Abion Adds Two Domestic Sites for Babamekeop Phase 2 Clinical Trial... "Accelerating Global Clinical Progress"

Abion announced on the 28th that two additional clinical sites have started institution initiation for the Phase 2 clinical trial of the non-small cell lung cancer treatment drug Babamekip (ABN401). The newly added clinical sites are Yonsei University Severance Hospital and Seoul Boramae Hospital.

With the addition of these clinical sites, Abion will conduct the Phase 2 trial at a total of 20 global institutions, including 11 domestic sites, 6 in Taiwan, and 3 in the United States. In the U.S., the first patient enrollment for the Phase 2 trial at MD Anderson Cancer Center was completed last year. The company plans to accelerate global patient enrollment and clinical trials while actively pursuing license-out (LO) opportunities.

Babamekip is a targeted therapy for non-small cell lung cancer with c-MET (hepatocyte growth factor receptor) mutations. The interim results of the global Phase 2 trial announced in October last year showed an ORR (objective response rate) of approximately 53%, with a 75% response rate observed in treatment-naive patient groups. Notably, only 8% of patients experienced Grade 3 or higher adverse reactions, which is a superior safety profile compared to competing drugs such as Novartis's Tabrecta and Merck's Tepmetko.

An Abion representative stated, “We will proceed with the clinical trial without any setbacks based on the disclosed competitive data. We will work closely with clinical experts to achieve encouraging results and ensure the successful development of innovative new drugs.”

Meanwhile, Abion completed the application for orphan drug designation (ODD) for Babamekip with the U.S. FDA (Food and Drug Administration) last month. The orphan drug designation system encourages the development of treatments for rare diseases with high unmet medical needs, typically affecting fewer than 100,000 patients. If designated as an orphan drug, various benefits are provided, including tax reductions and a seven-year market exclusivity period after new drug approval.