Immunovaccine Inc.

Immunovaccine Inc.

January 11, 2016 07:05 ET

Immunovaccine Announces U.S. FDA, Health Canada Clearance to Initiate Phase 1b Clinical Trial for DPX-Survivac in Combination with Incyte's IDO1 Inhibitor Epacadostat in Recurrent Ovarian Cancer

HALIFAX, NOVA SCOTIA--(Marketwired - Jan. 11, 2016) - Immunovaccine Inc. ("Immunovaccine" or the "Company") (TSX:IMV)(OTCQX:IMMVF), a clinical stage vaccine and immunotherapy company, today announced U.S. Food and Drug Administration (FDA) and Health Canada clearance to initiate a clinical study of DPX-Survivac in combination with low-dose cyclophosphamide and epacadostat. Resulting from a recently announced collaboration between Immunovaccine and Incyte Corporation ("Incyte"), the Phase 1b clinical trial will assess the safety and effectiveness of Immunovaccine's novel T cell activating therapy, DPX-Survivac, along with Incyte's investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat (INCB24360), and low-dose cyclophosphamide in patients with recurrent ovarian cancer who have measurable disease. Immunovaccine anticipates starting the trial, which Incyte will co-fund under the terms of the agreement between the two companies, by Q2 2016.

"This clearance marks a key regulatory milestone for our DPX-Survivac ovarian cancer program," said Marc Mansour, Ph.D., Immunovaccine Chief Executive Officer. "We have already established that DPX-Survivac combined with low dose oral cyclophosphamide is well tolerated, can induce a strong immune response, and has a potential clinical effect in individuals with ovarian cancer. This trial will build on this momentum by adding a promising, clinically advanced, immunotherapy developed by Incyte for study as a combination therapy. We hope that this triple combination can lead to a new and potent therapeutic option for the high unmet medical need in ovarian cancer."

Under the approved protocol, the Phase 1b clinical trial will be a single arm, non-randomized, open label, uncontrolled, safety and effectiveness study that will enroll up to 32 participants at up to six sites in the U.S. and Canada. The primary objective is to determine the safety and immunogenicity (the ability to produce an immune response) of the treatment, and to determine changes in the immune cell infiltration into tumors. Secondary objectives include objective response rate, duration of response and time to progression.

"It is our belief that the combination of immune-targeted therapies holds great promise in oncology, and may pave the way for new and potentially better therapeutic options for patients with ovarian cancer," said Rich Levy, M.D., Chief Drug Development Officer of Incyte. "We are pleased to announce the initiation of an additional clinical study examining the use of epacadostat alongside another promising therapy and look forward to future results."

DPX-Survivac and epacadostat both target pathways that have been linked to cancer progression, namely survivin and IDO1. High levels of survivin and IDO1 are found in a broad range of cancers, including ovarian cancer. Individually, they have been shown to correlate with poor patient outcomes. DPX-Survivac is designed to activate the T cells of the immune system to recognize survivin-expressing cancer cells. Epacadostat, on the other hand, is designed to inhibit IDO1-mediated immune suppression in the tumor microenvironment. Thus, co-administering these immunotherapies may lead to enhanced anti-tumor effects by both activating the immune system to recognize the cancer, and simultaneously lessening suppression of the immune response.

"Based on what we have seen from these novel immunotherapeutic candidates individually and when combined with other immune modulators, we hypothesize that, when co-administered, they will work together synergistically for the benefit of underserved patients with advanced cancers," added Dr. Mansour.

About Ovarian Cancer

According to the American Cancer Society (ACS)(i), ovarian cancer ranks fifth in cancer deaths among women, accounting for more deaths than any other cancer of the female reproductive system. Often diagnosed in its advanced stages, about 21,290 women received a new diagnosis of ovarian cancer in 2015; approximately 14,180 women would die from the disease, according to ACS estimates.

Ovarian cancer has a significant impact globally as well. The World Cancer Research Fund(ii) reports that ovarian cancer is the seventh most common cancer in women worldwide (18 most common cancer overall), with 239,000 new cases diagnosed in 2012.

(i) What Are the Key Statistics about Ovarian Cancer?" The American Cancer Society, 12 Mar. 2015. Web. Accessed 29 Dec. 2015.

(ii) "Ovarian Cancer Statistics." Cancer Facts and Figures - Data on Specific Cancers. World Cancer Research Fund International. Web. Accessed 29 Dec. 2015.

About DPX-Survivac

DPX-Survivac consists of survivin-based peptide antigens formulated in the DepoVax™ adjuvanting platform. The National Cancer Institute (NCI) has recognized survivin as a promising tumor-associated antigen (TAA) because of its therapeutic potential and its cancer specificity. Survivin is broadly over-expressed in multiple cancer types in addition to ovarian cancer, including breast, colon and lung cancers. Survivin plays an essential role in antagonizing cell death, supporting tumor-associated angiogenesis, and promoting resistance to anti-cancer therapies. Survivin is also a prognostic factor for many cancers and it is found in a higher percentage of tumors than other TAA's.

The DPX-Survivac vaccine is thought to work by eliciting a cytotoxic T-cell immune response against cells presenting survivin peptides. This targeted therapy attempts to use the immune system to search actively and specifically for tumor cells and destroy them. Survivin-specific T-cells have been shown to target and kill survivin-expressing cancer cells while sparing normal cells.

DPX-Survivac has been granted Fast Track designation by the FDA as maintenance therapy in individuals with advanced ovarian, fallopian tube, and peritoneal cancer who have no measureable disease following surgery and front-line platinum/taxane chemotherapy to improve their progression-free survival.

About DepoVax™

DepoVax™ is a patented formulation that provides controlled and prolonged exposure of antigens plus adjuvant to the immune system, resulting in a strong, specific and sustained immune response with the potential for single-dose effectiveness. The DepoVax™ platform is flexible and can be used with a broad range of target antigens for preventative or therapeutic applications. The technology is designed to be commercially scalable, with the potential for years of shelf life stability.

About Epacadostat (INCB24360)

Indoleamine 2,3-dioxygenase 1 (IDO1) is an immunosuppressive enzyme that has been shown to induce regulatory T cell generation and activation, and allow tumors to escape immune surveillance. Epacadostat is an orally bioavailable small molecule inhibitor of IDO1 that has nanomolar potency in both biochemical and cellular assays and has demonstrated potent activity in enhancing T lymphocyte, dendritic cell and natural killer cell responses in vitro, with a high degree of selectivity. Epacadostat has shown proof-of-concept clinical data in patients with unresectable or metastatic melanoma in combination with the CTLA-4 inhibitor ipilimumab, and is currently in four proof-of-concept clinical trials with PD-1 and PD-L1 immune checkpoint inhibitors in a variety of cancer histologies. A Phase 3 study evaluating the combination of epacadostat with pembrolizumab as first-line treatment for patients with advanced or metastatic melanoma is expected to begin in the first half of 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.

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Immunovaccine Forward-Looking Statements

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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