BridgeBio Pharma's IND Application For BBO-8520 Gets FDA Clearance

(RTTNews) - BridgeBio Pharma, Inc. (BBIO) Wednesday announced FDA clearance for its investigational new drug application for BBO-8520, an orally bioavailable, small molecule direct inhibitor of KRASG12C (ON) state in patients with KRASG12C mutant cancers.

BBO-8520 binds covalently to the Switch II pocket in both the GTP-bound (ON) and GDP-bound (OFF) state conformations of KRASG12C, leading to rapid and robust inhibition of KRASG12C activity.

The commercial-stage biopharmaceutical company focused on genetic diseases and cancers said BBO-8520 could drive substantial tumor growth inhibition in multiple preclinical models.

Enrollment of patients with KRASG12C mutant non-small cell lung cancer into the ONKORAS-101 trial is expected to begin in H1 of this year.