The European Medicines Agency (EMA) granted orphan drug status to ImmunoVaccine's (OTCQX:IMMVF; TSX:IMV) lead immuno-oncology product candidate, DPX-Survivac, for the treatment of ovarian cancer in the EU.
"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," CMO, Dr. Gabriela Rosu, said in a statement.
"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," she added.
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, and that it demonstrated the ability to generate a relevant, sustained immune response.
The FDA previously granted DPX-Survivac fast track status as maintenance therapy in individuals with advanced ovarian, fallopian tube, and peritoneal cancer that 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, which is valid for all applications without restriction to a specific stage of disease.