Immunovaccine Inc, a clinical stage vaccine and immunotherapy company, 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 (“Incyte”), 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 Q2 2016.
“This clearance marks a key regulatory milestone for our DPX-Survivac ovarian cancer program,” said Marc Mansour, Ph.D., Immunovaccine Chief Executive Officer. “We have already established that DPX-Survivac combined with low dose oral cyclophosphamide is well tolerated, can induce a strong immune response, and has a potential clinical effect in individuals with ovarian cancer. This trial will build on this momentum by adding a promising, clinically advanced, immunotherapy developed by Incyte for study as a combination therapy. We hope that this triple combination can lead to a new and potent therapeutic option for the high unmet medical need in ovarian cancer.”
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.
“It is our belief that the combination of immune-targeted therapies holds great promise in oncology, and may pave the way for new and potentially better therapeutic options for patients with ovarian cancer,” said Rich Levy, M.D., Chief Drug Development Officer of Incyte. “We are pleased to announce the initiation of an additional clinical study examining the use of epacadostat alongside another promising therapy and look forward to future results.”
DPX-Survivac and epacadostat both target pathways that have been linked to cancer progression, namely survivin and IDO1. High levels of survivin and IDO1 are found in a broad range of cancers, including ovarian cancer. Individually, they have been shown to correlate with poor patient outcomes. DPX-Survivac is designed to activate the T cells of the immune system to recognize survivin-expressing cancer cells. Epacadostat, on the other hand, is designed to inhibit IDO1-mediated immune suppression in the tumor microenvironment. Thus, co-administering these immunotherapies may lead to enhanced anti-tumor effects by both activating the immune system to recognize the cancer, and simultaneously lessening suppression of the immune response.
“Based on what we have seen from these novel immunotherapeutic candidates individually and when combined with other immune modulators, we hypothesize that, when co-administered, they will work together synergistically for the benefit of underserved patients with advanced cancers,” added Dr. Mansour.
