HALIFAX, NOVA SCOTIA--(Marketwired - Nov. 22, 2016) - Immunovaccine Inc. ("Immunovaccine" or the "Company") (TSX:IMV)(OTCQX:IMMVF), a clinical stage vaccine and immunotherapy company, today announced that the European Medicines Agency ("EMA") has granted 'Orphan Drug Designation' status to the Company's lead immuno-oncology product candidate, DPX-Survivac for the treatment of ovarian cancer in the European Union (EU).
The EMA grants Orphan Designation to medicines intended to treat, prevent or diagnose life threatening and debilitating disease, with a prevalence no greater than five in 10,000 in the EU and where no satisfactory method of treatment, prevention or diagnosis exists, unless the proposed medicine offers a significant benefit to those with the condition.
"As our recent clinical program has demonstrated, ovarian cancer-one of the most underserved cancers in today's treatment landscape-is a strong focus for Immunovaccine and, in particular, our DPX-Survivac program," said Gabriela Rosu, M.D., Chief Medical Officer of Immunovaccine. "We plan to leverage this important designation as we continue evaluating DPX-Survivac, with the goal of bringing a new option to patients fighting this disease."
According to recent EMA reports, ovarian cancer affects approximately 150,000 women at any given time in the European Union and has a prevalence of approximately three per 10,000. Following receipt of the 'Orphan Designation' status, drug developers can access a number of incentives, including protocol assistance, market exclusivity for a ten-year period following approval, and potential fee reductions. The receipt of Orphan Designation does not change the regulatory requirements or process for obtaining marketing approval.
DPX-Survivac activates and directs an immune response to the tumor antigen survivin, which is a protein found in tumors of more than 90 percent of ovarian cancer patients and is involved in multiple critical pathways of cancer cell growth and survival. The EMA granted DPX-Survivac this status following its review of Immunovaccine's pre-clinical and clinical data submission.
This designation marks one of several recent milestones for Immunovaccine's DPX-Survivac ovarian cancer program. The Company recently announced topline results of a Phase 1/1b clinical trial evaluating DPX-Survivac in ovarian cancer, which indicated that the product candidate was well tolerated, with no unexpected treatment-related serious adverse events (SAEs), and that it demonstrated the ability to generate a relevant, sustained immune response.
Previously, the U.S. Food & Drug Administration (FDA) granted DPX-Survivac Fast Track status 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. The FDA also granted Orphan Drug status to DPX-Survivac for the treatment of ovarian cancer. This FDA designation is valid for all applications of DPX-Survivac in ovarian cancer without restriction to a specific stage of disease.
DPX-Survivac is Immunovaccine's lead cancer immunotherapy candidate, generated by its novel proprietary DepoVax™ adjuvanting technology platform. 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 more than 20 solid tumors and blood cancers including ovarian, breast, colon and lung cancers. 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.
Immunovaccine Inc. is a clinical-stage biopharmaceutical company dedicated to making immunotherapy more effective, more broadly applicable, and more widely available to people facing cancer and infectious diseases. Immunovaccine develops cancer immunotherapies and infectious disease vaccines based on the Company's DepoVax™ platform, a patented delivery agent 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 1/1b study with Incyte Corporation assessing lead cancer therapy, DPX-Survivac, as part of a triple combination therapy in ovarian cancer, as well as a Phase 2 study in recurrent lymphoma. The Company is also advancing an infectious disease pipeline, including innovative vaccines for respiratory syncytial virus (RSV), and currently has clinical projects ongoing to assess the potential of DepoVax™ to address malaria and the Zika virus. Connect at www.imvaccine.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 of the Company 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 results and 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 applicable law.
Chief Executive Officer
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