Atara Biotherapeutics Announces FDA Clearance to Proceed with Enrollment at U.S. Sites for Ongoing Global Phase 1 Clinical St...
January 10 2018 - 7:00AM
Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading off-the-shelf
T-cell immunotherapy company developing novel treatments for
patients with cancer, autoimmune and viral diseases, today
announced that it received clearance of its Investigational New
Drug (IND) application from the U.S. Food and Drug Administration
(FDA) to proceed with patient enrollment at U.S. sites for its
ongoing global Phase 1 clinical study to evaluate ATA188 in
patients with progressive or relapsing-remitting multiple sclerosis
(MS). ATA188, the Company's off-the-shelf T-cell immunotherapy
using a complementary targeted antigen recognition technology
licensed from QIMR Berghofer Medical Research Institute,
selectively targets specific Epstein-Barr virus (EBV) antigens
believed to play an important role in the pathogenesis of MS. Atara
initiated the open-label, single arm Phase 1 study in MS patients
in the fourth quarter of 2017 in Australia.
“We are pleased with FDA’s decision to allow off-the-shelf
ATA188 to proceed into clinical development in patients with MS in
the U.S.,” said Chris Haqq M.D., Ph.D., Executive Vice President of
Research and Development and Chief Scientific Officer of Atara
Biotherapeutics. “We believe that an off-the-shelf T-cell
immunotherapy such as ATA188 may allow for a more consistent
reactivity against target EBV antigens, which may be correlated
with clinical improvements based on data from a previous autologous
ATA190 Phase 1 study in patients with progressive MS. We look
forward to the first results from the ATA188 Phase 1 study in
patients with progressive MS in the first half of 2019.”
The primary objective of Atara’s ongoing Phase 1 clinical study
is to assess the safety of ATA188 in patients followed for at least
one year after the first dose. Key secondary endpoints in the study
include measures of clinical improvement such as expanded
disability status scale (EDSS) and annualized relapse rate (ARR) as
well as MRI imaging. The study is expected to enroll a total of 60
patients across the U.S., Australia and Europe: 30 patients with
progressive forms of MS, either primary progressive MS (PPMS) or
secondary progressive MS (SPMS), and 30 patients with
relapsing-remitting MS (RRMS). For more information about the
study, please visit ClinicalTrials.gov (NCT03283826).
About Multiple SclerosisMS is a chronic
neurological autoimmune disease that affects an estimated 2.3
million people around the world. Relapsing-remitting MS (RRMS) is
the most common form of MS and is characterized by episodes of new
or worsening signs or symptoms (relapses) followed by periods of
recovery. Despite available disease-modifying treatments, most
individuals with RRMS continue to experience disease activity and
disability progression.
Progressive MS (PMS) is a severe form of the disease with few
therapeutic options. PMS comprises two conditions, both
characterized by persistent progression and worsening of MS
symptoms and physical disability over time. Primary Progressive MS
(PPMS) occurs when continuous progressive disease is present at
diagnosis and occurs in approximately 15% of newly diagnosed
cases. Secondary Progressive MS (SPMS) initially begins as
RRMS and develops into a progressive form. Up to 80% of people with
RRMS will eventually develop SPMS. There is substantial unmet
medical need for new and effective therapies for patients with PPMS
and SPMS. Most treatment options that work well in reducing flares
in RRMS have not been shown to be effective in slowing or reversing
disability in PMS.
About ATA188 and ATA190Epstein-Barr Virus (EBV)
is associated with a wide range of hematologic malignancies and
solid tumors, as well as certain autoimmune conditions such as
multiple sclerosis (MS). T-cells are a critical component of the
body's immune system and can selectively target specific EBV
antigens believed to be important for the potential treatment of
MS. Off-the-shelf ATA188 and autologous ATA190, using the Company’s
complementary T-cell immunotherapy technology developed by
Professor Rajiv Khanna at QIMR Berghofer, have the potential to
precisely recognize and eliminate EBV-infected B-cells and plasma
cells in the central nervous system that may catalyze autoimmune
responses and MS pathophysiology. Professor Michael Pender from The
University of Queensland presented updated results from the first
autologous ATA190 study, which was partially funded by MS Research
Australia, MS Queensland and Perpetual Foundation, at MSParis 2017
Congress, the 7th Joint ECTRIMS and ACTRIMS Meeting in October
2017. This study tested adoptive immunotherapy in patients with MS
and showed that autologous ATA190 led to encouraging clinical
improvements in MS symptoms that correlated with autologous
ATA190’s reactivity against target EBV antigens (EBV reactivity).
In addition to the ongoing Phase 1 autologous ATA190 clinical study
in patients with progressive MS, Atara also initiated a global
Phase 1 ATA188 clinical study in patients with progressive or
relapsing-remitting MS in Australia in the fourth quarter of 2017
with patient enrollment at U.S. sites beginning in early 2018.
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, or
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 (formerly known as ATA129), is being developed for
the treatment of patients with rituximab-refractory Epstein-Barr
virus (EBV) associated post-transplant lymphoproliferative disorder
(EBV+PTLD), as well as other EBV associated hematologic and solid
tumors, including nasopharyngeal carcinoma (NPC). Tabelecleucel 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 a Phase 1/2 study of
tabelecleucel 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. Tabelecleucel is also available to eligible patients with
EBV associated hematologic and solid tumors through an ongoing
multicenter expanded access protocol (EAP) clinical study.
Off-the-shelf ATA188 and autologous ATA190, the Company's T-cell
immunotherapies using a complementary targeted antigen recognition
technology, target 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 initiated a global Phase 1 ATA188 clinical
study in patients with progressive or relapsing-remitting MS in
Australia in the fourth quarter of 2017 with patient enrollment at
U.S. sites beginning in early 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, expected results and completion of its Phase
1 study to evaluate allogeneic ATA188 in patients with progressive
or relapsing-remitting MS; the expected opening of U.S. sites
in early 2018; the expected start of a Phase 1/2 study of
tabelecleucel 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 in 2018;
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 November 9, 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
Biotherapeutics 650-410-3012 jcraighead@atarabio.com
Steve Klass, Burns McClellan 212-213-0006 x331
sklass@burnsmc.com
Media: Justin Jackson, Burns McClellan
212-213-0006 x327 jjackson@burnsmc.com
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