The Company’s lead product (TPIV 200) is entering multiple Phase II clinical trials for the treatment of triple negative breast cancer and ovarian cancer. After conventional therapies (surgery, radiation and chemotherapy) patients in these indications are at high risk of cancer recurrence with poor overall prognosis. TPIV 200 stimulates the body’s cellular immune system to recognize and fight cancer cells and in particular targets metastatic disease which is the biggest threat to survival. The Company’s approach is to broadly stimulate T-cells to recognize and remember specific targets (antigens) on tumor cells throughout the body.
LEVERAGING TRANSLATIONAL MEDICINE RESEARCH AT MAYO CLINIC
TapImmune has a worldwide exclusive license to commercialize proprietary vaccine technologies discovered in the laboratory of Dr Keith Knutson at the Mayo Clinic. These technologies (called multiple epitope vaccines) are against cancers that over-express the HER2neu (in HER2neu breast cancer and ovarian cancer) or Folate Receptor Alpha (in ovarian, triple-negative breast and non-small cell lung cancer) antigens. Vaccine compositions were derived from studies in cancer patients that showed that the immune system could recognize a number of small peptide antigens. In Phase I studies in patients with ovarian and breast cancer completed at the Mayo Clinic, Rochester, MN, both technologies were shown to be safe and well tolerated, and produced robust T-cell immune responses in over 90% of patients treated. TPIV 200, which contains 5 (Class II) peptide antigens, has been formulated and manufactured as a single lyophilized product that in Phase I protocols was administered once a month for six months. It is an “off the shelf” product that can be administered through a simple injection.
Based on the exciting results from Phase I studies TapImmune plans to conduct multiple Phase II studies on TPIV 200 in triple negative breast and ovarian cancer starting in 2016. Initial studies will test the ability of vaccines in a therapeutic setting to prevent or slow disease recurrence in patients that have completed standard therapies. In triple negative breast cancer a large 280 patient, double-blinded, placebo-controlled study will be started at the Mayo Clinic, Jacksonville. This study will be funded by a $13.3 million grant awarded to the Mayo Clinic by the US Department of Defense (DOD) and will start later in 2016. TapImmune will provide TPIV 200 for these studies and will have access to clinical results. The endpoints of this study will be time to disease progression. A smaller (80 patients) TapImmune sponsored open-label study (already enrolling) will study the vaccine dose and boost strategy and the endpoints will be safety, immune responses and therapeutic responses. This study has already started at multiple centers. Two studies are planned in ovarian cancer. The first has started at Memorial Sloan Kettering Cancer Center, New York, NY, and will study the combination of TPIV 200 and a PL-1 inhibitor (durvalumab; AstraZeneca) in 40 patients with platinum resistant ovarian cancer. An additional study will also examine the efficacy of TPIV 200 as a maintenance therapy in ovarian cancer patients that are responding to platinum treatment. The Company also plans to complete formulation and manufacturing on TPIV 110 so that they can start trials in HER2neu positive breast cancer at the start of 2017. Thus, TapImmune anticipates a number of clinical milestones including submission of new INDs to the FDA, start of new clinical programs and recruitment and treatment of patients.
Patient Population – Market Opportunity
It is predicted that Immunotherapy will become the leading treatment for cancer with sales of $41 billion predicted for 2020 (http://www.researchandmarkets.com/research/qjhgbh/global_and_usa). It is the Company’s view that its cancer vaccines will be use as stand-alone therapies or in combination with other immunotherapy approaches.
The current markets have an urgent need for new therapies to prevent cancer recurrence. Triple negative breast cancer represents ~ 15% of breast cancer patients with over 40,000 new patients in the US being diagnosed each year. Standard of care includes surgery, radiation and chemotherapy but after these treatments there is a high probability of cancer recurrence. Approximately 30,000 new patients in the US are diagnosed with ovarian cancer and the 5 year survival rate is ~ 45%. In HER2neu breast cancer (which represents ~ 30% of all breast cancer patients) Herceptin (Roche) is currently standard of care. This monoclonal antibody can effectively treat ~20% of patients that have the HER2neu antigen and has annual sales ~$6 billion. TapImmune’s ability to treat over 85% of the patient population provides large market opportunities. As TPIV 200 and TPIV 110 can be used as stand-alone products or in combination with other therapies it gives the Company significant market flexibility.
ORPHAN DRUG AND FAST TRACK STATUS
The FDA has granted TapImmune Orphan Drug Status for TPIV 200 in ovarian cancer which will give the Company tax benefits and a period of market exclusivity when the drug comes to market. The FDA has also designated the investigation of multiple-epitope Folate Receptor Alpha Peptide Vaccine (TPIV 200) with GM-CSF adjuvant for maintenance therapy in subjects with platinum-sensitive advanced ovarian cancer as a Fast Track Development Program. Designation as a Fast Track product for a new drug or biological product means that the FDA will take such actions as are appropriate to expedite the development and review of the application for approval of such product.
NEXT GENERATION VACCINES
TapImmune has developed internally a novel DNA vaccine technology called PolyStart with the potential to become the next generation of T-cell stimulating vaccines. This technology facilitates the expression of multiple peptide antigens to produce a stronger immune response. It has the potential to be a stand-alone vaccine platform. Patent claims on the technology were recently issued. The Company’s immediate goal is to complete preclinical work to include PolyStart constructs into current clinical programs and to seek out-licensing and collaborative opportunities for PolyStart in both cancer and non-cancer indications.
EXPERIENCED MANAGEMENT AND DEVELOPMENT TEAM
TapImmune has established a top-tier management and development team that can execute the Company’s plans. Chairman & CEO, Dr Glynn Wilson has a broad background in Product & Corporate Development in large pharmaceutical organizations (Ciba-Geigy; SmithKline Beecham) and start-up organizations (Tacora; TapImmune). He was responsible for in-licensing vaccine technologies from Mayo Clinic and in developing the current product pipeline. The Company’s Strategic Advisor, Dr John Bonfiglio has successfully run several Biotech Companies, including Peregrine, Immune Response Corporation, Argos, and Oragenics, and has broad experience in product development and financing. Dr Robert Florkiewicz, Head of Research, is a molecular cell biologist with experience at Synergen, TSRI, GSK and Seed IP, and is the inventor of the PolyStart technology. Dr Patrick Yeramian, Consultant Medical Director has over 25 years experience in the clinical development of new drugs, biopharmaceuticals and vaccines with corporate experience at Viragen and Searle. This team together with advisors has demonstrated the ability to execute and progress clinical and preclinical programs.
BUSINESS & FINANCIAL STRATEGY
TapImmune is positioned with the best in class T-cell vaccines for breast and ovarian cancer. The Company’s business strategy is to fund the completion of Phase II clinical trials where successful results will provide significant value inflection points. At a current market valuation of ~$40 million, in one of the most attractive investment areas, there is the potential for significant growth and the Company represents a compelling investment opportunity.
Robust T-cell responses in over 90% patients treated with TapImmune’s T-cell vaccines. Multiple Phase II studies to study clinical efficacy have been initiated.
Lead product TPIV 200 is a multi-epitope vaccine against Folate Receptor Alpha over-expressed in triple negative and ovarian cancer.
TapImmune plans to achieve a number of value-creating milestones in 2016 and beyond.
For more inforamtion about TapImmune, Inc., please visit: www.TapImmune.com
The company paid consideration to SNN or its affiliates for this article.
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