Zymeworks Announces FDA Clearance of Investigational New Drug Application for ZW191, a Novel Folate Receptor-⍺ Targeted Topoisomerase I Inhibitor Antibody-Drug Conjugate
2024年7月22日 - 7:00PM
Zymeworks Inc. (Nasdaq: ZYME), a clinical-stage biotechnology
company developing a diverse pipeline of novel, multifunctional
biotherapeutics to improve the standard of care for
difficult-to-treat diseases, today announced that the United States
Food and Drug Administration (FDA) has cleared the investigational
new drug (IND) application for ZW191, the Company’s novel folate
receptor-⍺ (FR⍺) targeted topoisomerase I inhibitor (TOPO1i)
antibody-drug conjugate (ADC).
“ZW191 is a differentiated product candidate in our pipeline
that reflects the strength of our approach in developing
best-in-class antibody-drug conjugates,” said Paul Moore, Chief
Scientific Officer of Zymeworks. “Developed to target FR⍺, which is
expressed in several types of difficult-to-treat cancers, ZW191
incorporates a novel antibody and drug-linker that provide a unique
combination of antibody-linker stability and payload potency,
together with strong bystander activity, which could result in
improved efficacy and enable targeting lower levels of FR⍺ compared
to previously developed drug candidates. We are pleased to reach
this R&D milestone following on the heels of our recent FDA
clearance for ZW171 in June and look forward to initiating clinical
development of both ZW191 and ZW171 during 2024.”
ZW191 was designed using the Company’s drug conjugate platforms,
including the novel TOPO1i-based payload technology, ZD06519, to
target FR⍺-expressing tumors including ovarian and other
gynecological cancers, as well as non-small cell lung cancer
(NSCLC). A drug-antibody-ratio (DAR) of eight was selected to
balance both tolerability and efficacy. The FR⍺ monoclonal antibody
incorporated in ZW191 was generated in-house and selected based on
enhanced internalization characteristics to enable targeting of
high, mid, and low levels of FR⍺ expression. FR⍺ is a clinically
validated target that is expressed in approximately 75% of ovarian
carcinomas and 70% of NSCLC. ZW191 has demonstrated robust
anti-tumor activity and a strong safety profile in preclinical
models.
The Company expects to file applications seeking regulatory
authorization to initiate clinical studies for ZW191 in non-US
jurisdictions in the second half of 2024. ZW191 is the first of
three ADC molecules incorporating the Company’s proprietary ZD06519
payload designated for clinical development, with IND filings for
ZW220 (NaPi2b ADC) and ZW251 (GPC3 ADC) on schedule for 2025.
About Zymeworks Inc. Zymeworks is a global
clinical-stage biotechnology company committed to the discovery,
development, and commercialization of novel, multifunctional
biotherapeutics. Zymeworks’ mission is to make a meaningful
difference in the lives of people impacted by difficult-to-treat
cancers and other diseases. The Company’s complementary therapeutic
platforms and fully integrated drug development engine provide the
flexibility and compatibility to precisely engineer and develop
highly differentiated antibody-based therapeutic candidates.
Zymeworks engineered and developed zanidatamab, a HER2-targeted
bispecific antibody using the Company’s proprietary Azymetric™
technology. Zymeworks has entered into separate agreements with
BeiGene, Ltd. (BeiGene) and Jazz Pharmaceuticals Ireland Limited
(Jazz), granting each exclusive rights to develop and commercialize
zanidatamab in different territories. Zanidatamab is currently
being evaluated in multiple global clinical trials as a potential
best-in-class treatment for patients with HER2-expressing cancers.
A Biologics License Application (BLA) to the U.S. Food and Drug
Administration (FDA) seeking accelerated approval for zanidatamab
as a treatment for previously-treated, unresectable, locally
advanced, or metastatic HER2-positive biliary tract cancer (BTC)
has been accepted and granted Priority Review. A BLA has also been
accepted for review by the Center for Drug Evaluation (CDE) of the
National Medical Products Administration (NMPA) in China. If
approved, zanidatamab would be the first HER2-targeted treatment
specifically approved for BTC in each of the U.S. and China.
Zymeworks is rapidly advancing a deep pipeline of product
candidates based on its experience and capabilities in both
antibody-drug conjugates and multispecific antibody therapeutics
across multiple novel targets in indications that represent areas
of significant unmet medical need. In addition to Zymeworks’ wholly
owned pipeline, its therapeutic platforms have been further
leveraged through strategic partnerships with global
biopharmaceutical companies. For information about Zymeworks, visit
www.zymeworks.com and follow @ZymeworksInc on X.
Cautionary Note Regarding Forward-Looking
Statements
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 addressable market of Zymeworks’ product candidates;
Zymeworks’ development of its product candidates; the timing and
status of ongoing and future studies and the related data;
expectations and timing regarding future regulatory filings and
approvals; the timing of and results of interactions with
regulators; potential safety profile and therapeutic effects of
zanidatamab and Zymeworks’ other product candidates; the commercial
potential of technology platforms and product candidates and other
information that is not historical information. When used herein,
words such as “plan”, “believe”, “expect”, “may”, “continue”,
“anticipate”, “potential”, “will”, “progress”, 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: 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; Zymeworks may not achieve milestones or
receive additional payments under its collaborations; regulatory
agencies may impose additional requirements or delay the initiation
of clinical trials; the impact of new or changing laws and
regulations; market conditions; the impact of pandemics and other
health crises 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; clinical trials
may not demonstrate safety and efficacy of any of Zymeworks’ or its
collaborators’ product candidates; Zymeworks’ assumptions and
estimates regarding its financial condition, future financial
performance and estimated cash runway may be incorrect; 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 (copies 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.
Contacts:
Investor Inquiries:
Shrinal InamdarDirector, Investor Relations(604)
678-1388ir@zymeworks.com
Media Inquiries:
Diana PapoveSenior Director, Corporate Communications(604)
678-1388media@zymeworks.com
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