Biotechnology platform company NovaBridge Biosciences (NBP) announced Tuesday that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to givastomig in combination with nivolumab and chemotherapy for the treatment of patients with previously untreated HER2-negative advanced or metastatic gastroesophageal adenocarcinomas (GEA) whose tumors are both Claudin 18.2 (CLDN18.2) and PD-L1 positive.
Givastomig is a novel CLDN18.2 x 4-1BB bispecific antibody. The registrational Phase 3 Trial is expected to begin as early as the fourth quarter of 2026.
The Phase 1b data demonstrated robust efficacy and favorable overall tolerability for givastomig in combination with immunochemotherapy, supporting its potential as a premier CLDN18.2-directed therapy for gastric cancer.
The Fast Track Designation is intended to accelerate development and review of therapies for serious conditions with unmet medical need.
In Tuesday's pre-market trading, NBP is trading on the Nasdaq at $1.62, up $0.15 or 10.20 percent.
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