- U.S. FDA Fast Track designation granted to ZW191, an antibody-drug conjugate targeting folate receptor-α (FRα), for the treatment of patients with advanced or metastatic platinum-resistant ovarian cancer (PROC)
- Ongoing Phase 1 clinical trial of ZW191 enrolling patients with advanced solid tumors to evaluate safety, tolerability, pharmacokinetics, and preliminary anti-tumor activity
VANCOUVER, British Columbia, March 30, 2026 (GLOBE NEWSWIRE) -- Zymeworks Inc. (Nasdaq: ZYME), a biotechnology company managing a portfolio of licensed healthcare assets, while developing a diverse pipeline of novel, multifunctional biotherapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to ZW191, an antibody-drug conjugate (ADC) targeting folate receptor-α (FRα), for the treatment of patients with advanced or metastatic platinum-resistant ovarian cancer (PROC).
ZW191 is an ADC engineered to target FRα, a protein expressed in several tumor types, including approximately 75% of high-grade serous ovarian carcinomas1, over 50% of endometrial cancers,2,3 and ~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.
The FDA’s Fast Track designation program is designed to expedite the development and review timelines of drugs that demonstrate the potential to treat serious conditions, aiming to deliver therapeutics to patients more quickly in areas of unmet need.
“Receiving Fast Track Designation for ZW191 highlights the potential of this program to address significant unmet medical needs for patients with previously treated advanced ovarian cancer. Notably, the designation was granted irrespective of FRα expression highlighting ZW191’s potential of extending treatment benefits to a broad group of patients without need for biomarker selection,” said Sabeen Mekan, M.D., Senior Vice President and Chief Medical Officer at Zymeworks. “This designation also further reinforces our expertise in ADC development, and we look forward to working closely with the FDA to advance this program for patients with difficult-to-treat cancers.”
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.
About Zymeworks Inc.
Zymeworks is a global biotechnology company managing a portfolio of licensed healthcare assets and developing a diverse pipeline of novel, multifunctional biotherapeutics to improve the standard of care for difficult-to-treat diseases, including cancer, inflammation, and autoimmune disease. Zymeworks’ asset and royalty aggregation strategy focuses on optimizing positive future cash flows from an emerging portfolio of licensed products such as Ziihera® (zanidatamab-hrii) and other licensed products and product candidates, such as pasritamig. In addition, Zymeworks is also building a portfolio of healthcare assets that can generate strong cash flows, while supporting the development of innovative medicines.
Zymeworks engineered and developed Ziihera, a HER2-targeted bispecific antibody using the Zymeworks’ proprietary Azymetric™ technology and has entered into separate agreements with BeOne Medicines Ltd. (formerly BeiGene, Ltd.) and Jazz Pharmaceuticals Ireland Limited granting each exclusive rights to develop and commercialize zanidatamab in different territories.
Zymeworks is rapidly advancing a robust pipeline of product candidates, leveraging its expertise in both antibody drug conjugates and multispecific antibody therapeutics targeting novel pathways in areas of significant unmet medical need. Zymeworks’ complementary therapeutic platforms and fully integrated drug development engine provide the flexibility and compatibility to precisely engineer and develop highly differentiated antibody-based therapeutics. These capabilities have been further leveraged through strategic partnerships with global biopharmaceutical companies.