Phase 2 Study May Be Added to Ongoing Trial of Combo Ovarian Cancer Immunotherapy

Phase 2 Study May Be Added to Ongoing Trial of Combo Ovarian Cancer Immunotherapy
Immunovaccine and Incyte Corporation are expanding their collaboration on a clinical trial, and plan to add a Phase 2 to their ongoing Phase 1b study in advanced ovarian cancer. The open-label Phase 1b trial (NCT02785250) is evaluating the safety and efficacy of Immunovaccine’s lead candidate DPX-Survivac in combination with Incyte’s IDO1 enzyme inhibitor epacadostat and low-dose cyclophosphamide in about 40 patients with recurrent ovarian cancer. DPX-Survivac consists of small fractions of the survivin protein, which are able to trigger an immune response. DPX-Survivac is thought to work by eliciting a toxic T-cell immune response against cells presenting survivin peptides. Survivin, seen as a promising tumor-associated antigen, is broadly over-expressed in most cancer types and promotes tumor growth. It plays an essential role in supporting tumor blood vessel growth and promoting resistance to anti-cancer therapies. Epacadostat is a potent, selective oral inhibitor of IDO1, an enzyme expressed in many cancers that suppresses T-cell response. The study's Phase 2 part will include up to 32 additional patients and also be open label, meaning all enrolled will receive the treatment.  Its goal, the companies said in a press release, will be to evaluate the clinical contribution of each investigational therapy in the combination treatment. The Phase 1b study is taking place five sites in the U.S. and in Ontario, Canada, and recruiting patients. More information is available here. Data reported from a first group of 10 patients treated in Phase 1b show that the combination regimen — DPX-Survivac, epacadostat at 100 mg and low-dose cyclophosphamide— showed a 70 percent disease control rate, including partial response in three of these patients,
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