Long-term follow-up shows all patients who
demonstrated sustained disability improvement (SDI) maintained it
at all subsequent timepoints
50 percent of patients in the two highest dose
Cohorts (3 and 4) demonstrated SDI at 15 months
Cohort 4 dose selected for the ongoing
randomized placebo-controlled clinical trial (RCT) based on higher
proportion of patients showing sustained EDSS improvements and
consistent safety profile over 15 months
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a pioneer in T-cell
immunotherapy, leveraging its novel allogeneic EBV T-cell platform
to develop transformative therapies for patients with serious
diseases including solid tumors, hematologic cancers and autoimmune
disease, today announced the Company will present for the first
time 15-month safety and efficacy data from all patients in the two
highest dose cohorts of the Phase 1a open-label extension (OLE)
study of ATA188 for the treatment of progressive forms of multiple
sclerosis (MS). The results are featured in a poster presentation
at the European Charcot Foundation (ECF) 28th Annual Meeting, held
November 15-19, 2020.
“We are very pleased to see dose-related and durable responses
maintained long-term which likely indicate a treatment effect with
ATA188,” said Jakob Dupont, Global Head, Research and Development
at Atara. “Seeing 50 percent of patients achieve long-term
sustained disability improvement out to 15 months is remarkable in
progressive forms of MS and supports the continued clinical
investigation of ATA188 for this devastating disease for which
there are currently no treatment options that substantially alter
the course of disease.”
Findings presented include data on 24 patients from the 12-month
dose escalation portion of the trial, 16 of whom entered the OLE
and have ≥15-month data available as of October 2020. Throughout
the entire Phase 1a and OLE study, nine of the 16 patients who
entered the OLE demonstrated sustained disability improvement (SDI)
with ATA188 treatment (seven achieved SDI in the first twelve
months and two during the OLE). In seven out of the nine patients,
SDI was driven by sustained improvement in Expanded Disability
Status Score (EDSS).
A dose-related increase in the number of patients meeting SDI
criteria was observed. Similar safety profile with no dose-limiting
toxicities was shown in the highest dose cohorts (Cohorts 3 and 4).
In the two highest dose cohorts, five out of 12 total patients
(42%) and six out of 12 total patients (50%) demonstrated SDI at 12
and 15 months, respectively. SDI was driven by EDSS in all but one
of the patients in Cohorts 3 and 4; all SDI observed in Cohort 4
was based on EDSS improvement. The Cohort 3 and 4 doses
demonstrated similar efficacy profile based on SDI, with the Cohort
4 dose trending toward greater effect on EDSS.
Given encouraging clinical results to date in ATA188 studies and
the significant unmet medical need in progressive forms of MS, the
Company is increasing its investment in the ATA188 program. Atara
is expanding the size of the RCT to at least 64 patients, changing
the primary endpoint of the study to disability improvement, and
maintaining biological and functional endpoints.
“With a higher proportion of patients demonstrating sustained
EDSS improvements and a continued favorable safety profile, we will
start treating newly enrolled patients with the Cohort 4 dose per
the amended protocol in the randomized placebo-controlled study,”
said AJ Joshi, M.D., Senior Vice President and Chief Medical
Officer of Atara Biotherapeutics. “Additionally, we are making
great progress enrolling the randomized trial and advancing the
overall development program. We look forward to continuing to
periodically provide meaningful data updates from the OLE.”
The Company recently submitted material to the U.S. Food and
Drug Administration (FDA), that includes the Phase 1a data, planned
updated design of the RCT and discussion of potential opportunities
for expedited development of ATA188 for patients living with
progressive forms of MS. Feedback from the agency is expected at
the end of 2020.
About ATA188
Epstein-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 EBV believed to be important in the pathogenesis
of MS.
Off-the-shelf, investigational ATA188, has the potential to
target EBV-infected B cells and plasma cells in the central nervous
system that may catalyze autoimmune responses and MS
pathophysiology.
Atara is advancing the clinical development of ATA188 with a
double-blind, randomized, placebo-controlled clinical trial (RCT)
in patients with progressive MS across clinical sites in the U.S.
and Australia. In addition to measuring disability progression, the
study will also evaluate many facets of the disease, including:
cognition and outpatient ambulatory activity; fatigue, and
biological end points in blood and cerebrospinal fluid/CSF (IgG,
synthesis and index, OCBs, product kinetics); and MRI imaging.
About Atara Biotherapeutics, Inc.
Atara Biotherapeutics, Inc. (@Atarabio) is a pioneer in T-cell
immunotherapy leveraging its novel allogeneic EBV T-cell platform
to develop transformative therapies for patients with serious
diseases including solid tumors, hematologic cancers and autoimmune
disease. With our lead program in Phase 3 clinical development,
Atara is the most advanced allogeneic T-cell immunotherapy company
and intends to rapidly deliver off-the-shelf treatments to patients
with high unmet medical need. Our platform leverages the unique
biology of EBV T cells and has the capability to treat a wide range
of EBV-associated diseases, or other serious diseases through
incorporation of engineered CARs (chimeric antigen receptors) or
TCRs (T-cell receptors). Atara is applying this one platform to
create a robust pipeline including: tab-cel® (tabelecleucel) in
Phase 3 development for Epstein-Barr virus-driven post-transplant
lymphoproliferative disease (EBV+ PTLD); ATA188, a T-cell
immunotherapy targeting EBV antigens as a potential treatment for
multiple sclerosis; and multiple next-generation chimeric antigen
receptor T-cell (CAR-T) immunotherapies for both solid tumors and
hematologic malignancies. Improving patients’ lives is our mission
and we will never stop working to bring transformative therapies to
those in need. Atara is headquartered in South San Francisco and
our leading-edge research, development and manufacturing facility
is based in Thousand Oaks, California. For additional information
about the company, please visit atarabio.com and follow us on
Twitter and LinkedIn.
Forward-Looking Statements
This 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 potential benefits, safety and efficacy of ATA188; data from
the Phase 1a study of ATA188; planned updates to the design of the
ATA188 RCT; the timing and progress of clinical trials of ATA188,
and Atara’s ability to successfully advance the development of
ATA188. 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, without limitation, risks and
uncertainties associated with the costly and time-consuming
pharmaceutical product development process and the uncertainty of
clinical success; the COVID-19 pandemic, which may significantly
impact (i) our business, research, clinical development plans and
operations, including our operations in South San Francisco and
Southern California and at our clinical trial sites, as well as the
business or operations of our third-party manufacturer, contract
research organizations or other third parties with whom we conduct
business, (ii) our ability to access capital, and (iii) the value
of our common stock; the sufficiency of Atara’s cash resources and
need for additional capital; and other risks and uncertainties
affecting Atara’s and its development programs, including those
discussed in Atara Biotherapeutics' filings with the Securities and
Exchange Commission (SEC), including in the “Risk Factors” and
“Management’s Discussion and Analysis of Financial Condition and
Results of Operations” sections of the Company’s most recently
filed periodic reports on Form 10-K and Form 10-Q and subsequent
filings and in the documents incorporated by reference therein.
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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20201115005099/en/
INVESTOR & MEDIA: Media Kerry Beth Daly Head,
Corporate Communications Atara Biotherapeutics 516-982-9328
kdaly@atarabio.com
Investors Eric Hyllengren Vice President, Investor
Relations & Finance Atara Biotherapeutics 805-395-9669
ehyllengren@atarabio.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