FX.co ★ Zymeworks Says FDA Cleared IND Application For ZW171 For Mesothelin-expressing Cancers

Zymeworks Inc. (ZYME) announced on Monday that the Food and Drug Administration (FDA) has approved the investigational new drug application for ZW171, aimed at treating mesothelin (MSLN)-expressing cancers.

The company intends to submit applications to additional regulatory bodies to seek authorization for clinical trials of ZW171 in the latter half of 2024.

ZW171, a bispecific antibody, is designed to facilitate T cell-mediated tumor cell destruction by simultaneously binding to the extracellular domain of the MSLN protein on cancer cells and engaging CD3 on T cells. Moderate to high membranous MSLN expression is frequently observed in ovarian cancer, non-small cell lung cancer, mesothelioma, and other malignancies.