Givastomig (CLDN18.2 x 4-1BB bispecific antibody)

June 16, 2026: NovaBridge Biosciences (NASDAQ: NBP) said the FDA granted Fast Track Designation to givastomig (TJ033721/ABL111), a CLDN18.2 x 4-1BB bispecific antibody, in combination with nivolumab and chemotherapy for first-line treatment of HER2-negative advanced/metastatic gastroesophageal adenocarcinomas whose tumors are CLDN18.2- and PD-L1-positive. The company said Phase 1b data showed “compelling” efficacy and tolerability for the immunochemotherapy combination and noted the FDA had previously confirmed eligibility for an accelerated approval pathway.

Upcoming catalysts/timelines mentioned: detailed Phase 1b data are expected to be presented at a major medical conference in H2 2026; a registrational Phase 3 trial is expected to begin as early as Q4 2026. NovaBridge also noted givastomig is being evaluated in a global, randomized Phase 2 study.

Other pipeline updates: VIS-101 (dual VEGF-A x ANG-2 inhibitor) completed a randomized Phase 2a study in wet AMD and expects to initiate a dose-determining Phase 2b study in H2 2026. The company also referenced collaboration with ABL Bio on ragistomig (PD-L1 x 4-1BB) and ownership of rights (outside China) to uliledlimab (anti-CD73).