Fore Biotherapeutics’ FORE8934 Gains Fast Track Status

The FDA has granted Fore Biotherapeutics’ a Fast Track designation for FORE8934, its small-molecule, orally available inhibitor for treatment of patients with cancers with BRAF gene alterations who have exhausted prior therapies.

Unlike first-generation BRAF inhibitors, FORE8934 does not unintentionally activate certain enzymes that can cause cancer cells to grow and it could have potential to treat acquired resistance to current RAF inhibitors while improving efficacy and safety, the company said.

Philadelphia, Pa.-based Fore Biotherapeutics expects to begin a global phase 2 clinical trial in the fourth quarter of this year.