Zymeworks Reports Preliminary Phase 1 Trial Results for Zanidatamab Zovodotin (ZW49) at European Society for Medical Oncology Annual Congress
September 12 2022 - 4:15PM
Business Wire
- Company to hold conference call and webcast on Monday,
September 12th at 4:30 PM Eastern Standard Time (EST)
Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical
company developing multifunctional biotherapeutics, today presented
preliminary results from the company’s Phase 1 clinical trial
evaluating zanidatamab zovodotin (ZW49) for the treatment of
HER2-positive tumors. The presentation, entitled “Preliminary Results From a Phase 1 Study Using the
Bispecific, Human Epidermal Growth Factor 2 (HER2)-targeting
Antibody-drug Conjugate (ADC) zanidatamab zovodotin (ZW49) in Solid
Cancers”, was presented by Komal Jhaveri, MD, FACP, medical
oncologist, Memorial Sloan Kettering Cancer Center in NYC, in a
mini-oral presentation today during the European Society for
Medical Oncology Annual Congress at the Paris Expo Porte de
Versailles in Paris, France.
A total of 77 patients were enrolled in this first-in-human
trial, which was designed to determine the maximum tolerated dose
of zanidatamab zovodotin, characterize its safety and tolerability,
and evaluate anti-tumor activity in HER2-expressing cancers as
monotherapy. The patients represented a variety of HER2-expressing
cancers including breast, gastroesophageal, ovarian, endometrial,
bladder, biliary tract, anal, colorectal, pancreatic and lung. At
the time of the analysis, the maximum tolerated dose had not yet
been reached.
Commenting on the data, Dr. Jhaveri noted, “The preliminary
results of this trial are very encouraging. Zanidatamab zovodotin
dosed on an every three week (Q3W) schedule is active and has a
manageable safety profile. I am excited to see further clinical
development of zanidatmab zovodotin across a variety of
HER2-expressing cancers.”
In the trial, zanidatamab zovodotin was shown to have a
manageable safety profile with the majority of adverse events being
Grade 1 or 2 in severity. In patients with HER2-positive cancers
treated with zanidatamab zovodotin at 2.5 mg/kg Q3W (dose
escalation + dose expansion), the confirmed objective response rate
was 31% and the disease control rate was 72%. The Phase 1 clinical
trial is ongoing and continues to enroll patients to study safety,
tolerability and activity for an alternate qW dosing regimen. The
Company expects to present results of this dosing regimen at a
medical meeting in 2023.
“We are grateful to the patients who participated in this trial
and appreciate the collaborative efforts and dedication of the
outstanding group of clinical investigators who are participating
in this Phase 1 study,” said Neil Josephson, MD, Chief Medical
Officer of Zymeworks. “These promising results provide significant
momentum for the further clinical development of zanidatamab
zovodotin, as a monotherapy, and in combination with standard of
care agents, for the treatment of cancers expressing HER2 or
harboring HER2 gene alterations.”
Conference Call
Dr. Jhaveri’s complete presentation at the ESMO 2022 Congress is
available for review on Zymeworks’ website. Zymeworks will hold a
conference call to discuss Dr. Jhaveri’s presentation and future
clinical development plans for zanidatamab zovodotin on Monday,
September 12th at 4:30 pm EST. Interested parties can access the
live webcast via Zymeworks’ website at
https://ir.zymeworks.com/events-and-presentations. A recorded
replay will be accessible after the event through the Zymeworks
website.
Disclosure: Dr. Jhaveri has a consulting relationship with
Zymeworks.
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 therapeutic platforms and its fully integrated drug development
engine enable precise engineering of highly differentiated product
candidates. Zymeworks’ lead clinical candidate, zanidatamab, is a
novel Azymetric™ HER2-targeted bispecific antibody currently being
evaluated in multiple Phase 1, Phase 2, and pivotal clinical trials
globally as a targeted treatment option for patients with solid
tumors that express HER2. Zymeworks’ second clinical candidate,
zanidatamab zovodotin (ZW49), is a novel bispecific HER2 ‑targeted
antibody-drug conjugate currently in Phase 1 clinical development
and combines the unique design and antibody framework of
zanidatamab with Zymeworks’ proprietary ZymeLink™ linker and
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 global
biopharmaceutical companies. For more information on our ongoing
clinical trials visit www.zymeworksclinicaltrials.com. For
additional information about Zymeworks, visit www.zymeworks.com and
follow @ZymeworksInc on Twitter.
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 the
potential therapeutic effects of zanidatamab, zanidatamab zovodotin
and Zymeworks’ other product candidates; Zymeworks’ clinical
development of its product candidates and enrollment in its
clinical trials; anticipated clinical data presentations; and other
information that is not historical information. When used herein,
words such as “will”, “plans”, “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: the impact of the COVID-19 pandemic on Zymeworks’
business, research and clinical development plans and timelines and
results of operations, including impact on its clinical trial
sites, collaborators, and contractors who act for or on Zymeworks’
behalf, may be more severe and more prolonged than currently
anticipated; clinical trials may not demonstrate safety and
efficacy of any of Zymeworks’ or its collaborators’ product
candidates; any of Zymeworks’ or its partners’ product candidates
may fail in development, may not receive required regulatory
approvals, or may be delayed to a point where they are not
commercially viable; regulatory agencies may impose additional
requirements or delay the initiation of clinical trials; the impact
of new or changing laws and regulations; market conditions;
inability to maintain or enter into new partnerships or strategic
collaborations and the factors described under “Risk Factors” in
Zymeworks’ quarterly and annual reports filed with the Securities
and Exchange Commission, including its Quarterly Report on Form
10-Q for its quarter ended June 30, 2022 (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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version on businesswire.com: https://www.businesswire.com/news/home/20220912005256/en/
Jack Spinks (604) 678-1388 ir@zymeworks.com
Media Inquiries: Diana Papove (604) 678-1388
media@zymeworks.com
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