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Immunovaccine Announces Regulatory Clearance for Phase 2 Clinical Trial Evaluating DPX-Survivac in Combination with Merck's Checkpoint Inhibitor Pembrolizumab in DLBCLHALIFAX, Nova Scotia, Nov. 08, 2017 (GLOBE NEWSWIRE) -- Immunovaccine Inc. (TSX:IMV) (OTCQX:IMMVF), a clinical stage vaccine and immuno-oncology company, today announced that Health Canada has granted Sunnybrook Research Institute regulatory clearance to begin recruiting patients for its Phase 2 clinical study of a triple-combination immunotherapy in patients with measurable or recurrent diffuse large B-cell lymphoma (DLBCL). This trial, announced initially in May 2017, is designed to evaluate the safety and efficacy of Immunovaccine’s lead product candidate, DPX-Survivac, along with Merck’s pembrolizumab and low-dose cyclophosphamide in this patient population. “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,” said Frederic Ors, Chief Executive Officer at Immunovaccine. “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.i 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.” Primary investigator Neil Berinstein, MD, Affiliate Scientist, Sunnybrook Research Institute, Professor of Medicine/Immunology, University of Toronto, is leading the non-randomized, open-label study, which is expected to enroll 25 evaluable participants at several centers in Canada. Researchers conducting the study will test the novel immunotherapy combination in patients hose DLBCL expresses survivin, a tumor antigen highly expressed in 60 percent of DLBCL patients. The study’s primary objective is to document a minimal objective response rate. Secondary objectives include measuring tumor regression and documenting durations of response. In addition, researchers will perform analyses to assess circulating tumor infiltrating T cell immune responses and potential biomarkers of immune and clinical response. DLBCL is the most common type of non-Hodgkin lymphoma (NHL) in the United States and worldwide, accounting for up to one-third of patients with newly diagnosed NHL in the United States. About DPX-Survivac About Immunovaccine Immunovaccine Forward-Looking Statements Contacts for Immunovaccine: MEDIA INVESTOR RELATIONS Patti Bank, Managing Director, Westwicke Partners _____________________ i 1. Chi Young Ok and Ken H. Young, Checkpoint inhibitors in hematological malignancies, Journal of Hematology and Oncology (2017). 10.1186/s13045-017-0474-3 |