Zymeworks announces FDA clearance of investigational new drug application for ZW251, a novel glypican 3-targeted topoisomerase I inhibitor antibody-drug conjugate

CAR-T Digest - August 2020

Weekly Digest - August 2025

28 July 2025: Zymeworks announces FDA clearance of investigational new drug application for ZW251, a novel glypican 3-targeted topoisomerase I inhibitor antibody-drug conjugate

Zymeworks received FDA IND clearance for ZW251, a novel ADC targeting glypican-3 (GPC3) for hepatocellular carcinoma (HCC)
ZW251 incorporates Zymeworks’ proprietary topoisomerase I payload ZD06519, a cleavable linker, and a DAR of 4 on a humanized IgG1 framework
Preclinical studies showed strong anti-tumor activity and good tolerability in non-human primates at doses up to 120 mg/kg
ZW251 is the second ADC from Zymeworks’ pipeline to advance into clinical development, following ZW191
A Phase 1 clinical trial for ZW251 in HCC is planned to start in 2025