NovaBridge Biosciences (NBP) announced that it has enrolled the first patient in a global Phase 2 study evaluating Givastomig in patients with human epidermal growth factor receptor 2(HER2) negative, first-line metastatic gastric cancer.
Metastatic gastric cancer occurs when cancer that started in the stomach spreads to other parts of the body, most commonly the liver, peritoneum, lungs, or bones.
Givastomig is a bispecific antibody targeting Claudin 18.2 or CLDN18.2 positive tumour cells. Givastomig is being developed for potential treatment of gastric cancer and other Claudin 18.2-positive gastrointestinal malignancies.
The global randomised Phase 2 study is designed to evaluate the addition of Givastomig, at 8 mg/kg and 12 mg/kg doses, to standard of care immunochemotherapy of nivolumab and mFOLFOX6 in patients with first-line metastatic gastric cancer.
The earlier Phase 1b dose expansion data showed that patients treated with givastomig dosed at 8 mg/kg and 12 mg/kg every two weeks experienced an objective response rate (ORR) of 75%, median progression-free survival (mPFS) of 16.9 months and 82% six-month landmark progression-free survival.
Detailed Phase 1b expansion data are expected to be presented at a major medical conference in H2 2026.
"The Phase 2 study is designed to confirm these results in a broader setting and validate givastomig as a potential best-in-class therapy for 1L metastatic gastric cancer, with the potential for broad utilisation across CLDN18.2 levels in Programmed Death-Ligand 1 (PD-L1) positive patients," said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge.
NovaBridge noted that top-line Phase 2 results are expected in 2027 and that Phase 1b data, if positive, may position Givastomig as a potential CLDN18.2-directed therapy for gastric cancer, with a projected $12 billion market opportunity by 2030.
NBP has traded between $0.60 and $6.79 in the last year.On Tuesday, NBP traded between $3.05 and $3.31. The stock closed trading at $3.22, up 0.31%.
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