ABL Bio Partnered CLDN18.2 Bispecific Advances Toward Potential Registrational Phase 3 in Gastric Cancer

According to a recent LinkedIn post from BioSpectator Inc, Korean biotech company ABL Bio and its partner Novabridge Biosciences (formerly I‑Mab) appear to see a potential U.S. FDA accelerated approval pathway for their CLDN18.2×4‑1BB bispecific antibody, givastomig (ABL111), in first‑line gastric and gastroesophageal cancer. The post indicates that, following a Type B meeting, the FDA aligned on an accelerated pathway based on positive phase 1b combination data in HER2‑negative, CLDN18.2‑positive, PD‑L1‑positive patients.

The LinkedIn post notes that the partners have set overall response rate as the primary endpoint for accelerated approval and aim to start a registrational phase 3 trial for the combination regimen as early as Q4 this year, with final trial design still to be discussed with the FDA. For investors, the suggested regulatory alignment and transition toward phase 3 could signal a de‑risking of the program’s development path and a potential future revenue stream in a competitive first‑line gastric cancer segment, though ultimate value will depend on confirmatory data, safety profile, and differentiation versus existing standards of care.