NovaBridge to present givastomig Phase 1b data at ESMO 2026

NovaBridge Biosciences is set to present expanded clinical data for givastomig at the European Society for Medical Oncology Congress 2026, taking place in Madrid from 23 to 27 October. The poster presentation, scheduled for 25 October, will cover updated safety, efficacy and durability findings from the Phase 1b study of givastomig in combination with nivolumab and mFOLFOX6 chemotherapy in first-line metastatic gastroesophageal adenocarcinoma (GEA).

Givastomig is a bispecific antibody targeting Claudin 18.2 (CLDN18.2) and the T-cell co-stimulatory receptor 4-1BB. The candidate is designed to conditionally activate T cells within the tumour microenvironment where CLDN18.2 is expressed, an approach the company describes as a Conditional T-cell Engager and Immune Amplifier. The Phase 1b study enrolled participants with previously untreated, HER2-negative, CLDN18.2-positive and PD-L1-positive locally advanced or metastatic GEA.

Regulatory status and next steps

The US Food and Drug Administration has granted givastomig Fast Track Designation for the first-line HER2-negative advanced or metastatic GEA indication, in combination with nivolumab and chemotherapy. NovaBridge has also initiated a global, randomised Phase 2 study following positive topline results from the Phase 1b programme.

Phillip Dennis, Chief Medical Officer at NovaBridge, said the ESMO data would provide "a more mature view of the safety, efficacy and durability observed to date," adding that the findings "further strengthen our confidence in the program as we advance toward registrational development in first-line metastatic gastroesophageal adenocarcinoma." The presentation will be delivered by Samuel Klempner, Associate Professor of Medicine at Massachusetts General Hospital.

Market context

Gastroesophageal cancer remains one of the most difficult-to-treat GI malignancies, with five-year survival rates for metastatic disease remaining low despite recent advances in immunotherapy. CLDN18.2 has emerged as a validated tumour-associated target in gastric and gastroesophageal cancers following the approval of the anti-CLDN18.2 monoclonal antibody zolbetuximab in combination with chemotherapy in HER2-negative, CLDN18.2-positive gastric and GEJ adenocarcinoma in several markets. The 4-1BB co-stimulatory axis has attracted significant drug development interest, though earlier monospecific 4-1BB agonists encountered hepatotoxicity challenges that tempered clinical enthusiasm. The bispecific approach, anchoring 4-1BB agonism to a tumour-associated antigen such as CLDN18.2, is designed to limit systemic immune activation and improve the therapeutic window. Several other CLDN18.2-targeted bispecifics and antibody-drug conjugates are in earlier stages of clinical development, meaning the competitive field is active and the ESMO dataset will be closely watched by both investors and oncologists.

Beyond GEA, NovaBridge has flagged givastomig's potential applicability in other CLDN18.2-positive gastrointestinal malignancies, including biliary tract cancer and pancreatic ductal adenocarcinoma. The company's broader oncology portfolio also includes ragistomig and uliledlimab, referenced in its forward-looking disclosures, though no clinical updates on those programmes accompanied this announcement.

Investors will be focused on whether the mature Phase 1b data support the response rates and duration of benefit necessary to power a registrational endpoint, and on any signals around the safety profile of the CLDN18.2 and 4-1BB combination in a triple-combination backbone with nivolumab and FOLFOX chemotherapy.