On March 16, 2026 NovaBridge Biosciences (Nasdaq: NBP) ("NovaBridge" or the "Company"), a global biotechnology platform company committed to accelerating access to innovative medicines, reported that based on a productive Type B meeting with the U.S. Food and Drug Administration (the "FDA") and receipt of written minutes, NovaBridge has secured FDA alignment on givastomig’s potential eligibility for an accelerated approval pathway in 1L Her2-, CLDN 18.2+, PD-L1+ GEC patients, building on positive data from the Phase 1b combination trial. The Company intends to initiate a registrational Phase 3 trial, in combination with immunochemotherapy, as early as Q4 2026. Final study design details will be discussed with FDA.
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"We are thrilled to receive the positive feedback from FDA confirming givastomig’s eligibility for an accelerated approval pathway," said Phillip Dennis, MD, PhD, Chief Medical Officer of NovaBridge. "This important regulatory milestone builds on compelling Phase 1b givastomig results that showed robust efficacy and favorable overall tolerability, with marked improvement relative to historical benchmarks for the standard of care in cross trial comparisons. Givastomig has the potential to be a first-in-class and best-in-class Claudin 18.2 therapeutic for gastric cancer in combination with immunochemotherapy. We are looking forward to continuing our discussions with FDA and to bringing givastomig to patients as quickly as possible."
About the Givastomig Phase 1b Dose Escalation and Expansion Combination Study in 1L Gastric Cancer
The Phase 1b dose expansion data (per the Company’s January 6, 2026 press release) 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 a 75% objective response rate (ORR) (77% ORR observed at 8 mg/kg, 73% ORR observed at 12 mg/kg, n=52 evaluable)
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Responses across a wide range of PD-L1 and CLDN18.2 expression levels
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Durable responses with 16.9-month mPFS (median progression free survival) and an 82% 6-month landmark PFS rate (n=53 evaluable)
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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 Givastomig
Givastomig (TJ033721 / ABL111) is a bispecific antibody targeting Claudin 18.2 (CLDN18.2)-positive (CLDN 18.2+) 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+ gastrointestinal malignancies. In Phase 1 trials, givastomig has shown promising anti-tumor activity attributable to a potential synergistic effect of the 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, MAR 16, 2026, View Source [SID1234663571])