NovaBridge Biosciences Reports Mature Phase 1b Data at ESMO 2026 Positioning Givastomig for Registrational Development
Key Highlights
- ➤8 mg/kg dose selected for registrational development after efficacy, safety and follow-up review
- ➤8 mg/kg cohort delivered 79% objective response rate among efficacy-evaluable patients
- ➤Median progression-free survival reached 16.9 months at the selected 8 mg/kg dose
- ➤FDA alignment achieved on global registrational study protocol and Phase 3 design elements
- ➤Clinical activity extended to lower-expression tumors, with 75% response rate at 1%-74% CLDN18.2 expression
Expert Statements
Samuel J. Klempner, M.D., Associate Professor of Medicine at Massachusetts General Hospital
“These updated data provide greater confidence in the durability of clinical benefit observed with givastomig and are encouraging given the persistent need for more effective first-line treatment options for patients with metastatic gastroesophageal adenocarcinoma.”
Samuel J. Klempner, M.D., Associate Professor of Medicine at Massachusetts General Hospital
“What stands out in the updated analysis is not only the durability of benefit with longer follow-up, but also the strength and consistency of efficacy results across a broad range of CLDN18.2 expression, including very low expression.”
Samuel J. Klempner, M.D., Associate Professor of Medicine at Massachusetts General Hospital
“The updated dataset provides a more mature view of givastomig’s activity and supports its continued advancement to a Phase 3 trial.”
Phillip Dennis, M.D., Ph.D., Chief Medical Officer of NovaBridge
“The updated dataset provides a more mature view of givastomig's clinical profile, including longer follow-up, greater insight into durability and safety, and increased confidence in the 8 mg/kg dose, which has been selected for registrational development.”
Phillip Dennis, M.D., Ph.D., Chief Medical Officer of NovaBridge
“Over the past year, we have significantly strengthened the clinical and regulatory foundation for the program through continued dataset maturation, dose selection, and productive engagement with the FDA, culminating in alignment on a Phase 3 study design.”
Phillip Dennis, M.D., Ph.D., Chief Medical Officer of NovaBridge
“Together with the program's Orphan Drug and Fast Track Designations, we believe these advances position givastomig as a registrational-ready program.”
Srishti Gupta, M.D., M.P.P., Chief Executive Officer of NovaBridge
“The maturation of the givastomig dataset over the past year has significantly increased our confidence in the program.”
Srishti Gupta, M.D., M.P.P., Chief Executive Officer of NovaBridge
“The updated efficacy, durability and safety findings, together with productive interactions with the FDA and important regulatory milestones, have advanced givastomig into a late-stage development program.”
Srishti Gupta, M.D., M.P.P., Chief Executive Officer of NovaBridge
“We believe this represents an important inflection point for givastomig and its potential to make a meaningful difference for patients with metastatic gastroesophageal adenocarcinoma.”
* Updated Phase 1b dataset provides nearly 18 months of median follow-up and shows the durability of clinical benefit observed with givastomig * Clinical activity observed across CLDN18.2 expression levels, including in patients with lower-expression tumors not eligible for currently approved CLDN18.2-targeted therapies * Totality of efficacy, safety and long-term follow-up data supports selection of the 8 mg/kg dose for registrational development * Ongoing U.S. Food and Drug Administration (FDA) interactions, Orphan Drug Designation, Fast Track Designation and progress on Phase 3 planning further support a defined path towards registrational development * NovaBridge to host investor webcast on November 2, 2026, to discuss the updated data and registrational development strategy ROCKVILLE, Md., Oct. 25, 2026 (GLOBE NEWSWIRE) -- NovaBridge Biosciences (“NovaBridge” or “Company”) (Nasdaq: NBP) today announced the presentation of updated results from the ongoing Phase 1b study of givastomig, a CLDN18.2 x 4-1BB bispecific antibody, in combination with nivolumab and chemotherapy for patients with HER2-negative first-line metastatic gastroesophageal adenocarcinoma. The results were presented at the European Society for Medical Oncology (ESMO) Congress 2026 in Madrid, Spain.
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