Givastomig (CLDN18.2 x 4-1BB bispecific antibody)
- Indication
- HER2-negative metastatic gastric cancer, solid tumors
- Stage
- phase2
- Event
- Conference Presentation
- Details
August 20, 2026: NovaBridge Biosciences (NASDAQ: NBP) provided a business update and 1H 2026 financial results centered on two lead programs.
Givastomig (TJ033721 / ABL111): In first-line metastatic gastric cancer / gastroesophageal adenocarcinoma, the Claudin 18.2 x 4-1BB bispecific reported January 2026 Phase 1b combination data showing 77% ORR at 8 mg/kg and 73% ORR at 12 mg/kg among 52 evaluable patients, plus 16.9-month median PFS at 8 mg/kg among 27 evaluable patients, with responses across PD-L1 and Claudin 18.2 expression levels and favorable tolerability without dose-dependent toxicity. NovaBridge started a global randomized Phase 2 trial in February 2026 in HER2-negative 1L metastatic gastric cancer. In March, the company said the program may be eligible for an FDA accelerated approval pathway in 1L HER2-negative, Claudin 18.2-positive, PD-L1-positive GEA; in June, FDA granted Fast Track designation for previously untreated HER2-negative advanced/metastatic GEA with nivolumab plus chemotherapy. Upcoming catalysts: ESMO 2026 poster on October 25, 2026 and Phase 3 registrational study initiation as early as year-end 2026; Phase 3 interim readout is planned for 2028.
VIS-101 (ASKG712/AM712): In neovascular retinal diseases, March 2026 Phase 2a data in nAMD showed favorable safety/tolerability, meaningful visual acuity improvements, and encouraging durability. Phase 2b in nAMD is planned for 2H 2026, with global Phase 3 planned in 2027.
NovaBridge ended June 30, 2026 with $215.9 million in cash, equivalents, short-term investments, and equity investment at fair value.
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