Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical
company developing multifunctional therapeutics, today announced
updated Phase 1 data for single agent ZW25 in heavily pretreated
patients with HER2‑expressing solid tumors in a mini oral
presentation by Dr. Do-Youn Oh, study investigator and Professor at
Seoul National University, at the ESMO Asia 2019 Congress, taking
place November 22 - 24 in Singapore. Zymeworks and its collaborator
BeiGene, Ltd. plan to advance ZW25 into potentially
registration-enabling global studies in HER2-expressing biliary
tract cancer (BTC) and gastroesophageal adenocarcinoma (GEA), based
on these durable and consistent clinical data.
“The promising ZW25 data at ESMO Asia further build momentum for
the expanding footprint of our ZW25 clinical development program
with BeiGene,” said Ali Tehrani, Ph.D., President and CEO of
Zymeworks. “Cancer is a global fight, and this strong collaboration
helps us to rapidly execute on upcoming late-stage studies for
people with HER2-expressing cancers worldwide.”
“The encouraging clinical data on ZW25 supports further
evaluation of this bispecific antibody in HER2-expressing solid
tumors,” said John V. Oyler, Co-Founder, CEO, and Chairman of
BeiGene. “We’re enthusiastic about the meaningful progress of ZW25
since we established the collaboration with Zymeworks one year ago
and look forward to leveraging our unique strengths and expertise
to advance ZW25 clinical development globally.”
The updated single agent results of the ongoing Phase 1 trial of
ZW25 in patients with HER2‑expressing solid tumors include
additional safety and anti-tumor activity data from those presented
at the ESMO 2019 Congress.
ZW25 Clinical Results Presented Today
Safety, Anti-Tumor Activity, and Biomarker Results of the
HER2-Targeted Bispecific Antibody ZW25 in HER2-Expressing Solid
Tumors (Presentation# 61O, Mini Oral on Friday, November 22 at 3:30
pm SGT)
Data were reported from 69 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. Overall, patients received a median of three
prior systemic therapies. Those with BTC, GEA, and colorectal
cancer (CRC) received a median of 4.5, 3, and 5.5 prior systemic
therapies, respectively. Forty-one (59%) patients received prior
HER2‑targeted therapies, including 93% of GEA patients. Eleven
patients were diagnosed with BTC, 28 with GEA, 14 with CRC, and 16
with other HER2‑expressing cancers, including endometrial, ovarian,
pancreatic, and salivary gland.
Fifty-seven of 69 patients were response evaluable at the time
of data cut-off. Overall, the disease control rate (DCR) was 70%,
comprising 25 (44%) partial responses and 15 (26%) with stable
disease, and 18 (32%) patients experienced disease control for
greater than six months. In the nine evaluable biliary tract cancer
patients, the DCR was 78%, and the objective response rate (ORR)
was 67%. In the 13 CRC and 23 GEA patients, ORRs were 46% and 39%,
respectively. Notably, confirmed responses were seen across
additional tumor types, including a 100% decrease in target lesions
in a patient with pancreatic cancer. The overall median
progression-free survival was 5.5 months and is still evolving.
Among all patients, ZW25 was well tolerated as an outpatient
therapy. The most common treatment-related adverse events (TRAE)
were diarrhea (43%), infusion-related reaction (26%), and nausea
(13%). All TRAEs 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. More information about ZW25 clinical trials
can be found at clinicaltrials.gov.
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 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20191121005148/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
Zymeworks (NYSE:ZYME)
Historical Stock Chart
From Aug 2024 to Sep 2024
Zymeworks (NYSE:ZYME)
Historical Stock Chart
From Sep 2023 to Sep 2024