Immunovaccine Inc., a clinical stage vaccine and immunotherapy company, today announced that the U.S. Food and Drug Administration (FDA), has granted orphan drug status to DPX-Survivac for the treatment of ovarian cancer. This designation is valid for all applications of DPX-Survivac in ovarian cancer without restriction to a specific stage of disease.
DPX-Survivac is the company’s lead clinical-stage cancer immunotherapy. It activates and directs an immune response to the tumor antigen survivin, a protein that is found in tumors of more than 90% of ovarian cancer patients. DPX-Survivac was granted this status following a review by the FDA of pre-clinical and clinical data submitted by the company. This data included the recently published Phase 1 data in advanced ovarian cancer, which demonstrated strong and durable immune responses in the majority of patients receiving DPX-Survivac in combination with low dose oral cyclophosphamide.
“Receiving Orphan Drug Designation for ovarian cancer underlines the fact that DPX-Survivac may address a significant unmet medical need for this important disease,” said Marc Mansour, CEO of Immunovaccine. “Immunotherapy could change the way we treat all cancers in the future and we plan to continue to study of DPX-Survivac for the treatment of ovarian cancer as well as other solid tumor types and blood cancers.”
The data package also included a detailed description of a case study demonstrating a significant reduction in tumor size following treatment with DPX-Survivac. In this reported case, a strong and durable immune response was detected after two vaccinations, followed by a gradual and persistent tumor reduction to approximately half of its original size. A persistent drop in the blood marker CA-125 was also observed during that time. This durable partial response may be attributed to the DPX-Survivac immunotherapy and the persistent T cell response generated.
The FDA has previously granted Fast Track Designation for this treatment as a maintenance therapy specifically for patients with advanced ovarian, fallopian tube, or peritoneal cancer who have no measureable disease following their initial surgery and front-line platinum/taxane chemotherapy.
The FDA’s orphan drug designation program provides orphan status to drugs and biologics intended to treat, diagnose or prevent rare diseases/disorders, defined as affecting fewer than 200,000 people in the U.S.
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.
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.
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Halifax, Nova Scotia, July 15, 2015