The US Food and Drug Administration (FDA) has granted Fast Track Designation to OPN-6602, an oral small-molecule EP300/CBP inhibitor, for patients with relapsed or refractory multiple myeloma (MM) who have received at least four prior lines of therapy.
OPN-6602 is an oral, small molecule inhibitor that targets the EP300 and CREB-binding protein (CBP) proteins, which are involved in the proliferation and survival of MM cells, according to Opna Bio, the manufacturer of the drug. The drug is currently in a phase 1 clinical trial evaluating safety, tolerability, pharmacokinetics and preliminary clinical activity in patients with relapsed or refractory MM.
The therapy was previously granted Orphan Drug Designation in early 2025 by the FDA.
“Opna Bio has been a pioneer in the EP300/CBP inhibitor space and OPN-6602 was selected for its potency, selectivity, and optimized pharmacokinetic properties. We are encouraged by the progress of the study to date and look forward to reporting emerging clinical data at an upcoming scientific congress,” said Reinaldo Diaz, Opna Bio CEO, in a press release by the drug’s manufacturer, Opna Bio.
