NovaBridge Biosciences (NBP) KOL event summary

Introduction and agenda

• Open-label first-in-human Phase 1 study NCT04900818 evaluated givastomig plus nivolumab and mFOLFOX6 in 1L metastatic CLDN18.2-positive, HER2-negative gastroesophageal adenocarcinoma.

• Updated data cutoff was Aug. 6, 2026; 71 patients received 8 mg/kg (n=31) or 12 mg/kg (n=40), with 17.8 months’ median follow-up at 8 mg/kg.

KOL background and credentials

• Samuel Klempner, Associate Professor of Medicine at Massachusetts General Hospital, is a GI medical oncologist focused on upper GI cancers and the Phase I-B lead investigator.

• Klempner had treated more than 30 trial patients and said longer follow-up strengthened confidence in durable disease control.

Market insights and analysis

• Givastomig binds CLDN18.2 and engages 4-1BB on tumor-infiltrating T cells, aiming to localize T-cell activation and limit systemic immune and liver toxicity.

• Klempner said CLDN18.2 expression of ≥1% occurs in ~80% of gastroesophageal cancers; activity was reported across CLDN18.2 and PD-L1 subgroups.

• Klempner cited lower-than-predicted U.S. adoption of zolbetuximab, partly due to early infusion nausea and vomiting; later-onset givastomig gastritis could differentiate the profile.

• Separate chemotherapy, checkpoint inhibitor and givastomig components allow givastomig to be held for gastritis while other treatment continues; late-line claudin-targeted ADCs are also validating claudin as a target.