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 it will host a virtual key opinion leader
(KOL) event on its CAR-NKT technology on Monday, December 13th, at
9:00 am ET.
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. These data will also
be featured in a poster presentation at the American Society of
Hematology (ASH) Annual Meeting and Exposition, being held
from December 11th to December 14th. Dr. Neelapu
will discuss the current treatment landscape and unmet medical
needs in lymphoma/myeloma.
Presentations from Kurt Gunter, M.D., Chief
Medical Officer for Cell Therapy at Athenex, and Daniel Lang, M.D.
President, Athenex Cell Therapy, will follow. Dr. Gunter will
discuss clinical milestones and company objectives.
A question-and-answer session will follow the
formal presentations. To register for the webinar, please click
here.
Presenting Key Opinion Leaders:
Dr. Carlos Ramos is currently
an Associate Professor of Medicine in the Center for Cell and Gene
Therapy at the Baylor College of Medicine, and an Attending
Physician in the Blood and Marrow Transplantation Service at the
Houston Methodist Hospital. As a faculty member, he has focused his
research efforts on T-cell therapy for malignancies and viral
infections. He has broad experience in cellular therapy for
hematologic cancers, being the principal investigator in trials
using chimeric antigen receptor (CAR)-modified T cells targeting
CD19, CD30 and kappa light chain as therapy for non-Hodgkin and
Hodgkin lymphoma and multiple myeloma. He is also implementing
cellular therapy approaches for patients with Human Papilloma Virus
(HPV)-associated malignancies, using HPV-specific T cells. Dr.
Ramos earned his Medical Degree with Honors from the University of
Lisbon, Portugal, and was a Resident in Internal Medicine at the
Baylor College of Medicine, in Houston. He completed Fellowships in
Hematology and Medical Oncology at the Memorial Sloan-Kettering
Cancer Center, in New York, and in Blood and Marrow Transplantation
at the University of Texas M. D. Anderson Cancer Center, in
Houston.
Dr. Leonid Metelitsa is
involved in research focused on understanding the role of
Vα24-invariant natural killer T cells (iNKTs) in tumor immunity.
Using clinical samples from neuroblastoma patients, his lab
demonstrated for the first time that iNKTs localize to primary
tumors and their presence at the tumor site is associated with good
outcome. In the pursuit of the underlying mechanistic basis for the
observed association between iNKTs and clinical outcome, Dr.
Metelitsa’s group has published a series of high-impact papers that
revealed the mechanisms of iNKT cell tumor localization and
function in the tumor microenvironment. In one of these studies,
they discovered the mechanism by which iNKTs attack
tumor-associated macrophages (TAMs). That study has had a major
impact in the fields of NKT cell and neuroblastoma research. First,
it explained how iNKTs can mediate antitumor activity against
CD1d-negative tumors, the majority of solid tumors in humans.
Second, it showed for the first time that macrophages infiltrate
primary tumors in a subset of neuroblastoma patients, their
products directly support tumor growth, and their presence at the
tumor site is associated with poor clinical outcome. This discovery
has been validated in large international study validated using
large independent cohorts of patients, concluding that the presence
of M2-like macrophages is associated with a novel inflammatory
signature in neuroblastoma that serves as an independent prognostic
factor of extremely poor outcome. Most recently, Dr. Metelitsa has
been focused on the development of therapeutic applications using
iNKTs and their synthetic ligands.
Dr. Sattva Neelapu is professor
and deputy chair of Lymphoma and Myeloma at The University of Texas
MD Anderson Cancer Center in Houston, Texas. As a
physician-scientist at MD Anderson, Dr. Neelapu is focused on
clinical and translational development of novel immunotherapies for
B-cell malignancies. His laboratory characterized some of the major
immunosuppressive mechanisms in the tumor microenvironment of
B-cell malignancies, identified TCL1 as a novel shared
tumor-associated antigen for B-cell lymphomas, and investigated
novel targets for CAR T-cell therapy in lymphoma and myeloma. His
work on the pivotal trial of axicabtagene ciloleucel CD19 CAR
T-cell therapy in aggressive B-cell lymphomas led to its FDA
approval as the first CAR T therapy for lymphoma. Dr. Neelapu has
authored or co-authored over 150 publications.
Presenting Athenex Cell Therapy Management:
Dr. Dan Lang has over 25 years
of medicine, healthcare investment as well as leadership and
business experience. Prior to joining Athenex, Dan was the Chief
Investment Officer of the RS Value franchise focused on domestic
equity strategies. Dan was on the executive team of RS Investment
Management (RSIM) that led the sale of RSIM to Victory Capital in
2016. Prior to joining RSIM in 2009, he was an analyst at Farallon
Capital Management covering biotech, medical device, pharma, and
healthcare services globally. Previously, he was a senior associate
at a venture capital firm, Brilleon Capital and the co-founder and
CFO of Sapient Medical Group. Dan’s 25+ years of business and
investment experience is preceded by a distinguished career in
medicine. He was a post-doctoral research and clinical fellow in
cardiology at the University of California, San Francisco and the
Gladstone Cardiovascular Research Institute. He was board certified
in internal medicine and a Chief Medical Resident at Mount Sinai
Hospital in New York. Dan holds a BA in Chemistry from Cornell
University and an MD from Cornell University Medical College.
Dr. Kurt Gunter has devoted his
career to the development of cell and gene therapies and brings
significant experience to Athenex from his previous positions at
Kuur Therapeutics, Hospira, ViaCell, and Transkaryotic Therapies.
As past President of the International Society for Cellular Therapy
(ISCT), Dr. Gunter played a worldwide leadership role in promoting
understanding of the clinical, regulatory, manufacturing, and
marketing requirements for the successful development of cell and
gene therapies. Prior to his biotech career, he worked at the
United States Food and Drug Administration as a Medical Officer in
the Center for Biologics and was appointed Acting Deputy Director
of the Division of Cell and Gene Therapy within the Center for
Biologics Evaluation and Research. He also served for 5 years on
FDA’s Cellular, Tissue and Gene Therapies Advisory Committee. He
earned his MD from the University of Kansas and also has a BS in
biological sciences, with distinction, from Stanford University.
His postdoctoral training included Johns Hopkins and the US
National Institutes of Health.
ASH Poster Presentation:
Session Name: 704. Cellular Immunotherapies:
Clinical: Poster II Date: Sunday, December 12, 2021 Presentation
Time: 6:00 PM - 8:00 PM Location: Georgia World Congress Center,
Hall B5
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.
Contacts
Investors:
Daniel Lang, MDAthenex, Inc.Email: danlang@athenex.com
Caileigh DoughertyAthenex, Inc.Email: cdougherty@athenex.com
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