On February 17, 2026 NovaBridge Biosciences (Nasdaq: NBP) (NovaBridge or the Company) a global biotechnology platform company committed to accelerating access to innovative medicines, reported enrollment of the first patient in the global Phase 2 randomized combination study evaluating givastomig, a Claudin 18.2 (CLDN18.2) x 4-1BB bispecific antibody, in combination with nivolumab and chemotherapy (mFOLFOX6) in patients with HER2-negative, 1L metastatic gastric cancer. Positive Phase 1b data position givastomig to be a potential best-in-class CLDN18.2-directed therapy for gastric cancer with a projected $12 billion market opportunity by 20301. Top line Phase 2 results are expected in 2027.
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"We are pleased to be advancing givastomig one step closer towards commercialization, with the initiation of the global randomized Phase 2 study. The study builds on the compelling Phase 1b givastomig results, showing robust efficacy and favorable overall tolerability, and demonstrating a potential marked improvement relative to historical benchmarks for the standard of care. The Phase 2 study is designed to confirm these results in a broader setting and validate givastomig as a potential best in class therapy for 1L metastatic gastric cancer, with the potential for broad utilization across CLDN18.2 levels in PD-L1 positive patients," said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge. "We expect to present results from this study in 2027. In addition, we expect to present updated results from the Phase 1b dose expansion study in the second half of this year."
"We continue to be encouraged by givastomig’s high response rate across a wide range of Claudin 18.2 and PD-L1 expression levels. The depth and duration of responses achieved with combination therapy coupled with the tolerability enabled the swift enrollment in the Phase 1b study and provides a strong basis to move to the next stage of development," said Samuel J. Klempner, MD, Associate Professor of Medicine at Mass General Brigham Cancer Institute. "We are hopeful that, with continued positive clinical results, givastomig will ultimately become a standard of care for gastric and esophageal cancer."
"Initiation of the Phase 2 study marks a pivotal moment for NovaBridge as we transition to a mid-stage clinical Company. Compelling Phase 1b efficacy and safety data validate givastomig’s potential as a premier CLDN18.2-directed therapy for gastric cancer and beyond. The strong and durable response data underscore our conviction in givastomig’s significant commercial potential," said Sean Fu, PhD, MBA, Chief Executive Officer of NovaBridge. "We remain focused on developing novel, differentiated therapies that can transform the treatment of patients worldwide and believe that givastomig will be a cornerstone of our future growth."
About the Givastomig Phase 1b Dose Escalation and Expansion Combination Study in 1L Gastric Cancer
The Phase 1b dose expansion data (per the January 6, 2026 press release and corporate presentation) showed that givastomig, dosed at 8 mg/kg every two weeks (Q2W) and 12 mg/kg Q2W, produced:
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Robust efficacy, with 75% ORR (77% ORR observed at 8 mg/kg, 73% ORR observed at 12 mg/kg, n=52 evaluable)
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Responses observed across a wide range of PD-L1 and CLDN18.2 expression levels
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Durable responses with 16.9-month mPFS and an 82% 6-month landmark PFS rate (n=53 evaluable)
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With good overall tolerability in combination with immunochemotherapy, without dose dependent toxicity
Detailed Phase 1b expansion data are expected to be presented at a major medical conference in H2 2026
About the Global, Randomized Phase 2 Study of Givastomig in the Setting of 1L Gastric Cancer
The Phase 2 global, randomized study is evaluating the safety and efficacy of givastomig, used in combination with nivolumab and mFOLFOX6, as 1L therapy in patients with CLDN18.2-positive gastric cancer, including gastroesophageal cancer (GEC), gastroesophageal junction cancer (GEJ), gastroesophageal adenocarcinoma (GEA), with CLDN18.2 levels of ≥1+ immunohistochemistry (IHC) intensity on ≥1% of cells, and PD-L1 expression ≥1. The study is expected to enroll approximately 180 patients (randomized equally to 8mg/kg givastomig, 12 mg/kg givastomig or nivolumab+mFOLFOX6). The primary endpoint is progression free survival (PFS); secondary endpoints include objective response rate (ORR), overall survival (OS), duration of response (DoR) and disease control rate (DCR). The study will enroll patients globally.
About Givastomig
Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive tumor cells. It conditionally activates T cells through the 4-1BB signaling pathway in the tumor microenvironment where CLDN18.2 is expressed. Givastomig is being developed for potential treatment of gastric cancer and other Claudin 18.2-positive gastrointestinal malignancies. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of proximal interaction between CLDN18.2 on tumor cells and 4-1BB on T cells in the tumor microenvironment, while minimizing toxicities commonly seen with other 4-1BB agents.
Givastomig is being jointly developed through a global partnership with ABL Bio, in which NovaBridge is the lead party and shares worldwide rights, excluding Greater China and South Korea, equally with ABL Bio.
(Press release, NovaBridge Biosciences, FEB 17, 2026, View Source [SID1234662720])