NovaBridge Biosciences Reports Positive Mature Phase 1b Data for Givastomig
NovaBridge Biosciences announced updated Phase 1b data for its CLDN18.2 x 4-1BB bispecific antibody, givastomig, presented at ESMO 2026. The mature dataset, with nearly 18 months of median follow-up for the selected 8 mg/kg dose, demonstrated a 79% objective response rate and a 97% disease control rate in first-line metastatic gastroesophageal adenocarcinoma patients. The company has selected the 8 mg/kg dose for registrational development, citing durable clinical benefit across various CLDN18.2 expression levels and manageable safety. NovaBridge has also aligned with the FDA on a Phase 3 study protocol, positioning givastomig as a registrational-ready program. An investor webcast is scheduled for November 2, 2026.
Key Highlights
- NovaBridge Biosciences reports mature Phase 1b data for givastomig at ESMO 2026.
- Updated Phase 1b dataset shows nearly 18 months of median follow-up for the 8 mg/kg dose cohort.
- Objective response rate of 79% and disease control rate of 97% observed in efficacy-evaluable patients at the 8 mg/kg dose.
- Median duration of response of 15.2 months and median progression-free survival of 16.9 months at the 8 mg/kg dose.
- Clinical activity observed across CLDN18.2 expression levels, with an 82% ORR in patients with CLDN18.2 expression ≥75%.
- The 8 mg/kg dose has been selected for registrational development based on efficacy, safety, and long-term follow-up data.
- Company has achieved alignment with the FDA on a global registrational study protocol.
- NovaBridge to host an investor webcast on November 2, 2026, to discuss the data and development strategy.
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