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Zymeworks Submits Investigational New Drug (IND) Application for ZW49 and Presents IND-Enabling Studies at the San Antonio Breast Cancer Symposium

  • ZW49 combines Azymetric™ and ZymeLink™ technologies to broaden the
    therapeutic window of antibody-drug conjugates (ADCs)
  • Complete tumor regressions observed in high and low HER2-expressing
    models
  • Superior preclinical efficacy compared to approved HER2 ADCs
  • Toxicology results support clinical dosing well above predicted
    efficacy levels
  • Potential to address unmet need in high and low HER2-expressing
    cancers, including brain metastases

VANCOUVER, Canada–(BUSINESS WIRE)–Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical
company developing multifunctional therapeutics, presented IND-enabling
data for ZW49, a novel biparatopic HER2-targeted ADC, at the San Antonio
Breast Cancer Symposium in San Antonio, TX.

“These data highlight the potential efficacy of ZW49 versus leading HER2
ADCs and demonstrate the power of combining our therapeutic platforms to
achieve greater efficacy and tolerability, thereby increasing the
therapeutic window,” said Ali Tehrani, Ph.D., President and CEO of
Zymeworks. “With the recent submission of our IND for ZW49 we are
pleased with the speed and trajectory of ZW49’s development and look
forward to starting clinical trials in early 2019.”

ZW49 is a HER2-targeted bispecific ADC that capitalizes on the unique
geometry and antibody framework of Zymeworks’ lead clinical candidate,
ZW25, and is armed with the Company’s proprietary ZymeLink-cytotoxic
payload. This design results in enhanced internalization and delivery of
the cytotoxin to cancer cells. In preclinical studies, ZW49 demonstrated
complete tumor regressions in a panel of high and low HER2-expressing
patient derived xenografts and promising efficacy in a model of breast
cancer brain metastases. These results compared favorably when
benchmarked against approved and leading HER2 ADCs in clinical
development. Importantly, efficacy was observed at exposures that were
well tolerated in preclinical studies suggesting a broad therapeutic
window.

The poster is available through the conference website or through
Zymeworks’ website at http://ir.zymeworks.com/events-and-presentations.

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. This unique 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 ZymeLink™ Platform

The ZymeLink platform is a modular suite of site-specific conjugation
technologies, customizable linkers, and proprietary cytotoxic payloads
designed for the targeted delivery of therapeutics with optimal
tolerability and efficacy. The ZymeLink platform is compatible with
traditional antibodies and with the Azymetric platform and is intended
to facilitate the development of next-generation antibody-drug
conjugates with broad therapeutic windows.

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. An Investigational New
Drug (IND) application was recently submitted to the Food and Drug
Administration (FDA) for its second product candidate, ZW49, a novel
bispecific antibody drug conjugate (ADC). 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.

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 statements that relate to ZW49
and its potential as an anti-cancer treatment, Zymeworks’ clinical plans
and future results including the anticipated timing of clinical trials
for ZW49, Zymeworks’ technology platform, and other information that is
not historical information. When used herein, words such as “believe”,
“may”, “plan”, “will”, “estimate”, “continue”, “anticipate”, “intend”,
“expect”, 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
fiscal 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. You 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.

Contacts

Investor Inquiries:
Ryan Dercho, Ph.D.
(604) 678-1388
ir@zymeworks.com

Media
Inquiries:
Angela Bitting
(925) 202-6211
a.bitting@comcast.net

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