NovaBridge Biosciences announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to givastomig for the treatment of previously untreated HER2-negative advanced or metastatic gastroesophageal adenocarcinomas (GEA). The designation applies to patients whose tumors are both Claudin 18.2 (CLDN18.2) and PD-L1 positive, and covers the use of givastomig in combination with nivolumab and chemotherapy. This regulatory milestone is intended to accelerate the development and review of the therapy for a serious condition with unmet medical need.

Givastomig is a novel CLDN18.2 x 4-1BB bispecific antibody. Phase 1b data demonstrated compelling efficacy and tolerability for givastomig in combination with immunochemotherapy. The company stated that responses were deep and durable across a broad patient population, showing marked improvement relative to historical benchmarks for the standard of care. The FDA had previously confirmed the therapy's eligibility for the accelerated approval pathway.

Development Timeline and Partnership

The Fast Track Designation facilitates a more efficient path to a registrational Phase 3 trial, which is expected to begin as early as Q4 2026. Additionally, detailed Phase 1b data is expected to be presented at a major medical conference in H2 2026. Givastomig is being jointly developed through a global partnership with ABL Bio, in which NovaBridge is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.

Pipeline Overview

NovaBridge's differentiated pipeline is led by givastomig and VIS-101, a dual VEGF-A X ANG-2 inhibitor. VIS-101 has completed a randomized, dose-ranging Phase 2a study for wet age-related macular degeneration (AMD) and expects to initiate a dose-determining Phase 2b study in H2 2026. The company is also collaborating with ABL Bio on ragistomig, a bispecific antibody for solid tumors, and owns worldwide rights outside of China to uliledlimab, an anti-CD73 antibody.