NovaBridge Biosciences disclosed that its Phase 1b study of the Claudin 18.2 × 4‑1BB bispecific antibody givastomig, given with nivolumab and mFOLFOX6, achieved an overall response rate of 77 % at the 8 mg/kg dose and 73 % at 12 mg/kg in patients with HER2‑negative, first‑line metastatic gastric cancer. Responses were rapid, deepened over time, and occurred across all levels of CLDN18.2 and PD‑L1 expression, indicating broad applicability of the bispecific platform.
The safety profile was consistent with earlier observations. Only low‑grade gastritis was reported, and the incidence of gastritis correlated with higher response rates, suggesting a manageable safety profile that does not compromise efficacy.
These results represent the first evidence of high efficacy for a CLDN18.2‑directed bispecific in a first‑line setting. The data support the potential of givastomig to become a best‑in‑class therapy for gastric cancer, a market projected to reach $12 billion by 2030. The findings also reinforce NovaBridge’s bispecific antibody platform, which has attracted partnership interest from Bristol Myers Squibb and ABL Bio, and position the company to pursue regulatory discussions and a randomized Phase 2 trial.
The announcement triggered a positive market reaction, with NovaBridge shares rising over 11 % in pre‑market trading. Investors were driven by the high overall response rates and a median progression‑free survival of 16.9 months at the 8 mg/kg dose, both of which underscore the clinical promise of givastomig and the potential commercial upside.
CEO Sean Fu said, “The compelling Phase 1b data presented today have the potential to establish givastomig as the leading CLDN18.2‑directed therapy for first‑line gastric cancer, where the unmet medical need remains high and the commercial opportunity is significant.” He added that the company will present the full data at a medical meeting later in 2026 and pursue a global randomized trial to confirm the benefit.
The study’s success strengthens NovaBridge’s pipeline, validates its bispecific antibody platform, and enhances the company’s competitive positioning in the gastric cancer therapeutic area. It also signals to investors that NovaBridge is progressing toward a potentially transformative product that could capture a sizable share of the growing CLDN18.2‑targeted therapy market.
The content on BeyondSPX is for informational purposes only and should not be construed as financial or investment advice. We are not financial advisors. Consult with a qualified professional before making any investment decisions. Any actions you take based on information from this site are solely at your own risk.