Opna Bio, a clinical-stage biopharmaceutical company focused on the discovery and development of novel oncology therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to OPN-6602, a dual EP300/CBP inhibitor, for the treatment of multiple myeloma (MM). The Fast Track designation applies to patients with relapsed/refractory MM who have received at least four prior lines of therapy.
OPN-6602 is an oral, small molecule inhibitor of EP300 and CREB-binding protein (CBP) currently in a Phase 1 clinical trialevaluating safety, tolerability, pharmacokinetics and preliminary clinical activity in patients with relapsed and/or refractory MM.
Multiple myeloma is a hematologic malignancy marked by the uncontrolled proliferation of plasma cells in the bone marrow, often leading to bone damage, kidney dysfunction and immune suppression. Despite therapeutic advances, most patients ultimately relapse or become refractory to available therapies, highlighting an unmet need for novel treatment options.
