NEWS
Zymeworks Announces FDA Clearance of Investigational New Drug Application for ZW191, a Novel Folate Receptor-⍺ Targeted Topoisomerase I Inhibitor Antibody-Drug Conjugate
Zymeworks Inc. (Nasdaq: ZYME) announced FDA clearance of its Investigational New Drug (IND) application for ZW191, a novel folate receptor-⍺ (FR⍺) targeted topoisomerase I inhibitor antibody-drug conjugate (ADC). ZW191 targets FR⍺-expressing tumors, including ovarian, gynecological cancers, and non-small cell lung cancer (NSCLC). The drug incorporates a unique combination of antibody-linker stability and payload potency, with strong bystander activity.
Key features of ZW191 include:
A drug-antibody ratio of eight for balanced tolerability and efficacy
In-house generated FR⍺ monoclonal antibody for enhanced internalization
Ability to target high, mid, and low levels of FR⍺ expression
Robust anti-tumor activity and strong safety profile in preclinical models
Zymeworks plans to initiate clinical development of ZW191 in 2024, with applications for non-US jurisdictions expected in the second half of 2024.
Key features of ZW191 include:
A drug-antibody ratio of eight for balanced tolerability and efficacy
In-house generated FR⍺ monoclonal antibody for enhanced internalization
Ability to target high, mid, and low levels of FR⍺ expression
Robust anti-tumor activity and strong safety profile in preclinical models
Zymeworks plans to initiate clinical development of ZW191 in 2024, with applications for non-US jurisdictions expected in the second half of 2024.
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