[BIO USA] ABL Bio CEO Sanghoon Lee: "Phase 3 Gastric Cancer Drug Trial to Begin This Year"

"NeocBio to Complete Phase 2 Clinical Trials Within Five Years"

ABL Bio will begin the global Phase 3 clinical trial of its new gastric cancer drug, Zivastomig (ABL111), within this year. The company is also accelerating its transition from the traditional domestic bio-business model, which focused on early-stage technology licensing, to a new model in which it directly leads late-stage clinical trials and commercialization.

Sanghoon Lee, CEO of ABL Bio, is being interviewed on the 24th (local time) at BioUSA held in San Diego, USA. Photo by Joint Press Corps

Sanghoon Lee, CEO of ABL Bio, met with reporters at BIO USA held in San Diego, USA on the 24th (local time) and stated, "Our current plan is to enter Phase 3 clinical trials in December this year," adding, "We are currently negotiating the budget with Novabridge, and are steadily progressing with detailed preparations such as substance manufacturing and clinical site selection."

Zivastomig is a bispecific antibody immuno-oncology drug that targets both Claudin 18.2 (CLDN18.2) and 4-1BB, and is being developed as a first-line therapy for gastric cancer. The drug has received Fast Track designation from the U.S. Food and Drug Administration (FDA). The ongoing Phase 2 trial has completed new patient enrollment, and the company now plans to focus its efforts on preparing for Phase 3. CEO Lee estimates the commercial value of Zivastomig to be approximately $2.5 billion (about KRW 3.4 trillion).

ABL Bio is also detailing its strategy to develop its U.S. subsidiary, NeocBio, which was established last year, as a forward base for global growth. CEO Lee said, "NeocBio was created with the goal of achieving a tenfold return on investment," and explained, "If we stayed in Korea, ABL Bio would just continue with clinical trials, but in the U.S., mergers and acquisitions (M&A) and even Nasdaq listing are possible." The plan is to complete Phase 2 clinical trials within five years, gain market recognition for the company’s value, and then proceed to attract Series B investment.

He also directly addressed the structural limitations of Korea’s bio ecosystem. CEO Lee remarked, "In Korea, CEOs often hold too large a stake, which makes it burdensome for global big pharma companies to pursue M&A," adding, "M&A has never happened based on platform technology alone; you absolutely need highly promising Phase 2 or 3 clinical assets." He further commented, "In Korea, there is a tendency to undervalue companies unless they achieve technology licensing deals, but in the U.S., company valuations rise exponentially as clinical trials progress. That’s why we established NeocBio—to break out of that structure."

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