Novel T Cell Vaccine TPIV 200 Benefits from FDA Fast Track and Orphan Drug Designation
JACKSONVILLE, Fla., Aug. 8, 2017 /PRNewswire/ -- TapImmune, Inc. (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 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 in first remission. 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.
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 immunotherapeutic products comprise one or 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. The company's technologies may be used as stand-alone medications or in combination with current treatment modalities.
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