NovaBridge Announces Productive FDA Type B Meeting on Potential Accelerated Approval Pathway for Givastomig in Gastric Cancer

Core Viewpoint - NovaBridge Biosciences has received FDA alignment on givastomig's potential eligibility for an accelerated approval pathway in specific gastric cancer patients, paving the way for a Phase 3 trial to begin in Q4 2026 [1][7]. Company Overview - NovaBridge is a global biotechnology platform focused on accelerating access to innovative medicines, combining business development expertise with clinical development to advance breakthrough assets [6]. Givastomig Development - Givastomig is a bispecific antibody targeting Claudin 18.2-positive tumor cells, designed to activate T cells in the tumor microenvironment, and is being developed for gastric cancer and other gastrointestinal malignancies [4][10]. - The Phase 1b trial showed a 75% objective response rate (ORR), with 77% ORR at 8 mg/kg and 73% at 12 mg/kg, alongside a median progression-free survival (mPFS) of 16.9 months and an 82% six-month landmark PFS rate [8]. Regulatory Milestones - The FDA confirmed givastomig's eligibility for an accelerated approval pathway, with the primary endpoint for the upcoming Phase 3 trial being the objective response rate [7]. - The company plans to present detailed Phase 1b expansion data at a major medical conference in the second half of 2026 [3]. Collaborative Development - Givastomig is being developed in partnership with ABL Bio, with NovaBridge as the lead party sharing worldwide rights, excluding Greater China and South Korea [5].