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BridgeBio Oncology Starts Phase 1 ONKORAS-101 Trial with BBO-8520 for KRASG12C Mutant Non-Small Cell Lung Cancer

Friday, June 07, 2024

BridgeBio Oncology Therapeutics (BBOT), a clinical-stage biopharmaceutical company focused on RAS-pathway cancers, has announced the commencement of the ONKORAS-101 clinical trial, marking the administration of BBO-8520 to the first patient. BBO-8520 is a novel oral small molecule designed to inhibit the active KRASG12C (ON) state. It binds to the Switch II pocket in both the GTP-bound (ON) and GDP-bound (OFF) forms of KRASG12C, thereby providing sustained inhibition of its activity.

Professor Benjamin Solomon, head of lung medical oncology at the Peter MacCallum Cancer Center, commented, “We are excited to collaborate with BridgeBio Oncology Therapeutics to introduce this innovative therapy for patients. Non-small cell lung cancer presents a significant global health challenge, and there is a pressing need for new precision oncology treatments to improve outcomes for those in the metastatic phase. BBO-8520 holds promise for significantly enhancing the prognosis for these patients.”

BBO-8520 is designed to inhibit the (ON) state of KRASG12C, addressing KRASG12C amplification and receptor tyrosine kinase activation—key mechanisms of resistance to current (OFF) state inhibitors. The compound has demonstrated substantial tumor growth inhibition in multiple preclinical models, even in cases where resistance to sotorasib, an FDA-approved inhibitor for the KRASG12C (OFF) state, has developed. The development of BBO-8520 is a collaborative effort involving the National Cancer Institute RAS Initiative at the Frederick National Laboratory for Cancer Research, Lawrence Livermore National Laboratory, and BridgeBio Oncology Therapeutics.

The ONKORAS-101 trial will enroll patients who have been treated previously with first-generation KRASG12C (OFF) inhibitors, as well as those who have not received prior KRASG12C targeted therapy. The study will be conducted across the US, Australia, Canada, and the EU.

BridgeBio Oncology Therapeutics, stated, "The launch of the Phase 1 clinical trial for BBO-8520 represents a crucial advancement for BBOT as we enter the clinical stage. We are committed to offering patients with KRASG12C-driven lung cancer a targeted therapy that is expected to significantly surpass current treatment standards.”

 

Source: businesswire.com

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