Atara Biotherapeutics Initiates 60 Patient, Global Phase 1 Clinical Study to Evaluate Allogeneic ATA188 in Patients with Prog...
October 19 2017 - 8:00AM
Enrollment to begin in Australia; U.S.
sites expected to open in early 2018
Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a leading
"off-the-shelf", or allogeneic, T-cell immunotherapy company
developing novel treatments for patients with cancer and autoimmune
diseases, announced today that the Company initiated a
multinational, multicenter Phase 1 clinical study to evaluate
allogeneic ATA188 in patients with progressive or
relapsing-remitting MS. Allogeneic ATA188, the Company’s next
generation T-cell immunotherapy 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.
“Starting the first allogeneic T-cell immunotherapy study in MS
is a significant milestone for Atara,” said Isaac Ciechanover,
M.D., Chief Executive Officer and President of Atara
Biotherapeutics. “Earlier this week, our collaborators reported
that autologous ATA190 demonstrated encouraging updated results in
a Phase 1 study, showing objective clinical improvements in five of
eight patients with progressive MS. Development of an off-the-shelf
version of ATA188 expands our allogeneic T-cell immunotherapy
platform beyond oncology to autoimmune diseases and is a potential
new approach to treat patients with progressive or
relapsing-remitting MS.”
The primary objective of Atara’s Phase 1 clinical study is to
assess the safety of allogeneic ATA188 in subjects observed for at
least 1 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 open-label, single-arm study is expected
to enroll a total of 60 patients: 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) across Australia, the US, and Europe. 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 allogeneic ATA188 and autologous
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. Allogeneic ATA188 and
autologous ATA190, the Company’s next generation T-cell
immunotherapies 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 the results of the first autologous ATA190 study, which
was partially funded by MS Research Australia, MS Queensland and
Perpetual Foundation, at the American Academy of Neurology (AAN)
meeting in April 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). A Phase 1 clinical study of autologous ATA190 in
progressive forms of MS is ongoing, and a Phase 1 allogeneic ATA188
clinical study in patients with progressive and relapsing-remitting
MS was recently initiated.
About Atara Biotherapeutics, Inc. Atara
Biotherapeutics, Inc. (@Atarabio) is a leading T-cell immunotherapy
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, selectively targets
specific EBV antigens believed to be important for the potential
treatment of multiple sclerosis (MS). A Phase 1 clinical study of
autologous ATA190 in progressive forms of MS is ongoing, and a
Phase 1 allogeneic ATA188 clinical study in patients with
progressive and relapsing-remitting MS was recently initiated.
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 belief that the clinical results of Autologous 190 in
progressive MS patients are encouraging and that the development of
an off-the-shelf version of ATA188 is a potential new approach to
treat patients with progressive or relapsing-remitting MS; the
Company’s expectation that the Phase I clinical study for
allogeneic ATA188 is expected to enroll a total of 60 patients: 30
patients with progressive forms of MS, either PPMS or SPMS, and 30
patients with RRMS across Australia, the US, and Europe; the
Company’s belief that ATA188 has 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; the Company’s expected initiation of Phase
3 studies of ATA129 in EBV-PTLD following a HCT or SOT in 2017 and
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 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
Biotherapeutics650-410-3012jcraighead@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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