Abion Receives FDA Approval for Phase 2 Clinical Trial Modification of Babamakeup

ABION announced on the 27th that it has received approval from the U.S. Food and Drug Administration (FDA) for the modification of the Phase 2 clinical trial plan for Babamekip (ABN401).

Babamekip is a c-MET (hepatocyte growth factor receptor) targeted anticancer agent. The clinical trial will begin targeting patients with advanced solid tumors of non-small cell lung cancer (NSCLC) who have shown resistance to epidermal growth factor receptor (EGFR) targeted anticancer agents and exhibit overexpression or amplification of epithelial-mesenchymal transition (MET). The goal of the trial is to confirm safety, efficacy, and tolerability by administering a combination of the EGFR targeted anticancer agent Lazertinib and the MET targeted anticancer agent Babamekip.

The clinical trial will be conducted on a total of 138 patients in Korea, Taiwan, and four hospitals in the United States. Approximately 30% of NSCLC patients treated with EGFR targeted anticancer agents often develop resistance due to c-MET overexpression or amplification. Babamekip and Lazertinib target the c-MET and EGFR signaling pathways respectively, acting complementarily. This combination therapy is expected to simultaneously achieve two major effects: inhibition of cancer cell growth and improvement of survival rates.

A company representative stated, "With the approval of the modification application, we will accelerate the combination clinical trial with Lazertinib," adding, "Since there are no approved drugs for this combination therapy yet, there is high anticipation for its potential as a first-in-class innovative drug."

This content was produced with the assistance of AI translation services.