Business
Zymeworks Reports 2020 Third Quarter Financial Results
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 reported financial results for the quarter ended September 30, 2020.\n\n“Zanidatamab’s clinical development continued to expand this quarter, having opened new sites across the globe for the pivotal trial in HER2-amplified biliary tract cancers toward our first potential BLA submission,” said Ali Tehrani, Ph.D., Zymeworks’ President & CEO. “We are well-resourced to achieve this milestone for zanidatamab, along with advancing the development of ZW49 into expansion cohorts and beyond.”\n\nThird Quarter 2020 Business Highlights and Recent Developments \n\n\nZanidatamab Pivotal Trial Expands to Europe and Asia-Pacific Region\nSites are active and recruiting in North America, Europe, and Asia in the global pivotal trial of single agent zanidatamab in previously-treated HER2 gene-amplified biliary tract cancers. This study aims to support accelerated approval and may enable filing of a Biologics License Application (BLA) as early as 2022.\n\n\n\nZW49 Continues Dose Escalation\nZymeworks’ second clinical candidate, ZW49, a bispecific antibody-drug conjugate targeting HER2, continues to be evaluated across multiple dosing regimens in the dose-escalation portion of a Phase 1 clinical trial.\n\n\n\nZymeworks Implements Expanded Access Program (EAP) for Patients not Eligible for Existing Trials\nZymeworks’ EAP or Compassionate Use program will enable critically ill patients who are not eligible for the Company's clinical trials and who may not have options for alternative therapies to be considered for access to Zymeworks' pipeline of investigational medicines. More on Zymeworks' EAP: https://www.zymeworks.com/patients/expanded-access-program.\n\n\n\nFirst Patients Dosed in Investigator-Initiated Trial of Zanidatamab in Endometrial Cancers\nDr. Vicky Makker at Memorial Sloan Kettering Cancer Center is conducting a Phase 2 trial to evaluate single agent zanidatamab in HER2-overexpressed advanced endometrial cancers and carcinosarcomas. This study is expected to enroll up to 25 patients with the primary endpoint of assessing the overall response rate.\n\n\nFinancial Results for the Quarter Ended September 30, 2020\n\nRevenue of $2.6 million for the three months ended Septem...