NovaBridge Presents Positive Givastomig Dose Expansion Data from the Phase 1b Combination Study in Patients with 1L Metastatic Gastric Cancer

• Givastomig, a CLDN18.2 x 4-1BB bispecific antibody, continues to show robust efficacy when combined with nivolumab and chemotherapy (mFOLFOX6) in 1L HER2-negative, metastatic gastric cancer patients, with 77% ORR observed at 8 mg/kg and 73% ORR observed at 12 mg/kg, across a wide range of PD-L1 and CLDN18.2 expression levels
• The median PFS was 16.9 months at 8 mg/kg; 12 mg/kg is immature with approximately 4-month shorter median follow-up; data will be updated in 2026
• Six-month landmark PFS was 73% for 8 mg/kg, and 91% for 12 mg/kg cohorts
• Combination was well tolerated; safety is comparable to the current standard of care treatment
• Data demonstrate that givastomig is a potential best-in-class CLDN18.2 asset when added to 1L standard of care
• NovaBridge is on track to initiate enrollment in a global, randomized Phase 2 study, evaluating both doses against standard of care, in Q1 2026
• Detailed Phase 1b dose expansion data are expected to be presented at a medical conference later in 2026

ROCKVILLE, Md., Jan. 06, 2026 (GLOBE NEWSWIRE) -- NovaBridge Biosciences (Nasdaq: NBP) (NovaBridge or the Company) a global biotechnology platform company committed to accelerating access to innovative medicines, today announced positive updated results from the Phase 1b combination study of givastomig, a Claudin 18.2 (CLDN18.2) x 4-1BB bispecific antibody, in combination with nivolumab and chemotherapy (mFOLFOX6) in patients with HER2-negative, first line (1L) metastatic gastric cancer.

The results combine data from patients in the Phase 1b dose escalation and expansion cohorts treated with 8 mg/kg or 12 mg/kg of givastomig. An ORR of 77% (20/26) at the 8 mg/kg dose, and 73% (19/26) at the 12 mg/kg dose, confirms and extends positive signals observed in the dose escalation cohorts. Responses continue to be rapid and deepen over time, and were observed across all levels of CLDN18.2 and PD-L1 expression levels. The safety profile of the combination was similar to earlier observations, except for the emergence of immune-related gastritis, which correlated with improved clinical outcomes. These data, outlined in detail below, position givastomig as a potential best-in-class CLDN18.2-directed therapy for gastric cancer, a potential $12 billion market opportunity by 2030. The full data are intended to be presented at a medical meeting later in 2026.

The Phase 1b study (NCT04900818) is evaluating the safety, efficacy, pharmacokinetics (PK), and pharmacodynamics (PD) of givastomig, used in combination with nivolumab and mFOLFOX6, as 1L therapy in patients with CLDN18.2-positive gastric cancer (GC) (≥1+ immunohistochemistry (IHC) intensity in ≥1% of cells), and any level of PD-L1 expression. The primary endpoint is safety. Secondary endpoints include progression free survival (PFS). The study enrolled only patients in the U.S.

“The dose expansion data reinforce the strong signals we observed in dose escalation. The efficacy is clear at 8 mg/kg, with robust ORRs, including in subgroups defined by low PD-L1 and/or CLDN18.2 expression. The PFS data are very promising and continue to mature. Emerging efficacy data at 12 mg/kg are also strong and similar in terms of ORR. The 12 mg/kg cohort was enrolled after the 8 mg/kg cohort, so follow-up is shorter and PFS is less mature. We expect to report these data later in 2026. We remain enthusiastic about the 12 mg/kg dose because exposure analysis shows higher exposure is consistently associated with a higher probability of response, without a higher probability of toxicity,” said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge.

“I continue to be encouraged by givastomig’s high response rate across a wide range of Claudin 18.2 and PD-L1 expression levels, and the depth and duration of responses achieved with combination therapy. The development of gastritis was not predicted by the monotherapy study, and may be related to longer givastomig exposure duration, something that has been seen with some CLDN18.2-directed agents. Most gastritis cases were low grade and manageable, and interestingly appear to be associated with higher response rates and longer survival,” said Samuel J. Klempner, MD, Associate Professor of Medicine at Massachusetts General Hospital. “Givastomig’s favorable benefit-risk balance has the potential to offer real world benefit to patients and is planned to be investigated in a randomized trial.”

“Givastomig is a core program for NovaBridge,” said Sean Fu, PhD, MBA, Chief Executive Officer of NovaBridge. “The compelling Phase 1b data presented today have the potential to establish givastomig as the leading CLDN18.2-directed therapy for 1L gastric cancer, where the unmet medical need remains high and the commercial opportunity is significant.”

Topline Data from the Givastomig Phase 1b Dose Escalation and Expansion Combination Study in 1L Gastric Cancer

• 54 advanced metastatic gastric cancer patients (metastatic gastric, esophageal or gastroesophageal adenocarcinomas) were enrolled in cohorts across the 8 mg/kg (n=27), and 12 mg/kg (n=27) dose levels as of the December 2, 2025 data cutoff. 52 patients were efficacy evaluable
• Demographics show characteristics typical of metastatic gastric cancer in patients
• All patients were HER2-negative, CLDN18.2-positive (defined as ≥1+ IHC staining intensity in ≥1% of tumor cells), regardless of PD-L1 expression levels
• Enrolled at sites only within the United States
• Biomarker expression consistent with prevalence, noting that in efficacy evaluable patients:
  • 8 mg/kg cohort was over-represented with tumors expressing CLDN18.2 >75% (63%)
  • 12 mg/kg cohort was over-represented with tumors expressing PD-L1

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