Zymeworks Announces FDA Clearance of Investigational New Drug Application for ZW251, a Novel Glypican 3-Targeted Topoisomerase 1 Inhibitor Antibody-Drug Conjugate
Preclinical results demonstrate strong anti-tumor activity and favorable tolerability profile
Phase 1 clinical trial evaluating ZW251 in hepatocellular carcinoma (HCC) expected to be initiated in 2025
VANCOUVER, British Columbia, July 28, 2025 (GLOBE NEWSWIRE) — Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease, today announced the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for ZW251, a novel glypican-3 (GPC3)-targeted ADC incorporating the company's proprietary topoisomerase 1 inhibitor (TOPO1i) payload, ZD06519, for the treatment of HCC.
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