Zymeworks Announces Abstract for Zanidatamab in First-line HER2-Expressing Gastroesophageal Cancers (GEA) at the European Society for Medical Oncology (ESMO) Annual Congress
September 12 2021 - 6:49PM
Business Wire
- Abstract data demonstrate encouraging antitumor activity in
first-line GEA
- Full ESMO presentation available September 16 at 8:30 am CEST,
2:30 am ET
- Conference call and webcast with principal investigator, Dr.
Geoffrey Ku, on September 16 at 7:30 am ET
Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical
company developing multifunctional biotherapeutics, today announced
the publication of an abstract highlighting new clinical data for
zanidatamab, a HER2-targeted bispecific antibody, in first-line
HER2-expressing GEA. An updated and expanded data set will be
presented at the ESMO Annual Congress taking place virtually on
September 16-21, 2021.
Abstract highlights from March 18, 2021 data cut:
- Thirty patients had been treated with zanidatamab in
combination with standard of care chemotherapy (either mFOLFOX6,
CAPOX, or FP), and 14 patients remained on treatment.
- The confirmed objective response rate was 68.2% and the disease
control rate was 90.9% in 22 HER2-positive response-evaluable
patients.
- Treatment related adverse events were generally consistent with
previous reports of zanidatamab and/or the chemotherapy regimens,
with the majority reported as Grade 1 or 2 in severity.
“The initial data from the abstract highlight an encouraging
objective response rate for zanidatamab combined with standard of
care chemotherapy in patients with metastatic HER2-positive GEA,”
said Neil Josephson, M.D., Zymeworks’ Interim Chief Medical
Officer. “We’re looking forward to presenting at the Congress the
full updated data, which further support zanidatamab’s potential as
the new foundational HER2-targeted therapy.”
ESMO Presentation The abstract is available on the ESMO
conference website. The presentation will be available on Thursday,
September 16 at 8:30 am CEST, 2:30 am ET, to conference registrants
on the ESMO conference website as well as to the general public on
the Zymeworks website at
https://ir.zymeworks.com/events-and-presentations.
Title: Phase (Ph) 2 Study of Zanidatamab + Chemotherapy (chemo)
in First Line (1L) HER2-expressing Gastroesophageal Adenocarcinoma
(GEA) Lead Author: Geoffrey Ku, M.D., Memorial Sloan Kettering
Cancer Center, New York, NY, US Abstract: 3678 E-poster: 1380P
Conference Call and Webcast The company will host a
conference call and webcast to discuss the updated data after it is
published on September 16. The event will be led by Ali Tehrani,
Ph.D., Zymeworks’ President and CEO and Neil Josephson, M.D.,
Zymeworks’ Interim Chief Medical Officer, and will include a
presentation by medical oncologist and principal investigator,
Geoffrey Ku, M.D., Memorial Sloan Kettering Cancer Center. Dr. Ku
and members of Zymeworks’ executive team will be available to
answer questions at the conclusion of the call.
Date: Thursday, September 16th Time: 7:30 am ET
Interested parties can access the live webcast via the
Zymeworks’ website at
https://ir.zymeworks.com/events-and-presentations. A recorded
replay will be accessible after the event through the Zymeworks
website.
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. 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 a single agent 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 for the treatment of biliary tract, gastric and
ovarian cancers from the FDA, as well as Orphan Drug designation
for the treatment of biliary tract and gastric cancer from the
European Medicines Agency.
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.
Cautionary Note Regarding Forward-Looking Statements 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, anticipated clinical data presentations, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20210912005060/en/
Investor Inquiries: Ryan Dercho, Ph.D. (604) 678-1388
ir@zymeworks.com
Jack Spinks (604) 678-1388 ir@zymeworks.com
Media Inquiries: Mary Klem (604) 678-1388
media@zymeworks.com
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