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Anti-PD-1 drug advances to Phase 2
HALIFAX, Nova Scotia—Clinical-stage company Immunovaccine Inc. has reported that the University Health Network's Princess Margaret Cancer Centre will be conducting a Phase 2 clinical trial testing a combination of Immunovaccine's and Merck's (also known as MSD) immunotherapies in patients with recurrent, platinum-resistant ovarian cancer. Specifically, the trial will evaluate the safety and efficacy of Immunovaccine’s DPX-Survivac cancer vaccine candidate when combined with Merck’s checkpoint inhibitor Pembrolizumab. The study will also assess doses of metronomic cyclophosphamide, a low-dose regimen with immuno-modulating effects.
This trial will be non-randomized and open label, with an expected enrollment of 42 patients with advanced epithelial ovarian, fallopian tube or primary peritoneal cancer. The primary objective will be determining overall response rate, with secondary objectives including progression-free survival rate, overall survival rate and potential side effects over the course of five years.
“Ovarian cancer is a main focus for Immunovaccine as we continue to develop DPX-Survivac,” stated Frederic Ors, CEO of Immunovaccine. “Combination therapies—particularly those with anti-PD-1 activity—are emerging as increasingly promising approaches for hard-to-treat cancers. We believe that the robust immunogenic and safety clinical profile for DPX-Survivac, along with its unique complementary activity to anti-PD-1 agents, which may boost their response rates, position our immuno-oncology candidate as an optimal co-therapy in this disease area.”
DPX-Survivac, Immunovaccine’s lead immuno-oncology candidate, was developed using its novel proprietary DepoVax adjuvanting technology platform. The DPX-Survivac target, survivin, is found in more than 20 different types of solid tumor and hematologic cancers— including ovarian, breast, colon and lung cancer—and plays a part in several critical pathways related cancer cell growth and survival. In a Phase 1/1b study, DPX-Survivac combined with a low dose of cyclophosphamide was found to be highly immunogenic in individuals with high-risk ovarian cancer, resulting in survivin-specific T cell immune responses in most participants. Other studies have shown that a combination immunotherapy featuring a DepoVax-based vaccine is capable of boosting the anti-tumor effects of a PD-1 blockage, to the point that even tumors that had previously failed to respond to anti-PD-1 agents showed controlled cancer growth in the face of the DepoVax compound.
The lead investigator for the trial is Dr. Amit M. Oza, senior staff physician and Associate Professor of Medicine at Princess Margaret. Merck will fund the study and contribute materials, while Immunovaccine will contribute its product candidate and a related portion of analytical assays.
“Ovarian cancer is among the most challenging cancers to treat, as it is associated with poor response rates to currently available medical interventions,” said Oza. “To support the tens of thousands of women battling this disease, we need to develop new and novel approaches. With this trial, we have the opportunity to explore a novel combination of promising immunotherapies.”
Immunovaccine also has a Phase 1b trial underway with Incyte Corporation to evaluate the triple combination of DPX-Survivac with Incyte’s investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, Epacadostat (INCB24360), and low-dose oral cyclophosphamide in patients with platinum-sensitive or -resistant ovarian cancer. Top-line interim results for this Phase 1b trial are expected by the end of March.
SOURCE: Immunovaccine press release