LianBio announced a clinical supply agreement with AstraZeneca in China to evaluate the safety and efficacy of BBP-398, an investigational SHP2 inhibitor, in combination with AstraZeneca's osimertinib, an epidermal growth factor receptor (EGFR) inhibitor, in a Phase 1 clinical study for the treatment of patients with non-small cell lung cancer (NSCLC) with EGFR mutations. EGFR mutations occur in approximately 40-50% of NSCLC cases in Asia, more than twice the rate observed in the United States. By combining SHP2 inhibition and EGFR inhibition, there is potential to prevent oncogenesis and overactive cellular proliferation.

The planned multi-center, open-label Phase 1 trial is designed to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of BBP-398 in combination with osimertinib in patients with locally advanced or metastatic NSCLC with EGFR mutations. The trial includes a dose escalation phase, followed by expansion cohorts. LianBio expects to initiate this trial in the second half of 2023.

About BBP-398 BBP-398 is a SHP2 inhibitor that is being developed for difficult-to-treat cancers and was founded through a collaboration between BridgeBio and The University of Texas MD Anderson Cancer Center's Therapeutics Discovery division. SHP2 is a protein-tyrosine phosphatase that links growth factor, cytokine and integrin signaling with the downstream RAS/ERK MAPK pathway to regulate cellular proliferation and survival. LianBio and BridgeBio have a strategic collaboration for clinical development and commercialization of BBP-398 in combination with various agents in solid tumors such as non-small cell lung cancer, colorectal and pancreatic cancer, in mainland China and other Asian markets.

BBP-398 is also being studied by BridgeBio and its clinical collaborators, including Bristol Myers Squibb for combination with OPDIVO(R) (nivolumab) in patients with advanced solid tumors with KRAS mutations; and with Amgen for combination with LUMAKRAS(R) (sotorasib), Amgen's KRASG12C inhibitor, in patients with advanced solid tumors with KRASG12C mutations.