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(RTTNews) - Biotechnology company Zymeworks, Inc. (ZYME) announced Monday that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZW191, an antibody-drug conjugate (ADC) targeting folate receptor-a (FRa), for the treatment of patients with advanced or metastatic platinum-resistant ovarian cancer (PROC).

ZW191 is an ADC engineered to target FRa, a protein expressed in several tumor types, including approximately 75% of high-grade serous ovarian carcinomas, over 50% of endometrial cancers, and about 70% of lung adenocarcinomas4.

ZW191's differentiated design strongly supports its ability to internalize into FR?-expressing cells with the potential to release bystander active topoisomerase-1 inhibitor (ZD06519), a novel proprietary payload developed by Zymeworks to kill tumor cells.

Zymeworks is currently evaluating ZW191 in a Phase 1 clinical study (NCT06555744) designed to assess safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity in patients with advanced solid tumors.

The study is designed to further characterize ZW191's clinical activity and safety to inform its future development strategy.

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