Novel T Cell Vaccine TPIV 200 Benefits from FDA Fast Track and Orphan Drug Designation
Jacksonville FL, August 7, 2017 – TapImmune, Inc. (NASDAQ: TPIV), a clinical-stage immuno-oncology company specializing in the development of immunotherapies targeting women’s cancers, today announced that, in coordination with the U.S. Food and Drug Administration (FDA), it has amended the patient inclusion criteria for its Phase 2 clinical trial of the Company’s T-cell therapeutic peptide vaccine TPIV200 to focus on women with Stage III and IV ovarian cancer who are in remission following their first round of successful platinum-based chemotherapy. TapImmune has enrolled the first women under this amended study protocol, which significantly expands the population of patients that can be addressed with TPIV 200 as a potential maintenance therapy designed to prevent disease recurrence.
TPIV200 targets the folate receptor alpha protein, which is overexpressed by most patients with ovarian cancer, and the vaccine has generated durable immune responses in a completed Phase 1 study. TapImmune sought to amend the clinical protocol following extensive discussion with its clinical advisors regarding the unmet need in this patient population and in anticipation of FDA approval of niraparib for women with recurrent disease. Patients in their first remission following platinum therapy currently have no approved therapeutic option to prevent disease recurrence, which occurs at a high rate. Therefore, these patients are in the best position to benefit from TPIV 200 maintenance therapy.
“Our investigators, as well as their ovarian cancer patients, are enthusiastic about this trial, which is intended to demonstrate enhanced progression-free survival for women prior to their first recurrence.” said Dr. Richard Kenney, Head of Clinical Development at TapImmune. “Shifting our focus to earlier in the treatment cycle enables TapImmune to showcase the potential of our novel T cell vaccine in a much larger patient population. Furthermore, should TPIV 200 demonstrate a significant benefit for these women in prolonging the time to disease recurrence, the Company will be well positioned within the current treatment paradigm for ovarian cancer, which now includes the PARP inhibitor niraparib for treating patients with recurrent disease.”
The Phase 2 ovarian cancer trial is a double-blind controlled study designed to examine the potential benefits of using the Company’s lead product candidate TPIV200 following standard of care platinum-based chemotherapy. Study size was increased to 120 patients to better evaluate the effect of the immunotherapy and to achieve statistical significance of efficacy data. TPIV200 has Fast Track designation from the FDA and Orphan Drug status for ovarian cancer.
TapImmune, Inc. is a leader in the 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) designed to comprehensively stimulate a patient's killer T-cells and helper T-cells, and to restore or further augment antigen presentation by 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 given without respect to HLA type. The company's technologies may be used as stand-alone medications or in combination with other treatment modalities.
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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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