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BridgeBio, BMS Partner to Study SHP2 Inhibitor Plus Opdivo in KRAS-Mutated Tumors

NEW YORK – BridgeBio and Bristol Myers Squibb on Tuesday announced a collaboration to evaluate BridgeBio's SHP2 inhibitor BBP-398 in combination with BMS' nivolumab (Opdivo) in advanced solid tumors with KRAS mutations.

The two companies will initiate a Phase I/II study to evaluate BBP-398 as a first- and second-line option in combination with nivolumab alone in patients with KRAS-mutated solid tumors, and with nivolumab plus a KRAS G12C inhibitor in KRAS-mutated non-small cell lung cancer patients.

Under the nonexclusive collaboration, BridgeBio is sponsoring the study and both companies are sharing clinical development costs for the combination trial.

"Cancers that are driven by hyperactive MAPK signaling, including certain RAS mutations such as KRAS G12C, may be sensitive to SHP2 inhibition," Frank McCormick, chairman of oncology at BridgeBio, said in a statement. "With this collaboration, we hope to better elucidate our SHP2 inhibitor's ability to enhance immuno-oncology and other targeted therapies to potentially provide options for patients with difficult-to-treat cancers as quickly and safely as possible."

BridgeBio is also studying BBP-398 in another Phase I study in patients with MAPK pathway- or RTK-driven advanced solid tumors. Earlier this year, the Palo Alto, California-based company also announced research collaborations with four academic centers.