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Zymeworks Announces Webcast to Present HERIZON-GEA-01 Pivotal Trial Design and Zanidatamab Commercial Strategy in Gastrointestinal Cancers
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Zymeworks Inc. (NYSE:ZYME) has announced a conference call and webcast on November 9 at 4:15 p.m. ET, detailing the launch of its Phase 3 HERIZON-GEA-01 study for zanidatamab in treating HER2-positive gastroesophageal adenocarcinoma (GEA). The study compares zanidatamab plus chemotherapy with the standard trastuzumab plus chemotherapy. Zanidatamab, a bispecific antibody, has received several FDA designations, including Breakthrough Therapy and Fast Track, indicating its potential in the treatment landscape for solid tumors expressing HER2.
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VANCOUVER, British Columbia--(BUSINESS WIRE)--
Zymeworks Inc. (NYSE:ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced 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.
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 http://ir.zymeworks.com/events-and-presentations, 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.
About Zymeworks Inc.
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the development of next-generation multifunctional biotherapeutics. Zymeworks’ suite of therapeutic platforms and its fully integrated drug development engine enable precise engineering of highly differentiated product candidates. Zymeworks’ lead clinical candidate, zanidatamab (ZW25), is a novel Azymetric™ bispecific antibody which has been granted Breakthrough Therapy designation by the FDA and is currently enrolling in a pivotal clinical trial for refractory HER2-amplified biliary tract cancer (HERIZON-BTC-01) as well as several Phase 2 clinical trials for HER2-expressing gastroesophageal, colorectal, and breast cancers. Zymeworks’ second clinical candidate, ZW49, is a novel bispecific HER2-targeting antibody-drug conjugate currently in Phase 1 clinical development and combines the unique design and antibody framework of zanidatamab with Zymeworks’ proprietary ZymeLink™ linker and cytotoxin. Zymeworks is also advancing a deep preclinical pipeline in oncology (including immuno-oncology agents) and other therapeutic areas. In addition, its therapeutic platforms are being leveraged through strategic partnerships with nine biopharmaceutical companies. For additional information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on Twitter.
This press release includes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995 and “forward-looking information” within the meaning of Canadian securities laws, or collectively, forward-looking statements. Forward-looking statements in this news release include, but are not limited to, statements that relate to Zymeworks’ clinical development of its product candidates, related clinical trials, potential therapeutic effects of zanidatamab, Zymeworks’ preclinical pipeline, and other information that is not historical information. When used herein, words such as “potential”, “will”, and similar expressions are intended to identify forward-looking statements. In addition, any statements or information that refer to expectations, beliefs, plans, projections, objectives, performance or other characterizations of future events or circumstances, including any underlying assumptions, are forward-looking. All forward-looking statements are based upon Zymeworks’ current expectations and various assumptions. Zymeworks believes there is a reasonable basis for its expectations and beliefs, but they are inherently uncertain. Zymeworks may not realize its expectations, and its beliefs may not prove correct. Actual results could differ materially from those described or implied by such forward-looking statements as a result of various factors, including, without limitation, market conditions and the factors described under “Risk Factors” in Zymeworks’ Quarterly Report on Form 10-Q for its quarter ended June 30, 2021 (a copy of which may be obtained at www.sec.gov and www.sedar.com). Consequently, forward-looking statements should be regarded solely as Zymeworks’ current plans, estimates and beliefs. Investors should not place undue reliance on forward-looking statements. Zymeworks cannot guarantee future results, events, levels of activity, performance or achievements. Zymeworks does not undertake and specifically declines any obligation to update, republish, or revise any forward-looking statements to reflect new information, future events or circumstances or to reflect the occurrences of unanticipated events, except as may be required by law.
When is Zymeworks' conference call for HERIZON-GEA-01?
The conference call for HERIZON-GEA-01 is scheduled for November 9 at 4:15 p.m. ET.
What is the HERIZON-GEA-01 study about?
The HERIZON-GEA-01 study is a Phase 3 clinical trial evaluating zanidatamab plus chemotherapy against standard care for HER2-positive gastroesophageal adenocarcinoma.
What is zanidatamab and its significance for Zymeworks?
Zanidatamab is a bispecific antibody developed by Zymeworks that targets HER2, showing promise in multiple clinical trials for treating solid tumors.
What FDA designations has zanidatamab received?
Zanidatamab has received Breakthrough Therapy designation and two Fast Track designations from the FDA.
How does the HERIZON-GEA-01 study compare treatments?
The study compares zanidatamab with chemotherapy, with or without tislelizumab, to standard care involving trastuzumab and chemotherapy.
