On October 26, 2021 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported that management will host a conference call and webcast to provide details related to the launch of its Phase 3 first-line gastroesophageal adenocarcinoma (GEA) pivotal study, HERIZON-GEA-01, and to discuss the commercial potential of zanidatamab in gastrointestinal cancers (Press release, Zymeworks, OCT 26, 2021, View Source [SID1234591964]).
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HERIZON-GEA-01 is a randomized, global Phase 3 study evaluating zanidatamab plus chemotherapy with or without tislelizumab, versus standard of care (trastuzumab plus chemotherapy), for first-line treatment of locally advanced, unresectable, or metastatic HER2-positive GEA.
Event: HERIZON-GEA-01 Conference Call and Webcast
Date: Tuesday, November 9th
Time: 4:15 p.m. ET
Interested parties can access a live webcast via a link from Zymeworks’ website at View Source, which will also host recorded replays available afterwards.
About Zanidatamab
Zanidatamab is a bispecific antibody, based on Zymeworks’ Azymetric platform, that can simultaneously bind two non-overlapping epitopes of HER2, known as biparatopic binding. Zanidatamab’s unique binding properties result in multiple mechanisms of action including HER2-receptor clustering, internalization, and downregulation; inhibition of growth factor-dependent and -independent tumor cell proliferation; antibody-dependent cellular cytotoxicity and phagocytosis; and complement-dependent cytotoxicity. Zymeworks is developing zanidatamab in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. The FDA has granted Breakthrough Therapy designation for zanidatamab in patients with previously treated HER2 gene-amplified biliary tract cancer (BTC), and two Fast Track designations to zanidatamab, one as monotherapy for refractory BTC and one in combination with standard of care chemotherapy for first-line gastroesophageal adenocarcinoma (GEA). These designations mean zanidatamab is eligible for Accelerated Approval, Priority Review and Rolling Review, as well as intensive FDA guidance on an efficient drug development program. Zanidatamab has also received Orphan Drug designations from the FDA for the treatment of GEA and BTC and from the European Medicines Agency for the treatment of biliary tract and gastric cancers.