Zymeworks Announces FDA Clearance of Investigational New Drug Application for ZW191, a Novel Folate Receptor-⍺ Targeted Topoisomerase I Inhibitor Antibody-Drug Conjugate

2024-07-24

July 22, 2024 -- Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology company developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, today announced that the United States Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application for ZW191, the Company’s novel folate receptor-⍺(FR⍺) targeted topoisomerase I inhibitor (TOPO1i) antibody-drug conjugate (ADC).

“ZW191 is a differentiated product candidate in our pipeline that reflects the strength of our approach in developing best-in-class antibody-drug conjugates,” said Paul Moore, Chief Scientific Officer of Zymeworks. “Developed to target FR⍺, which is expressed in several types of difficult-to-treat cancers, ZW191 incorporates a novel antibody and drug-linker that provide a unique combination of antibody-linker stability and payload potency, together with strong bystander activity, which could result in improved efficacy and enable targeting lower levels of FR⍺ compared to previously developed drug candidates. We are pleased to reach this R&D milestone following on the heels of our recent FDA clearance for ZW171 in June and look forward to initiating clinical development of both ZW191 and ZW171 during 2024.”

ZW191 was designed using the Company’s drug conjugate platforms, including the novel TOPO1i-based payload technology, ZD06519, to target FR⍺-expressing tumors including ovarian and other gynecological cancers, as well as non-small cell lung cancer (NSCLC). A drug-antibody-ratio (DAR) of eight was selected to balance both tolerability and efficacy. The FR⍺ monoclonal antibody incorporated in ZW191 was generated in-house and selected based on enhanced internalization characteristics to enable targeting of high, mid, and low levels of FR⍺ expression. FR⍺ is a clinically validated target that is expressed in approximately 75% of ovarian carcinomas and 70% of NSCLC. ZW191 has demonstrated robust anti-tumor activity and a strong safety profile in preclinical models.

The Company expects to file applications seeking regulatory authorization to initiate clinical studies for ZW191 in non-US jurisdictions in the second half of 2024. ZW191 is the first of three ADC molecules incorporating the Company’s proprietary ZD06519 payload designated for clinical development, with IND filings for ZW220 (NaPi2b ADC) and ZW251 (GPC3 ADC) on schedule for 2025.

About Zymeworks Inc.

Zymeworks is a global clinical-stage biotechnology company committed to the discovery, development, and commercialization of novel, multifunctional biotherapeutics. Zymeworks’ mission is to make a meaningful difference in the lives of people impacted by difficult-to-treat cancers and other diseases. The Company’s complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutic candidates. Zymeworks engineered and developed zanidatamab, a HER2-targeted bispecific antibody using the Company’s proprietary Azymetric™ technology. Zymeworks has entered into separate agreements with BeiGene, Ltd. (BeiGene) and Jazz Pharmaceuticals Ireland Limited (Jazz), granting each exclusive rights to develop and commercialize zanidatamab in different territories. Zanidatamab is currently being evaluated in multiple global clinical trials as a potential best-in-class treatment for patients with HER2-expressing cancers. A Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) seeking accelerated approval for zanidatamab as a treatment for previously-treated, unresectable, locally advanced, or metastatic HER2-positive biliary tract cancer (BTC) has been accepted and granted Priority Review. A BLA has also been accepted for review by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. If approved, zanidatamab would be the first HER2-targeted treatment specifically approved for BTC in each of the U.S. and China. Zymeworks is rapidly advancing a deep pipeline of product candidates based on its experience and capabilities in both antibody-drug conjugates and multispecific antibody therapeutics across multiple novel targets in indications that represent areas of significant unmet medical need. In addition to Zymeworks’ wholly owned pipeline, its therapeutic platforms have been further leveraged through strategic partnerships with global biopharmaceutical companies. For information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on X.

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