Health Canada OKs Start of Enrollment in Phase 2 DPX-Survivac Trial for DLBCL

Health Canada OKs Start of Enrollment in Phase 2 DPX-Survivac Trial for DLBCL

Sunnybrook Research Institute received regulatory clearance from Health Canada to begin patient recruitment for a new clinical study evaluating a triple-combination immunotherapy in patients with measurable or recurrent diffuse large B-cell lymphoma (DLBCL).

The Phase 2 clinical trial (NCT03349450) was first announced in May 2017, and is designed to evaluate the safety and efficacy of Immunovaccine’s lead product candidate, DPX-Survivac, with Merck’s Keytruda (pembrolizumab) and low-dose cyclophosphamide (Cytoxan) in this patient population.

DPX-Survivac is a new vaccine created to cause a T-cell immune response against cells presenting survivin peptides. Survivin is a tumor-associated antigen that is seen in many cancers, and is thought to play a key role in preventing cancer cell death.

According to the National Cancer Institute (NCI), survivin also supports tumor-associated angiogenesis (the physiological process through which new blood vessels form from pre-existing ones) and promotes resistance to anti-cancer therapies.

DPX-Survivac consists of survivin-based peptide antigens formulated using Immunovaccine’s proprietary DepoVax delivery platform.

“With clearance received from Health Canada, we hope to quickly begin the important work of evaluating a critically needed therapy for those who suffer from DLBCL – a fast-growing form of lymphoma that can spread to nearly every organ of the body,” Frederic Ors, the CEO of Immunovaccine, said in a press release.

“Despite promising results observed in the treatment of DLBCL with cutting-edge monotherapies like checkpoint inhibitors, a significant number of patients still do not respond to treatment,” Ors said. “It is our goal to increase the types of patients who are able to respond to these therapies via synergistic combinations that can activate and direct T-cell responses.

“Through complementary mechanisms of action, we believe the combination of DPX-Survivac and pembrolizumab could amplify T cell production and infiltration to help realize the desired immune response in a broader range of patients with this type of cancer,” he added.

The study is designed to document a minimal objective response rate as its primary outcome measure. Secondary measures include tumor regression and duration of response. Once the trial is up and running, researchers will analyze immune responses from tumor infiltrating T-cells in circulation and potential biomarkers of immune and clinical response.

Neil Berinstein, MD, primary investigator for the trial and an affiliate scientist at Sunnybrook, is seeking 25 patients whose DLBCL shows levels of the protein survivin. The protein is highly expressed in 60 percent of DLBCL patients.

The team will accept evaluable participants at several centers in Canada. To know more about locations and eligibility, patients can contact Dr. Berinstein by emailing him at [email protected] or calling him at 416-480-5248. DLBCL patients can also visit the trial registration page here.