Biomea Fusion to take BMF-219 into clinical trials for KRAS solid tumors

Biomea Fusion is all set to take BMF-219 into clinical trials in patients having unresectable, locally advanced, or metastatic non-small cell lung cancer (NSCLC), colorectal cancer (CRC), and pancreatic ductal adenocarcinoma (PDAC) with an activating KRAS mutation.

The upcoming milestone for the NASDAQ-listed biopharma company follows the clearance of the US Food and Drug Administration (FDA) of its investigational new drug (IND) application for starting a phase 1/1b clinical trial of the selective, covalent menin inhibitor.

Named COVALENT-102, the upcoming phase 1/1b clinical trial of BMF-219 will assess the safety, tolerability, and clinical activity of escalating doses of the drug candidate in oral administration in the targeted patient population.

Thomas Butler — Biomea Fusion CEO and board chairman said: “We are very excited to open this particular IND as we now look to validate the preclinical potential of BMF-219 in patients across several solid tumor types who have a KRAS mutation, which currently is associated with a very poor survival prognosis.

“In January 2022, we mapped out perhaps one of the more aggressive clinical development plans among peer companies to initiate clinical studies of BMF-219 in up to seven tumor types by the end of 2022.”