Zymeworks and BeiGene Announce License and Collaboration Agreement for Zymeworks’ HER2-Targeted Therapeutic Candidates, ZW25 and ZW49, in Asia-Pacific and Research and License Agreement for Zymeworks’ Azymetric and EFECT platforms globally


• BeiGene acquires exclusive development and commercial rights to Zymeworks’ bispecific
candidates, ZW25 and ZW49, in Asia (excluding Japan), Australia, and New Zealand.
The companies will collaborate on joint global development for selected indications.
• BeiGene also acquires licenses for Zymeworks’ Azymetric™ and EFECT™ platforms to
develop and commercialize up to three bispecific antibody therapeutics globally directed
to BeiGene’s targets.
• Zymeworks will receive total upfront payments of US$40 million under the ZW25 and
ZW49 agreements and US$20 million under the platform agreement and is eligible to
receive development and commercial milestone payments plus potential royalties on
product sales.
Vancouver, Canada; Beijing, China and Cambridge, MA, –
Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing
multifunctional therapeutics, and BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160), a commercialstage biopharmaceutical company focused on developing and commercializing innovative
molecularly-targeted and immuno-oncology drugs for the treatment of cancer, today announced
that the two companies have entered into a strategic collaboration for the clinical development
and commercialization of Zymeworks’ investigational ZW25 and ZW49 HER2-targeted
bispecific antibodies. In addition, Zymeworks granted BeiGene a license to Zymeworks’
proprietary Azymetric™ and EFECT™ platforms to develop and commercialize globally up to
three other bispecific antibodies using the platforms.
License and Collaboration for ZW25 and ZW49
Under the terms of the license and collaboration agreements for ZW25 and ZW49, Zymeworks
has granted BeiGene exclusive rights to develop and commercialize Zymeworks’ clinical-stage
bispecific antibody candidate ZW25 and its preclinical-stage bispecific antibody drug conjugate
(ADC) ZW49 in Asia (excluding Japan), Australia, and New Zealand. BeiGene will be
responsible for all clinical development and regulatory submissions in the licensed territories. The
companies also plan to collaborate on global development of ZW25 and ZW49 in
HER2-expressing solid tumors, including gastric and breast cancer, with BeiGene enrolling
patients and contributing clinical trial data from the licensed territories. Zymeworks retains full
rights to both ZW25 and ZW49 outside of the specified countries and will continue to lead global
development of these drug candidates.
“Partnering with BeiGene was a key component of our development and commercialization
strategy for ZW25 and ZW49,” said Ali Tehrani, Ph.D., President and CEO of Zymeworks. “This
collaboration allows Zymeworks to leverage BeiGene’s resources and expertise to accelerate the
development of our most advanced product candidates and broaden our reach globally including
in a key region of the world.”
“Zymeworks’ promising candidates ZW25 and ZW49 complement our oncology pipeline and
further advance our mission to develop treatments for patients who often have limited options,”
commented Dr. Xiaobin Wu, General Manager of China and President of BeiGene, Ltd. “Our
deep clinical experience in China is an integral part of our business development efforts, as these
trial data can be used to support global regulatory filings. We are excited by the clinical prospects
of ZW25 and ZW49 in HER2-expressing cancers.”
“At Zymeworks we are committed to developing new therapies to help address unmet medical
need on a global basis,” said Diana Hausman, MD, Zymeworks’ Chief Medical Officer. “We are
looking forward to collaborating with BeiGene and benefiting from their extensive experience in
oncology drug development in China and elsewhere. We expect that this collaboration will
accelerate the development of ZW25 and ZW49 as potential new therapies for patients with
HER2-expressing solid tumors, including gastric, breast and other cancers.”
License to Zymeworks’ Azymetric and EFECT Platforms
In addition to the license and collaboration agreements for ZW25 and ZW49, Zymeworks and
BeiGene entered into a separate research and license agreement for Zymeworks’ proprietary
Azymetric and EFECT platforms, under which BeiGene will have global rights to research,
develop and commercialize up to three bispecific antibody therapeutics directed to targets
selected by BeiGene. BeiGene will be responsible for all research, development, and commercial
activities under this agreement.
Financial Consideration
Under the terms of the license and collaboration agreements for ZW49 and ZW25, Zymeworks
will receive total upfront payments of US$40 million and is eligible to receive up to US$390
million in development and commercial milestone payments for both product candidates. In
addition, Zymeworks will be eligible to receive tiered royalties on future sales of ZW25 and
ZW49 in the licensed territory.
Under the terms of the research and license agreement for the Azymetric and EFECT platforms,
Zymeworks will receive an upfront payment of US$20 million and is eligible to receive up to an
aggregate of US$702 million in development and commercial milestone payments for up to three
bispecific product candidates developed under the agreement. In addition, Zymeworks will be
eligible to receive tiered royalties on future global sales of bispecific products developed by
BeiGene under the agreement.
Zymeworks’ Webcast and Conference Call
Zymeworks will host a webcast and conference call November 27th
, at 8:30 a.m. ET (5:30 a.m.
PT) to discuss the collaboration and license agreements.
Interested parties can access a live webcast of the presentation via a link from Zymeworks’
website at http://ir.zymeworks.com/events-and-presentations. A recorded replay will also be
available on the website shortly after the call concludes.
The live call and Q&A may be accessed by dialing 1-800-319-4610 for North American callers,
or 1-604-638-5340 for international callers. Callers should dial in five to ten minutes prior to the
scheduled start time and ask to join the “Zymeworks call.”
About ZW25
ZW25 is being evaluated in a Phase 1 clinical trial in the United States and Canada. 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 anti-tumor activity in patients. Zymeworks is developing ZW25 as a HER2-targeted
treatment option for patients with any solid tumor that expresses HER2. The FDA has granted
Orphan Drug Designation to ZW25 for the treatment of both gastric and ovarian cancers.
About ZW49
ZW49 is a novel bispecific ADC targeting two non-overlapping epitopes of HER2 resulting in
enhanced internalization and delivery of its proprietary ZymeLink cytotoxic payload. ADCs
incorporating ZymeLink have demonstrated a greater therapeutic window (range of doses that are
both efficacious and tolerable) in preclinical testing than those incorporating the commonly used
ADC payloads DM1 or MMAE. Zymeworks is developing ZW49 as a best-in-class HER2-
targeting ADC for several indications characterized by HER2 expression, especially those
patients whose tumors have progressed or are refractory to HER2-targeted agents, and those that
express lower levels of HER2 and are ineligible for treatment with current HER2-targeted
therapies. An IND application for ZW49 was recently submitted to the FDA.
About the Azymetric™ Platform
The Azymetric platform enables the transformation of monospecific antibodies into bispecific
antibodies, giving the antibodies the ability to simultaneously bind two different targets.
Azymetric bispecific technology enables the development of multifunctional biotherapeutics that
can block multiple signaling pathways, recruit immune cells to tumors, enhance receptor
clustering degradation, and increase tumor-specific targeting. These features are intended to
enhance efficacy while reducing toxicities and the potential for drug-resistance. Azymetric
bispecifics 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 with high yields and purity, potentially
significantly reducing drug development costs and timelines.
About the EFECT™ Platform
The EFECT platform is a library of antibody Fc modifications engineered to modulate the activity
of the antibody-mediated immune response, which includes both the up- and down-regulation of
effector functions. This platform, which is compatible with traditional monoclonal as well as
Azymetric bispecific antibodies, further enables the customization of therapeutic responses for
different diseases.
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 complementary therapeutic platforms and its fully-integrated drug
development engine provide the flexibility and compatibility to precisely engineer and develop
highly-differentiated product candidates. Zymeworks’ lead product candidate, ZW25, is a novel
bispecific antibody currently being evaluated in an adaptive Phase 1 clinical trial. Zymeworks is
also advancing a deep pipeline of preclinical product candidates and discovery-stage programs in
immuno-oncology and other therapeutic areas. In addition to Zymeworks’ wholly-owned
pipeline, its therapeutic platforms have been further leveraged through multiple strategic
partnerships with global biopharmaceutical companies.
About BeiGene, Ltd.
BeiGene is a global, commercial-stage, research-based biotechnology company focused on
molecularly-targeted and immuno-oncology cancer therapeutics. With a team of over 1,700
employees in China, the United States, Australia and Switzerland, BeiGene is advancing a
pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene
is also working to create combination solutions aimed to have both a meaningful and lasting
impact on cancer patients. BeiGene markets ABRAXANE® (nanoparticle albumin–bound
paclitaxel), REVLIMID® (lenalidomide), and VIDAZA® (azacitidine) in China under a license
from Celgene Corporation*
.
*ABRAXANE®, REVLIMID®, and VIDAZA® are registered trademarks of Celgene Corporation.
Zymeworks Cautionary Note Regarding Zymeworks’ 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 future
development activities in accordance with the terms of Zymeworks’ agreements with BeiGene,
potential payments and/or royalties payable to Zymeworks under these agreements, the speed and
outcome of drug development plans, Zymeworks’ potential global growth, and other information
that is not historical information. When used herein, words such as “enable”, “plan”, “expect”,
“allows”, “will”, “may”, “continue”, and similar expressions are intended to identify forwardlooking 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 forwardlooking 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 September 30, 2018 (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.
BeiGene Cautionary Note Regarding BeiGene’s Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private
Securities Litigation Reform Act of 1995 and other federal securities laws, including statements
regarding future research, development and potential commercialization activities under the
agreements with Zymeworks, potential payments and/or royalties payable to Zymeworks under
these agreements, the speed and outcome of drug development plans, and other information that
is not historical information. Actual results may differ materially from those indicated in the
forward-looking statements as a result of various important factors, including BeiGene’s ability to
demonstrate the efficacy and safety of its drug candidates; the clinical results for its drug
candidates, which may not support further development or marketing approval; actions of
regulatory agencies, which may affect the initiation, timing and progress of clinical trials and
marketing approval; BeiGene’s ability to achieve commercial success for its marketed products
and drug candidates, if approved; BeiGene’s ability to obtain and maintain protection of
intellectual property for its technology and drugs; BeiGene’s reliance on third parties to conduct
drug development, manufacturing and other services; BeiGene’s limited operating history and
BeiGene’s ability to obtain additional funding for operations and to complete the development
and commercialization of its drug candidates, as well as those risks more fully discussed in the
section entitled “Risk Factors” in BeiGene’s most recent quarterly report on Form 10-Q, as well
as discussions of potential risks, uncertainties, and other important factors in BeiGene’s
subsequent filings with the U.S. Securities and Exchange Commission. All information in this
press release is as of the date of this press release, and BeiGene undertakes no duty to update such
information unless required by law.
Contacts:
Zymeworks Investor Inquiries:
Ryan Dercho, Ph.D.
(604) 678-1388
ir@zymeworks.com
Zymeworks Media Inquiries:
Angela Bitting
(925) 202-6211
a.bitting@comcast.net
BeiGene Investor Inquiries:
Craig West
(857) 302-5189
ir@BeiGene.com
BeiGene Media Inquiries:
Liza Heapes
(857) 302-5663
media@BeiGene.com

Shiwani Sharma

Shiwani Sharma was Senior Editor at PharmaShots. She has in-depth knowledge of the life sciences industry including the Pharma and Biotech sectors. Any articles written by her can be contacted at connect@pharmashots.com.

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