Zymeworks Announces First Patient with Advanced HER2-Positive Breast Cancer Dosed with Zanidatamab in Combination with Tukysa® (Tucatinib) and Chemotherapy
July 28 2021 - 8:30AM
Business Wire
Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical
company developing multifunctional biotherapeutics, today announced
the first patient has been dosed with zanidatamab in combination
with Tukysa® (tucatinib) and capecitabine in a new cohort of a
Phase 1 trial for HER2-positive breast cancer patients with locally
advanced (unresectable) and/or metastatic disease.
“Recent clinical trials have demonstrated the benefit of
combining tucatinib with trastuzumab and chemotherapy in patients
with metastatic HER2-positive breast cancer,” said Neil Josephson,
M.D., Interim Chief Medical Officer at Zymeworks. “Given the
antitumor activity of zanidatamab observed across a range of
HER2-overexpressing tumors and preclinical studies demonstrating
improved anti-tumor activity of zanidatamab compared to
trastuzumab, we believe the combination of zanidatamab with
tucatinib and chemotherapy has the potential to be an impactful
treatment for patients with advanced HER2-positive breast cancer,
including those with brain metastases.” Josephson added, “this new
study cohort complements our ongoing trials with zanidatamab in
combination with other standard of care treatment regimens and
supports our goal of establishing zanidatamab as the foundational
therapy for HER2‑expressing cancers.”
Zanidatamab binds to HER2 across a range of expression levels
and has demonstrated multiple mechanisms of action including the
formation of receptor clusters, resulting in receptor
internalization and downregulation that affect signal transduction.
In addition, zanidatamab potently activates the immune system to
elicit antibody-dependent cellular cytotoxicity, antibody-dependent
cellular phagocytosis, and complement-dependent cytotoxicity.
Tucatinib is a tyrosine kinase inhibitor of HER2 and helps prevent
the cancer cells from growing. Several studies have shown that
combining agents that target HER2 with complementary mechanisms of
action result in proven efficacy. The U.S. Food and Drug
Administration last year approved tucatinib in combination with
trastuzumab and capecitabine for the treatment of adult patients
with advanced forms of HER2-positive breast cancer that can’t be
removed with surgery, or has spread to other parts of the body,
including the brain, and who have received one or more prior
treatments.
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
product 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 and breast cancers. Zymeworks’
second product candidate, ZW49, is a bispecific antibody-drug
conjugate currently in Phase 1 clinical development and combines
the unique design and antibody framework of zanidatamab with
Zymeworks’ proprietary ZymeLink™ linker-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.
Zymeworks 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
statements that relate to the potential benefit of the combination
of zanidatamab with tucatinib and chemotherapy in patients with
advanced HER2-positive breast cancer, Zymeworks’ preclinical
pipeline, and other information that is not historical information.
When used herein, words such as “believe”, “potential”, “goal”,
“may”, “plan”, 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, including assumptions regarding the efficacy of
zanidatamab. 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 fiscal quarter
ended March 31, 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. You 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/20210728005348/en/
Zymeworks Inc.
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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