NBP News & Events

The company states: "NovaBridge Biosciences announced that based on a productive Type B meeting with the U.S. Food and Drug Administration and receipt of written minutes, NovaBridge has secured FDA alignment on givastomig's potential eligibility for an accelerated approval pathway in 1L Her2-, CLDN 18.2+, PD-L1+ GEC patients, building on positive data from the Phase 1b combination trial. The Company intends to initiate a registrational Phase 3 trial, in combination with immunochemotherapy, as early as Q4 2026. Final study design details will be discussed with FDA."

NovaBridge Biosciences, a global biotechnology platform company committed to accelerating access to innovative medicines, and its subsidiary, Visara announced topline results from the Phase 2a study of VIS-101. VIS-101 produced rapid and robust efficacy, and durable treatment responses with both 3 mg and 6 mg dose cohorts: Mean improvement in Best Corrected Visual Acuity of greater than10 Early Treatment of Diabetic Retinopathy Study letters; Median central subfield thickness reduction of 100-150 mm; Potential best-in-class durability with: two thirds of patients retreatment-free at 4 months, half of patients retreatment-free at 6 months; Favorable safety and no dose limited toxicity

NovaBridge Biosciences named Emmett Cunningham, Jr, MD, PhD, MPH, Co-Founder and Executive Chairman of Visara, as Vice Chairman of the NovaBridge Board of Directors. Dr. Cunningham will also join the Research and Development Committee of the Board.

NovaBridge announced enrollment of the first patient in the global Phase 2 randomized combination study evaluating givastomig, a Claudin 18.2 x 4-1BB bispecific antibody, in combination with nivolumab and chemotherapy in patients with HER2-negative, 1L metastatic gastric cancer.