Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company
dedicated to the discovery, development and commercialization of
novel therapies for the treatment of cancer and related conditions,
today announced that its partner, Guangzhou Xiangxue Pharmaceutical
Co., Ltd., initiated a Phase I study in China of KX2-361 (formerly
known as KX-02) oral treating advanced malignant solid tumors.
KX2-361, which is being developed for the treatment of
glioblastoma multiforme (GBM), is the second compound derived from
Athenex’s Src kinase inhibition platform. It is a closely related
structural analog of Athenex’s tirbanibulin (formerly known as
KX2-391 or KX-01) with a distinct ability to cross the blood brain
barrier, making it a potential therapeutic candidate for treating
brain cancers, including GBM, as well as brain metastases. Studies
of KX2-361 oral in preclinical mouse GBM tumor models resulted in
complete tumor eradication as well as extended survival compared to
the current standard of care, temozolomide.
“KX2-361 is a potentially valuable treatment option for GBM
patients, and we are initiating this Phase I study on the strength
of encouraging results in preclinical studies,” stated Mr. YongHui
Wang, Chairman of Xiangxue Pharmaceutical. “We are excited to
advance this promising candidate in the clinic to potentially
improve the lives of patients with GBM.”
“We are impressed by the R&D capabilities of our partner and
delighted by their decision to advance another product candidate
from our Src kinase inhibition platform,” stated Dr. Johnson Lau,
Chairman and Chief Executive Officer of Athenex. “KX2-361 may
potentially expand the range of cancers we can address with our
broad oncology pipeline, especially for rare diseases with
significant unmet medical need like GBM.”
The Phase I clinical study in China is a single-center,
open-label dose escalation trial that will enroll 36-72 patients
with advanced malignant solid tumors who have no standard treatment
or standard treatment failed.
In 2012, Athenex out-licensed KX2-361 to Xiangxue Pharmaceutical
for development and marketing in Greater China and Singapore. In
May 2017, the China National Medical Products Administration (NMPA)
(formerly China FDA) allowed Xiangxue’s IND to commence clinical
trials of KX2-361 in China. Athenex also received U.S. IND
allowance for KX2-361 in 2014 and the product candidate was granted
Orphan Drug Designation by the U.S. FDA.
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; multiple locations
in Chongqing, China; and Manchester, UK. For more
information, please visit www.athenex.com.
About Guangzhou
Xiangxue Pharmaceutical Co.,
Ltd. (XPH)XPH was
founded in 1997 and is located in Guangzhou Science City, Guangzhou
Economic & Technical Development District (GETDD),
which is part of the core area of Guangdong, Hong
Kong and Macao, or the Greater Bay Area. XPH is a
high-tech enterprise integrating manufacturing, operation and
R&D of products including pharmaceuticals, biological medicine,
functional food, Chinese medicines and medical devices. XPH is
recognized as one of pharmaceutical enterprises with most
development potential in the industry in China and was
listed in Shenzhen Stock Exchange in 2010 (stock code:
300147). XPH has directed its attention to leading biomedical
technologies since 2012. XPH has built an international cooperative
innovation system focusing on focused scientific research led by
talent teams to introduce new medical innovative technologies. For
more information about XPH, visit www.xphcn.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,” “evaluate,” “expect,” “foresee,” “guidance,”
“intend,” “investigate,” “likely,” “may,” “plan,” “potential,”
“predict,” “preliminary,” “prepare,” “potential,” “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 uncertainty of when, if at all, we will
be able to resume producing API in our Chongqing plant;
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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