VANCOUVER, British Columbia, June 17, 2024 (GLOBE NEWSWIRE) -- 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 ZW171, a novel 2+1 T-cell targeting bispecific antibody
for mesothelin (MSLN)-expressing cancers.
"We are excited to reach this R&D milestone with ZW171, reflecting our
commitment to advancing innovative therapies for cancer treatment," said Paul
Moore, Chief Scientific Officer of Zymeworks. "ZW171's unique design is intended
to address the limitations of current bispecific T-cell engagers by enhancing
tumor selectivity and improving safety. With promising preclinical results,
ZW171 has the potential to provide a more effective and tolerable treatment
option for patients with MSLN-expressing cancers, including ovarian cancer, non-
small cell lung cancer, mesothelioma, and other cancers(1). We look forward to
initiating clinical development of ZW171 during 2024 and continuing to advance
additional product candidates in our '5 by 5' strategy over the next 24 months."
The Company expects to file applications seeking regulatory permission to
commence clinical studies for ZW171 in other non-US jurisdictions in the second
half of 2024.
ZW171 is a bispecific antibody designed to enable T cell-mediated tumor cell
killing through simultaneous binding to the extracellular domain of MSLN protein
on tumor cells and the engagement of CD3 on T cells. Moderate to high membranous
MSLN expression is frequent in ovarian cancer, non-small cell lung cancer,
mesothelioma and other cancers(1). Preliminary evidence of anti-tumor activity
with engineered T-cell therapy supports utility of T-cell targeted therapies in
treatment of MSLN-expressing solid tumors(2). ZW171's unique 2+1 format and
incorporation of a novel low-affinity anti-CD3 binder aims to improve the
therapeutic window in patients by limiting on-target, off-tumor effects and
cytokine release syndrome (CRS) while maintaining potent anti-tumor activity
against MSLN-expressing cancers(3). By selectively binding to tumors and sparing
normal tissues, ZW171 is designed to improve both tolerability and anti-tumor
activity against MSLN-expressing cancers. Engineered and optimized using our
Azymetric(TM) and EFECT(TM)(4) technologies, ZW171 demonstrates enhanced anti-tumor
activity and safety in preclinical models, inducing potent, preferential killing
of MSLN-overexpressing cells while mitigating the risk of on-target, off-tumor
activity, peripheral T cell activation, and CRS.
(1. Chang K, Pastan I, Proc Natl Acad Sci U S A. 1996;93(1):136-40)
(2. Hassan R, et al. Nat Med. 2023;29:2099-2109 )
(3. 1. Wang L, et al., Cancer Immunol Res. 2019; 7(12): 2013-2024)
(4. Afacan N, et al. Presented at: AACR. 2023 (abstr #2942))
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(TM) 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 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
(https://www.zymeworks.com/) and follow @ZymeworksInc
(https://twitter.com/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' preclinical candidates; Zymeworks' development
of its preclinical 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 Inamdar
Director, Investor Relations
(604) 678-1388
ir@zymeworks.com (mailto:ir@zymeworks.com)??
Media Inquiries:
Diana Papove
Senior Director, Corporate Communications
(604) 678-1388
media@zymeworks.com (mailto:media@zymeworks.com)
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