Atara Biotherapeutics Receives Positive Health Canada Regulatory Feedback for ATA129
September 11 2017 - 8:00AM
Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading
"off-the-shelf" T-cell immunotherapy company developing novel
treatments for patients with cancer and autoimmune diseases, today
announced receipt of positive regulatory feedback from Health
Canada for ATA129, the Company’s most advanced T-cell immunotherapy
in development for the treatment of cancer patients with
rituximab-refractory Epstein-Barr virus (EBV) associated
post-transplant lymphoproliferative disorder (EBV-PTLD) following a
hematopoietic cell transplant (HCT) or solid organ transplant
(SOT).
Based on feedback from a meeting with Health Canada’s Biologics
and Genetic Therapies Directorate (BGTD), Atara plans to request
advance consideration under the Notice of Compliance with
Conditions (NOC/c) policy for ATA129 in the treatment of patients
with rituximab-refractory EBV-PTLD after HCT. A Notice of
Compliance issued under the NOC/c policy is an authorization to
market a drug in Canada with the condition that the sponsor
undertake additional studies to verify the clinical benefit, and is
analogous to a conditional marketing authorization in the EU.
Consistent with Atara’s previously communicated regulatory plan
in Europe, the Canadian filing is expected to be based on results
from the Phase 1 and 2 clinical studies conducted at Memorial Sloan
Kettering Cancer Center (MSK) and supported by available data from
the Company’s planned MATCH and ALLELE Phase 3 studies, which are
anticipated to be ongoing at the time of the NDS filing.
"Health Canada represents the second major regulatory body to
provide feedback supporting the submission of ATA129 for an
expedited approval pathway based on the compelling results of the
prior Phase 1 and 2 studies," said Isaac Ciechanover, M.D., Chief
Executive Officer and President of Atara Biotherapeutics. "We look
forward to working closely with Health Canada and other global
health authorities to make ATA129 available to patients as
expeditiously as possible.”
Following completion of the Phase 3 studies, Atara also expects
to file a ATA129 supplemental NDS for the treatment of cancer
patients with rituximab-refractory EBV-PTLD after SOT, as well as
request to remove the conditions of the NOC/c for the HCT
indication.
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 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 EBV-PTLD
patients after 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 high-risk EBV-PTLD
patients after SOT is 36% and 0%, respectively.
About ATA129Atara’s most advanced T-cell
immunotherapy in development, ATA129, is a potential treatment for
cancer patients with rituximab-refractory EBV-PTLD as well as other
EBV positive hematologic and solid tumors including nasopharyngeal
carcinoma (NPC). In February 2015, FDA granted ATA129
Breakthrough Therapy Designation for EBV-PTLD following allogeneic
hematopoietic cell transplant (HCT) and in October 2016, ATA129 was
accepted into the EMA Priority Medicines (PRIME) regulatory pathway
for the same indication, providing enhanced regulatory
support. In addition, ATA129 also has orphan status in the
U.S. and EU. Phase 3 studies of ATA129 in EBV-PTLD after HCT
(MATCH study) or solid organ transplant (ALLELE study) are expected
to start in 2017, and a Phase 1/2 study in NPC is planned for 2018.
ATA129 is also available to eligible patients with EBV-positive
tumors through an ongoing multicenter expanded access protocol
(EAP) clinical study. Atara expects to submit ATA129 for
conditional marketing authorization in EBV-PTLD following HCT in
the EU in 2018.
About Atara Biotherapeutics, Inc. Atara
Biotherapeutics, Inc. (@Atarabio) is a leading cell therapy company
developing novel treatments for patients with cancer and autoimmune
diseases. The Company’s “off-the-shelf”, or allogeneic, T-cells are
engineered 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, ATA129, is being developed for
the treatment of cancer patients with rituximab-refractory
Epstein-Barr virus (EBV) associated post-transplant
lymphoproliferative disorder (EBV-PTLD), as well as other EBV
positive hematologic and solid tumors including nasopharyngeal
carcinoma (NPC). Phase 3 studies of ATA129 in EBV-PTLD following a
hematopoietic cell transplant (MATCH study) or solid organ
transplant (ALLELE study) are expected to start in 2017, and a
Phase 1/2 study of ATA129 in combination with Merck's anti-PD-1
(programmed death receptor-1) therapy, KEYTRUDA® (pembrolizumab),
in patients with platinum-resistant or recurrent EBV-associated NPC
is planned for 2018. ATA129 is also available to eligible patients
with EBV-positive tumors through an ongoing multicenter expanded
access protocol (EAP) clinical study. Atara expects to submit
ATA129 for conditional marketing authorization in EBV-PTLD
following HCT in the EU in 2018. ATA188, the Company’s next
generation T-cell immunotherapy for autoimmune diseases,
selectively targets specific EBV antigens believed to be important
for the potential treatment of multiple sclerosis (MS). A Phase 1
clinical study of autologous ATA188 in progressive forms of MS is
ongoing, and a Phase 1 allogeneic ATA188 clinical study is expected
to begin in the second half of 2017. 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: that the
Canadian filing is expected to be based on results from the Phase 1
and 2 clinical studies conducted at MSK and supported by available
data from the Company’s planned MATCH and ALLELE Phase 3 studies,
which are anticipated to be ongoing at the time of the NDS filing;
the Company’s expectation that it will work closely with Health
Canada and other global health authorities to make ATA129 available
to patients as expeditiously as possible; the Company’s expectation
that it will file a ATA129 supplemental NDS for the treatment of
cancer patients with rituximab-refractory EBV-PTLD after SOT, as
well as request to remove the conditions of the NOC/c for the HCT
indication; the Company’s expected initiation of Phase 3 studies of
ATA129 in EBV-PTLD following a HCT or SOT in 2017, a Phase 1/2
study of ATA129 in combination with Merck's anti-PD-1 therapy,
KEYTRUDA® (pembrolizumab), in patients with platinum-resistant or
recurrent EBV-associated NPC in 2018 and a Phase 1 allogeneic
ATA188 clinical study in the second half of 2017; and the Company’s
expected submission of a conditional marketing authorization
application in EBV-PTLD following HCT in the EU in 2018.
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 August
7, 2017, 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
Biotherapeutics650-491-5806jcraighead@atarabio.com
Steve Klass, Burns McClellan212-213-0006
x331sklass@burnsmc.com
Media:Justin Jackson, Burns
McClellan212-213-0006 x327jjackson@burnsmc.com
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