At the forefront of ImmunotherapyOTCQB: TPIV
1551 Eastlake Ave ESuite 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 & MilestonesWhy 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, KiteDendritic Cell Transfer: Dendreon, NW Bio, Prima BioMed
T-cell Stimulation – In VivoAntigen Approaches: ONTY, GALE, IMUCAntigens + 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 cytokinesActivate and grow T-killer cells
Peptide antigensPolystart™
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
TAPPolystart™
Peptide antigens & Polystart™ used together as a “Prime” and “Boost” strategy*Science published in over 20 peer-reviewed publications
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 StatusHer2neu Breast Cancer - Mayo Clinic Rochester MN
• 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
Phase l
TPIV 100/110 Clinical Status
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
Phase ll:
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 AntigensOvarian & 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 StatusStage 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 2015Phase 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 DiseasePlatform Technologies with Infinite Opportunities
High Global Priority for Vaccine Development for Emerging ThreatsEbola, 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 AdvisorsWorld 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
Mark ReddishAdvisor: Development, Board 25 years experience in cancer vaccines and biodefense Biomira, ID Biomedical, Baxter, Bayer AG
Denis CorinCorporate FinanceBeckman Coulter, Novartis, MIV Therapeutics, Business Objects (PeopleSoft)
Glynn Wilson, PhDCEO25 years experience in product & corporate developmentSmithKline Beecham, Ciba-Geigy, Tacora
Bob Florkiewicz, PhDHead of Research25 years experience, academic and biotechSynergen, TSRI, UW, GSK, Seed IP Law Group
Cap Structure and CompsReorganized Feb 2014
TPIV - TAPIMMUNE INCCapital Structure Shares Outstanding 19,603,815Public Float 8,000,000Market cap ~$8,000,000Stock Price $0.40
Comparisons in Immunotherapy and Biotech Shares Out Market Cap Stock Price GALE (Galena) 105,240,000 $ 250,000,000 $2.50LBIO (Lion Bio) 26,000,000 $ 180,000,000 $6.50INO (Inovio) 60,000,000 $ 565,550,000 $10.30DNDN (Dendreon) 160,000,000 $ 160,000,000 $1.00NWBO (Nothwest Bio) 53,400,000 $ 355,730,000 $5.95
Opportunity & MilestonesWhy 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