- Single Agent Activity and
Durable Disease Control Across Multiple Tumor Types
- Data Support the Initiation
of a Registration-Enabling Phase 2 Trial Evaluating Single Agent
ZW25 in Second-Line HER2-Expressing Biliary Tract
Cancers
Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage
biopharmaceutical company developing multifunctional therapeutics,
today announced updated data from the ongoing multi-center Phase 1
clinical trial evaluating ZW25 in patients with HER2‑expressing
solid tumors, including biliary tract cancer (BTC), colorectal
cancer (CRC), gynecological cancers, and gastroesophageal
adenocarcinoma (GEA), in a poster discussion presentation at the
ESMO 2019 Congress, taking place September 27 - October 1 in
Barcelona, Spain.
“The data presented today at ESMO confirm previous findings that
ZW25 monotherapy can provide durable disease control in patients
with a variety of HER2-expressing solid tumors that have progressed
following standard of care therapies, including HER2-targeted
agents,” said Diana Hausman, M.D., Chief Medical Officer at
Zymeworks. “Notably, the single agent objective response rate in
biliary tract cancer is highly encouraging given the poor prognosis
and limited treatment options for these patients. We are working
closely with regulatory agencies to initiate a
registration-enabling Phase 2 trial in second-line HER2‑expressing
biliary tract cancer with the goal of bringing ZW25 to patients as
quickly as possible.”
Based on the data from the ongoing Phase 1 study, Zymeworks has
initiated a broad clinical development program for ZW25 in multiple
HER2-expressing cancers. In addition to the Phase 2 BTC trial
announced today, Zymeworks is continuing to evaluate ZW25 as a
potential treatment for patients with other HER2-expressing
cancers, including CRC and gynecological cancers (Phase 1;
NCT02892123). For patients with HER2-expressing GEA, ZW25 is being
developed as a first-line treatment in combination with standard of
care chemotherapy (Phase 2; NCT03929666). Zymeworks also plans to
initiate a Phase 2 study of ZW25 in combination with a CDK4/6
inhibitor and hormone therapy in third-line HER2-expressing,
HR-positive breast cancer.
ZW25 Clinical Results Presented Today The Safety,
Efficacy and Biomarker Results of the HER2-Targeted Bispecific
Antibody ZW25 in HER2-Expressing Solid Tumors (Abstract# 3575,
Poster Discussion on Saturday, September 28 at 4:30 pm CEST)
Findings from this ongoing Phase 1 study of ZW25 in patients
with HER2-expressing solid tumors were last presented at the 2018
EORTC-NCI-AACR Symposium. The updated results were presented today
by Dr. Funda Meric-Bernstram, M.D., Clinical Investigator and Chair
of the Department of Investigational Cancer Therapeutics at The
University of Texas MD Anderson Cancer Center.
Data were reported from 58 patients diagnosed with
HER2-expressing solid tumors other than breast cancer who received
ZW25 at the recommended dose of either 10 mg/kg weekly or 20 mg/kg
every other week. Patients had a median age of 61 years and
received a median of four prior therapies. Thirty-two (55%)
patients received prior HER2‑targeted therapies including 87% of
GEA patients. Of all patients, 23 were diagnosed with GEA, 13 with
CRC, nine with BTC, and 13 with other HER2‑expressing cancers,
including endometrial, ovarian, pancreatic, and salivary gland.
At the time of data cut-off, 46 of 58 patients were response
evaluable. Overall, the majority of patients experienced a decrease
in their target lesions with a disease control rate of 72%,
comprising 16 (35%) patients with partial responses and 17 (37%)
with stable disease. The objective response rate in the six
evaluable biliary tract cancer patients was 67%, with the majority
of patients experiencing disease control greater than six months.
In the 11 CRC and 19 GEA patients, the objective response rates
were 36% and 32%, respectively. The overall median progression-free
survival was 5.2 months, with 27 (47%) of the 58 total patients
still on study at the time of data cut-off.
Among all patients, ZW25 was well tolerated as an outpatient
therapy. The most common adverse events were diarrhea,
infusion-related reaction, and nausea. All treatment-related
adverse events occurring in 10% or more of patients were Grade 1 or
2.
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
gastroesophageal and breast cancer 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 non-overlapping epitopes of 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20190928005012/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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