IMV Advances Phase 1b/2 Trial of DPX-Survivac Following Positive Feedback from FDA

IMV Advances Phase 1b/2 Trial of DPX-Survivac Following Positive Feedback from FDA
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. Epacadostat is a potent, selective oral IDO1 inhibitor. Belonging to the growing class of checkpoint inhibitors, such as CTLA-4, PD-1, and PD-L1 antibodies, IDO pathway inhibitors can regulate immune responses by suppressing tumor cell survival, growth, and invasion. The Phase 1b/2 trial, called DECIDE1 (NCT02785250), was designed to test a combination of DPX-Survivac, epacadostat and low-dose cyclophosphamide in ovarian cancer patients who received surgery and any number of prior chemotherapies. The Phase 1b trial included 53 patients who received one of two ep
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