NovaBridge (NASDAQ: NBP) Reports Promising Givastomig Data in Phase 1b Study for Metastatic Gastric Cancer
ROCKVILLE, Md., Jan. 06, 2026 (GLOBE NEWSWIRE) – NovaBridge Biosciences (Nasdaq: NBP) has announced significant findings from its ongoing Phase 1b combination study involving givastomig, a bispecific antibody targeting Claudin 18.2 (CLDN18.2) and 4-1BB. The study evaluates the efficacy of givastomig when combined with nivolumab and chemotherapy (mFOLFOX6) in patients with HER2-negative, first-line (1L) metastatic gastric cancer. The latest results indicate an overall response rate (ORR) of 77% at 8 mg/kg and 73% at 12 mg/kg.
Study Results Highlight Givastomig's Efficacy
The results show that responses to givastomig are rapid and become more profound over time, irrespective of PD-L1 and CLDN18.2 expression levels. In detail:
- Median Progression-Free Survival (PFS): 16.9 months at 8 mg/kg.
- Six-Month Landmark PFS: 73% for the 8 mg/kg cohort and 91% for the 12 mg/kg cohort.
- Patient Data: 54 patients enrolled, with promising efficacy results across different biomarker expressions.
Givastomig has shown a safety profile comparable to current standard treatments, although some cases of immune-related gastritis were noted, which may correlate with improved clinical outcomes.
Upcoming Phase 2 Study
NovaBridge is preparing to initiate a global, randomized Phase 2 study evaluating both doses of givastomig against standard care, set to commence in the first quarter of 2026. Detailed data from this ongoing Phase 1b study is expected to be presented at a medical conference later in 2026.
Expert Insights on Givastomig's Potential
Dr. Phillip Dennis, Chief Medical Officer of NovaBridge, commented, “The dose expansion data reinforce the strong signals we observed in dose escalation. The efficacy is clear at 8 mg/kg, showing robust ORRs, even in subgroups with low PD-L1 and/or CLDN18.2 expressions.”
Dr. Samuel J. Klempner of Massachusetts General Hospital noted, “Givastomig’s high response rate and manageable safety profile present a favorable benefit-risk balance for patients.”
Key Findings from Phase 1b Dose Escalation
Highlights from the Phase 1b study include:
- 54 patients were enrolled in total, including cohorts of 27 patients each at both the 8 mg/kg and 12 mg/kg doses.
- 52 patients were deemed efficacy evaluable.
- The majority were HER2-negative and CLDN18.2-positive, demonstrating industry-standard tumor characteristics.
The potential market opportunity for a successful CLDN18.2-directed therapy could reach $12 billion by 2030.
Conclusion
NovaBridge's innovative approach with givastomig in treating metastatic gastric cancer presents a promising advancement in oncology. As further studies progress, uphold the company's commitment to mobilizing transformative therapies in a high-need therapeutic area, garnering attention within the biopharmaceutical landscape.