Zymeworks Inc. Receives FDA Clearance for Investigational New Drug Application for ZW251, Targeting Hepatocellular Carcinoma
Reuters
Jul 28
Zymeworks Inc. Receives FDA Clearance for Investigational New Drug Application for ZW251, Targeting Hepatocellular Carcinoma
Zymeworks Inc., a clinical-stage biotechnology company, has announced the U.S. Food and Drug Administration (FDA) clearance of their investigational new drug $(IND.AU)$ application for ZW251. This novel glypican 3-targeted antibody-drug conjugate $(ADC)$ is designed to treat hepatocellular carcinoma $(HCC)$, the most common form of primary liver cancer. The IND clearance allows Zymeworks to initiate a Phase 1 clinical trial for ZW251, expected to begin in 2025. This marks the second ADC from Zymeworks' pipeline, utilizing their proprietary topoisomerase 1 inhibitor payload. Preclinical studies have shown ZW251 to have strong anti-tumor activity and a favorable tolerability profile, offering potential improvements over current HCC treatments.
Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. Zymeworks Inc. published the original content used to generate this news brief via GlobeNewswire (Ref. ID: GNW9501215-en) on July 28, 2025, and is solely responsible for the information contained therein.
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