Phase I Study in Ovarian & Breast Cancer Published in Abstracts of 2015 ASCO Annual Meeting
May 15, 2015
SEATTLE, Wash., May 15, 2015 /PRNewswire/ – TapImmune, Inc. (TPIV), is pleased to announce that an Abstract on a Phase I Study on the Safety and Immunogenicity of a folate receptor alpha (FRAα) peptide vaccine has been published in J Clin. Oncol., 33:5s, 2015 (suppl; abstr e14028) which, is a compilation of abstracts submitted to the 2015 ASCO Annual Meeting (http://am.asco.org/).
FRα is overexpressed by multiple cancers, including triple negative breast, ovarian and non-small cell lung cancers. Endogenous T-cell immunity to each of five FRα peptides had been demonstrated in patients with breast and ovarian cancer indicating the feasibility of targeting FRα via a vaccine approach. Phase 1 studies were conducted at the Mayo Clinic, Rochester, MN . Twenty-two patients with breast or ovarian cancer who had undergone standard surgery and adjuvant treatment were vaccinated with a mixture of the 5 FRα peptides for a maximum of 6 vaccination cycles. Vaccine treatments were generally well tolerated with mild to moderate toxicities.
Importantly, FRα-specific T cell responses were observed in 20 of 21 patients with immune response data. Of these, 16 of 16 patients with observation data had demonstrable CD4 and CD8+ T cell responses which, persisted after the completion of vaccine therapy.
“These immune response data provide a strong rationale for progression into Phase II trials. We have assembled an experienced team of advisors and experts to assist us in moving the next trial forward as quickly as possible,” commented Dr. Glynn Wilson, Chairman and CEO of TapImmune. “For example, GMP manufacturing of peptides for Phase II trials is already underway and final analysis of clinical plans and clinical sites for the treatment of triple negative breast cancer is nearing completion for the start of Phase II studies later in 2015,” Dr. Wilson added.
Triple-negative breast cancer comprises approximately 15-20% of all breast cancer patients. In the United States, there are approximately 40,000 new diagnoses a year and following chemotherapy many hundreds of thousands of patients are at high risk of cancer recurrence. This represents a huge clinical need with significant market potential.
Dr. Keith Knutson, Mayo Clinic, Jacksonville, FL, inventor of the FRα technology and Dr. Glynn Wilson, TapImmune, Seattle, WA, will be attending the ASCO meeting to discuss these results and meet with other thought leaders attending this premier oncology conference.
About TapImmune Inc.
TapImmune Inc. is an immunotherapy company specializing in the development of innovative technologies for the treatment of cancer, including metastases, 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 using proprietary nucleic acid-based expression systems. The Company’s technologies may be used as stand-alone medications or in combination with current treatments. Please visit the Company’s website at markertherapeutics.com for further 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 www.sec.gov. The Company assumes no obligation to update the forward-looking statements.
Glynn Wilson, Ph.D. Chairman & CEO +1(866)-359-7541+1(866)-359-7541 FREE
Kirin M. Smith Chief Operating Officer +1(646)-863-6519+1(646)-863-6519
Sean Leous Chief Communications Officer +1(646)-863-8998+1(646)-863-8998
J. Streicher Capital, LLC Robert Giordano +1(917)-327-3938+1(917)-327-3938
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