IMV has completed an amendment to the protocol of its Phase 1/2 clinical trial testing a triple combination of DPX-Survivac, epacadostat, and low-dose chemotherapy in recurrent ovarian cancer. The company now is recruiting participants into its Phase 2 part across multiple sites in the U.S. and Canada.
The announcement follows a meeting with the U.S. Food and Drug Administration in which the design of a future registration trial for accelerated approval also was discussed.
“This FDA meeting was an important milestone for the DPX-Survivac program, and we are very pleased to be aligned with the agency on key aspects of our clinical development plan,” Frederic Ors, chief executive officer at IMV, said in a press release.
DPX-Survivac consists of small fractions of the survivin protein, which is broadly over-activated in most cancer types and promotes tumor growth, according to IMV. Survivin plays an essential role in supporting tumor blood vessel growth and promoting resistance to anti-cancer therapies.
The therapy, administered as an injection under the skin, works by triggering a strong immune response against cancer cells producing the survivin protein, causing them to die.
IMV Advances Phase 1b/2 Trial of DPX-Survivac Following Positive Feedback from FDA
