FDA grants Fast Track Designation to NovaBridge’s bispecific antibody givastomig in combination with nivolumab and chemotherapy for first-line HER2-negative gastric cancer, supporting advancement to Phase 3 development in 2026.
Written By: Disha Jadhao, BPharm
Reviewed By: Pharmacally Editorial Team
NovaBridge Biosciences has received U.S. Food and Drug Administration (FDA) Fast Track Designation for givastomig in combination with nivolumab and chemotherapy for the first-line treatment of patients with HER2-negative advanced or metastatic gastroesophageal adenocarcinoma (GEA) whose tumors are positive for both Claudin 18.2 (CLDN18.2) and PD-L1.
The designation follows promising Phase 1b results and strengthens the regulatory pathway for the investigational therapy, with a registrational Phase 3 study expected to begin as early as the fourth quarter of 2026. Fast Track status allows more frequent FDA interactions and may support eligibility for rolling review, priority review, and accelerated approval if regulatory criteria are met.
Targeting CLDN18.2 With Tumor-Localized Immune Activation
Givastomig (TJ033721/ABL111) is a CLDN18.2 × 4-1BB bispecific antibody that binds CLDN18.2-expressing tumor cells while conditionally activating 4-1BB signaling on T cells within the tumor microenvironment. The approach is intended to enhance anti-tumor immune responses while limiting systemic toxicity.
The strategy is particularly relevant because development of earlier 4-1BB agonists was constrained by hepatotoxicity linked to broad immune activation. By restricting 4-1BB stimulation to CLDN18.2-positive tumors, givastomig may offer a more favorable therapeutic window.
CLDN18.2 has emerged as an important target in gastric and gastroesophageal cancers, where treatment outcomes remain poor despite advances in immunotherapy.
Advancing in a Competitive CLDN18.2 Landscape
Interest in CLDN18.2-directed therapies has increased following the approval of zolbetuximab in advanced gastric cancer. Multiple next-generation candidates, including bispecific antibodies and antibody-drug conjugates, are also progressing through clinical development.
NovaBridge believes givastomig’s dual mechanism of tumor targeting and immune co-stimulation could differentiate it within this growing treatment landscape.
Phase 1b Data Support Late-Stage Development
According to the company, Phase 1b data demonstrated compelling anti-tumor activity and favorable tolerability when givastomig was combined with immunochemotherapy in previously untreated patients. Responses were reported to be deep and durable across a broad patient population and compared favorably with historical outcomes observed with current standard-of-care regimens.
Detailed efficacy and safety findings are expected to be presented at a major medical conference in the second half of 2026. The FDA has also previously confirmed that the program may be eligible for an accelerated approval pathway.
Regulatory Path Forward
Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge, said the Fast Track Designation reflects the strength of the early clinical data and supports a more efficient regulatory path for the program.
NovaBridge plans to launch a registrational Phase 3 study in late 2026. While trial details have not yet been disclosed, upcoming clinical data presentations and pivotal study initiation will be key milestones as givastomig advances toward potential approval for metastatic gastric cancer. Givastomig is being co-developed with ABL Bio under a global partnership.
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About the Writer
Disha Sanjay Jadhao (LinkedIn) is a pharmacy graduate and healthcare writer with a strong interest in clinical documentation and simplifying healthcare information for better reader understanding. She is enthusiastic, adaptable, and eager to take on new challenges while contributing to clear, accurate, and engaging medical and pharmaceutical content.