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Zymeworks Announces FDA Clearance of Investigational New Drug Application for ZW171, a novel 2+1 T-cell Targeting Bispecific Antibody for Mesothelin-expressing Cancers
Zymeworks (Nasdaq: ZYME) announced that the FDA has cleared its investigational new drug (IND) application for ZW171, a novel 2+1 T-cell targeting bispecific antibody designed to treat mesothelin (MSLN)-expressing cancers such as ovarian cancer, non-small cell lung cancer, and mesothelioma. ZW171 aims to improve upon current bispecific T-cell engagers by enhancing tumor selectivity and safety, demonstrating promising preclinical results. The company plans to initiate clinical trials in 2024 and seek regulatory approval in other regions in the latter half of 2024, aligning with its ‘5 by 5’ strategy to advance additional therapies over the next two years. ZW171 has shown potential to provide a more effective and tolerable treatment option, leveraging Zymeworks' Azymetric™ and EFECT™ technologies to enhance anti-tumor activity and safety.
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