NovaBridge’s givastomig earns FDA Fast Track in gastric cancer

Edited by Robert McTiernan··2 min read

Maryland-based NovaBridge Biosciences (Nasdaq: NBP) announced that the US FDA has granted Fast Track Designation to givastomig (TJ033721 / ABL111), a Claudin 18.2 (CLDN18.2) × 4-1BB bispecific antibody. Specifically, the award covers givastomig’s potential use in combination with nivolumab and chemotherapy for the first-line treatment of previously untreated HER2-negative advanced or metastatic gastroesophageal adenocarcinomas (GEA) whose tumors are both CLDN18.2 and PD-L1 positive.

The designation follows a March 2026 Type B meeting in which the FDA agreed that givastomig may be eligible for an accelerated approval pathway. NovaBridge expects to initiate a registrational Phase III trial as early as Q4 2026, using ORR as the primary endpoint for a potential accelerated approval submission.

The supporting data package comes from a Phase Ib dose escalation and expansion study in first-line HER2-negative metastatic gastric cancer. As previously disclosed by NovaBridge in February 2026, givastomig dosed at 8 mg/kg and 12 mg/kg every two weeks in combination with nivolumab and mFOLFOX6 chemotherapy produced a 75% ORR across 52 evaluable patients (77% at 8 mg/kg; 73% at 12 mg/kg), a median progression-free survival of 16.9 months, and an 82% six-month landmark progression-free survival rate in 53 evaluable patients. The company reported favorable tolerability without dose-dependent toxicity. Detailed expansion data are expected at a major medical conference in H2 2026. A global, randomized Phase II study enrolled its first patient in February 2026, with topline results expected in 2027.

Givastomig works by binding CLDN18.2 on tumor cells and conditionally activating T cells through 4-1BB co-stimulation only in the tumor microenvironment where CLDN18.2 is expressed. This tumor-restricted activation is designed to limit the systemic toxicities associated with non-conditional 4-1BB agonists.

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Research context

The only approved CLDN18.2-directed therapy in this disease is zolbetuximab (Vyloy), a monospecific anti-CLDN18.2 monoclonal antibody approved by the US FDA in 2024 for first-line HER2-negative, CLDN18.2-positive gastric adenocarcinoma in combination with chemotherapy — without an immunotherapy backbone. Givastomig’s dual mechanism, pairing CLDN18.2 tumor targeting with conditional T cell co-stimulation, occupies a mechanistically distinct position from zolbetuximab and from approved PD-1 inhibitor combinations, which require PD-L1 expression for maximal benefit. No approved regimen currently combines a CLDN18.2-targeted agent with anti-PD-1 immunotherapy in the first-line setting. Other CLDN18.2-directed agents in late-stage development include Innovent’s IBI343, an antibody-drug conjugate in Phase III.

Givastomig is being jointly developed by NovaBridge and South Korea-based ABL Bio, with NovaBridge as lead party holding worldwide rights excluding Greater China and South Korea.

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