NovaBridge Biosciences (NASDAQ: NBP) has received Fast Track Designation from the U.S. Food and Drug Administration for its drug givastomig, used in combination with nivolumab and chemotherapy.
This treatment targets patients with previously untreated HER2-negative advanced or metastatic gastroesophageal adenocarcinomas whose tumors are positive for Claudin 18.2 and PD-L1.
Givastomig is a novel bispecific antibody that targets CLDN18.2 and 4-1BB. The Phase 1b trial data showed promising efficacy and tolerability, positioning givastomig as a leading therapy for gastric cancer.
NovaBridge plans to initiate a registrational Phase 3 trial as early as the fourth quarter of 2026, with detailed Phase 1b results expected to be presented at a major medical conference in the second half of 2026.
Fast Track Designation aims to expedite the development and review process for therapies addressing serious conditions with unmet medical needs.
Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge, stated, “Fast Track Designation is a valuable step forward for givastomig and for patients with first-line HER2-negative metastatic gastric cancer. Phase 1b results demonstrate robust efficacy and favorable overall tolerability in combination with immunochemotherapy.”
