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FDA grants orphan drug designation to DPX-Survivac for ovarian cancer
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The FDA granted orphan drug designation to DPX-Survivac, an immunotherapeutic agent designed to treat all stages of ovarian cancer, according to a press release from the drug’s manufacturer.
DPX-Survivac (Immunovaccine Inc.) — a vaccine that consists of survivin-based peptide antigens — activates a response to the tumor antigen survivin, a protein found in the tumors of more than 90% of patients with ovarian cancer.
The NCI has recognized survivin as a promising tumor-associated antigen because of its therapeutic potential and specificity to cancer, according to the press release. The protein is often overexpressed in solid tumors and blood cancers and plays an important role in the antagonizing of apoptosis, supporting angiogenesis and promoting resistance to several anti-cancer therapies. Survivin also is a prognostic factor for many cancers.
The FDA granted orphan drug status to DPX-Survivac following a review of pre-clinical and clinical data. These data included phase 1 data in advanced ovarian cancer that demonstrated strong and durable immune responses in most patients who received the drug in combination with low-dose oral cyclophosphamide.
Further, results from a case study showed a strong immune response after two vaccinations followed by tumor reduction to approximately half its original size.
The FDA previously granted fast track designation to DPX-Survivac as a maintenance therapy for patients with advanced ovarian, fallopian tube or peritoneal cancers who have no measurable disease following initial surgery and frontline chemotherapy.
“Receiving orphan drug designation for ovarian cancer underlines the fact that DPX-Survivac may address a significant unmet medical need for this important disease,” Marc Mansour, CEO of Immunovaccine, said in a press release. “Immunotherapy could change the way we treat all cancers in the future and we plan to continue to study DPX-Survivac for the treatment of ovarian cancer as well as other solid tumor types and blood cancers.”
The FDA’s Office of Orphan Products Development grants orphan drug designation to novel drugs and biologics that are intended for the safe and effective treatment, diagnosis or prevention of rare diseases or disorders that affect fewer than 200,000 people in the United States.