Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company
dedicated to the discovery, development and commercialization of
novel therapies for the treatment of cancer, today announced that
the U.S. Food and Drug Administration (FDA) has allowed the
Company’s Investigational New Drug (IND) application for the
clinical investigation of PT01 (Pegtomarginase) for the treatment
of patients with advanced malignancies. The allowance is contingent
upon formal submission of agreed upon updates to the IND.
Pegtomarginase is a biologic product candidate in Athenex’s
pipeline that is designed to provide a metabolic approach to the
treatment of cancer through arginine deprivation therapy.
Pegtomarginase is a PEGylated genetically modified human
arginase that targets cancer growth and survival by removing the
supply of an amino acid, arginine. A significant proportion of
cancer types lack the ability to synthesize arginine due to
deficient expression of certain metabolic enzymes of the urea
cycle, including argininosuccinate synthetase 1 (ASS1),
argininosuccinate lyase (ASL) or ornithine transcarbamylase (OTC).
By depleting circulating arginine, growth of cancers with a
disrupted urea cycle can be halted and cell death can be induced.
Healthy cells capable of producing sufficient arginine would be
largely unaffected. Previous arginine depleting therapies employed
enzymes that were derived from non-human origin, which can trigger
the development of neutralizing antibodies, or had multiple
PEGylation sites with multiple positional isomers in the product.
Athenex believes that its therapeutic Pegtomarginase, initially
developed by The Hong Kong Polytechnic University (PolyU) and
Avalon Biomedical (Management) Limited (Avalon Biomedical),
possesses many promising attributes, notably the human-derived
origin and recombinant modification that has enabled site-specific
PEGylation. The resulting single isomer has a predictable and
extended duration of action as demonstrated by durable arginine
depletion in preclinical studies.
“We are excited to further explore this innovative approach to
treating a broad range of cancers using this biologic product,”
stated Dr. Michael Smolinski, Senior Director, Preclinical
Operations of Athenex. “We were encouraged by Pegtomarginase’s
compelling profile, specifically the defined site-directed
PEGylation and the resulting high activity at well-tolerated doses
observed in preclinical studies. We are pleased to advance this
program into the clinic and believe it offers a step forward for
metabolic therapies in oncology.”
Dr. Johnson Lau, Chairman and Chief Executive Officer of
Athenex, added, “This will be the Company’s ninth IND candidate
allowed by the FDA, demonstrating the strong execution capabilities
of our research and development team. Advancing this program is in
line with our strategy to expand the types of therapeutic options
for cancer patients. We believe Pegtomarginase has significant
potential not only as a monotherapy, but also in combination with
other oncology therapeutics, including those in Athenex’s pipeline.
In addition, we believe this paves the way for the use of metabolic
therapeutics to condition the tumor microenvironment in order to
enhance the anti-tumor activity of different therapies in
combination.”
Ir Professor Alexander Wai, Vice President (Research
Development) of PolyU, commented, “We are delighted by this
significant milestone achieved for Pegtomarginase, which was
initially developed by the research team led by Professors Thomas
Leung and Thomas Lo in the Department of Applied Biology and
Chemical Technology and Lo Ka Chung Research Center for Natural
Anti-Cancer Drug Development at PolyU. We have learned a lot
through the collaboration with Avalon Biomedical and Athenex, which
has also been extremely rewarding. We are deeply impressed by the
strong execution capabilities at Athenex and the team’s commitment
to commercializing novel technologies for the treatment of a wide
range of cancers.”
Athenex recently presented preclinical study results of
Pegtomarginase in a poster session at the 2019 American Society of
Clinical Oncology Annual Meeting. The biologic agent demonstrated
high enzymatic activity, predictable
pharmacokinetic-pharmacodynamic profiles, and cytotoxicity in
vitro. Mouse xenograft models showed good tumor growth inhibition
activity at tolerable doses with only transient weight loss during
therapy.
Athenex licensed the worldwide rights to develop and
commercialize Pegtomarginase from Avalon PolyTom (HK) Limited, a
subsidiary of Avalon Biomedical. Pegtomarginase was initially
developed by PolyU and subsequently licensed to Avalon PolyTom
during the initial phase of preclinical development.
Arginine Deprivation Therapy:Arginine is an
essential amino acid to many tumor types for survival and growth.
Many cancers have deficient expression of certain metabolic enzymes
such as argininosuccinate synthetase 1 (ASS1), argininosuccinate
lyase (ASL) or ornithine transcarbamylase (OTC), which are needed
to synthesize arginine. Such cancers, also known as
arginine-auxotrophic cancers, depend on external sources of
arginine, making arginine deprivation therapy a potentially viable
strategy for tumor treatment.
About Athenex, Inc.Founded in
2003, Athenex, Inc. is a global clinical stage
biopharmaceutical company dedicated to becoming a leader in the
discovery, development and commercialization of next generation
drugs for the treatment of cancer. Athenex is organized
around three platforms, including an Oncology Innovation Platform,
a Commercial Platform and a Global Supply Chain Platform. The
Company’s current clinical pipeline is derived from four different
platform technologies: (1) Orascovery, based on non-absorbed
P-glycoprotein inhibitor, (2) Src kinase inhibition, (3) T-cell
receptor-engineered T-cells (TCR-T), and (4) Arginine deprivation
therapy. Athenex’s employees worldwide are dedicated to improving
the lives of cancer patients by creating more active and tolerable
treatments. Athenex has offices
in Buffalo and Clarence, New York; Cranford,
New Jersey; Houston, Texas; Chicago, Illinois; Hong
Kong; Taipei, Taiwan; and multiple locations
in Chongqing, China. For more information, please
visit www.athenex.com.
Forward-Looking Statements Except for
historical information, all of the statements, expectations, and
assumptions contained in this press release are forward-looking
statements. These forward-looking statements are typically
identified by terms such as “anticipate,” “believe,” “continue,”
“could,” “estimate,” “expect,” “foresee,” “guidance,” “intend,”
“likely,” “may,” “plan,” “potential,” “predict,” “preliminary,”
“probable,” “project,” “promising,” “seek,” “should,” “will,”
“would,” and similar expressions. Actual results might differ
materially from those explicit or implicit in the forward-looking
statements. Important factors that could cause actual results to
differ materially include: the development stage of our primary
clinical candidates and related risks involved in drug development,
clinical trials, regulation, manufacturing and commercialization;
our reliance on third parties for success in certain areas of
Athenex’s business; our history of operating losses and need to
raise additional capital to continue as a going concern;
competition; intellectual property risks; risks relating to doing
business in China; the uncertain impact of inspections to be
performed by the Department of Emergency Management of Chongqing on
the production of API in our Chongqing plant and our business
generally; and the other risk factors set forth from time to time
in our SEC filings, copies of which are available for
free in the Investor Relations section of our website
at http://ir.athenex.com/phoenix.zhtml?c=254495&p=irol-sec or
upon request from our Investor Relations Department. All
information provided in this release is as of the date hereof and
we assume no obligation and do not intend to update these
forward-looking statements, except as required by law.
CONTACTS Investor Relations: Tim McCarthy
Managing Director, LifeSci Advisors, LLC Tel: +1
716-427-2952 Direct: +1 212-915-2564
Athenex, Inc.: Randoll Sze Chief Financial Officer
Email: randollsze@athenex.com Jacqueline Li Corporate
Development and Investor Relations
Email: jacquelineli@athenex.com
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