptide based immunization strategies (e.g.,
prime and boost)
• Can be co-expressed with transporter protein known as TAP1 to
unmask hidden antigens
• Simple and cost-effective manufacturing
• New IP filed
Infectious Disease
Platform Technologies with Infinite Opportunities
High Global Priority for Vaccine Development for Emerging Threats
Ebola, Dengue, West Nile, Bird Flu, Smallpox
TAPvax:
Smallpox vaccine up to 100 times more effective
PolyStart™: Rapid vaccine development for emerging threats
TPIV 300:
Prototype peptide vaccine for smallpox (Mayo)
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 Patrick Yeramian (Vaccine & Gene Therapy Institute of Florida)
Medical Director
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)
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
19,603,815
8,000,000
~$8,000,000
$0.40
Comparisons 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
$ 160,000,000
$ 355,730,000
Stock Price
$2.50
$6.50
$10.30
$1.00
$5.95
Opportunity & Milestones
Why invest in TapImmune now?
Immunotherapy is the fastest growing pharmaceutical sector
Unique and broad product opportunities in cancer & infectious disease
Technology platforms:
Comprehensive approach to T-cell stimulation
PolyStart™ significant advance in vaccine design
Two Phase I Clinical Trials ready to progress to Phase II
HER2/neu breast cancer vaccine potential blockbuster
Ovarian cancer vaccine addresses urgent therapeutic need
“A” team of management and advisors
Series of preclinical and clinical value inflexion points
Undervalued - poised for significant growth – great buying opportunity
TAPIMMUNE VISION
• Immunotherapy will lead the fight against cancer
• Combination therapies will include monoclonal
antibodies and T-cell therapies
TapImmune has positioned itself to be the leader
in comprehensive in vivo T-cell therapies
THANK YOU
CONTACT:
GLYNN WILSON
Chief Executive Officer
[email protected]
OTCBB: TPIV

similar documents