Immunovaccine Inc.
TSX : IMV
OTCQX : IMMVF

Immunovaccine Inc.

December 02, 2015 07:05 ET

Immunovaccine's DPX-Survivac Induces an Immune Response in Diffuse Large B Cell Lymphoma

Early results in Phase 2 study show correlation between immune response and tumor changes: an important marker of a vaccine effect

HALIFAX, NOVA SCOTIA--(Marketwired - Dec. 2, 2015) - Immunovaccine Inc. (TSX:IMV)(OTCQX:IMMVF), a clinical stage vaccine and immunotherapy company, today announced that the initial results from a Phase 2 study demonstrated that DPX-Survivac can induce a strong immune response in diffuse large B cell lymphoma (DLBCL) tumors. This early result demonstrates that DPX-Survivac, Immunovaccine's lead cancer immune therapy, can induce immune responses in hematologic cancers, such as DLBCL. Researchers observed changes in tumor-infiltrating T cells following administration of the DPX-Survivac therapy, which correlated with an immune response produced by DPX-Survivac and detected in the blood.

Detailed analysis of tumors collected from vaccinated patients also provided a rationale for combining the DPX-Survivac therapy with checkpoint inhibitors, including anti-PD-1 agents, to further enhance the potential clinical benefit of DPX-Survivac in DLBCL patients.

"We believe that these initial results demonstrate the broad applicability and market potential of DPX-Survivac in targeting survivin, which is present in more than 20 types of solid tumor and hematologic cancers," said Marc Mansour, Ph.D., Immunovaccine Chief Executive Officer. "Earlier trials we've conducted have shown a similar result in ovarian cancer, for example."

The Phase 2 study results announced today were from the first two evaluable patients who completed their scheduled DPX-Survivac therapy. In one of the patients, the T cell immune response measured in the blood correlated with a four-fold increase in T cells in tumor biopsies collected during the study. The results in this patient address one of the important goals of the study, suggesting that vaccinating with DPX-Survivac can induce T cells in the blood, which can then induce immune changes at the tumor level.

DPX-Survivac is a novel cancer therapy that stimulates the immune system to produce T cell responses targeting survivin, a commonly expressed tumor antigen involved in multiple critical pathways of cancer cell growth and survival across a broad range of cancers.

Prior to treatment both patients showed significant PDL-1 expression in their tumors, which likely suppressed the anti-tumor activity of their T cells. PDL-1 is produced by cells in the tumor and has a potent suppressive effect on immune cells, which can be alleviated with anti PD-1 or anti PDL-1 agents. Recent data published in scientific journals and presented at the American Society of Hematology meeting demonstrate that anti-PD-1 monoclonal antibodies can control DLBCL tumors in a significant number of patients, which supports Immunovaccine's contention that DLBCL is an immune responsive cancer in which T cells play a major role.

"These additional findings indicate that our immunotherapy candidate may work synergistically with checkpoint inhibitors. We believe it provides a strong rationale for combining DPX-Survivac with a checkpoint inhibitor targeting PD-1 or PDL-1 to maximize the clinical benefit in patients with DLBCL and, possibly, other cancers," continued Dr. Mansour. "We are evaluating such opportunities with multiple partners."

DLBCL is the most common lymphoma and represents about half of Non-Hodgkin's lymphomas. Survivin is strongly upregulated in approximately 60 percent of DLBCL patients.

In this ongoing Phase 2 study, researchers are investigating treatment with DPX-Survivac and low dose cyclophosphamide in patients with recurrent, survivin-expressing B cell lymphomas. The study will continue to enroll patients and evaluate the immune and clinical activities of DPX-Survivac in this indication. Additional study data are expected in 2016.

About Immunovaccine

Immunovaccine Inc. develops cancer immunotherapies and infectious disease vaccines based on the Company's DepoVax™ platform, a patented formulation 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 2 study with its lead cancer vaccine therapy, DPX-Survivac, in recurrent lymphoma. DPX-Survivac is expected to enter additional Phase 2 clinical studies in ovarian cancer and glioblastoma (brain cancer). The Company is also advancing an infectious disease pipeline including innovative vaccines for respiratory syncytial virus (RSV) and anthrax.

Connect at www.imvaccine.com

This press release contains forward-looking information under applicable securities law. All information that addresses activities or developments that we expect to occur in the future is forward-looking information. Forward-looking statements are based on the estimates and opinions of management on the date the statements are made. However, they should not be regarded as a representation that any of the plans will be achieved. Actual results may differ materially from those set forth in this press release due to risks affecting the Company, including access to capital, the successful completion of clinical trials and receipt of all regulatory approvals. Immunovaccine Inc. assumes no responsibility to update forward-looking statements in this press release except as required by law.

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