U.S. FDA Grants Orphan Drug Designation to TapImmune’s TPIV 200 in the Treatment of Ovarian Cancer

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 ion to TapImmune’s TPIV 200 in the Treatment of Ovarian Cancer

10 Dec 2015

Company preparing for Phase II ovarian cancer trial based on positive data in Mayo Clinic Phase I trial

JACKSONVILLE, Florida, December 9, 2015 /PRNewswire/ –
TapImmune, Inc. (TPIV), a clinical-stage immunology-oncology company specializing in the development of innovative peptide and gene-based immunotherapeutics and vaccines for the treatment of cancer & metastatic disease, announced today that it has received Orphan Drug Designation from the U.S. Food & Drug Administration’s Office of Orphan Products Development (OOPD) for its cancer vaccine TPIV 200 in the treatment of ovarian cancer. The TPIV 200 ovarian cancer clinical program will now receive benefits including tax credits on clinical research and 7-year market exclusivity upon receiving marketing approval.

 TPIV 200 is a multi-epitope peptide vaccine that targets Folate Receptor Alpha which is overexpressed in multiple cancers including over 90% of ovarian cancer cells.  In Phase I clinical studies conducted at the Mayo Clinic in patients with breast and ovarian cancer this vaccine was shown to be safe and well tolerated and to give robust cellular immune responses in 20 out of 21 evaluable patients.  Further, the data showed that 16 out of 16 patients in the observation stage still showed immune responses. Data from the Phase I studies were published in the Journal of Clinical Oncology covering the American Society of Clinical Oncology meeting in May 2015.   Multiple Phase II studies will examine the efficacy of this vaccine in ovarian and triple negative breast cancer.....