Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical
company developing next-generation multifunctional biotherapeutics,
today announced that it has completed enrollment in its global
HERIZON-BTC-01 pivotal clinical trial evaluating the antitumor
activity of zanidatamab monotherapy in patients with previously
treated advanced or metastatic HER2-amplified biliary tract cancers
(BTC), including gallbladder cancer and cholangiocarcinoma (bile
duct cancer). Efficacy and safety results from HERIZON-BTC-01 are
expected to be announced by early 2023.
“Completing enrollment in our first pivotal trial is a
tremendous accomplishment for Zymeworks. I’m extremely proud of our
team and our collaborators at BeiGene for their hard work in
reaching this milestone ahead of expectations,” said Neil
Josephson, M.D., Chief Medical Officer. “Currently there are
limited options for patients with advanced HER2-amplified biliary
tract cancer who experience disease progression after front-line
therapy. Zanidatamab has the potential to meet the urgent global
clinical need for a safe and effective therapy for patients with
this difficult to treat cancer.”
Biliary tract cancers, including gallbladder cancer and
cholangiocarcinoma, account for approximately 3% of all adult
cancers and is often associated with a poor prognosis1. Globally,
more than 210,000 people are diagnosed with BTC every year2 and
most patients (> 65%) with BTC are diagnosed with tumors that
cannot be removed surgically. The human epidermal growth factor
receptor 2 (HER2) is a well-described target for anti-cancer
therapy. About 5% to 19% of patients with BTC have tumors that
express HER23, suggesting that these patients may have the
potential to benefit from HER2-targeted therapy. Currently no
HER2-targeted therapy has been approved for the treatment of
BTC.
HERIZON-BTC-01 is a global, multicenter, open-label, single-arm
study (NCT04466891) with a primary endpoint of confirmed objective
response rate (ORR) by independent central review (ICR) per the
Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST
1.1). Secondary endpoints are duration of response (DOR),
proportion of subjects with a DOR ≥16 weeks, disease control rate
(DCR), progression-free survival (PFS), overall safety (OS) and
safety. HER2 amplification, as determined by in situ hybridization
(ISH) in tumor tissue, was an inclusion criterion for all subjects
enrolled into the two study cohorts: Cohort 1, the primary efficacy
cohort, with tumor tissue showing HER2 immunohistochemistry (IHC)
2+ or 3+ staining, and cohort 2 with tumor tissue showing HER2 IHC
0 or 1+ staining. The study was initiated in July 2020 and has
active sites in North America, Asia Pacific, Europe and South
America.
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. Zanidatamab is currently being
evaluated in two pivotal clinical trials, one for the first-line
treatment of advanced or metastatic HER2-positive gastroesophageal
adenocarcinoma (HERIZON-GEA-01) and one for previously treated
HER2-amplified biliary tract cancer (HERIZON-BTC-01). Zanidatamab
is also being evaluated in several Phase 2 clinical trials for
HER2‑expressing gastroesophageal, colorectal, and breast cancers.
The FDA has granted zanidatamab Breakthrough Therapy designation
for patients with previously treated HER2 gene-amplified biliary
tract cancer, as well as two Fast Track designations, one as
monotherapy for refractory biliary tract cancer and one in
combination with standard of care chemotherapy for first-line
gastroesophageal adenocarcinoma. 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 received Break
Through Designation from the Center of Drug Evaluation (CDE) in
China for treating patients with biliary tract cancer who have
failed prior systemic therapies. Zanidatamab has also received
Orphan Drug designations from the FDA as well as the European
Medicines Agency for the treatment of biliary tract and gastric
cancers.
Zymeworks has an existing intermediate-size Expanded Access
Protocol (EAP) for use of zanidatamab in patients with
HER2-positive advanced solid tumors who are not eligible for other
zanidatamab clinical trials, and who in the opinion of the treating
oncologist, would potentially benefit from treatment with
zanidatamab. Additional information is available on our website at
https://zymeworks.com/patients.
About the Zymeworks-BeiGene Collaboration
In November 2018, Zymeworks and BeiGene entered into license and
collaboration agreements in which BeiGene was granted an exclusive
license for the research, development, and commercialization of
zanidatamab and ZW49 in Asia (excluding Japan), Australia, and New
Zealand. The companies are collaborating on joint global
development for selected indications, with the goal of developing
zanidatamab and ZW49 worldwide across multiple HER2-expressing
cancers and lines of therapy.
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,
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.
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 the
expected timing of the announcement of efficacy and safety results
from HERIZON-BTC-01, the potential therapeutic effects of
zanidatamab and Zymeworks’ other product candidates, Zymeworks’
clinical development of its product candidates, related clinical
trials, the commercial potential of technology platforms and
product candidates, Zymeworks’ preclinical pipeline, and other
information that is not historical information. When used herein,
words such as “expect”, “may”, “potential”, 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: 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; 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 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 Annual Report on Form 10-K
for its year ended December 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. 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.
__________________________________ 1 Valle JW, Lamarca A, Goyal
L, Barriuso J, Zhu AX. New Horizons for precision medicine in
biliary tract cancers. Cancer Discov. 2017;7(9):943-962. 2 GBD 2017
Disease and Injury Incidence and Prevalence Collaborators. Global,
regional, and national incidence, prevalence, and years lived with
disability for 354 diseases and injuries for 195 countries and
territories, 1990-2017: a systematic analysis for the Global Burden
of Disease Study 2017. Lancet. 2018;392(10159):1789-1858. 3 Galdy
S, Lamarca A, McNamara MG, et al. HER2/HER3 pathway in biliary
tract malignancies; systematic review and meta-analysis: a
potential therapeutic target? Cancer Metastasis Rev.
2017;36(1):141-157.
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Investor Inquiries: Jack Spinks (604) 678-1388
ir@zymeworks.com
Media Inquiries: Diana Papove (604) 678-1388
media@zymeworks.com
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