NovaBridge Biosciences (NBP) announced that it has received positive written feedback from a recent FDA Type B meeting, confirming that its lead bispecific antibody, Givastomig, may be eligible for an accelerated approval pathway in first-line gastric and gastroesophageal cancer.
Gastric cancer remains one of the leading causes of cancer mortality worldwide, and treatment options for patients with HER2-negative, Claudin 18.2-positive, PD-L1- positive tumors are limited.
NovaBridge is developing Givastomig as a potential first-in-class therapy designed to activate T cells directly within the tumor microenvironment.
The FDA indicated that Givastomig's existing Phase 1b data- which showed a 75% objective response rate and durable responses across biomarker subgroups- could support accelerated approval if confirmed in a registrational study.
NovaBridge plans to initiate a Phase 3 combination trial with immunochemotherapy as early as the fourth quarter of 2026, using objective response rate as the primary endpoint.
In the Phase 1b expansion study, Givastomig demonstrated robust anti-tumor activity, including a median progression-free survival of 16.9 months and an 82% six-months PFS rate. The therapy was generally well tolerated, with no dose-dependent toxicity observed. Detailed data are expected to be presented at a major medical conference in the second half of 2026.
Beyond Givastomig, NovaBridge is advancing a pipeline that includes Ragistomig, a PD-L1/4-1BB bispecific antibody for solid tumors, and VIS-101, a dual VEGF-A/ANG-2 inhibitor being developed for retinal vascular diseases.
NBP has traded between $0.59 and $6.79 over the past year. The stock is currently trading at $2.72, down 3.89%.
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