Zymeworks Announces Novel Application ZW191 for Antibody-Drug Conjugate Targeting Folate Receptor-α
Zymeworks has announced the clearance of its investigational new drug (IND) application for ZW191 by the United States Food and Drug Administration (FDA).ZW191 is an antibody-drug conjugate (ADC) targeted at the folate receptor-α (FRα) and utilizes technology based on topoisomerase I inhibitors (TOPO1i).
ZW191 targets FR⍺, a receptor expressed in several hard-to-treat cancers, including ovarian and other gynecological cancers, as well as non-small cell lung cancer (NSCLC). This receptor is known to be present in approximately 75% of ovarian carcinomas and 70% of NSCLC cases, making it a clinically validated target.
The drug has been developed using Zymeworks' proprietary drug conjugate platforms and includes a novel antibody and drug-linker. This combination enhances the stability and potency of the treatment, which may result in improved effectiveness, even at lower FR⍺ levels compared to earlier drug candidates. ZW191’s design also incorporates a drug-antibody ratio (DAR) of eight to ensure a balance between tolerability and efficacy.
Preclinical research indicates that ZW191 exhibits notable anti-tumor effects and a robust safety profile. These results support its potential for treating cancers that express FRα.
Future Plans
- Global Expansion
Zymeworks intends to submit applications to regulatory agencies in non-U.S. regions in the latter half of 2024. These applications will request approval to initiate clinical trials outside of the United States. - Pipeline Expansion
ZW191 is the initial one among three antibody-drug conjugates featuring the ZD06519 payload that Zymeworks intends to advance into clinical trials. Future IND filings for ZW220, which targets NaPi2b, and ZW251, which targets GPC3.
Zymeworks continues to make strides in advancing its ADC pipeline, with ZW191 being a key milestone following FDA clearance. The company aims to begin clinical trials for both ZW191 and ZW171, further strengthening its position in developing next-generation cancer therapeutics.
