ABL Bio said it plans to launch a global Phase 3 clinical trial this year for its investigational gastric cancer therapy Givastomig (ABL111).
CEO Sang Hoon Lee told reporters on June 24 at the BIO International Convention 2026 in San Diego that the company is targeting December to begin the Phase 3 trial and is currently discussing the development budget with co-development partner NovaBridge.
“We are preparing manufacturing operations and selecting clinical trial sites for the Phase 3 study,” Lee said. “Enrollment for the Phase 2 trial has been completed, and we will now focus on preparing for Phase 3.”
Givastomig is a bispecific immuno-oncology antibody targeting both Claudin 18.2 (CLDN18.2) and 4-1BB, and is being developed as a first-line treatment for gastric cancer.
ABL Bio previously received Fast Track designation from the U.S. Food and Drug Administration (FDA) for Givastomig.
The Fast Track program is designed to facilitate the development of therapies for serious conditions with unmet medical needs by enabling more frequent communication between drug developers and the FDA.
Lee also expressed confidence in the drug’s commercial potential.
“If development proceeds as planned, we expect commercialization to be achievable,” he said. “We estimate Givastomig’s market opportunity at around $2.5 billion.”
ABL Bio is also advancing its global expansion strategy through its U.S. subsidiary, Neok Bio.
“Technology licensing is the typical business model in Korea, but in the United States, company valuations can increase significantly as clinical development progresses,” Lee said. “After establishing proof of concept (PoC) through Phase 2 clinical trials at Neok Bio, we will evaluate various growth options, including additional fundraising, an initial public offering (IPO), and mergers and acquisitions (M&A).”
Meanwhile, ABL Bio signed a licensing agreement last year with U.S. pharmaceutical company Eli Lilly for its blood-brain barrier (BBB) shuttle platform technology and is currently conducting joint research to develop next-generation platform technologies.