NovaBridge wins FDA Fast Track for givastomig in gastric cancer

NovaBridge Biosciences has received FDA Fast Track Designation for givastomig, its CLDN18.2 x 4-1BB bispecific antibody, in combination with nivolumab and chemotherapy for patients with previously untreated HER2-negative advanced or metastatic gastroesophageal adenocarcinoma whose tumours are both CLDN18.2 and PD-L1 positive. The Rockville-based company said a registrational Phase 3 trial is expected to begin as early as Q4 2026.

Givastomig works by conditionally activating T cells through the 4-1BB signalling pathway specifically within the tumour microenvironment where CLDN18.2 is expressed. The company says this conditional mechanism is designed to minimise the systemic toxicities historically associated with direct 4-1BB agonists, which have encountered safety obstacles in earlier clinical programmes from other developers.

Phase 1b data and regulatory path

Phase 1b results, described by the company as showing robust efficacy and favourable tolerability in combination with immunochemotherapy, have not yet been published in full. Detailed data are expected to be presented at a major medical conference in the second half of 2026. NovaBridge reported that responses were deep and durable across a broad patient population, with improvement relative to historical benchmarks for the current standard of care, though no objective response rates, hazard ratios or median duration of response figures were included in the announcement.

Phillip Dennis, Chief Medical Officer of NovaBridge, said: "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."

Fast Track status allows for more frequent FDA interactions during development, rolling review of regulatory submissions, and potential eligibility for Priority Review and Accelerated Approval, subject to meeting the relevant criteria. The designation does not guarantee approval.

Competitive landscape

The CLDN18.2 target has attracted significant interest across the gastric and gastroesophageal cancer space. Zymeworks and Astellas have both advanced CLDN18.2-directed programmes, and Astellas's zolbetuximab, a CLDN18.2-targeting monoclonal antibody, received approval in multiple markets in 2024 for HER2-negative, CLDN18.2-positive gastric cancer in combination with chemotherapy. Givastomig's bispecific design, pairing CLDN18.2 targeting with conditional 4-1BB co-stimulation, represents a mechanistically distinct approach that the company is positioning as potentially superior, though head-to-head data do not yet exist.

Gastric and gastroesophageal cancers collectively represent a substantial global disease burden, with incidence particularly high in East Asia. The dual partnership structure with ABL Bio, under which NovaBridge leads development and the two parties share worldwide rights excluding Greater China and South Korea, gives the programme a broad geographic reach while managing development costs. Full Phase 1b data at a H2 2026 conference will be the next critical read for investors and clinicians assessing givastomig's place in an increasingly crowded but commercially significant field.