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,
announced today it will host a virtual Key Opinion Leader (KOL)
event today at 9:00am ET to discuss its NKT cell therapy programs.
Athenex had previously announced best responses
from five patients of 2 partial responses (PR), 1 complete response
with incomplete hematological recovery (CRi) and 1 complete
response (CR) from the ANCHOR Phase 1 study of KUR-502 (allogeneic
CD19 CAR-NKT cells) in relapsed /refractory lymphoma and leukemia.
At the ASH Annual Meeting yesterday, the Company provided updated
results from the study, which included a conversion of one patient
(NHL-4) treated with dose level (DL) 2, from a PR to a CR. Safety
profile of treatment with the allogeneic CAR-NKT cells remains
favorable and further enrollment is ongoing.
Register for the KOL webinar on the Investor Relations portion
of the website.
The webinar will feature presentations by KOLs Leonid Metelitsa,
M.D., and Carlos Ramos, M.D., both from Baylor College of Medicine,
and Sattva Neelapu, M.D., from MD Anderson Cancer Center. Dr.
Metelitsa will provide an overview of Athenex's CAR-NKT cell-based
approaches. Dr. Ramos will discuss the interim data from the
ongoing ANCHOR study evaluating KUR-502 in relapsed or refractory
lymphoma and leukemia. Dr. Neelapu will discuss the current
treatment landscape and unmet medical needs in lymphoma and
leukemia.
Presentations from Kurt Gunter, M.D., Chief Medical Officer for
Cell Therapy at Athenex, and Daniel Lang, M.D., President of
Athenex Cell Therapy, will follow to discuss clinical milestones
and company objectives.
A question-and-answer session will follow the formal
presentations.
About the Phase I Study of KUR-502 (Allogeneic CD19
CAR-NKT Cells) in Patients with Relapsed or Refractory B-Cell
Malignancies (ANCHOR)
The phase I study is an open-label, dose-escalation study. NKT
cells were isolated from the leukapheresis product of one
HLA-unmatched healthy individual, transduced with the CAR, expanded
ex vivo for 14 days (99.8% NKT purity), and cryopreserved. Patients
received 107 (DL 1) or 3×107 (DL 2) CAR-NKT cells per square meter
of body surface area following lymphodepleting conditioning with
cyclophosphamide/fludarabine. Adverse events were evaluated per NCI
criteria. When accessible, patients underwent core biopsies of an
involved site at 2-5 weeks post-infusion. Response to therapy was
assessed at 4 weeks per Lugano Criteria (for NHL) or NCCN
guidelines (for ALL).
For further information about the study, visit
ClinicalTrials.gov, identifier: NCT03774654.
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 mainly from the following core technologies:
(1) Orascovery, based on P-glycoprotein inhibitor, (2) Src kinase
inhibition, and (3) Cell therapy. Athenex’s employees worldwide are
dedicated to improving the lives of cancer patients by creating
more active 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,” “estimate,” “expect,” “foresee,”
“goal,” “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, including NKT Cell Therapy and
related risks involved in drug development, clinical trials,
regulation, uncertainties around regulatory reviews and approvals;
our ability to pivot our business and to find new uses for the
capacity at our Dunkirk manufacturing facility, once operational;
our ability to scale our manufacturing and commercial supply
operations for current and future approved products, and ability to
commercialize our products, once approved; 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; the
preclinical and clinical results for Athenex’s drug candidates,
which may not support further development of such drug candidates;
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; our history of operating losses and our need and ability
to raise additional capital to continue as a going concern;
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;
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; uncertainties around our ability to successfully
integrate acquired and merged businesses in a timely and
cost-effective manner and to achieve synergies; 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 facilities as well as
our ability to find alternative sources of supply to meet our
obligations and requirements; 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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