TapImmune Vaccine to be Studied in a $13.3 Million U.S. Department of Defense Grant to Mayo Clinic for Phase II Clinical Trial in Triple Negative Breast Cancer
Trial will Utilize Folate Receptor Alpha Vaccine Licensed to TapImmune for Commercialization
JACKSONVILLE, Florida, September 15, 2015 /PRNewswire/ --
TapImmune, Inc. (OTCMKTS: TPIV), congratulates 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.
TapImmune, a clinical stage cancer immunotherapy company, has the commercial rights for this vaccine, which has the potential to treat ovarian, breast, endometrial and non-small cell lung cancer. The Company has been working closely with Dr. Knutson on the clinical development of HER2/neu and Folate receptor alpha vaccines. TapImmune will work closely with Mayo Clinic on this clinical trial by providing clinical and manufacturing expertise as well as providing GMP vaccine formulations. These vaccine formulations are being developed for multiple Phase II clinical programs in triple negative breast and ovarian cancer in combination with other immunotherapeutics.
TapImmune recently announced positive Phase 1 clinical data from the Folate Receptor Alpha vaccine trial in triple negative breast and ovarian cancer. This trial demonstrated the experimental therapy was safe, well-tolerated and provided a robust immune response in 19 out of 20 patients. Data from the Phase 1 trials were submitted and published in abstract form http://meetinglibrary.asco.org/content/148110-156.
The Company plans to utilize funds from its recently restructured financing to start Proof of Concept Phase 2 clinical studies in triple negative breast and ovarian cancer patients beginning the second half of 2015. The design of these studies will complement that of the clinical trial to be conducted at Mayo Clinic.
Dr. Glynn Wilson, Chairman & CEO of TapImmune, stated "We congratulate our collaborators on this outstanding achievement. This award from the Department of Defense will fully fund a large Phase II trial on the folate receptor alpha vaccine, greatly expanding clinical programs on the Folate receptor alpha vaccine and is synergistic with our own clinical pathway. In addition, our ability to contribute GMP manufactured vaccines should greatly facilitate this program. Department of Defense financing is part of its long standing commitment to breast cancer research and the combination of this grant together with our own independent financing of clinical programs provides a significant boost to developing this extremely promising approach to provide new therapeutic options for the treatment of triple negative breast cancer."
Mayo Clinic and Dr. Knutson have a financial interest in TapImmune, sponsor of the clinical trial.
About TapImmune Inc.
TapImmune Inc. is an immunotherapy company specializing in the development of innovative technologies for the treatment of cancer, including metastasis, and infectious disease. The Company's peptide or nucleic acid-based immunotherapeutics comprise one or multiple naturally processed epitopes (NPEs) designed to comprehensively stimulate a patient's 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. Please visit the Company's website at http://www.tapimmune.com for details.
Forward-Looking Statement Disclaimer
This release contains forward-looking information within the meaning of the Private Securities Litigation Reform Act of 1995. Statements in this news release concerning the Company's expectations, plans, business outlook or future performance, and any other statements concerning assumptions made or expectations as to any future events, conditions, performance or other matters, are "forward-looking statements". Forward-looking statements are by their nature subject to risks, uncertainties and other factors which could cause actual results to differ materially from those stored in such statements. Such risks, uncertainties and factors include, but are not limited to the risks set forth in the Company's most recent Form 10-K and other SEC filings which are available through EDGAR at http://www.sec.gov. The Company assumes no obligation to update the forward-looking statements.
CONTACTS:
TapImmune Inc.,
Glynn Wilson, Ph.D.
Chairman & CEO
+1-866-359-7541
PCG Advisory
Kirin M. Smith
Chief Operations Officer
+1-646--863-6519
Sean Leous
Chief Communications Officer
+1-646-863-8998
http://www.pcgadvisory.com
J. Streicher Capital, LLC
Robert Giordano
+1-917-327-3938
SOURCE TapImmune, Inc.
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