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Zymeworks Announces Expansion of Zanidatamab Pivotal Trial in HER2-Amplified Biliary Tract Cancer in Asia in Collaboration With BeiGene
Zymeworks to receive US$10 million milestone payment from BeiGene Multiple sites active and recruiting globally in North America, Europe, and Asia VANCOUVER,
About this update from Zymeworks Inc.
[{"type":"text","content":"\n\nZymeworks to receive US$10 million milestone payment from BeiGene\n\n\nMultiple sites active and recruiting globally in North America, Europe, and Asia\n\n\n VANCOUVER, British Columbia--(BUSINESS WIRE)--\nZymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced that its partner, BeiGene, Ltd., has dosed the first patient in South Korea in a pivotal, single-arm clinical trial of zanidatamab (formerly ZW25) monotherapy in patients with advanced or metastatic HER2-amplified biliary tract cancer (BTC). Zymeworks will receive a US$10 million payment under its collaboration with BeiGene as a result of the achievement of this development milestone.\n\n“Patients with biliary tract cancer generally have a poor prognosis and few treatment options,” said Diana Hausman, M.D., Chief Medical Officer at Zymeworks. “While BTC occurs in patients throughout the world, the incidence is particularly high in Asia. Our collaboration with BeiGene expands the potential of zanidatamab to help address this global unmet need.”\n\nZymeworks and BeiGene are progressing the opening of multiple clinical trial sites in support of the global registration-enabling Phase 2b clinical trial of zanidatamab in patients with HER2-amplified BTC. In the Asia region, multiple sites are open for enrollment in South Korea, and in China all sites have been selected with enrollment anticipated to begin in the first quarter of 2021.\n\nThis global zanidatamab study may enable the submission of a Biologics License Application by Zymeworks in the United States as early as 2022. Multiple clinical sites are now open to enrollment in the U.S., Europe, and Asia, with additional sites planned, including in Canada and South America.\n\n“We are pleased to have been able to initiate this important clinical trial and hope that it may help contribute to improving the lives of patients with advanced or metastatic BTC and HER2 amplification,” said Lai Wang, Ph.D., Senior Vice President, Head of Global Research and APAC Clinical Development at BeiGene. “As our collaboration with Zymeworks continues, this trial may help lead to expedited global regulatory approvals, including in China and South Korea.”\n\nThis pivotal Phase 2b clinical trial is a global, multicenter, open-label, single-arm study designed to evalua...