Immunovaccine Inc. (“Immunovaccine” or the “company”) (TSX: IMV; OTCQX: IMMVF), a clinical stage vaccine and immunotherapy company, today announced that it has entered into a non-exclusive clinical trial collaboration with Incyte Corporation (Nasdaq: INCY) to evaluate the combination of Immunovaccine’s novel T cell activating immunotherapy, DPX-Survivac, with Incyte’s investigational oral indoleamine 2,3-dioxygenase 1 (IDO1) inhibitor, epacadostat (INCB24360).
Immunovaccine and Incyte will co-fund and conduct a multicenter, open-label Phase 1B study to evaluate the safety, tolerability and efficacy of the novel combination in platinum-sensitive ovarian cancer patients who are at high risk of recurrence.
The investigational new drug (IND) application for the study, which will test the triple combination of DPX-Survivac, epacadostat and low dose oral cyclophosphamide, is expected to be filed this year in the U.S. and Canada and the study is expected to enroll approximately 20 patients. Results from this study may lead to an expansion of the clinical collaboration to investigate other cancers.
“DPX-Survivac and epacadostat represent two exciting classes of immune based therapies with promising activity demonstrated in clinical trials,” said Marc Mansour, CEO of Immunovaccine. “We believe a multi-pronged immune-based treatment approach may be favorable as an alternative to chemotherapy for recurrent ovarian cancer disease.”
“We believe that combining immune-targeted therapies may hold great potential in oncology,” said Dr. Rich Levy, chief drug development officer of Incyte. “This clinical trial collaboration further demonstrates our commitment to efficiently testing our selective IDO1 inhibitor with other promising immunotherapies.”
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, and individually have been shown to correlate with poor patient outcomes. DPX-Survivac is designed to activate 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. It is therefore hypothesized that co-administration of these immunotherapies may lead to enhanced anti-tumor effects by both activating the immune system to recognize the cancer and simultaneously weakening its defenses.
DPX-Survivac consists of survivin-based peptide antigens formulated in the DepoVax™ adjuvanting platform. Survivin has been recognized by the National Cancer Institute (NCI) as a promising tumor-associated antigen (TAA) because of its therapeutic potential and its cancer specificity. Survivin is broadly over-expressed in solid tumors and blood cancers including ovarian, breast, colon and lung cancers, among others. Survivin plays an essential role in antagonizing apoptosis, supporting tumor-associated angiogenesis, and promoting resistance to various anti-cancer therapies. Survivin is also a prognostic factor for many cancers and it is found in high percentage of cancer patients.
The DPX-Survivac vaccine is thought to work by eliciting a cytotoxic T cell immune response against cells presenting survivin peptides on HLA class I molecules. This targeted therapy attempts to use the immune system to actively search for tumor cells expressing survivin and destroy them.
In previous DPX-Survivac studies conducted in ovarian cancer patients, robust and durable CD8 T cell responses were observed in almost all patients receiving a specified regimen of the vaccine when combined with low dose oral cyclophosphamide. A patient with measurable and stable disease achieved a 43 per cent reduction in tumor size, demonstrating a durable clinical benefit associated with the therapy. DPX-Survivac is currently being tested in combination with low dose oral cyclophosphamide in a Phase 2 study for Diffuse Large B Cell Lymphoma (DLBCL). Plans are underway to initiate a 250 patient randomized Phase 2 in collaboration with the National Cancer Institute of Canada Clinical Trials Group (NCIC-CTG) for ovarian cancer patients with no measurable disease after their initial surgery and chemotherapy. DPX-Survivac has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) as maintenance therapy in patients 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 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 types.
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 I human clinical trials. Lead cancer vaccine therapy, DPX-Survivac, is expected to enter Phase II clinical studies in both 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.
About Incyte Corporation
Incyte Corporation is a Wilmington, Delaware-based biopharmaceutical company focused on the discovery, development and commercialization of proprietary therapeutics, primarily for oncology. For additional information on Incyte, please visit the company’s website at www.incyte.com.
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.
Incyte Forward-Looking Statements
Except for the historical information set forth herein regarding Incyte, the matters set forth in this press release regarding Incyte contain predictions, estimates and other forward-looking statements, including without limitation statements regarding: the potential efficacy, safety and therapeutic value of Incyte’s epacadostat and its potential for treatment, in combination with DPX-Survivac and low dose oral cyclophosphamide, of platinum-sensitive ovarian cancer patients who are at high risk of recurrence; and the timing of this planned combination study; and the potential effects of combining immune-targeted therapies to treat cancer.
These forward-looking statements are based on Incyte’s current expectations and subject to risks and uncertainties that may cause actual results to differ materially, including unanticipated developments in and risks related to the efficacy or safety of epacadostat or Incyte’s other products and product candidates, the results of further research and development, the risks that results of clinical trials may be unsuccessful or insufficient to meet applicable regulatory standards, other market or economic factors, competitive and technological advances, and other risks detailed from time to time in the company’s reports filed with the Securities and Exchange Commission, including its Form 10-Q for the quarter ended March 31, 2015. Incyte disclaims any intent or obligation to update these forward-looking statements.
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Sam Brown Inc.
Halifax, Nova Scotia, June 25, 2015