- ZW25 Plus Chemotherapy Shows
Durable Activity in Patients with Heavily Pretreated
Gastroesophageal Adenocarcinoma
- Data Continue to Support
Ongoing Phase 2 Trial of ZW25 Plus Standard of Care Chemotherapy
Therapy as First-Line Treatment
Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical
company developing multifunctional therapeutics, today announces
the first data from its Phase 1 study evaluating novel bispecific
antibody ZW25 in combination with chemotherapy in HER2-expressing
gastroesophageal adenocarcinoma (GEA) in a poster presentation at
the AACR-NCI-EORTC International Conference on Molecular Targets
and Cancer Therapeutics, taking place October 26 - 30 in
Boston.
“Today we report the promising anti-tumor activity of ZW25 in
combination with chemotherapy for people with HER2-expressing GEA,”
said Diana Hausman, M.D., Chief Medical Officer at Zymeworks.
“These results compare favorably with current standard of care
treatments for patients who have progressed after first-line
therapies, including trastuzumab and chemotherapy. The data further
support the prioritization of our ongoing Phase 2 trial of ZW25
plus chemotherapy as a first-line treatment for GEA and our goal of
establishing ZW25 as the new best-in-class therapy for people with
HER2‑expressing cancers.”
The FDA has granted Fast Track designation to ZW25 for
first-line HER2-positive GEA in combination with standard of care
chemotherapy, and a Phase 2 trial evaluating combination treatment
in this setting is actively enrolling patients (NCT03929666).
“The patients in this Phase 1 study have a difficult-to-treat,
advanced stage of cancer, which has progressed despite multiple
prior therapies,” said Funda Meric-Bernstam, M.D., Professor and
Chair of the Department of Investigational Cancer Therapeutics,
Medical Director of the Institute for Personalized Cancer Therapy
at The University of Texas MD Anderson Cancer Center. “The
preliminary activity and tolerability of ZW25 combination treatment
with paclitaxel or capecitabine brings hope to these patients and
warrants further investigation in a first-line setting.”
Clinical Data Presented Today
Safety and Efficacy of ZW25, a HER2-Targeted Bispecific Antibody
in Combination with Chemotherapy in Patients with Locally Advanced
and/or Metastatic HER2-Expressing Gastroesophageal Cancer
(Abstract# B001, Poster Presentation on Monday, October 28 at 12:30
pm ET)
The results from part three of an ongoing Phase 1 study present
the safety and efficacy of ZW25, at the recommended dose of 20
mg/kg every other week, in combination with paclitaxel or
capecitabine as a treatment for 14 patients with heavily pretreated
HER2-expressing GEA. Patients received a median of 2.5 prior
systemic therapies, and 93% had progressed following trastuzumab
treatment.
Nine of 14 patients were response-evaluable. Overall, the
majority of patients experienced a decrease in their target lesions
with a disease control rate of 78%, comprising five (56%) partial
responses and two (22%) stable disease. These responses were
observed in both low and high HER2-expressing GEA. At the time of
the data cut-off, four of the five partial responses had been
confirmed, and five (56%) response-evaluable patients were still on
study.
The overall safety profile of ZW25 plus chemotherapy was similar
to that seen with chemotherapy alone. The most common
treatment-related adverse events (TRAE) occurring in two or more
patients were primarily Grade 1 or 2 and manageable with
symptomatic treatment. Of the TRAE occurring in two or more
patients, Grade 3 or higher events attributed to ZW25 and/or
chemotherapy were fatigue and neutropenia (2 patients each) and
stomatitis, peripheral neuropathy, and hypokalaemia (1 patient
each). Five patients had chemotherapy dose reductions due to TRAEs,
but no patients needed ZW25 dose reductions due to adverse
events.
About the Phase 1 Clinical Trial
Zymeworks’ Phase 1 study has three parts. From part one of the
study (the dose-escalation phase), the recommended single-agent
dose was determined to be 20 mg/kg once every two weeks or 10 mg/kg
weekly. In the second part of the study (the cohort expansion
phase), additional patients are being enrolled to further assess
ZW25’s single-agent tolerability and anti-tumor activity against a
variety of cancer types in different settings. The third part of
the study (the combination phase) is underway and evaluating ZW25
in combination with selected chemotherapy agents in patients with
HER2 high or lower HER2 expression levels.
About ZW25
ZW25 is being evaluated in Phase 1 and Phase 2 clinical trials
across North America and South Korea. It is a bispecific antibody,
based on Zymeworks’ Azymetric™ platform, that can simultaneously
bind two distinct locations on 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 Fast
Track designation to ZW25 for first-line gastroesophageal
adenocarcinoma in combination with standard of care chemotherapy
and Orphan Drug designation to ZW25 for the treatment of both
gastric and ovarian cancers.
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 immuno-oncology 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 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 ZW25 and its potential as an anti-cancer
treatment, Zymeworks’ clinical plans and future results, Zymeworks’
technology platform, and other information that is not historical
information. When used herein, words such as “believe”, “may”,
“plan”, 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 the three month period
ended June 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191028005019/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
info@zymeworks.com
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