Zymeworks Highlights 2018 Achievements and Announces 2019 Priorities
Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, today reviewed its key 2018 accomplishments and outlined the Companys priorities for 2019.
Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical
company developing multifunctional biotherapeutics, today reviewed its
key 2018 accomplishments and outlined the Company’s priorities for 2019.
“With our clinical, preclinical, and business development achievements
in 2018, along with a robust balance sheet, we believe we are in a
strong position to continue delivering on our corporate objectives in
2019 and beyond,” said Ali Tehrani, Ph.D., President and CEO of
Zymeworks. “Our priorities include aggressively advancing our clinical
and preclinical programs and continuing the development of our
therapeutic platforms, which not only underpin our in-house pipeline but
have also served as the basis of eight major pharmaceutical
partnerships. We remain committed to our mission of creating novel
biotherapeutics that allow patients worldwide to return home to their
loved ones, disease free.”
2018 Achievements
-
Presented Expanded ZW25 Data, Underscoring its Anti-Tumor
Activity and Tolerability
Zymeworks reported clinical
results for ZW25, a novel Azymetric™ bispecific HER2-targeting
antibody, at multiple medical meetings. Data continues to demonstrate
ZW25’s robust single-agent anti-tumor activity and tolerability in
heavily pretreated patients across a variety of HER2-expressing
cancers.
-
ZW49 Investigational New Drug (IND) Application Accepted by the
FDA
ZW49, Zymeworks’ second clinical candidate, is a
novel bispecific HER2-targeting antibody drug conjugate. IND-enabling
studies demonstrated promising efficacy and tolerability, suggesting a
wide therapeutic window.
-
New Corporate Partnerships Established and Existing Ones Expanded
Zymeworks
entered into new collaborations with BeiGene, which includes a
licensing agreement in the Asia Pacific region (excluding Japan) for
ZW25 and ZW49, and with LEO Pharma, which expands Zymeworks’ pipeline
into new disease areas. The Company also expanded its existing
collaborations with Daiichi Sankyo and Celgene. Zymeworks
currently has eight active collaborations that offer up to US$7.6
billion in potential milestone payments plus royalties.
-
Drug Candidate from First Corporate Partnership Poised to Enter
Clinical Studies
Eli Lilly submitted an IND application
for one of its bispecific antibodies enabled by Zymeworks’ Azymetric
platform resulting in a milestone payment to the Company.
-
Introduced Robust Immune Oncology (IO) Preclinical Pipeline
Zymeworks
unveiled a number of IO programs showcasing the versatility of its
platform technologies. Leveraging the Azymetric platform, Zymeworks
showed how optimizing bispecific geometry and formats can maximize
activity, potentially creating new classes of precision therapeutics.
-
Expanded Executive Leadership Team
Tony Polverino,
Ph.D., joined Zymeworks as Executive VP of Early Development and CSO.
In this newly created role, he oversees the Company’s R&D strategy and
advances product candidates from discovery through translational
research/early development.
-
Built Strong Balance Sheet
Zymeworks completed a
US$97.8 million public financing and added non-dilutive capital from
its corporate partnerships totaling US$89 million in 2018.
2019 Corporate Priorities
Zymeworks will focus on achieving the following in 2019:
- Initiating multiple Phase 2 studies for ZW25
- Expanding the global clinical development of ZW25 into Asia and Europe
-
Reporting ZW25 data from combination studies (chemotherapy and/or
targeted agents) - Reporting data from the Phase 1 trial for ZW49
-
Establishing additional drug development collaborations with a focus
on new platforms
In addition, Zymeworks expects its pharmaceutical partners to continue
nominating new Azymetric bispecific antibody therapeutic candidates for
clinical development in 2019.
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 Azymetric™ bispecific antibody
currently being evaluated in an adaptive Phase 1 clinical trial. The
Company’s second clinical candidate, ZW49, capitalizes on the unique
design and antibody framework of ZW25 and is a bispecific antibody-drug
conjugate, armed with the Company’s proprietary ZymeLink™ cytotoxic
payload. Zymeworks is also advancing a deep pipeline of preclinical
product candidates and discovery-stage programs in immune 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 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
Zymeworks’ anticipated achievement of corporate milestones in 2019,
expected clinical results and preclinical data, the nature and progress
of Zymeworks’ current and projected corporate partnerships, its
strategies for the development of ZW25 and ZW49, 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, including
assumptions regarding anticipated reporting of additional clinical and
preclinical data, the efficacy of ZW25, ZW49 and the Azymetric platform
and Zymeworks’ ability to enter into new partnership arrangements.
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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190106005068/en/