LianBio, a biotechnology company focused on delivering groundbreaking medicines to patients in China and other key Asian markets, has revealed a clinical supply agreement with AstraZeneca in China.

The collaboration aims to assess the safety and effectiveness of BBP-398, an investigational SHP2 inhibitor developed by LianBio, in combination with AstraZeneca’s osimertinib, an epidermal growth factor receptor (EGFR) inhibitor, in Phase 1 clinical study.

The study specifically targets patients diagnosed with non-small cell lung cancer (NSCLC) who have EGFR mutations. This partnership represents an important step in the pursuit of new treatment options for patients affected by this type of lung cancer.

LianBio CEO Yizhe Wang said: “In China, a disproportionately high percentage of NSCLC patients harbour EGFR mutations.

“While EGFR inhibitors are a critical part of the standard of care, most patients eventually acquire resistance to these therapies. We believe BBP-398 is a differentiated SHP2 inhibitor with the potential to restore sensitivity to EGFR inhibitors when used in a combination setting.”

EGFR mutations are significantly more prevalent in Asian cases of non-small cell lung cancer (NSCLC) compared to the United States, occurring in approximately 40-50% of cases. This rate is more than double that observed in the US. Given this higher prevalence, combining SHP2 inhibition with EGFR inhibition presents an opportunity to potentially inhibit oncogenesis and regulate abnormal cellular proliferation.

LianBio has planned a multi-centre, open-label Phase 1 clinical trial to investigate the safety, tolerability, pharmacokinetics, and anti-tumour activity of BBP-398, an SHP2 inhibitor, in combination with AstraZeneca’s osimertinib. The trial will focus on patients diagnosed with locally advanced or metastatic NSCLC with EGFR mutations. It will consist of a dose escalation phase followed by expansion cohorts. LianBio anticipates commencing this trial in the second half of 2023.

BBP-398, the SHP2 inhibitor under investigation, was developed 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 plays a role in linking growth factor, cytokine, and integrin signalling to the RAS/ERK MAPK pathway, which regulates cell proliferation and survival. LianBio and BridgeBio have formed a strategic collaboration for the clinical development and commercialization of BBP-398 in combination with various agents for solid tumours, including non-small cell lung cancer, colorectal cancer, and pancreatic cancer in mainland China and other Asian markets.

BBP-398 is also being investigated by BridgeBio and its clinical partners, such as Bristol Myers Squibb, for combination with OPDIVO (nivolumab) in patients with advanced solid tumours with KRAS mutations, as well as with Amgen in combination with LUMAKRAS (sotorasib), an Amgen KRASG12C inhibitor, in patients with advanced solid tumours harbouring KRASG12C mutations.