BridgeBio's BBO-8520 Receives FDA Fast Track for KRASG12C Non-Small Cell Lung Cancer

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--TheRas, Inc., operating as BridgeBio Oncology Therapeutics (BBOT), is making strides in the biopharmaceutical industry by focusing on malignancies linked to the RAS-pathway. The company has announced a significant achievement: the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for BBO-8520, an oral treatment designed for adult patients with KRAS G12C-mutated metastatic non-small cell lung cancer (NSCLC) that have already undergone treatment.

BBO-8520 is an innovative therapy engineered to inhibit both the "ON and OFF" states, aiming for comprehensive target coverage. This approach is designed to tackle two primary adaptive resistance mechanisms: KRAS G12C amplification and receptor tyrosine kinase activation, which current "OFF" state inhibitors struggle to address. In preclinical models, BBO-8520 has shown significant potential in inhibiting tumor growth, even in cases where resistance to sotorasib, an FDA-approved "OFF" state inhibitor for KRAS G12C, has developed.

The development of BBO-8520 is a result of collaboration between the National Cancer Institute RAS Initiative at Frederick National Laboratory for Cancer Research, Lawrence Livermore National Laboratory, and BBOT. This cooperative effort underscores the potential impact of BBO-8520 in cancer treatment.

Dr. Yong Ben, MD, Chief Medical and Development Officer at BBOT, stated, "Receiving Fast Track designation for BBO-8520 represents a significant milestone in our efforts to overcome the limitations of existing therapies for KRAS G12C-mutant cancers." He emphasized that BBO-8520 offers a novel approach with the potential to address significant unmet medical needs and revolutionize cancer treatment strategies. BBOT is committed to working closely with the FDA to expedite the development process for BBO-8520, which is currently being assessed in a Phase 1 clinical trial (NCT06343402) involving KRAS G12C NSCLC patients who have been pre-treated with first-generation KRAS G12C "OFF" inhibitors or have not previously received KRAS G12C targeted therapy.

The Fast Track designation is an FDA program designed to streamline the development and review processes for therapeutic candidates that show promise in treating serious conditions with unmet medical needs. This designation is expected to facilitate a more efficient development timeline for BBO-8520, potentially bringing a new therapeutic option to patients sooner.

BridgeBio Oncology Therapeutics (BBOT) is a clinical-stage biopharmaceutical company dedicated to advancing a pipeline of next-generation small molecule therapeutics targeting RAS and PI3K-related cancers. Originally formed as a subsidiary of BridgeBio, BBOT successfully secured $200 million in private financing from external investors in 2024. This financial backing aims to enhance the treatment outcomes for patients with cancers driven by two of the most common oncogenes found in human tumors.

BBOT's focus on addressing the challenges associated with RAS-pathway malignancies positions it as a leader in the development of new cancer therapies. The company remains committed to leveraging its expertise and resources to bring innovative treatments to patients in need.