IMV Inc. said it has expanded its clinical program with a phase II basket trial evaluating its lead candidate, DPX-Survivac, in combination with low dose cyclophosphamide and Merck’s anti-PD-1 therapy, Keytruda (pembrolizumab) in patients with select advanced or recurrent solid tumors.
“The clinical data from our recent ASCO meeting presentation demonstrated for the first time the unique potential of DPX-Survivac to generate solid tumor regressions in ovarian cancer,” said Frederic Ors, chief executive officer of IMV Inc.
The open-label, multicenter, phase II basket study will evaluate the safety and efficacy of the immunotherapeutic combination agents in patients with bladder, liver (hepatocellular carcinoma), ovarian, or non-small cell lung cancers as well as tumors shown to be positive for the microsatellite instability high biomarker.
Investigators plan to enroll more than 200 patients across five indications at multiple medical centers in Canada and the United States. IMV expects to initiate trial enrollment in the 4th quarter of 2018.
This is the third clinical trial evaluating the combination of DPX-Survivac, low dose cyclophosphamide, and pembrolizumab in advanced recurrent cancers. Two ongoing investigator-sponsored phase II trials are evaluating this combination in patients with advanced ovarian cancer and diffuse large B-cell lymphoma.
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 against cancer.
This mechanism of action is key to generating durable regressions in solid tumors, IMV said. DPX-Survivac consists of survivin-based peptide antigens formulated in IMV’s proprietary DPX drug delivery platform. DPX-Survivac is believed to work by eliciting a prolonged cytotoxic T cell attack on cancer cells presenting survivin peptides.
Survivin, recognized by NCI as a 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 FDA as maintenance therapy in advanced ovarian cancer, as well as orphan drug designation status from the U.S. FDA and the European Medicines Agency in the ovarian cancer indication. It is currently being evaluated in multiple phase Ib/II clinical trials.
