Opna Bio, a clinical-stage biopharmaceutical company focused on the discovery and development of novel oncology therapeutics, announced today that the FDA has granted orphan drug designation (ODD) to one of its lead programs, OPN-6602, for the treatment of multiple myeloma (MM). OPN-6602 is an oral, small molecule inhibitor of the E1A binding protein (EP300) and CREB-binding protein (CBP) currently being tested in a Phase 1 trial in patients with relapsed or refractory MM.
Multiple myeloma is a rare and aggressive cancer of the plasma cells in the bone marrow that often leads to serious complications such as bone damage, kidney failure and immune suppression. The disease is typically diagnosed in older adults, with limited treatment options available for patients with relapsed or refractory disease.