Zymeworks Inc. announced on July 28, 2025, that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for ZW251. ZW251 is a novel glypican-3 (GPC3)-targeted antibody-drug conjugate (ADC) incorporating the company’s proprietary topoisomerase 1 inhibitor (TOPO1i) payload, ZD06519, for the treatment of hepatocellular carcinoma (HCC).
HCC is the most common type of primary liver cancer, with GPC3 expressed in over 75% of cases, making it an appealing target. ZW251 is engineered as a potential first-in-class ADC, designed with a drug-antibody-ratio (DAR) of four, which could allow for a broader range of dose levels, a potential benefit for HCC patients often challenged by liver function impairment.
Preclinical studies demonstrated strong activity for ZW251 across various HCC models and noteworthy tolerability in non-human primate toxicology studies at doses up to 120 mg/kg. Zymeworks plans to commence Phase 1 clinical studies for ZW251 in 2025, marking it as the second ADC from its wholly-owned pipeline to advance into clinical development utilizing the proprietary TOPO1i payload.
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