NovaBridge Agrees with FDA on Phase 3 Following 18-Month Data

NovaBridge Biosciences (Nasdaq: NBP) reached a protocol agreement with the US Food and Drug Administration (FDA) to advance its candidate givastomig, developed for the treatment of gastroesophageal cancer, to Phase 3 following long-term data from a Phase 1b clinical trial involving 71 patients. Updated results presented at the ESMO 2026 Congress in Madrid, Spain, demonstrated the drug's efficacy and safety profile in combination with nivolumab and chemotherapy.

What did the Givastomig Phase 1b clinical data show?

The analysis shared at the congress in Madrid, covering patient follow-up through August 6, 2026, included the 8 mg/kg and 12 mg/kg dose groups. The company reported that median follow-up in the 8 mg/kg cohort, selected as the final development dose, reached approximately 18 months. In the trial, givastomig generated clinical responses even at the lowest levels, regardless of CLDN18.2 protein expression levels in tumor cells.

No treatment-related Grade 4 or Grade 5 serious adverse events were observed in the clinical study. Immune-related adverse events were rare, while the most frequently reported Grade 2 gastritis cases remained manageable. Dr. Samuel J. Klempner, faculty member at Massachusetts General Hospital, stated that consistent responses and durable efficacy achieved across the broad patient population support advancing the drug into Phase 3.

What Phase 3 protocol did NovaBridge and the FDA agree on?

NovaBridge Chief Medical Officer Dr. Phillip Dennis stated that discussions with the FDA finalized the global Phase 3 protocol, including the target patient population, dosing, and primary endpoints. Under the program, which previously received Orphan Drug and Fast Track designations from US authorities, plans are in place to initiate the global Phase 3 trial that will serve as the basis for the regulatory approval process.

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