An email has been sent to your address with instructions for changing your password.
There is no user registered with this email.
Sign Up
To create a free account, please fill out the form below.
Thank you for signing up!
A confirmation email has been sent to your email address. Please check your email and follow the instructions in the message to complete the registration process. If you do not receive the email, please check your spam folder or contact us for assistance.
Welcome to our platform!
Oops!
Something went wrong while trying to create your new account. Please try again and if the problem persist, Email Us to receive support.
Zymeworks Inc. (NYSE: ZYME) has announced the upcoming presentation of mature Phase 2 data for zanidatamab in combination with chemotherapy as a first-line treatment for HER2-positive gastroesophageal adenocarcinoma (GEA). This presentation is set to occur at the ASCO Gastrointestinal Cancers Symposium from January 19-21, 2023. The GEA cohort was fully recruited by March 1, 2022, and enrollment for additional cancer cohorts continues. Positive Phase 2 results could support zanidatamab's further development in the Phase 3 HERIZON-GEA-01 study.
Positive
Upcoming presentation of mature Phase 2 data for zanidatamab at a prominent symposium.
Full recruitment of the GEA cohort by March 1, 2022.
Continuous enrollment in additional cancer cohorts.
Positive Phase 2 data could support progression to Phase 3 clinical trials.
Negative
None.
VANCOUVER, British Columbia--(BUSINESS WIRE)--
Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today announced the upcoming presentation of mature Phase 2 data evaluating zanidatamab in combination with chemotherapy as first-line treatment for HER2-positive gastroesophageal adenocarcinoma (GEA) at the ASCO Gastrointestinal Cancers Symposium, taking place in San Francisco, CA and virtually on January 19-21, 2023.
The GEA cohort of this Phase 2 clinical trial (NCT03929666) was fully recruited as of March 1, 2022 with clinical trial sites in the United States, Canada, Chile and South Korea. Enrollment into the biliary tract cancer and colorectal cancer cohorts of the trial continues. The Phase 2 data in GEA supports zanidatamab development in the Phase 3 HERIZON-GEA-01 study, evaluating zanidatamab in combination with chemotherapy with or without tislelizumab for the first-line treatment of HER2-positive GEA (NCT05152147).
Title: Zanidatamab + chemotherapy as first-line treatment for HER2-expressing metastatic gastroesophageal adenocarcinoma (mGEA)
Lead Author: Elena Elimova, MD, MSc, Princess Margaret Cancer Center, Toronto, Canada Abstract: 347
Poster Session A: Cancers of the Esophagus and Stomach and Other GI Cancers
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. This unique design results in multiple mechanisms of action including dual HER2 signal blockade, increased binding and removal of HER2 protein from the cell surface, and potent effector function leading to encouraging antitumor activity in patients. 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. Zymeworks has entered into separate agreements with each of BeiGene, Ltd. (BeiGene) and Jazz Pharmaceuticals Ireland Limited (Jazz), granting each of BeiGene and Jazz with exclusive rights to develop and commercial zanidatamab throughout various counties around world.
About Zymeworks Inc.
Zymeworks is a clinical-stage biopharmaceutical company dedicated to the discovery, development and commercialization 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, is a novel Azymetric™ HER2-targeted bispecific antibody currently being evaluated in multiple Phase 1, Phase 2, and pivotal clinical trials globally as a targeted treatment option for patients with solid tumors that express HER2. Zymeworks’ second clinical candidate, zanidatamab zovodotin (ZW49), is a novel bispecific HER2 ‑targeted 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 global biopharmaceutical companies. For more information on our ongoing clinical trials visit www.zymeworksclinicaltrials.com. For additional information about Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on Twitter.
This press release includes “forward-looking statements” or information within the meaning of the applicable securities legislation, including Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements in this press release include, but are not limited to, statements that relate to the potential therapeutic effects of zanidatamab and Zymeworks’ other product candidates; Zymeworks’ clinical development of its product candidates and enrollment in its clinical trials; anticipated clinical data presentations; the commercial potential of technology platforms and product candidates; the ability to advance product candidates into later stages of development; and other information that is not historical information. When used herein, words such as “plan”, “believe”, “expect”, “may”, “anticipate”, “potential”, “will”, “continues”, 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: future clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; clinical trials may not demonstrate safety and efficacy of any of Zymeworks’ or its collaborators’ product candidates; any of Zymeworks’ or its partners’ product candidates may fail in development, may not receive required regulatory approvals, or may be delayed to a point where they are not commercially viable; regulatory agencies may impose additional requirements or delay the initiation of clinical trials; the impact of the COVID-19 pandemic on Zymeworks’ business, research and clinical development plans and timelines and results of operations, including impact on its clinical trial sites, collaborators, and contractors who act for or on Zymeworks’ behalf, may be more severe and more prolonged than currently anticipated; the impact of new or changing laws and regulations; market conditions; inability to maintain or enter into new partnerships or strategic collaborations; and the factors described under “Risk Factors” in Zymeworks’ quarterly and annual reports filed with the Securities and Exchange Commission, including its Quarterly Report on Form 10-Q for its quarter ended September 30, 2022 (a copy of which may be obtained at www.sec.gov and www.sedar.com).
Although Zymeworks believes that such forward-looking statements are reasonable, there can be no assurance they will prove to be correct. Investors should not place undue reliance on forward-looking statements. The above assumptions, risks and uncertainties are not exhaustive. Forward-looking statements are made as of the date hereof and, except as may be required by law, Zymeworks undertakes no 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.
What are the results from Zymeworks' Phase 2 trial for zanidatamab?
Zymeworks will present mature Phase 2 data for zanidatamab at the ASCO Gastrointestinal Cancers Symposium.
When will the Phase 2 data for zanidatamab be presented?
The Phase 2 data will be presented during the ASCO Gastrointestinal Cancers Symposium from January 19-21, 2023.
What is the significance of the zanidatamab trial for GEA?
The trial evaluates zanidatamab's effectiveness in combination with chemotherapy for HER2-positive gastroesophageal adenocarcinoma, which could impact treatment options.
What is the next step for zanidatamab after the Phase 2 trial?
If the Phase 2 results are positive, zanidatamab will advance to the Phase 3 HERIZON-GEA-01 study.
