(U.S.) FDA Grants Multi-Epitope Vaccine Orphan Designation for Ovarian Cancer

science news
 Published Online:5:41 AM, Mon December 28, 2015
An orphan drug designation has been granted to the multi-epitope folate receptor alpha (FRα) vaccine TPIV 200 as a treatment for patients with ovarian cancer by the FDA.

According to a statement from the drug's developer, TapImmune, the designation was based on findings from a phase I study, which were electronically published in conjunction with the 2015 ASCO Annual Meeting.

"Ovarian cancer is highly aggressive, clinically evasive, and, with current treatment modalities, time to recurrence is relatively short and prognosis upon recurrence is poor," Patrick Yeramian, MD, vice president and chief medical officer at TapImmune, said in a statement. "The FDA's decision to grant TPIV 200 orphan designation underscores the need for additional therapeutic options and validates the scientific rationale of TapImmune's approach."

Treatment with the vaccine was associated with FRα-specific T-cell response that persisted beyond the completion of the study for a majority of patients. In total, FRα is expressed on nearly 90% of ovarian cancer cells.

In the phase I study, 22 patients with breast or ovarian cancer were enrolled following surgery and adjuvant therapy. Prior to receiving the vaccine, patients were treated with 1 cycle of cyclophosphamide on days 1 to 7 and 15 to 22, to reduce immunosuppressive T regulatory cells (Tregs). The vaccine, which contained the 5 peptides FR30, FR56, FR76, FR113, and FR238, was administered intradermally at three sites on the first day of each subsequent cycle following cyclophosphamide for a maximum of 6 cycles......