Zymeworks Announces Milestone Payment as Janssen Achieves First Patient Dosed for its Bispecific Antibody Utilizing Zymeworks’ Azymetric™ and EFECT™ Therapeutic Platforms
August 03 2021 - 8:30AM
Business Wire
Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical
company developing multifunctional biotherapeutics, today announced
that Janssen Biotech, Inc. (Janssen) dosed the first patient with
JNJ-78278343, a bispecific antibody developed using Zymeworks’
Azymetric™ and EFECT™ therapeutic platforms.
“On behalf of everyone at Zymeworks, I’d like to congratulate
the team at Janssen for advancing this bispecific candidate into
the clinic,” said Ali Tehrani Ph.D., Zymeworks’ President &
CEO. “This represents our fourth pharmaceutical collaboration with
programs reaching clinical development. We look to continue to
demonstrate the value and strength of our platform technologies,
which are an important part of our business model, complementing
the value derived from our two lead clinical assets and preclinical
pipeline.”
Zymeworks will receive a payment in connection with this
milestone under Zymeworks’ 2017 licensing agreement with Janssen.
Under the terms of that agreement, Zymeworks provided Janssen with
a worldwide, royalty-bearing license to research, develop and
commercialize up to six bispecific antibodies directed to Janssen
therapeutic targets using Zymeworks’ Azymetric and EFECT platforms.
Janssen is responsible for all research, development and commercial
activities under the licensing agreement. Zymeworks received an
upfront payment of US$50 million and is eligible to potentially
receive up to US$282 million in development and up to US$1.12
billion in commercial milestone payments, as well as tiered
royalties on potential sales. Janssen also has the option to
develop two additional bispecific programs under the agreement
subject to a future option payment.
About the Azymetric™ Platform
The Azymetric platform enables the transformation of
monospecific antibodies into bispecific and multispecific
antibodies, allowing simultaneous binding to several different
disease targets. This unique technology enables the development of
multifunctional therapeutics that can block multiple signaling
pathways, recruit immune cells to tumors, enhance receptor
clustering and internalization and increase tumor-specific
targeting. These features are designed to enhance efficacy while
reducing toxicities and the potential for drug resistance.
Azymetric therapeutics have been engineered to retain the desirable
drug-like qualities of naturally occurring antibodies, including
low immunogenicity, long half-life and high stability. In addition,
they are compatible with standard manufacturing processes that
deliver high yields and purity, potentially reducing drug
development costs and timelines.
About the EFECT™ Platform
The EFECT platform is a library of antibody Fc modifications
engineered to activate or suppress the antibody-mediated immune
response. This platform, which is compatible with traditional
monoclonal as well as Azymetric bispecific antibodies, further
enables the customization and optimization of therapeutic responses
for different diseases.
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, colorectal 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 press release
include, but are not limited to, statements that relate to
Zymeworks’ expectations regarding the receipt of payments under its
licensing agreement with Janssen, the continued importance of
Zymeworks’ platform technologies to its business model, and other
information that is not historical information. When used herein,
words such as “will”, “continue”, “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, market conditions and the factors described under “Risk
Factors” in Zymeworks’ Quarterly Report on Form 10-Q for its
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. 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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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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