IMV Inc. Reaches Multiple Milestones in Advanced Ovarian Cancer Clinical Trial
- Enrollment Completed for Phase 1b Cohorts
- First Dosing Occurred in Phase 2 Portion of the Program
“Completion of the Phase 1b enrollment and initiation of the Phase 2 component of our clinical program are key milestones in our goal to accelerate the clinical evaluation and path to market of our novel immuno-therapy,” said
Investigators have completed enrollment in the Phase 1b cohorts of the study, with a total of 50 patients across the two dosing groups. The Phase 1b study is evaluating the safety and efficacy of combining DPX-Survivac, 100 mg or 300 mg of epacadostat, and low dose cyclophosphamide in individuals with advanced, platinum-sensitive and resistant ovarian cancer.
Investigators plan to enroll up to 32 evaluable patients in the Phase 2 cohort, which will evaluate DPX-Survivac and low dose cyclophosphamide with, or without, epacadostat in patients with advanced recurrent ovarian cancer. In accordance with regulatory guidelines for combination trials, the goal of this component of the program is to evaluate the clinical contribution of each investigational drug in the combination regimen.
Investigators recently announced positive preliminary data from the Phase 1b dosing arms in an oral presentation at the 2018 meeting of the
DPX-Survivac is the lead candidate in IMV’s new class of immunotherapies that programs targeted T cells in vivo. It has demonstrated the potential for industry-leading targeted, persistent, and durable T cell activation. IMV believes this MOA is key to generating durable solid tumor regressions. DPX-Survivac consists of survivin-based peptide antigens formulated in IMV’s proprietary DPX drug development platform. DPX-Survivac is believed to work by eliciting a cytotoxic T cell immune response against cells presenting survivin peptides.
Survivin, recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen, is broadly over-expressed in most cancer types, and plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to anti-cancer therapies. IMV has identified over 15 cancer indications in which the over-expression of survivin can be targeted by DPX-Survivac.
DPX-Survivac has received Fast Track designation from the U.S. Food & Drug Administration (FDA) as maintenance therapy in advanced ovarian cancer, as well as orphan drug designation status from the FDA and the
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Source: IMV Inc.