European Medicines Agency Approves Orphan Medicinal Product Application of DCPrime's AML Vaccine

DCPrime has announced that the Committee for Orphan Medical Products (COMP) of the European Medicines Agency has issued a positive opinion recommending DCPrime’s application for orphan drug designation of, the company’s dendritic cell-based cancer vaccine candidate, which targets Acute Myeloid Leukemia (AML).

"This orphan drug designation is a major step in DCPrime’s work towards approval of our AML vaccine, and clearly reflects the COMP’s view of the potential of this vaccine in improving survival of patients with AML”, said DCPrime’s CEO and CSO Dr. Ada Kruisbeek.

Kruisbeek continued, "At the present time, AML patients lack an approved therapy to prevent the cancer from returning after standard chemotherapy. In 75% of the patients treated, the leukemia returns within 2 years. Our vaccine is intended as a therapy to prevent the cancer from coming back, and in our current clinical study we are establishing if we can delay or prevent AML from returning. If we succeed, this will improve survival outcomes in AML.”