Immunovaccine Receives FDA Fast Track Designation for DPX-Survivac for Treatment of Ovarian Cancer
DPX-Survivac vaccine is a potential maintenance therapy for newly diagnosed ovarian cancer patients following initial surgery and chemotherapy; future FDA discussions to explore accelerated development and approval pathways in this patient population
Halifax, Nova Scotia; December 10, 2014 – Immunovaccine Inc. (“Immunovaccine” or “IMV”) (TSX: IMV), a clinical stage vaccine and immunotherapy company, today announced that DPX-Survivac, the Company’s lead cancer vaccine candidate, has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) as maintenance therapy in subjects 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. Ovarian cancer patients who have no measurable disease following their initial standard surgery and chemotherapy treatments have an unmet need that may be served by the DPX-Survivac therapy. DPX-Survivac is designed to activate T cells of the immune system that are expected to recognize and eliminate cancer cells in an attempt to keep patients in remission longer.
The FDA’s Fast Track program is designed to facilitate the development and expedite the review of new drugs with the potential to treat serious or life-threatening conditions and address an unmet medical need. This designation provides companies the opportunity for more frequent interactions with FDA during clinical development and the “rolling” submission of individual sections of a Biologics License Application (BLA) as they are completed for review by FDA. Additionally, therapies with Fast Track designation are eligible for priority review and/or accelerated approval, which have the potential to reduce the time required for FDA review and make a therapy available to patients earlier than would be traditionally possible.
“This Fast Track designation highlights the urgent need for new, innovative ovarian cancer treatments that can maintain patients in remission longer and ultimately increase survival,” said Dr. Marc Mansour, chief executive officer of Immunovaccine.
Immunovaccine has previously reported positive results from DPX-Survivac clinical studies in ovarian cancer patients. In these studies, robust and durable CD8 T cell responses were observed in almost all patients receiving a specified regimen of the vaccine. The vast majority of ovarian cancer patients enrolled in these studies were in remission with no evidence of disease. Notably, a patient with stable but measurable disease achieved a partial response (PR) as measured by Response Evaluation Criteria In Solid Tumors (RECIST 1.1). The PR, which persisted following discontinuation of treatment, was accompanied by reduction in levels of a commonly used ovarian cancer biomarker (CA125) and a significant increase in vaccine-induced immune responses. The patient benefited from the DPX-Survivac therapy for more than 8 months demonstrating a potentially durable effect of the therapy.
Immunovaccine is finalizing the design of a large randomized Phase II trial in ovarian cancer to be sponsored and conducted by Canada’s NCIC Clinical Trials Group (NCIC CTG).
The company also recently announced that it has received clearance from Health Canada to conduct a Phase II clinical study of DPX-Survivac in patients with diffuse large B cell lymphoma (DLBCL). The Company-sponsored trial, expected to begin in early 2015, will evaluate DPX-Survivac in combination with oral cyclophosphamide, an immune modulating agent, in patients with recurrent DLBCL. Immunovaccine expects initial data from this study in the second half of 2015. Positive trial results could provide rationale for the initiation of a pivotal trial in recurrent DLBCL which could lead to the approval of DPX-Survivac for the treatment of DLBCL.
About Ovarian Cancer
Ovarian cancer accounts for more deaths than any other gynecologic cancer. In 2014, it is expected that there will be more than 22,000 new cases of ovarian cancer in the United States and more than 40,000 new cases in the European Union. Symptoms do not occur until it is in the later stages of the disease, reducing the chance for successful treatment and remission. It kills more than 100,000 women annually around the world. Improved surgical techniques have helped to reduce the rate of recurrence according to some studies, but the average life expectancy of newly diagnosed ovarian cancer patients is less than four years.
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.
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.
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), with Immunovaccine also exploring additional studies in other indications including lymphoma and recurrent ovarian cancer. The Company is also advancing an infectious disease pipeline including innovative vaccines for respiratory syncytial virus (RSV), anthrax and Ebola virus.
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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Dr. Marc Mansour, Chief Executive Officer, Immunovaccine Inc.
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Tim Brons, Vida Strategic Partners (media)
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