TapImmune's HER2/neu-Targeted Breast Cancer Vaccine to be Studied in a Large Phase 2 Immunotherapy Combination Study Funded by an $11 Million U.S. Department of Defense Grant

Mayo Clinic Receives $11 Million to Study TPIV110 in Combination with Trastuzumab (Herceptin®)     

JACKSONVILLE, Fla., Oct. 10, 2018 /PRNewswire/ -- TapImmune Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company, congratulates Mayo Clinic for being awarded a grant of $11 million from the U.S. Department of Defense (DoD). This grant will cover the costs of a large Phase 2 study of TapImmune's HER2/neu-targeted breast cancer vaccine, TPIV110, in combination with another immunotherapeutic, trastuzumab (Herceptin®), for treating women with HER2/neu-positive breast cancer.

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Award recipients are Keith L. Knutson, Ph.D., Professor of Immunology in the Department of Immunology and Saranya Chumsri, M.D. in the Division of Hematology and Oncology at Mayo Clinic in Jacksonville, Florida. 

TapImmune will work closely with Mayo Clinic on this clinical trial by providing clinical and manufacturing expertise as well as providing GMP vaccine formulations.

Peter L. Hoang, President and CEO of TapImmune, stated, "I am delighted that the U.S. Department of Defense has again chosen to support our technology and therapeutic platform with another funding commitment. This grant speaks to the strength and quality of the DoD's relationship with Dr. Knutson and the Mayo Clinic. This new 380-patient trial will be the largest to date for TapImmune, and I note that the Department of Defense has now awarded almost $30 million in grants to study our novel vaccine candidates in Phase 2 clinical studies.  We are grateful to the DoD for their continued efforts to support the development of new and potentially life-saving treatment modalities for women suffering from breast cancer. Like Dr. Knutson's team at the Mayo, we believe that the underlying science indicates that TPIV110 has strong potential to synergize with Herceptin® and generate enhanced levels of protective immunity in patients with aggressive HER2-positive breast cancer."

This is the second DoD grant to be awarded to the Mayo Clinic to study TPIV110, which is also the subject of a planned, DoD-funded Phase 2 study in women with ductal carcinoma in situ (DCIS).  This newest grant also marks the third awarded to fully fund clinical trials of TapImmune's novel peptide vaccine candidates.

Previously, TapImmune announced that the Mayo Clinic plans to conduct a Phase 2 clinical study of TPIV110 that will enroll women diagnosed with DCIS, an early form of breast cancer. If successful, the vaccine may be positioned to complement standard surgery and chemotherapy in this setting and potentially could become part of a routine immunization schedule for preventing breast cancer in healthy women.

TapImmune is also currently enrolling women into a 280-patient Phase 2 randomized, multi-center, double-blinded, placebo-controlled clinical trial of its novel therapeutic vaccine candidate TPIV200, which is funded by a $13.3 million DoD grant. This study is evaluating TPIV200 in the prevention of cancer recurrence in women with triple-negative breast cancer (TNBC) who have completed first-line surgery and radiotherapy/chemotherapy. This program is eligible for FDA Fast Track designation.

Mayo Clinic and Dr. Knutson have a financial interest in the technology referenced in this news release.

About TapImmune Inc.
TapImmune Inc. is a leader in the development of novel immunotherapies for cancer, with multiple Phase 2 and Phase 1b/2 clinical studies currently ongoing for the treatment of ovarian and breast cancer. The company's peptide- or nucleic acid-based immunotherapeutic products comprise multiple naturally processed epitopes (NPEs) that are designed to comprehensively stimulate a patient's killer T cells and helper T cells, and to restore or further augment antigen presentation using proprietary nucleic acid-based expression systems. This unique approach can produce off-the-shelf T cell vaccine candidates that elicit a broad-based T cell response and can be used without respect to HLA type. The company's technologies may be used as stand-alone medications or in combination with other treatment modalities. TapImmune has announced a proposed merger with Marker Therapeutics, Inc., a privately-held clinical stage developer of a transformative, non-genetically engineered, multi-antigen T cell therapy platform, which will add a significant portfolio of clinical-stage cell therapies to create a leading immuno-oncology pipeline.

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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, 10-Q and other SEC filings which are available through EDGAR at www.sec.gov. The company assumes no obligation to update the forward-looking statements. 

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SOURCE TapImmune Inc.


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