NEW YORK – BridgeBio Pharma said on Thursday that it has licensed its investigational SHP2 inhibitor BBP-398 to Bristol Myers Squibb.
In exchange for the exclusive license to develop and commercialize the agent, BMS will pay BridgeBio $90 million upfront. BridgeBio is also eligible for up to $815 million in development, regulatory, and sales milestone payments as well as tiered royalties in the low- to mid-teens. BridgeBio can acquire a greater share of the royalties in the US, if it decides to partially fund BBP-398's development within registrational trials.
Palo Alto, California-based BridgeBio will continue conducting three ongoing Phase I clinical trials evaluating BBP-398 as a monotherapy and in combination with other agents for biomarker-selected solid cancers. BMS, however, will pay for and conduct all future clinical trials and assume responsibility for other development and commercial activities.
Of the three Phase I trials BridgeBio will continue to conduct, one study is exploring BBP-398 plus BMS's Opdivo (nivolumab) in patients with KRAS-mutated advanced solid tumors. The latest licensing agreement for BBP-398 extends from an earlier collaboration deal between the two drugmakers to conduct this trial.
In the second Phase I trial, BridgeBio is exploring single-agent BBP-398 in patients with MAPK pathway or RTK-driven advanced solid tumors. The firm announced a third Phase I/II trial in January to study BBP-398 with Amgen's Lumakras (sotorasib) in patients with KRAS G12C-mutated advanced solid tumors.
BridgeBio also has a strategic collaboration with LianBio to develop and market BBP-398 with other drugs for solid tumors in mainland China and other Asian markets.