Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf,
allogeneic T-cell immunotherapy company developing novel treatments
for patients with cancer, autoimmune and viral diseases, today
announced the opening of its Atara T-Cell Operations and
Manufacturing (ATOM) facility in Thousand Oaks, California. ATOM
features approximately 90,000 square feet dedicated to
manufacturing the Company’s off-the-shelf T-cell immunotherapies,
as well as additional space for R&D labs and offices for
Atara’s Southern California technical operations. The facility
provides production capacity to support Atara’s robust pipeline,
and its flexible design allows for potential manufacturing
expansion of tab-cel™ (tabelecleucel), Atara’s most advanced
off-the-shelf T-cell immunotherapy.
“The opening of ATOM in Thousand Oaks is a key milestone
distinguishing Atara’s leading off-the-shelf T-cell immunotherapy
technology platform,” said Isaac Ciechanover, M.D., Chief Executive
Officer and President of Atara Biotherapeutics. “As the cornerstone
of our Southern California R&D and manufacturing hub, this
dedicated facility will allow us to expand and accelerate our
robust pipeline. Our celebration today is also an opportunity to
reflect on what we hope to accomplish for patients with serious
medical conditions, as well as their families and communities.”
At the ATOM grand opening ceremony taking place today, Richard
J. O'Reilly, M.D., pioneer of tab-cel™ and Chief of the Pediatric
Bone Marrow Transplant Service at Memorial Sloan Kettering Cancer
Center (MSK), will join the Company to share his experiences
treating post-transplant lymphoma patients. The program will also
feature Doug Worthen, a bone marrow transplant recipient and
post-transplant lymphoma survivor. Other guests will include Atara
employees, board members, partners and investors, as well as local
industry leaders and public officials.
“Memorial Sloan Kettering and Atara have been pioneers in
developing off-the-shelf T-cell immunotherapies for the treatment
of a number of virus-associated malignancies, including
EBV-associated lymphomas, which are aggressive cancers associated
with exceedingly poor outcomes”, said Dr. O’Reilly. “The ATOM
facility is a superb center that will help advance the development
of promising T-cell immunotherapies that may transform many
patients’ lives.”
Atara is a rapidly growing, 200+ employee company that is
co-located by design in South San Francisco and Southern
California, with a newly established European headquarters in Zug,
Switzerland. Atara also has an R&D site in Aurora,
Colorado and office in New York City. The ATOM facility is
projected to create around 100 new highly skilled jobs in the City
of Thousand Oaks and Ventura County.
“ATOM encompasses all aspects of T-cell immunotherapy
manufacturing and technical operations, and we designed the
facility to provide flexibility to expand capacity as required,”
stated Atara’s Joe Newell, Executive Vice President, Chief
Technical Operations Officer and Steve Bertram, Senior Vice
President of Global Human Resources. “ATOM is further demonstration
of Atara’s dedication to supporting the growth of the innovative
life sciences community in Southern California.”
Atara is advancing Phase 3 development of tab-cel™, the
potential first commercially available off-the-shelf T-cell
immunotherapy for the treatment of patients with Epstein-Barr virus
associated post-transplant lymphoproliferative disorder (EBV+
PTLD). The Company recently announced positive long-term outcomes
for tab-cel™ in Phase 2 studies of patients with EBV+ PTLD at the
23rd Congress of European Hematology Association held in Stockholm,
Sweden.
“I am thrilled to welcome Atara and its state-of-the-art
facilities to the Thousand Oaks biotech community,” said City
Manager Drew Powers. “This company holds tremendous promise and
brings cutting edge technology to our region. We are truly grateful
they have selected Thousand Oaks for this important work.”
Atara plans to submit a conditional marketing authorization
application in the EU for tab-cel™, as well as report initial
efficacy results from its Phase 3 program, in the first half of
2019.
About EBV+ PTLDSince its discovery as the first
human oncovirus, Epstein-Barr virus (EBV) has been implicated in
the development of a wide range of lymphoproliferative disorders,
including lymphomas, and other cancers. EBV is widespread in all
human populations and persists as a lifelong, asymptomatic
infection. In immunocompromised patients, such as those undergoing
allogeneic hematopoietic cell transplants (HCT) or solid organ
transplants (SOT), EBV-associated post-transplant
lymphoproliferative disorder (EBV+ PTLD) represents a
life-threatening condition. Median overall survival in patients
with EBV+ PTLD following HCT who have failed rituximab-based first
line therapy is 16-56 days. In EBV+ PTLD following SOT, patients
failing rituximab experience increased chemotherapy-induced
treatment-related mortality compared to other lymphoma patients.
One- and two-year survival in patients with high-risk EBV+ PTLD
following SOT is 36% and 0%, respectively.
About tab-cel™ (tabelecleucel; formerly known as
ATA129)Atara's most advanced T-cell immunotherapy in
development, tab-cel™, is a potential treatment for patients with
Epstein-Barr virus (EBV) associated post-transplant
lymphoproliferative disorder (EBV+ PTLD) who have failed rituximab,
as well as other EBV-associated hematologic and solid tumors,
including nasopharyngeal carcinoma (NPC). In February 2015,
FDA granted tab-cel™ Breakthrough Therapy Designation for EBV+ PTLD
following allogeneic hematopoietic cell transplant (HCT), and in
October 2016, tab-cel™ was accepted into the EMA Priority Medicines
(PRIME) regulatory pathway for the same indication, providing
enhanced regulatory support. Atara also received positive
regulatory feedback from Health Canada in September 2017 supporting
the submission of tab-cel™ for an expedited approval pathway. In
addition, tab-cel™ has orphan status in the U.S. and
EU. Tab-cel™ is in Phase 3 clinical development for the
treatment of EBV+ PTLD following an allogeneic hematopoietic cell
transplant (MATCH study) or solid organ transplant (ALLELE study),
and Atara is planning a Phase 1/2 study in NPC. Tab-cel™ is also
available to eligible patients with EBV-associated hematologic and
solid tumors through an ongoing multicenter expanded access
protocol clinical study, positive interim results of which were
presented in December 2017 at the 59th American Society of
Hematology (ASH) Annual Meeting.
About Atara Biotherapeutics, Inc.Atara
Biotherapeutics, Inc. (@Atarabio) is a
leading T-cell immunotherapy company developing novel treatments
for patients with cancer, autoimmune and viral diseases. The
Company's off-the-shelf, allogeneic T-cells are bioengineered from
donors with healthy immune function and allow for rapid delivery
from inventory to patients without a requirement for pretreatment.
Atara's T-cell immunotherapies are designed to precisely recognize
and eliminate cancerous or diseased cells without affecting normal,
healthy cells. Atara's most advanced T-cell immunotherapy in
development, tabelecleucel, or tab-cel™ (formerly known as ATA129),
is being developed for the treatment of patients with Epstein-Barr
virus (EBV) associated post-transplant lymphoproliferative disorder
(EBV+ PTLD) who have failed rituximab, as well as other
EBV-associated hematologic and solid tumors, including
nasopharyngeal carcinoma (NPC). Tab-cel™ is in Phase 3 clinical
development for the treatment of EBV+ PTLD following an allogeneic
hematopoietic cell transplant (MATCH study) or solid organ
transplant (ALLELE study). Atara is also developing off-the-shelf,
allogeneic ATA188 and autologous ATA190 T-cell immunotherapies
using a complementary targeted antigen recognition technology for
specific EBV antigens believed to be important for the potential
treatment of multiple sclerosis (MS). A Phase 1 clinical study of
autologous ATA190 in patients with progressive MS is ongoing. Atara
also is advancing a Phase 1 ATA188 clinical study in patients with
progressive or relapsing-remitting MS across clinical sites in the
U.S. and Australia in March 2018. Atara's clinical pipeline also
includes ATA520 targeting Wilms Tumor 1 (WT1) and ATA230 directed
against cytomegalovirus (CMV).
Forward-Looking StatementsThis press release
contains or may imply "forward-looking statements" within the
meaning of Section 27A of the Securities Act of 1933 and Section
21E of the Securities Exchange Act of 1934. For example,
forward-looking statements include statements regarding: the
Company's enrollment, expansion, expected results and completion of
its Phase 3 studies of tab-cel™; the timing of the Company’s
submission of a CMA for tab-cel™ in the EU; the Company’s ability
to leverage its platform in other indications and initiate
development of additional immunotherapies; and the potential
advantages of its product candidates. Because such statements
deal with future events and are based on Atara Biotherapeutics'
current expectations, they are subject to various risks and
uncertainties and actual results, performance or achievements of
Atara Biotherapeutics could differ materially from those described
in or implied by the statements in this press release. These
forward-looking statements are subject to risks and uncertainties,
including those discussed under the heading "Risk Factors" in Atara
Biotherapeutics' quarterly report on Form 10-Q filed with the
Securities and Exchange Commission (SEC) on May 8, 2018, including
the documents incorporated by reference therein, and subsequent
filings with the SEC. Except as otherwise required by law, Atara
Biotherapeutics disclaims any intention or obligation to update or
revise any forward-looking statements, which speak only as of the
date hereof, whether as a result of new information, future events
or circumstances or otherwise.
INVESTOR & MEDIA CONTACTS:
Investors:John Craighead, Atara
Biotherapeutics650-410-3012jcraighead@atarabio.com
Steve Klass, Burns McClellan212-213-0006
x331sklass@burnsmc.com
Media:Justin Jackson, Burns
McClellan212-213-0006 x327jjackson@burnsmc.com
Atara Biotherapeutics (NASDAQ:ATRA)
Historical Stock Chart
From Mar 2024 to Apr 2024
Atara Biotherapeutics (NASDAQ:ATRA)
Historical Stock Chart
From Apr 2023 to Apr 2024