NovaBridge Biosciences (NBP) has received FDA Fast Track Designation for its Givastomig, a bispecific antibody being developed for patients with previously untreated HER2-negative metastatic gastric cancer whose tumors express both CLDN18.2 and PD-L1. The designation is intended to accelerate the development and review of promising treatments for serious conditions with unmet medical needs.
Gastric cancer remains one of the leading causes of cancer-related deaths worldwide, and patients with HER2-negative metastatic disease often have limited treatment options. Tumors expressing CLDN18.2 and PD-L1 represent a biologically distinct subgroup that may benefit from targeted and immune-based therapies.
Givastomig is a CLDN18.2 x 4-1BB bispecific antibody, designed to activate the immune system while selectively targeting tumor cells that express CLDN18.2.
In a Phase 1b study, Givastomig combined with nivolumab and chemotherapy demonstrated compelling efficacy and favorable tolerability, with deep and durable responses across a broad patient population.
According to NovaBridge Chief Medical Officer Phillip Dennis, the results showed marked improvement relative to historical benchmarks for the standard-of-care regimens, supporting the therapy's potential as a first-in-class and best-in-class CLDN18.2-directed option for gastric cancer.
Next Steps
NovaBridge expects to begin a registrational Phase 3 trial as early as Q4 2026, evaluating Givastomig in combination with nivolumab and chemotherapy in first-line HER2-negative metastatic gastroesophageal adenocarcinomas (GEA) patients.
The company also plans to present detailed Phase 1b data at a major medical conference in the second half of 2026.
NBP has traded between $1.46 and $6.79 over the past year. The stock closed Monday's trading at $1.47, down 1.34%. In pre-market trading the stock is at $1.58, up 7.48%.
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