[Asia Economy Reporter Chunhee Lee] Abion announced on the 18th that it has completed the first patient dosing in the global Phase 2 clinical trial of its non-small cell lung cancer treatment candidate, ‘ABN401’.
The global Phase 2 clinical trial of ‘ABN401’, conducted in the United States and Korea, targets Cohort 1 (monotherapy, exon14 deletion). Cohort 1 is a monotherapy aimed at breakthrough in the market based on excellent safety for patients with c-MET mutations who have exon14 gene deletions.
The primary objective of this Phase 2 trial is to confirm the objective response rate (ORR) according to the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). In the global Phase 1 safety trial conducted in Australia and Korea in 2021, no adverse reactions such as edema, hypoalbuminemia, or hepatotoxicity?major grade 3 or higher drug-related adverse events commonly seen with other c-Met treatments?were observed, confirming excellent safety. In terms of drug responsiveness, there was also a case where a patient’s tumor size was reduced by more than 50% and maintained for over one and a half years.
Abion plans to conduct an additional clinical trial to evaluate the combined administration effect of an epidermal growth factor receptor (EGFR) inhibitor therapy, in addition to Cohort 1 of this Phase 2 trial. The goal is to submit a protocol amendment for the second cohort of the global Phase 2 trial to the U.S. Food and Drug Administration (FDA) within this year and initiate the combination trial.
An Abion representative stated, “With the first cohort dosing of ABN401 underway, we will do our best to complete dosing promptly and derive results. We plan to report interim results for Cohort 1 within this year, and we expect that the efficacy data obtained will lead to more active licensing discussions.”
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