South Korean platform biotech company ABL Bio announced that development remains firmly on track despite investor concerns over Sanofi’s recent reprioritization of its Parkinson's disease asset, ABL301. Shifting focus to its near-term growth drivers, the company highlighted its stomach cancer treatment candidate, ABL111, outlining a strategy to enter the first-line CLDN18.2 stomach cancer market currently led by Astellas Pharma.
Speaking at a corporate briefing on July 7 at the Conrad Seoul in Yeouido, ABL Bio CEO Lee Sang-hoon sought to reassure the market. “We received a letter from Sanofi explaining the situation regarding ABL301,” Lee Sang-hoon said. “The letter clearly states that Sanofi will begin clinical trials as soon as the biomarker they are preparing is in place, and that development of this asset is not being terminated.” According to the company, work will proceed once a suitable biomarker is established to assess drug efficacy, select appropriate patient cohorts, and evaluate overall treatment response in follow-on trials.
ABL301 is a bispecific antibody candidate targeting Parkinson’s disease that combines an alpha-synuclein antibody with ABL Bio’s blood-brain barrier (BBB) shuttle platform, Grabody-B. The asset was licensed to Sanofi in 2022, with U.S. Phase 1 clinical trial results announced in September last year. However, investor sentiment took a hit earlier this year when Sanofi noted a reprioritization of ABL301 in its 2025 annual financial results.
“I believe the roughly 30% drop in our share price over this issue is an overreaction,” Lee Sang-hoon said, addressing the sharp stock correction that followed Sanofi’s announcement.
Shifting Focus to ABL111 and the Stomach Cancer Market
After addressing the concerns surrounding ABL301, Lee Sang-hoon devoted a substantial portion of the presentation to ABL111. ABL111 is a bispecific antibody candidate for stomach cancer that simultaneously targets Claudin (CLDN) 18.2 and 4-1BB. As a flagship pipeline program developed on the company's 4-1BB-based platform, Grabody-T, ABL Bio is positioning ABL111 to compete in the first-line CLDN18.2 stomach cancer market, where Astellas Pharma’s zolbetuximab has already established a foothold.
ABL Bio highlighted a key competitive advantage: unlike zolbetuximab, which primarily targets patients with high CLDN18.2 expression, ABL111 has shown efficacy in patients with low CLDN18.2 expression. According to company data, an ABL111 combination therapy achieved an objective response rate (ORR) exceeding 75% and a disease control rate (DCR) of over 98% in an early-stage clinical trial. Notably, in the low CLDN18.2 expression cohort, the combined ORR across two dose levels reached 78.3% (18/23). In patients presenting with both low CLDN18.2 and low PD-L1 expression—a population traditionally difficult to treat—the ORR was confirmed at 83.3% (5/6).
In terms of survival metrics, the median progression-free survival (mPFS) in the 8 mg/kg dose cohort was reported at 16.9 months, indicating a prolonged duration before disease progression following treatment.
Regarding safety, the company reported that ABL111 exhibited gastrointestinal adverse events and other side effects typical of the CLDN18.2-targeted drug class, all within manageable levels. However, industry observers note that because the ABL111 data are still early-stage, direct comparisons remain limited against zolbetuximab, which carries the weight of large-scale clinical trials and regulatory approval.
To accelerate its timeline as a late entrant to the market, ABL Bio plans to leverage an FDA Fast Track designation and advance straight into a registrational Phase 3 trial. “Astellas is currently conducting a Phase 3 trial evaluating a combination of a PD-1 inhibitor, zolbetuximab, and chemotherapy as a first-line treatment, with results expected around the end of 2029,” Lee Sang-hoon said. “Following discussions with the FDA, ABL Bio has opted for a strategy to move directly into a registrational Phase 3 trial, with the goal of securing data around 2030.”
Ultimately, establishing a meaningful competitive edge over Astellas will depend on hard survival endpoints, such as progression-free survival (PFS) and overall survival (OS), which must be validated in the upcoming registrational Phase 3 study.
