Immunovaccine Announces Initiation of Patient Dosing in Investigator-Sponsored Phase 2 Clinical Trial of Its Lead Candidate DPX-Survivac Used in Combination with Pembrolizumab in Patients with DLBCL
HALIFAX, Nova Scotia, March 28, 2018 (GLOBE NEWSWIRE) -- Immunovaccine Inc. (TSX:IMV) (OTCQX:IMMVF), 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.
DPX-Survivac consists of survivin-based peptide antigens formulated in the Company’s patented platform. DPX-Survivac is thought to work by eliciting a cytotoxic T cell immune response against cells presenting survivin peptides. Survivin, recognized by the National Cancer Institute (NCI) as a promising 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. Immunovaccine has identified over 15 cancer indications in which the over-expression of survivin can be targeted by DPX-Survivac. DPX-Survivac received Fast Track designation from the U.S. Food & Drug Administration (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 (EMA) in the ovarian cancer indication.
Immunovaccine Inc. is a clinical-stage biopharmaceutical corporation dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and infectious diseases. Immunovaccine develops T cell activating cancer immunotherapies and infectious disease vaccines based on DepoVax™, the Corporation’s patented platform that provides controlled and prolonged exposure of antigens and adjuvant to the immune system. Immunovaccine has advanced two T cell activation therapies for cancer through Phase 1 human clinical trials and is currently conducting a Phase 1b study with Incyte Corporation assessing lead cancer therapy, DPX-Survivac, as a combination therapy in ovarian cancer. The Corporation is also exploring additional applications of DepoVax™, including DPX-RSV, an innovative vaccine candidate for respiratory syncytial virus (RSV), which has recently completed a Phase 1 clinical trial. Immunovaccine also has ongoing clinical projects to assess the potential of its platform to address malaria and the Zika virus. Connect at www.imvaccine.com.
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