NovaBridge Biosciences announced that the U.S. Food and Drug Administration has aligned with the company on a potential accelerated approval pathway for its bispecific antibody givastomig in first‑line HER2‑negative, CLDN18.2+, PD‑L1+ gastric cancer. The alignment follows a productive Type B meeting with FDA reviewers and is based on robust Phase 1b combination data that showed a 75 % objective response rate and a median progression‑free survival of 16.9 months.
The Phase 1b study, which combined givastomig with standard immunochemotherapy, demonstrated a response rate that exceeds historical benchmarks for first‑line therapy in this biomarker‑selected population. A 75 % ORR and 16.9‑month mPFS provide a strong surrogate signal that the FDA will consider for accelerated approval, potentially allowing earlier patient access while the company completes confirmatory trials.
Givastomig’s bispecific design targets the tumor‑specific antigen CLDN18.2 while engaging T‑cells through the 4‑1BB costimulatory pathway, a mechanism that differentiates it from existing CLDN18.2 agents such as zolbetuximab. The partnership with ABL Bio, which holds shared worldwide rights outside Greater China and South Korea, expands the commercial footprint and shares development risk.
NovaBridge plans to launch a registrational Phase 3 trial in combination with immunochemotherapy as early as Q4 2026, using objective response rate as the primary endpoint for accelerated approval. The trial design will be finalized in collaboration with the FDA, and the company expects the data to confirm the clinical benefit observed in Phase 1b and support full approval.
Chief Medical Officer Phillip Dennis said, “We are thrilled to receive the positive feedback from FDA confirming givastomig’s eligibility for an accelerated approval pathway. This important regulatory milestone builds on compelling Phase 1b givastomig results that showed robust efficacy and favorable overall tolerability, with marked improvement relative to historical benchmarks for the standard of care in cross‑trial comparisons.” Chief Executive Officer Sean Fu added, “Givastomig is a core program for NovaBridge. The compelling Phase 1b data presented today have the potential to establish givastomig as the leading CLDN18.2‑directed therapy for 1L gastric cancer, where the unmet medical need remains high and the commercial opportunity is significant.”
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