Kinnate Biopharma Gets Fast Track Status for Bile Duct Cancer Candidate

Kinnate Biopharma received Fast Track status for its KIN-3248 drug, an investigational candidate for the treatment of patients with unresectable, locally advanced or metastatic cholangiocarcinoma harboring fibroblast growth factor receptor 2 (FGFR2) gene fusions or other alterations and who received at least one prior systemic therapy.

KIN-3248 is a pan-FGFR inhibitor that addresses alterations related to FGFR2 and FGFR3, alterations which can lead to resistance to current FGFR-targeted therapies.

The investigational drug has shown promise in preclinical studies, demonstrating inhibitory activity across a wide range of relevant mutations.

Fast Track status allows a company to receive more frequent interactions with the FDA and could lead to Priority Review and Accelerated Approval.