Immuno Vaccine Inc (IMV)

[xr_biotech_consult]

Immunovaccine's Lead Immuno-Oncology Candidate to Enter Investigator-Sponsored Phase 2 Clinical Trial in DLBCL in Combination with Approved Anti-PD-1 Drug

Company's Clinical Program Continues to Expand with Second Phase 2 Trial Announced This Year Evaluating the Combination of DPX-Survivac and Anti-PD-1 Therapies in Hard-to-Treat Cancers
HALIFAX, NOVA SCOTIA--(Marketwired - May 16, 2017) - Immunovaccine Inc. (TSX:IMV)(OTCQX:IMMVF), a clinical stage vaccine and immuno-oncology company, today announced that an investigator-sponsored Phase 2 clinical trial will evaluate the use of a triple-combination immunotherapy in patients with measurable or recurrent diffuse large B-Cell lymphoma (DLBCL). Investigators will assess the efficacy and safety of Immunovaccine's lead candidate, DPX-Survivac, along with a checkpoint inhibitor drug currently marketed by a large pharmaceutical company, and low-dose cyclophosphamide. Immunovaccine expects the trial to begin enrolling patients following receipt of regulatory clearance from Health Canada.
"While immunotherapies, such as checkpoint inhibitors, are rapidly changing the standard of care in many cancers, it has been reported that only about 20 percent of patients are able to respond to these therapies alone, leaving the vast majority of patients with a significant unmet medical need," said Frederic Ors, Chief Executive Officer at Immunovaccine.i "Our clinical strategy builds on our earlier research, which indicated that novel combination immunotherapies-particularly those with the ability to increase T-cell tumor infiltration-may work together synergistically to increase the number of patients responding to today's advanced treatments. We remain committed to working with world-class partners to bring these combinations through clinical development. Our goal is to generate more therapeutic options for patients currently underserved in today's treatment landscape."
Researchers conducting the investigator-sponsored study will test the novel immunotherapy combination in patients whose DLBCL expresses survivin, a tumor antigen highly expressed in 60 percent of DLBCL patients. DPX-Survivac stimulates the immune system to produce T cell responses targeting survivin. The non-randomized, open-label study is expected to enroll 25 evaluable participants at five centers in Canada.
This clinical trial is the third ongoing triple-combination study using DPX-Survivac with low-dose cyclophosphamide and other immuno-modulating agents. The Company announced earlier this year that an investigator-sponsored Phase 2 study will evaluate the anti-tumor activity of Merck's pembrolizumab with DPX-Survivac and cyclophosphamide in patients with recurrent, platinum-resistant ovarian cancer. In addition, Immunovaccine recently released positive early data from its Phase 1b triple-combination trial with Incyte Corporation, evaluating DPX-Survivac, low-dose cyclophosphamide and Incyte's IDO1 inhibitor epacadostat in patients with recurrent ovarian cancer.
Advanced analysis of one of the patients in Immunovaccine's initial Phase 2 study in DLBCL patients provided a strong rationale for this novel triple combination. Early data indicated that there was a correlation between immune response and tumor changes following administration of DPX-Survivac. Specifically:
The patient experienced changes in tumor-infiltrating T cells, which correlated with an immune response produced by DPX-Survivac and detected in the blood.
Tumor cells showed significant PD-L1 expression, which indicates the likely suppression of the anti-tumor activity of their T cells. This effect may be alleviated with anti PD-1 or anti PD-L1 agents.
Based on these findings, and to bring the clinical program in line with Immunovaccine strategy of focusing its immuno-oncology pipeline on combinations with checkpoint inhibitors, Immunovaccine has elected to conclude operations on its initial Phase 2 DLBCL study, opting to replace it with this triple-combination trial.

http://www.marketwired.com/press-release/immunovaccines-lead-immuno-oncology-candidate-enter-investigator-sponsored-phase-2-clinical-tsx-imv-2216565.htm