Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical
company developing multifunctional biotherapeutics, and ALX
Oncology Holdings Inc. (NASDAQ: ALXO), a clinical-stage
immuno-oncology company developing therapies that block the CD47
checkpoint pathway, today announced the first patient has been
dosed in an open-label, multi-center Phase 1b/2 clinical trial
conducted by Zymeworks.
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the full release here:
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The trial is designed to evaluate the safety and efficacy of
zanidatamab, Zymeworks’ lead HER2‑targeted bispecific antibody, in
combination with evorpacept (ALX148), ALX’s CD47 blocker, in
patients with advanced HER2-positive breast cancer, HER2-low breast
cancer and additional non-breast HER2-expressing solid tumors.
This collaboration builds on the promising antitumor activity
observed in clinical trials of evorpacept combined with a
HER2-targeted antibody in patients with advanced HER2‑positive
gastric or gastroesophageal junction cancer. The addition of CD47
blockade is designed to enhance zanidatamab’s immunotherapeutic
effects and has the potential to provide benefit to a broad
population of patients, including those with advanced
HER2‑expressing breast cancer and potentially other HER2‑expressing
cancers.
About the Zanidatamab-Evorpacept Combination
Zanidatamab is designed to have multiple mechanisms of action,
including immune clearance of HER2‑expressing tumor cells by
macrophages through antibody-dependent cellular phagocytosis
(ADCP). CD47 is a “don’t eat me” signal that acts as a checkpoint
inhibitor to macrophages. Cancer cells that express CD47 are
resistant to immune clearance even when targeted with therapeutic
antibodies. Treatment with zanidatamab plus evorpacept has the
potential to increase the immune clearance of HER2-expressing
cancer cells by combining a biparatopic antibody capable of binding
at higher density than monospecific antibodies with a molecule that
blocks CD47 on the same targeted cancer cells.
About Zanidatamab
Zanidatamab is a bispecific antibody, based on Zymeworks’
Azymetric™ platform, that can simultaneously bind two
non-overlapping epitopes of HER2, known as biparatopic binding.
Zanidatamab’s unique binding properties result in multiple
mechanisms of action including HER2-receptor clustering,
internalization, and downregulation; inhibition of growth
factor-dependent and -independent tumor cell proliferation;
antibody-dependent cellular cytotoxicity and phagocytosis; and
complement-dependent cytotoxicity. Zymeworks is developing
zanidatamab in multiple Phase 1, Phase 2, and pivotal clinical
trials globally as a targeted treatment option for patients with
solid tumors that express HER2. The FDA has granted Breakthrough
Therapy designation for zanidatamab in patients with previously
treated HER2 gene-amplified biliary tract cancer (BTC), and two
Fast Track designations to zanidatamab, one as monotherapy for
refractory BTC and one in combination with standard of care
chemotherapy for first-line gastroesophageal adenocarcinoma (GEA).
These designations mean zanidatamab is eligible for Accelerated
Approval, Priority Review and Rolling Review, as well as intensive
FDA guidance on an efficient drug development program. Zanidatamab
has also received Orphan Drug designations from the FDA as well as
the European Medicines Agency for the treatment of biliary tract
and gastric cancers.
About Evorpacept
Evorpacept is a next-generation CD47 blocking therapeutic that
combines a high-affinity CD47 binding domain with an inactivated,
proprietary Fc domain. Evorpacept is designed to avoid the
limitations caused by hematologic toxicities inherent in other CD47
blocking approaches, and to leverage the immune activation of
broadly used anti-cancer agents through combination strategies. ALX
Oncology is developing evorpacept in multiple Phase 1 and Phase 2
clinical trials globally across a range of hematologic and solid
malignancies in combination with a number of leading anti-cancer
agents. The FDA has granted two Fast Track designations to
evorpacept, one for the first-line treatment of patients with head
and neck squamous cell carcinoma, and one for the second-line
treatment of patients with HER2-positive gastric or
gastroesophageal junction carcinoma. The FDA’s Fast Track
designation provides the opportunity for more frequent meetings
with the FDA over the course of drug development and allows for
eligibility for Accelerated Approval and Priority Review if
relevant criteria are met, as well as for Rolling Review.
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, zanidatamab (ZW25), is a novel Azymetric™
bispecific antibody which has been granted Breakthrough Therapy
designation by the FDA and is currently enrolling in a pivotal
clinical trial for refractory HER2-amplified biliary tract cancer
(HERIZON-BTC-01) as well as several Phase 2 clinical trials for
HER2-expressing gastroesophageal, colorectal, and breast cancers.
Zymeworks’ second clinical candidate, ZW49, is a novel bispecific
HER2-targeting 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 nine
biopharmaceutical companies. For additional information about
Zymeworks, visit www.zymeworks.com and follow @ZymeworksInc on
Twitter.
About ALX Oncology
ALX Oncology is a publicly traded, clinical-stage
immuno-oncology company focused on helping patients fight cancer by
developing therapies that block the CD47 checkpoint pathway and
bridge the innate and adaptive immune system. ALX Oncology’s lead
product candidate, evorpacept, has demonstrated promising clinical
responses across a range of hematologic and solid malignancies in
combination with a number of leading anti-cancer agents. ALX
Oncology intends to continue clinical development of evorpacept for
the treatment of multiple solid tumor indications and hematologic
malignances, including acute myeloid leukemia and myelodysplastic
syndrome. ALX Oncology has entered into strategic partnerships with
multiple biopharmaceutical companies to support indications that
entail large unmet medical needs. For additional information about
ALX Oncology, visit www.alxoncology.com and follow @AlxOncology on
Twitter.
Zymeworks 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
Zymeworks’ expectations regarding the beneficial characteristics,
safety, and therapeutic effects of zanidatamab, its trial combining
zanidatamab and evorpacept, the potential benefits of that
combination, and other information that is not historical
information. When used herein, words such as “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, market conditions and the
factors described under “Risk Factors” in Zymeworks’ Quarterly
Report on Form 10-Q for its quarter ended June 30, 2021 (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.
ALX Oncology Cautionary Note Regarding Forward-Looking
Statements
This press release contains forward-looking statements that
involve substantial risks and uncertainties. Forward-looking
statements include statements regarding future results of
operations and financial position, business strategy, product
candidates, planned preclinical studies and clinical trials,
results of clinical trials, research and development costs,
regulatory approvals, timing and likelihood of success, plans and
objects of management for future operations, as well as statements
regarding industry trends. Such forward-looking statements are
based on ALX Oncology’s beliefs and assumptions and on information
currently available to it on the date of this press release.
Forward-looking statements may involve known and unknown risks,
uncertainties and other factors that may cause ALX Oncology’s
actual results, performance or achievements to be materially
different from those expressed or implied by the forward-looking
statements. These and other risks are described more fully in ALX
Oncology’s filings with the Securities and Exchange Commission
(“SEC”), including ALX Oncology’s Annual Reports on Form 10-K,
Quarterly Reports on Form 10-Q and other documents ALX Oncology
files with the SEC from time to time. Except to the extent required
by law, ALX Oncology undertakes no obligation to update such
statements to reflect events that occur or circumstances that exist
after the date on which they were made.
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version on businesswire.com: https://www.businesswire.com/news/home/20211005005450/en/
Zymeworks Inc.
Investor Inquiries: Ryan Dercho, Ph.D. (604) 678-1388
ir@zymeworks.com
Jack Spinks (604) 678-1388 ir@zymeworks.com
Media Inquiries: Mary Klem (604) 678-1388
media@zymeworks.com
ALX Oncology
Investor Inquiries
Peter Garcia Chief Financial Officer, ALX Oncology (650)
466-7125 Ext. 113 peter@alxoncology.com
Argot Partners (212)-600-1902 alx@argotpartners.com
Media Inquiries Karen Sharma MacDougall (781) 235-3060
alx@macbiocom.com
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