The study is expected to include at least 200 patients with bladder, liver, ovarian, or non-small cell lung (NSCLC) cancers, as well as tumors positive for the microsatellite instability high (MSI-H) biomarker.
Enrollment is expected to begin during the fourth quarter of 2018, across several clinical centers in Canada and the U.S.
“With this new study evaluating the combination of IMV and Merck immunotherapies, our goal is to expand the patient impact and market potential of our lead candidate across a broad range of cancers,” Joseph Sullivan, senior vice president of business development at IMV, said in a press release. “The Merck team has significant experience in the field, and we are very enthusiastic about exploring this combination with them in multiple solid tumor indications.”
DPX-Survivac is a cancer vaccine that triggers a strong immune response against the survivin protein. Survivin is broadly over-activated in most cancer types, playing an essential role in tumor growth and resistance to anti-cancer therapies.
DPX-Survivac is meant to kill cancer cells producing the survivin protein and potentially sensitize them to the effects of other therapeutic agents.
Keytruda is an immune checkpoint inhibitor that restores the immune surveillance mechanisms within tumors, increasing the body’s ability to fight cancer.
The upcoming Phase 2 trial will be the third testing a combination of DPX-Survivac, Keytruda, and low-dose cyclophosphamide. The other two are studying the combination in patients with ovarian cancer (NCT03029403) and diffuse large B-cell lymphoma (NCT03349450).
Results to date have shown that 70% of patients in the trial reached at least stable disease, including 30% with partial responses. The treatment was also well-tolerated by patients.
“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, CEO of IMV. “We are delighted to expand our clinical program and collaboration with Merck across multiple cancer indications, and look forward to investigating the potential added benefit of combining DPX-Survivac and Keytruda.”
DPX-Survivac received fast track designation from the U.S. Food and Drug Administration as a maintenance therapy for advanced ovarian cancer patients. It also received orphan drug status from the FDA and the European Medicines Agency for the same indication.