On June 16, 2026 NovaBridge Biosciences (Nasdaq: NBP) (NovaBridge or the Company) a global biotechnology platform company committed to accelerating access to innovative medicines that address significant unmet needs, reported 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.
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Phase 1b data demonstrated compelling efficacy and tolerability for givastomig in combination with immunochemotherapy, supporting its potential as a premier CLDN18.2-directed therapy for gastric cancer. Fast Track Designation is intended to accelerate development and review of therapies for serious conditions with unmet medical need.
"Fast Track Designation is a valuable step forward for givastomig and for patients with first-line HER2-negative metastatic gastric cancer," said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge. "Phase 1b results demonstrate robust efficacy and favorable overall tolerability in combination with immunochemotherapy. Responses were deep and durable across a broad patient population, with marked improvement relative to historical benchmarks for the standard of care. Fast Track Designation, combined with FDA’s prior confirmation of accelerated approval pathway eligibility, enables a more efficient path to a registrational Phase 3 trial, reflecting givastomig’s promise as a first-in-class and best-in-class CLDN18.2-directed therapy for gastric cancer. We look forward to ongoing dialog with the FDA to bring givastomig to patients as quickly as possible."
About Fast Track Designation
Fast Track Designation is an FDA process designed to facilitate the development and expedite the review of new therapies intended to treat serious or life-threatening conditions that demonstrate the potential to address an unmet medical need. Drugs receiving Fast Track Designation may benefit from more frequent interactions with the FDA throughout the development process. Programs receiving Fast Track Designation may also be eligible for Rolling Review of the regulatory submission, Priority Review, and Accelerated Approval, if relevant criteria are met.
About Givastomig
Givastomig (TJ033721 / ABL111) is a CLDN 18.2 X 4-1BB bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive (CLDN 18.2+) tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for potential treatment of gastric cancer and other Claudin 18.2+ gastrointestinal malignancies. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of the proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents.
Givastomig is being jointly developed through a global partnership with ABL Bio, in which NovaBridge is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.
(Press release, NovaBridge Biosciences, JUN 16, 2026, View Source [SID1234668756])