ABION released data from an ongoing Phase 2 trial of ABN401, the company's wholly owned tyrosine kinase inhibitor intended to treat adult patients with advanced non-small cell lung cancer that exhibit the MET Exon 14 skipping mutation. In eight treatment-naive patients, the objective response rate was 75% (6/8), and in the evaluable population of 17 patients, the objective response rate is 52.9% (9/17). Patients were dosed 800 mg QD and the median duration of response was 5.4 months as of the data cut-off on July 25, 2023.

The data are not mature enough to measure progression-free survival and duration of response. All patients are MET inhibitor naive. Overall efficacy was comparable to currently marketed drugs and demonstrate superior efficacy in treatment-naive patients.

The median age is 69 (41-81) and 70.6% were male, with 1 (0-3) as the median prior lines of treatment. 41.2% of 17 patients were non-sm smokers and 58.8% were smokers. ABN401 continued to demonstrate outstanding safety compared to the currently marketed drugs.

The results were presented in a poster session at the AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics in Boston, and at a separate company event nearby. Based on these results, ABION plans to initiate a Phase 2 combination trial with a multiple drug regimen. The c-MET mutation is the most common mutation shown by NSCLC patients after treatment with EGFR TKIs.

ABN401 is the small molecule which specifically inhibit the phosphorylation site of c-MET tyrosine kinase. In Phase 1 clinical trial, ABN401 demonstrate 0 patients with G3 or higher treatment-related adverse events and no dose-limiting toxicity. 2 partial responses confirmed NSCLC MET overexpression in patients in a dose escalation study, and 2 partial responses confirmed in NSCLC MET exon 14 skipping patients in an expansion study.

ABN401 is currently in a Phase 2 trial. Recently released cut-off data from the Phase 2 study, which target the MET Exon 14 skipping patients, confirmed ABN401's superior safety profile.