BBP-398

BBP-398 is a SHP2 inhibitor that is being developed for difficult-to-treat cancers. SHP2, encoded by the PTPN11 gene, links growth factor signaling with the downstream RAS/ERK/MAPK pathway to regulate cell growth and division. Over-activity of this pathway, often driven by distinct gene mutations, causes or contributes to many human cancers. Inhibiting SHP2 offers a new approach to treat tumors relying on this pathway. SHP2 also suppresses T-cell activity against growing tumors through regulation of the adaptive immune response. SHP2 inhibition may relieve this negative effect, enhancing the patient's immune response to fight cancer proliferation. BridgeBio is currently advancing its Phase 1 clinical trial in patients with solid tumors driven by mutations in the MAPK signaling pathway, including RAS and receptor tyrosine kinase genes. In May 2022, BridgeBio entered an exclusive license with Bristol Myers Squibb to develop and commercialize BBP-398 in oncology worldwide, except for in mainland China and other Asian markets, which are part of BridgeBio’s separate strategic collaboration with LianBio announced in 2020. Additionally, BridgeBio has a non-exclusive clinical collaboration and supply agreement with Amgen to evaluate the combination of BBP-398 with LUMAKRAS® (sotorasib) in patients with advanced solid tumors with the KRAS G12C mutation. BridgeBio is currently advancing its Phase 1/2 clinical trial in patients with solid tumors with a KRAS G12C mutation. The US FDA also granted Fast Track designation for the investigation of BBP-398 in combination with LUMAKRAS for adult patients with previously treated, KRAS G12C-mutated, metastatic NSCLC.