Abion Receives MFDS Approval to Change Babamakeup Phase 2 Clinical Trial... "Aiming for Innovative Drug Development"

ABION announced on the 17th that the Ministry of Food and Drug Safety (MFDS) has approved the change in the Phase 2 clinical trial plan for Vabametkib (ABN401). The goal is to confirm safety, efficacy, and tolerability through a combination clinical trial of Lazertinib and Vabametkib.

This clinical trial targets patients with advanced solid tumors, especially those with non-small cell lung cancer (NSCLC) who have shown resistance to epidermal growth factor receptor (EGFR) targeted anticancer therapy. Among them, a total of 138 patients exhibiting overexpression or amplification of mesenchymal-epithelial transition (MET) will participate in the combination clinical study conducted in the United States, Korea, and Taiwan.

The clinical trial will be conducted in three parts until the fourth quarter of 2027. Part 1 will adjust the doses of Lazertinib and Vabametkib to evaluate safety. Part 2 will conduct a randomized clinical trial to find the optimal doses of the two drugs confirmed for safety and tolerability. Part 3 will compare the efficacy between the existing treatment and the combination drugs.

An ABION representative said, "Since the interim results of the Phase 2 monotherapy showed higher efficacy than competing drugs, we expect to produce innovative results in the combination clinical trial as well," adding, "We will successfully complete the global Phase 2 combination trial and develop an innovative new drug for NSCLC treatment to become a global leading bio company."

The company also reported that the Taiwan Food and Drug Administration (TFDA) has approved the Phase 2 combination clinical trial. The trial will be conducted at six hospitals in Taiwan, following the same three-part study design as in the United States and Korea.

ABION plans to accelerate the clinical trial after the approval of the changes. The combination clinical trials in Korea, the United States, and Taiwan aim to administer the first dose to patients as soon as possible. The company plans to collaborate with global research institutions to facilitate rapid patient recruitment and data acquisition.