TapImmune Announces Fully Funded Phase 2 Clinical Study of HER2-Targeted Vaccine in Early Breast Cancer

Collaborators at Mayo Clinic Secure New $3.7 Million Grant from U.S. Department of Defense

Second TapImmune T-cell vaccine candidate to be tested in a DoD-funded study

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Mar 14, 2017, 09:15 ET

JACKSONVILLE, Fla., March 14, 2017 /PRNewswire/ -- TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics for the treatment of cancer and metastatic disease, today announced that its collaborators at the Mayo Clinic, recently received a $3.7 million grant from the U.S. Department of Defense (DoD) to conduct a Phase 2 clinical study on TapImmune's HER2/neu-targeted T-cell vaccine that will enroll women diagnosed with an early form of breast cancer called ductal carcinoma in situ (DCIS). If successful, TapImmune's vaccine may replace standard surgery and chemotherapy, and potentially could become part of a routine immunization schedule for preventing breast cancer in healthy women.

"This is our second T-cell vaccine candidate to be tested in a DoD-funded Phase 2 study to the Mayo Clinic, and it marks our expansion into a second breast cancer indication," said Dr. Glynn Wilson, chairman and CEO of TapImmune. "In addition to ongoing and planned Phase 2 studies of our lead TPIV 200 vaccine for treating triple-negative breast cancer, this new study of our HER2neu vaccine in DCIS has the potential to validate our novel approach to establishing lasting immunity against breast cancer and precancerous lesions. Her2neu is overexpressed in about 30% of all breast cancer patients amounting to approximately 220,00 patients per year. We look forward to the advancement of this fully funded study, as it further broadens our robust clinical pipeline, which also includes two additional Phase 2 trials for treating ovarian cancer."

The study is expected to begin in 2017 and will be led by Keith Knutson, Ph.D., Director of the Discovery and Translational Labs Cancer Research Program at Mayo Clinic's Florida campus. It is expected to enroll 40-45 women with DCIS, who will receive the vaccine six weeks prior to standard surgical resection. The vaccine has already been shown to stimulate production of T-cells directed against breast cancer cells that overexpress the oncogene HER2 in a completed Phase 1 study.

TapImmune has licensed the HER2neu vaccine technology that will be used in this study and has the worldwide exclusive rights to commercialize the technology. TapImmune will be funded for providing the manufactured product for this trial.

Dr. Knutson added, "DCIS is a significant health problem, accounting for about 20% of U.S. cases of breast cancer. We ultimately want to eliminate ductal carcinoma in situ, which means preventing disfiguring surgeries and toxic therapies in the 60,000 women who receive this diagnosis every year in the U.S."

About TapImmune, Inc.
TapImmune, Inc. is a leader in the immunotherapy of woman's cancers advancing multiple Phase 2 and Phase 1b/2 clinical studies for the treatment of ovarian and breast cancer. 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 www.tapimmune.com for more 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, 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.

SOURCE TapImmune, Inc.