TapImmune Inc.(OTCMKTS:TPIV) continues to move higher in recent trading on slowly accelerating volume. The stock made a spectacular move up earlier this year from lows of $0.121 to highs of $1.71 a share.
The move on TPIV started in anticipation of the ASCO Annual Meeting at the McCormick Place in Chicago which started back on May 29 and continued on positive Phase 1 clinical data from its Folate Receptor Alpha trial in triple negative breast and ovarian cancer as well as an exclusive licensing agreement with the Mayo Foundation.
TapImmune Inc.(OTCMKTS:TPIV) peptide or nucleic acid-based immunotherapeutics, comprise one or multiple naturally processed epitopes (NPEs) designed to comprehensively stimulate a patients’ killer T-cells, helper T-cells and to restore or further augment antigen presentation by using proprietary nucleic acid-based expression systems. The Company’s technologies may be used as stand-alone medications or in combination with current treatment modalities.
The Company recently announced positive Phase 1 clinical data from its Folate Receptor Alpha trial in triple negative breast and ovarian cancer. This trial demonstrated the experimental therapy was safe, well-tolerated and provided a robust immune response. Data from the Folate Receptor Alpha trial and the HER2Neu Phase 1 trial are very encouraging and a further data release from the Her2neu breast cancer Phase 1 trial is expected shortly. The infusion of capital from the exercise of the series B and C warrants will ensure the Company will complete the planned Phase 2 trial program.
TPIV said they intend to move two of its products into phase 2 clinical trials in 2015 and mentioned that a financing raise will be necessary to continue with its operating plan.
TPIV has an exclusive Licensing Option agreement with Mayo Clinic, Rochester, MN, for clinical development of a breast cancer vaccine technology. The option to license this technology can be exercised after Phase I clinical trials under terms agreed between Mayo Clinic and TapImmune. Mayo Clinic will conduct a Phase I clinical trial in breast cancer patients who have a form of breast cancer that express Her2/neu receptors (also called Her2/neu breast cancer). Dr. Keith Knutson, Ph D. will serve as Principal Investigator.
Back in March TPIV announced a US$1 million investment from Eastern Capital Limited under the same terms as the recent January 12, 2015 round of financing.
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In Phase 1 over 95% of patients in both Her2neu positive breast cancer and in folate receptor alpha positive ovarian cancer demonstrated positive immune responses to TapImmune’s antigens. Success in these trials has provided a strong basis for progression to Phase 2. “We plan to initiate a Phase 2 clinical trial in triple negative breast cancer in the near future,” said Wilson.
Triple-negative breast cancer is breast cancer that is unresponsive to standard biomarker-targeted or hormonal treatment. TNBC tumors test negative for the estrogen and progesterone receptors and positive for the HER2 receptor. Approximately 15-20% of all breast cancer patients are triple negative and there are few treatment options for these patients. In the United States approximately 40,000 women are diagnosed with TNBC each year and there are many hundreds of thousands of recovered breast cancer patients at high risk of recurrence. This indication and lack of available therapeutics make this drug an ideal candidate for Fast Track and Orphan Drug designations from the FDA and the company will be making those applications along with its Phase 2 FDA filings.
On September 15 TPIV congratulated the Mayo Clinic for being awarded a grant of $13.3 million from the U.S. Department of Defense. This grant, commencing September 15, 2015, will cover the costs for a 280 patient Phase II Clinical Trial of Folate Receptor Alpha Vaccine in patients with Triple Negative Breast Cancer.
Award recipients are Keith L. Knutson. Ph.D., professor of Immunology at the Mayo Clinic Center for Immunology and Immune Therapies, and Edith A. Perez, M.D., deputy director at large for Mayo Clinic Cancer Center and the Serene M. and Frances C. Durling Professor of Medicine at Mayo Clinic College of Medicine, both at Mayo Clinic’s Florida campus in Jacksonville.
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Currently trading at a $30 million market valuation TPIV has $1.4 million in the treasury, no revenues to date and rising short term debt. But this is an exciting story developing in small caps; the Company has been making some huge advancements recently announcing positive Phase 1 clinical data from its Folate Receptor Alpha trial in triple negative breast and ovarian cancer as well as an exclusive licensing agreement with the Mayo Foundation for Medical Research & Education for the Folate Receptor Alpha technology. We will be updating on TPIV when more details emerge so make sure you are subscribed to Microcapdaily so you know what’s going on with TPIV.
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Disclosure: we hold no position in TPIV either long or short and we have not been compensated for this article.