Immunovaccine Inc. said today that the European Medicines Agency granted orphan drug designation for its immunotherapy candidate for ovarian cancer in the EU.
Orphan drug designation is granted to medicines intended for disease with a prevalence no greater than 5 in 10,000 people. According to the Nova Scotia-based company, ovarian cancer affects 3 per 10,000 people in the European Union or 15,000 women at any given time.
Immunovaccine’s therapy, DPX-Survivac, activates an immune response to a compound known as survivin – a protein found in more than 90% of ovarian cancer patients’ tumors. Survivin is also involved in pathways for cancer cell growth and survival.
The designation is one of several milestones for the company’s ovarian cancer program. Immunovaccine said in August that in a Phase I/Ib clinical trial, its DPX-Survivac was well tolerated with no serious adverse events and that the therapy initiated a sustained immune response.
DPX-Survivac won Fast Track status from the FDA 2 years as a maintenance therapy for patients with advanced ovarian, fallopian tube and peritoneal cancer. The U.S. federal watchdog also granted orphan drug status to the company’s candidate for the treatment of ovarian cancer, no matter the stage of progression.
“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,” chief medical officer Dr. Gabriela Rosu said in prepared remarks. “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.”