BridgeBio Oncology Therapeutics Announces First Patient Dosed with BBO-8520 in the ONKORAS-101 Trial for KRASG12C NSCLC

The first patient has been dosed in the ONKORAS-101 trial for the study of BBO-8520 in adult subjects with KRASG12C non-small cell lung cancer. BBO-8520 is a first-in-class orally bioavailable and highly potent small molecule direct inhibitor of KRASG12C that binds to the Switch II pocket in both the GTP-bound (ON) and GDP-bound (OFF) state conformations of KRASG12C. It is expected to meaningfully improve outcomes for patients with KRASG12C driven malignancies by providing optimal target coverage and addressing mechanisms of adaptive resistance to first generation KRASG12C (OFF) state inhibitors.

Professor Benjamin Solomon, head of lung medical oncology at the Peter MacCallum Cancer Center, expressed excitement about the partnership with BridgeBio Oncology Therapeutics, highlighting the significant need for new precision oncology medicines to improve outcomes for patients in the metastatic setting. BBO-8520 was designed to inhibit the (ON) state to provide optimal target coverage and to address KRASG12C amplification and receptor tyrosine kinase activation, the two key mechanisms of adaptive resistance to current (OFF) state inhibitors.

The ONKORAS-101 study will enroll patients pre-treated with first generation KRASG12C (OFF) inhibitors as well as patients with no prior KRASG12C targeted therapy experience. The trial will enroll across the US, Australia, Canada, and the EU. BridgeBio Oncology Therapeutics’ CEO, Eli Wallace, PhD, emphasized the importance of this Phase 1 clinical trial as a significant advancement for the company, now a clinical-stage organization, offering patients with KRASG12C-driven lung cancer a targeted therapy expected to provide a significant improvement over current standards of care.