Zymeworks Highlights 2019 Achievements and Announces Corporate Priorities
January 13 2020 - 8:30AM
Business Wire
Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical
company developing multifunctional biotherapeutics, today
highlighted its key accomplishments in 2019 and updated its
corporate priorities. Zymeworks also announced multiple clinical
program advances for its lead candidates, ZW25 and ZW49.
Recent ZW25 and ZW49 Program Advances
- Zymeworks initiated a Phase 2 clinical trial evaluating ZW25 in
combination with Ibrance® (palbociclib), an oral CDK4/6 inhibitor,
and the hormone therapy fulvestrant with the goal of providing a
chemotherapy-free treatment option to people with advanced
HER2-positive, hormone receptor-positive breast cancer. Zymeworks
entered into a clinical collaboration with Pfizer to advance the
study.
- ZW25 achieved two additional regulatory milestones, recently
being granted Fast Track and Orphan Drug Designations by the FDA in
refractory biliary tract cancer (BTC). These were ZW25’s second
Fast Track and third Orphan Drug Designations. ZW25 already holds a
Fast Track Designation for 1st line gastroesophageal adenocarcinoma
(GEA) and Orphan Drug Designations for GEA and ovarian cancer.
- An interim update from the ongoing ZW49 Phase 1 dose-escalation
study highlighted that there have been no dose-limiting toxicities
observed and the maximum tolerated dose has not been reached. With
over ten patients treated, the majority of treatment-related
adverse events have been grade 1 or 2, and were reversible and
manageable on an outpatient basis. Importantly, preliminary results
from these initial dose cohorts include anti-tumor activity.
“Our significant achievements in 2019 demonstrate that we are
executing on our vision to establish ZW25 as the foundational HER2
therapy across the spectrum of HER2-expressing cancers and lines of
therapy,” said Ali Tehrani, Ph.D., President and CEO at Zymeworks.
“As our second therapeutic candidate, ZW49, continues to advance in
the clinic, we are excited about its transformative potential for
both patients with HER2-expressing cancers and for the development
of future antibody-drug conjugate therapies. With a visionary
leadership team, key hires company-wide, and a strong financial
position, we are ready to deliver on our clinical programs and
partnering priorities for 2020.”
2019 Achievements
ZW25 Single Agent and Chemotherapy Combination Data Presented
at Multiple Medical Meetings; Data Support Plans for Multiple
Registration-Enabling Studies
- ZW25 demonstrated robust single agent anti-tumor activity and
durable disease control across multiple HER2-expressing tumors that
have progressed after standard‑of‑care (SOC) therapies, including
HER2-targeted agents. These data support the initiation of a
registration-enabling Phase 2 trial evaluating single agent ZW25 in
refractory HER2‑positive BTC followed by additional HER2‑expressing
tumor types.
- ZW25 plus chemotherapy showed durable anti-tumor activity for
patients with heavily pretreated GEA, which supports the ongoing
Phase 2 trial of ZW25 plus SOC chemotherapy and a planned
registration-enabling trial in 1st line HER2-posititve GEA vs
Herceptin plus SOC chemotherapy.
ZW49 Enters Phase 1 Clinical Testing for HER2-Expressing
Cancers
- ZW49 is a HER2-targeted bispecific antibody-drug conjugate
(ADC) that capitalizes on the unique geometry and antibody
framework of ZW25, and is armed with Zymeworks’ proprietary
ZymeLink™ cytotoxin. This design results in enhanced
internalization and delivery of the cytotoxin to cancer cells. ZW49
is being evaluated in an ongoing Phase 1 clinical trial.
Partnerships Continue to Advance; Milestone Payments
Received
- Zymeworks’ pharmaceutical partner Lilly entered the clinic with
a novel bispecific, Merck, Celgene, and Daiichi Sankyo advanced
bispecific candidates toward clinical testing, GSK expanded its
Azymetric™ partnership, and the first ZymeLink ADC collaboration
was signed with Iconic Therapeutics. These events resulted in
multiple milestone payments and increased future potential
milestone payments and royalties for Zymeworks.
Expertise Added to Leadership Team
- Extensive development and commercial experience was added to
the executive management team and board of directors. In addition,
a Chief People Officer was hired to strategically manage the growth
of Zymeworks’ human resources.
Balance Sheet Strengthened
- During the year, Zymeworks completed a public financing raising
US $201.3 million, and added additional non-dilutive capital from
multiple pharmaceutical partners.
Updated Corporate Priorities
- Initiate ZW25 registration-enabling studies in 2nd line
HER2-positive BTC and 1st line HER2-positive GEA
- Report ZW49 Phase 1 dose-escalation data and initiate expansion
cohorts
- Expand ZW25 clinical development into additional
HER2-expressing cancers
- Report ZW25 Phase 2 chemotherapy combination data from 1st line
HER2-positive GEA
- Continue building a strong preclinical pipeline through
internal R&D and external partnerships
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
clinical candidate, ZW25, is a novel Azymetric™ bispecific antibody
currently in Phase 2 clinical development. Zymeworks’ second
clinical candidate, ZW49, is a bispecific antibody-drug conjugate
currently in Phase 1 clinical development and combines the unique
design and antibody framework of ZW25 with Zymeworks’ proprietary
ZymeLink™ cytotoxic payload. 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 more information,
visit www.zymeworks.com.
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’ vision to establish ZW25 as
the foundational HER2 therapy, Phase 2 clinical trial evaluating
ZW25 in combination with palbociclib and clinical collaboration
with Pfizer, strategies for the development of ZW25 and ZW49,
anticipated achievement of corporate priorities, and expected
clinical results and preclinical data, as well as the nature and
progress of Zymeworks’ current and projected corporate partnerships
and other information that is not historical information. When used
herein, words such as “believe”, “may”, “plan”, “estimate”,
“continue”, “anticipate”, “expect”, “goal”, “vision”, “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, including
assumptions regarding anticipated reporting of additional clinical
and preclinical data, the efficacy of ZW25, ZW49, and Zymeworks’
therapeutic platforms, 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, 2019 (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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200113005337/en/
Investor Inquiries: Ryan Dercho, Ph.D. (604) 678-1388
ir@zymeworks.com
Tiffany Tolmie (604) 678-1388 ir@zymeworks.com
Media Inquiries: Kavita Shah, Ph.D. (604) 678-1388
media@zymeworks.com
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