Immunovaccine Inc., a clinical stage immuno-oncology company, today announced that the first patient has been treated in a Phase 2 Study combining DPX-Survivac with Low Dose Cyclophosphamide administered with Pembrolizumab in Patients with persistent or recurrent/refractory Diffuse Large B-Cell Lymphoma (DLBCL). Sunnybrook Research Institute is sponsoring the study, which is assessing the safety and efficacy of Immunovaccine’s novel T cell activating therapy, DPX-Survivac, in combination with Merck’s anti-PD-1 drug, Pembrolizumab, and low-dose cyclophosphamide in this patient population.
“We are very pleased to have this triple combination clinical trial underway for these patients. These types of advanced lymphomas remain difficult-to-treat, and have not benefitted from recent advances in breakthrough monotherapies in the same way other forms of the disease have,” said Frederic Ors, Immunovaccine’s Chief Executive Officer. “We designed DPX-Survivac in large part to boost the rates of other novel immuno-modulating agents, and continue to see clinical data that support this goal in other cancer types. We look forward to working with our partners at Sunnybrook Research Institute and Merck Canada to further this endeavor.”
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.
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 whose DLBCL expresses survivin, a tumor antigen highly expressed in 60 percent of DLBCL patients.
The study’s primary objective is to document the objective response rate. Secondary objectives include measuring tumor regression and documenting durations of response. In addition, researchers will perform analyses to assess circulating antigen specific immune responses and changes in tumor infiltrating T cell immune responses within the tumor microenvironment. Potential biomarkers of immune and clinical response will be identified.
“We are pleased to be able to assess this novel combination immunotherapy in patients with advanced DLBCL,” said Dr. Berinstein. “Despite recent breakthroughs, this is an unmet medical need and this approach may have relevance to many other cancers. Working with Immunovaccine’s candidate DPX-Survivac gives us the opportunity to assess whether these patients may experience enhanced anti-cancer activity with novel combination treatments.”
Immunovaccine announced regulatory clearance for this trial at the end of 2017. This trial is supported in part by a research grant from the Investigator-Initiated Studies Program of Merck Canada Inc. and Immunovaccine.
This investigator-sponsored DLBCL trial also marks the second Phase 2 study evaluating anti-cancer activity of Immunovaccine’s lead candidate, DPX Survivac, in combination with Merck’s pembrolizumab and cyclophosphamide. The other Phase 2 trial is evaluating the triple combination immunotherapy in patients with advanced ovarian cancer.