LianBio doses 1st patient in Phase 1 of BBP-398 in Chinese patients with tumors

LianBio announced the first patient has been dosed in its Phase 1 clinical trial of BBP-398, a SHP2 inhibitor, in Chinese patients with advanced solid tumors.SHP2 is a protein-tyrosine phosphatase that links growth factor, cytokine and integrin signaling with the downstream RAS/MAPK pathway to regulate cellular proliferation and survival. Overactivity of SHP2 is a critical contributor to many forms of cancer, is a mechanism of resistance to several targeted therapies, and can suppress antitumor immunity.In this two-part, open label, dose escalation and dose expansion Phase 1 study, safety and preliminary anti-tumor activity will be examined. Part 1 is a dose escalation to establish the recommended Phase 2 dose ( of BBP-398 and assess the pharmacokinetic profile of BBP-398 in Chinese patients. Part 2 is a dose expansion to examine preliminary antitumor activity in patients with advanced or metastatic EGFR-mutant non-small cell lung cancer/"SHP2 inhibition has the potential to overcome resistance mechanisms to various important standard of care cancer therapies," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "Data generated to date suggest BBP-398 has a promising pharmacokinetic profile that could provide key advantages as a backbone combination therapy. Chinese NSCLC patients have approximately 2-3-fold higher EGFR mutation rate than Western patients, and while EGFR inhibitors represent an important advancement in treatment, many patients go on to develop treatment-resistant disease. We look forward to conducting this monotherapy study and progressing BBP-398 into combination trials with an EGFR inhibitor beginning in 2023."