Zymeworks Announces Agreement with Pfizer & Initiation of a New Phase 2 Trial Evaluating ZW25 in Combination with Ibrance® (...
January 12 2020 - 10:00AM
Business Wire
- Potential
for a Novel Chemotherapy-Free Treatment Option for People with
Advanced HER2-positive, HR-positive Breast Cancer
Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical
company developing multifunctional therapeutics, today announced
the initiation of a Phase 2 trial evaluating ZW25 combination
therapy and an agreement with Pfizer which advances the study.
Zymeworks’ HER2-targeted bispecific antibody ZW25 is being
evaluated in combination with Pfizer’s Ibrance® (palbociclib), an
oral CDK4/6 inhibitor, and the hormone therapy fulvestrant in
patients with previously-treated locally advanced and/or metastatic
HER2-positive, HR-positive breast cancer. Zymeworks will sponsor
the study, and Pfizer will provide palbociclib.
“The initiation of this Phase 2 trial and collaboration with
Pfizer mark significant milestones in our progress towards
establishing ZW25 as the foundational HER2 therapy in multiple
regimens across breast and other cancers,” said Diana Hausman,
M.D., Chief Medical Officer at Zymeworks. “Together, ZW25 and
palbociclib have the potential to improve anti-tumor activity and
minimize side effects for people living with advanced
HER2‑positive, HR-positive breast cancer.”
This Phase 2 clinical trial is a multicenter, open-label,
two-part study (clinicaltrials.gov: NCT04224272). Part one of the
study will evaluate the safety and tolerability of ZW25 in
combination with palbociclib and fulvestrant and identify the
recommended doses (RD) of ZW25 and palbociclib. Part two of the
study will evaluate anti-tumor activity at the RD level. The trial
will enroll up to 76 patients at sites in the United States and
Canada, and expansion to Spain is planned.
ZW25 is being evaluated within a broad clinical development
program in multiple HER2‑expressing cancers, including biliary
tract, gastroesophageal adenocarcinoma (GEA), breast, colorectal,
and gynecologic cancers. In an ongoing Phase 1 clinical trial,
Zymeworks is evaluating ZW25 as a single agent and in combination
with chemotherapy as potential treatments for patients with
HER2-expressing cancers (clinicaltrials.gov: NCT02892123). For
patients with HER2-positive GEA, ZW25 is being studied in a Phase 2
trial as a first-line treatment in combination with standard of
care chemotherapy (clinicaltrials.gov: NCT03929666). Zymeworks
plans to initiate a registration-enabling Phase 2 trial in
previously-treated or recurrent HER2-positive biliary tract cancer
in 2020.
About Breast Cancer
Breast cancer occurs when cells of the breast grow
uncontrollably. According to the World Health Organization, each
year, over 2 million new cases of breast cancer are diagnosed and
over 600,000 deaths occur globally. Rates are increasing in nearly
every region of the world. For locally advanced or metastatic
breast cancer, the American Cancer Society estimates over 271,000
new US cases in men and women this year. About 15 to 20 percent of
all breast cancers are positive for human epidermal growth factor
receptor 2, or HER2. These cancers make too much HER2 protein,
which may cause them to grow more quickly and spread to other parts
of the body. Despite the advances with available HER2-targeted
therapies, there is still an unmet medical need for people with all
HER2-expressing cancers, particularly recurrent or metastatic
disease that has progressed after standard of care therapy.
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 solid tumors that express 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 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 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’ collaboration with Pfizer and the potential
efficacy of ZW25 in combination with palbociclib, Zymeworks’
clinical plans and future results, Zymeworks’ technology platform,
and other information that is not historical information. When used
herein, words such as “will”, “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.
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version on businesswire.com: https://www.businesswire.com/news/home/20200112005029/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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