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Zymeworks Highlights 2020 Achievements and Announces Corporate Priorities
VANCOUVER, British Columbia--(BUSINESS WIRE)-- Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional
About this update from Zymeworks Inc.
[{"type":"text","content":" VANCOUVER, British Columbia--(BUSINESS WIRE)--\nZymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today highlighted its key accomplishments in 2020 and updated its corporate priorities.\n\n“2020 was a leap forward for our lead clinical program in terms of a potential first approval and future approvals,” said Ali Tehrani, Ph.D., President and CEO at Zymeworks. “The launch of our first pivotal trial and achievement of Breakthrough Therapy designation for zanidatamab mark important milestones towards our accelerated commercialization strategy, and our new clinical partnerships further strengthen zanidatamab’s broad therapeutic profile. 2021 promises to be a data-rich year for both zanidatamab and ZW49 as we continue to demonstrate their potential to become foundational therapies in the treatment of HER2-expressing cancers.”\n\n2020 Achievements \n\nZanidatamab Enters Late-Stage Clinical Development with Accelerated Strategy\n\n\nZymeworks initiated a global pivotal trial (HERIZON-BTC-01) for zanidatamab monotherapy in patients with previously treated HER2 gene-amplified biliary tract cancer (BTC). This single arm trial is designed to support accelerated approval based on a primary endpoint of objective response rate and may enable submission of a Biologics License Application (BLA) as early as 2022.\n\n\nZanidatamab received additional drug review special designations in the U.S. and the European Union. The U.S. Food and Drug Administration (FDA) granted Breakthrough Therapy designation for BTC and the European Commission (EC) granted Orphan Drug designation for gastroesophageal adenocarcinoma (GEA), expediting potential commercialization. Previously the FDA granted two Fast Track designations to zanidatamab, in BTC and GEA, in addition to Orphan Drug designations for BTC, GEA, and ovarian cancer.\n\n\nZanidatamab Data and Partnerships Continue to Support Broad Therapeutic Potential\n\n\nGastric Cancer: Clinical data from patients with refractory GEA treated with zanidatamab monotherapy as well as zanidatamab in combination with chemotherapy were updated and support plans to launch a second pivotal trial as 1st line treatment for advanced HER2-positive GEA in mid-2021 with partner BeiGene. These data will be updated as part of an oral presentation at the upcoming A...