Athenex Announces Clinical Collaboration with Merck to Evaluate Oraxol plus KEYTRUDA® (pembrolizumab) in Patients with Non-Small Cell Lung Cancer (NSCLC)
May 16 2022 - 8:00AM
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 a clinical trial collaboration and supply agreement
with Merck (known as MSD outside the US and Canada). The agreement
applies to the expansion phase of the Phase 1 clinical trial
evaluating Athenex’s oral paclitaxel in combination with Merck’s
anti-PD-1 therapy KEYTRUDA® (pembrolizumab) for certain NSCLC
patients.
The agreement will support the expansion phase
of the trial to further investigate the preliminary encouraging
results of the KX-ORAX-011 Phase 1 clinical trial evaluating Oraxol
(encequidar plus oral paclitaxel) in combination with pembrolizumab
for certain NSCLC patients. The two companies will form a Joint
Development Committee to review the clinical trial results.
“We are keen to collaborate with Merck to
further investigate the therapeutic potential of Oraxol plus
KEYTRUDA® in patients with NSCLC patients who progressed on
previous anti-PD1/ anti-PD-L1 therapy or in combination with
chemotherapy,” said Dr. Rudolf Kwan, Chief Medical Officer of
Athenex. “If the preliminary efficacy and safety data can be
confirmed, it may lead to a new paradigm in the treatment of
certain NSCLC patients.”
KX-ORAX-011 is an ongoing Phase 1 trial
evaluating Oraxol in combination with pembrolizumab in patients
with advanced solid tumors. Following completion of the dose
escalation phase, the expansion phase is currently evaluating the
combination therapy in patients with NSCLC who progressed on
previous anti-PD1/ anti-PD-L1 therapy or in combination with
chemotherapy. The NSCLC expansion cohort is actively recruiting and
aims to enroll approximately 50 patients.
KEYTRUDA® is a registered trademark of Merck
Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc.,
Rahway, NJ, USA.
About Oral Paclitaxel Athenex’s
oral paclitaxel and encequidar (“oral paclitaxel”) is in the
earlier stages of development for solid malignancies. Encequidar,
the cornerstone of Athenex’s Orascovery technology platform, is a
highly specific and potent inhibitor of the transport protein
called P-glycoprotein (P-gp) in the gastrointestinal (GI) tract. By
localizing P-gp inhibitory activity in the GI tract, encequidar
improves the absorption of chemotherapeutic agents while limiting
the potential for unnecessary P-gp inhibition at other sites in the
body. The potency, selectivity, and low absorption of encequidar
enables the oral administration of IV chemotherapies.
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 cell therapy drugs for the
treatment of cancer. In pursuit of this mission,
Athenex leverages years of experience in research and
development, clinical trials, regulatory standards, and
manufacturing. The Company’s current clinical pipeline is derived
mainly from the following core technologies: (1) Cell therapy based
on NKT cells, (2) Orascovery, based on a P-glycoprotein inhibitor,
and (3) Src Kinase Inhibition. Athenex’s employees worldwide are
dedicated to improving the lives of cancer patients by creating
more active, accessible and tolerable treatments. 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,” “expect,” “guidance,”
“implementing,” “intend,” “may,” “plan,” “underway,” “will,” 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: our history of operating losses and our need
and ability to raise additional capital to continue as a going
concern; our ability to successfully redirect our resources and
reduce our operating expenses; our ability to uncertainties around
our ability to enter into new financing agreements as we are unable
to meet funding conditions under our existing financing agreements
and access to capital thereunder; the development stage of our
primary clinical candidates, including NKT Cell Therapy and related
risks involved in drug development, clinical trials, regulation,
uncertainties around regulatory reviews and approvals; the
preclinical and clinical results for Athenex’s drug candidates,
which may not support further development of such drug candidates;
the Company’s ability to successfully demonstrate the safety and
efficacy of its drug candidates and gain approval of its drug
candidates on a timely basis, if at all; risks related to our
ability to successfully integrate the business of Kuur into our
existing businesses, including uncertainties associated with
maintaining relationships with customers, vendors and employees, as
well as differences in operations, cultures, and management
philosophies that may delay successful integration and our ability
to support the added cost burden of Kuur’s business; risks related
to counterparty performance, including our reliance on third
parties for success in certain areas of Athenex’s business; risks
and uncertainties inherent in litigation, including purported
stockholder class actions; risks and uncertainties related to the
COVID-19 pandemic and its ongoing impact on our operations, supply
chain, cash flow and financial condition; competition; intellectual
property risks; risks relating to doing business internationally
and in China; the risk of development, operational delays,
production slowdowns or stoppages or other interruptions at our
manufacturing facility as well as our ability to find alternative
sources of supply to meet our obligations and requirements; whether
we enter into a preferred contract manufacturing agreement with
ImmunityBio; the risk that our common stock will be delisted from
the Nasdaq Global Market if we are unable to regain compliance with
its continued listing standards, 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.
Athenex Contacts
Investors
Daniel Lang, MDAthenex, Inc.Email: danlang@athenex.com
Caileigh DoughertyAthenex, Inc.Email: cdougherty@athenex.com
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