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Zymeworks Announces Expansion of Zanidatamab Pivotal Trial in Asia in Collaboration with BeiGene and Associated Milestone Payment
First patient dosed in South Korea under Zymeworks and BeiGene collaboration agreement HERIZON-GEA-01 enrollment progresses with multiple active sites and
About this update from Zymeworks Inc.
[{"type":"text","content":"\n\nFirst patient dosed in South Korea under Zymeworks and BeiGene collaboration agreement\n\n\nHERIZON-GEA-01 enrollment progresses with multiple active sites and continued global recruitment\n\n\nZymeworks to receive US$8MM development milestone payment from BeiGene\n\n\n \n\n VANCOUVER, British Columbia--(BUSINESS WIRE)--\nZymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that its collaborator, BeiGene, Ltd., has dosed the first patient in South Korea in the HERIZON‑GEA‑01 trial. As a result of this development milestone, Zymeworks will receive a US$8 million payment under its zanidatamab collaboration agreement with BeiGene.\n\nZymeworks and BeiGene continue to work to expedite the opening of approximately 300 clinical trial sites across 38 countries in support of the global Phase 3 pivotal trial. With a 24-month projected enrollment period, this study may enable the submission of a supplemental Biologics License Application by Zymeworks in the United States as early as 2024.\n\nAbout the HERIZON-GEA-01 Clinical Trial\n\nHERIZON-GEA-01 is a global, randomized, Phase 3 clinical trial [NCT05152147] designed to evaluate the efficacy and safety of zanidatamab in combination with physician’s choice chemotherapy [CAPOX (capecitabine/oxaliplatin) or FP (5FU/cisplatin)] with or without the PD-1 inhibitor, tislelizumab, compared to trastuzumab plus physician’s choice chemotherapy for first-line treatment in subjects with advanced or metastatic HER2-positive gastroesophageal adenocarcinomas. Primary endpoints are progression-free survival per RECIST 1.1 criteria, as assessed by blinded independent central review, and overall survival. The trial is expected to enroll approximately 700 patients at approximately 300 sites across 38 countries. Zymeworks’ collaborator, BeiGene, will oversee trial sites in Asia (excluding Japan), Australia and New Zealand, and Zymeworks will oversee trial sites in the rest of the world, including North and South America, Japan, Europe, Middle East and Africa.\n\nAbout the Zymeworks-BeiGene Collaboration\n\nIn November 2018, Zymeworks and BeiGene entered into license and collaboration agreements in which BeiGene was granted an exclusive license for the research, development, and commercialization of zanidatamab and ZW49 in Asia...