ImmunoVaccine Inc. announced U.S. Food and Drug Administration (FDA) and Health Canada clearance to initiate a clinical study of DPX-Survivac in combination with low-dose cyclophosphamide and epacadostat. Resulting from a recently announced collaboration between Immunovaccine and Incyte Corporation, the Phase 1b clinical trial will assess the safety and effectiveness of Immunovaccine's novel T cell activating therapy, DPX-Survivac, along with Incyte's investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat (INCB24360), and low-dose cyclophosphamide in patients with recurrent ovarian cancer who have measurable disease. Immunovaccine anticipates starting the trial, which Incyte will co-fund under the terms of the agreement between the two companies, by the second quarter of 2016. Under the approved protocol, the Phase 1b clinical trial will be a single arm, non- randomized, open label, uncontrolled, safety and effectiveness study that will enroll up to 32 participants at up to six sites in the U.S. and Canada.

The primary objective is to determine the safety and immunogenicity (the ability to produce an immune response) of the treatment, and to determine changes in the immune cell infiltration into tumors. Secondary objectives include objective response rate, duration of response and time to progression.