Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical
company developing multifunctional biotherapeutics, today announced
that its partner, BeiGene, Ltd., has dosed the first patient in a
two-arm Phase 1b/2 trial evaluating Zymeworks’ HER2-targeted
bispecific antibody ZW25 in combination with chemotherapy as a
first-line treatment for patients with metastatic HER2-positive
breast cancer and in combination with chemotherapy and BeiGene’s
PD-1-targeted antibody tislelizumab as a first-line treatment for
patients with metastatic HER2-positive gastroesophageal
adenocarcinoma (GEA). Zymeworks will receive a payment under its
collaboration with BeiGene as a result of the achievement of this
development milestone.
“To date, ZW25 has demonstrated promising activity in
late-stage, treatment-refractory HER2‑expressing tumors. This new
clinical trial provides a unique opportunity to evaluate the
additional potential benefit of ZW25 in first-line metastatic
breast tumors which have not developed resistance to multiple
HER2-targeted therapeutics,” said Diana Hausman, M.D., Chief
Medical Officer at Zymeworks. “In addition, the GEA arm of this
trial complements our ongoing Phase 2 trial of ZW25 plus
chemotherapy in first-line GEA, and we are excited to examine
possible synergies between ZW25 and BeiGene’s PD-1 inhibitor
tislelizumab. We look forward to the results of these trials, which
have the potential to further expand the population of patients who
may benefit from ZW25.”
“Through this collaboration with Zymeworks, our broad
development program for tislelizumab is expanding into
HER2-expressing tumors as a potential first-line treatment,” said
Lai Wang, Ph.D., Senior Vice President, Head of Global Research and
APAC Clinical Development at BeiGene. “ZW25 has demonstrated
appealing clinical activity against HER2-positive tumors, and we
are excited to gain additional understanding of its use as a
monotherapy and in combinations as well.”
This Phase 1b/2 clinical trial is a multicenter, open-label,
two-arm study (NCT04276493). Arm one of the trial will evaluate the
safety, tolerability, and preliminary antitumor activity of ZW25 in
combination with docetaxel in patients with metastatic
HER2‑positive breast cancer. The second arm of the trial will
evaluate the safety, tolerability, and preliminary antitumor
activity of ZW25 in combination with tislelizumab and chemotherapy
in patients with HER2-positive GEA, including gastric and
gastroesophageal junction (GEJ) adenocarcinomas.
An ongoing Phase 1 trial is evaluating the safety and antitumor
activity of ZW25 as a single agent and in combination with
chemotherapy in HER2‑expressing cancers that have progressed after
prior standard of care treatments, including HER2-targeted agents
(Phase 1: NCT02892123). ZW25 is also being evaluated in a Phase 2
trial in first-line HER2-positive GEA in combination with standard
of care chemotherapy (Phase 2: NCT03929666) as well as in
combination with the oral CDK4/6 inhibitor palbociclib (Ibrance®,
Pfizer) and fulvestrant in advanced HER2‑positive, HR‑positive
breast cancer (Phase 2: NCT04224272). Zymeworks, in collaboration
with BeiGene, also plans to initiate registration-enabling studies
of ZW25 in patients with previously treated HER2-positive biliary
tract cancer and develop ZW25 as a potential first-line treatment
for patients with HER2-positive GEA.
About ZW25
ZW25 is being evaluated in multiple Phase 1 and Phase 2 clinical
trials globally. It 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 ZW25 as a targeted treatment option for patients with
solid tumors that express HER2. The FDA has granted two Fast Track
Designations to ZW25, one as a single agent for refractory biliary
tract cancer and one in combination with standard of care
chemotherapy, for first-line GEA. ZW25 has also received Orphan
Drug Designations for the treatment of biliary tract, gastric, and
ovarian cancers.
About the Zymeworks-BeiGene Collaboration
In November 2018, Zymeworks and BeiGene entered into license and
collaboration agreement in which BeiGene was granted an exclusive
license for the research, development and commercialization of ZW25
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 ZW25 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 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, ZW25, is a novel Azymetric™ bispecific antibody
currently in Phase 2 clinical development. Zymeworks’ second
clinical candidate, ZW49, is a bispecific antibody-drug conjugate
currently in Phase 1 clinical development and combines the unique
design and antibody framework of ZW25 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 more information, visit
www.zymeworks.com.
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 press release
include, but are not limited to, statements that relate to
Zymeworks’ clinical and preclinical development of its product
candidates, payment as a result of BeiGene’s achievement of a
development milestone, and other information that is not historical
information. When used herein, words such as “will”, “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. 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’ Annual Report
on Form 10-K for its fiscal year ended December 31, 2019 (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/20200401005656/en/
Investor Inquiries: Ryan Dercho, Ph.D. (604) 678-1388
ir@zymeworks.com Tiffany Tolmie (604) 678-1388 ir@zymeworks.com
Media Inquiries: Kavita Shah, Ph.D. (604) 678-1388
media@zymeworks.com
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