Sustained Improvement Observed in ATA188
Treated Patients Achieving Confirmed Disability Improvement (CDI)
in Open Label Extension (OLE) with up to 46 Months Follow up
Patients Treated with ATA188 that Achieved CDI
Demonstrate Significantly Less Brain Atrophy in Longitudinal
Analysis Through 42 Months
All Patients in the OLE with Stable Disease
Remained Stable for up to 48 Months
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell
immunotherapy, leveraging its novel allogeneic Epstein-Barr virus
(EBV) T-cell platform to develop transformative therapies for
patients with cancer and autoimmune diseases, today announced new
magnetic resonance imaging (MRI) biomarker and open-label extension
(OLE) clinical data from the study of ATA188, an investigational
Epstein-Barr virus (EBV)-targeted T-cell immunotherapy, in
progressive multiple sclerosis (MS). These findings will be
presented as a late-breaking ePoster at the 38th Congress of the
European Committee for Treatment and Research in Multiple Sclerosis
(ECTRIMS) taking place October 26-28, 2022, in Amsterdam, the
Netherlands.
During the initial 12 months, or in the OLE, seven of the 24
patients achieved confirmed disability improvement (CDI), by
expanded disability status scale (EDSS), defined as EDSS
improvement versus baseline that is confirmed at two consecutive
timepoints; 13 had stable EDSS and four had confirmed disability
progression (CDP). Additionally, nine met sustained disability
improvement (SDI) criteria, a composite scale combining confirmed
improvement in either the EDSS score or timed 25-foot walk test in
the initial 12-month period (n=7) or in the OLE (n=2). These data
demonstrate that ATA188 continues to be well-tolerated, and safety
is consistent with previous reports with no Grade >3 events,
dose limiting toxicities, cytokine release syndrome, or graft
versus host disease.
“New biomarker imaging data presented at ECTRIMS suggest brain
structural changes and potential remyelination may underlie
clinical disability improvements observed with ATA188 treatment,”
said AJ Joshi, MD, Chief Medical Officer at Atara. “We are pleased
to see a majority of patients experiencing either long term
durability of CDI based on EDSS improvement or long-term stability
in EDSS, which would also represent a transformational profile
relative to the expected natural course of the disease.”
As of September 2022, patients achieving CDI continuing in the
OLE have been followed for up to 46.5 months. Five of five patients
continued to maintain CDI for a median of 27.5 (range, 23.8–36.7)
months. Eight of eight participants with stable EDSS remaining in
the OLE continued to have a stable EDSS for a median of 41.2
(36.3–48.5) months.
In the study, changes in whole-brain and regional brain volumes
were assessed longitudinally utilizing T1-weighted and FLAIR MRI
images. Specific measures of atrophy included percentage brain
volume change (PBVC), percentage ventricular volume change (PVVC,
where increasing ventricular volume is indicative of increased
atrophy in general, and specifically subcortical atrophy), and
thalamic volume change (TVC) assessed on T1-weighted MRI. Myelin
density was assessed longitudinally through nMTR images in T2
unenhancing lesions and in the normal-appearing brain tissue.
During the initial 12 months:
- Patients who achieved SDI (n=7) had significantly less
ventricular enlargement (PVVC, p=0.019), reflecting less brain
atrophy, and similar PBVC (p=0.538) and TVC (p=0.529) versus those
who did not (n=16).
- Similar trends were observed in patients achieving CDI, who
tended to have less ventricular enlargement (PVVC; p=0.108) at 12
months while PBVC (p=0.437) and TVC (p=0.742) were similar.
In a longitudinal analysis through 42 months, patients achieving
CDI (versus not) had:
- Significantly less decrease in PBVC over time ([95% CI:
0.02–0.66], p=0.037) and there was a trend for less ventricular
volume enlargement over time ([95% CI: −0.6–0.03], p=0.074), both
reflecting less brain atrophy; TVC did not differ by CDI
status.
- Significantly increased signal on nMTR in unenhancing T2
lesions (reflective of possible increased myelin density) ([95% CI:
0.05–0.24], p=0.005) suggesting that brain structural changes,
potentially including remyelination, persist over time and may
underlie the durable CDI associated with ATA188.
- A trend for increased myelin density (nMTR) in normal appearing
brain tissue over time ([95% CI: −0.04–0.35], p=0.112).
Further detail on MRI and nMTR data as well as updated safety
and efficacy data will be presented in the October 26 ePoster
presentation, EP1242.
In separate ePosters (EP1070 & EP1190), Atara will also
present health economics and outcomes research data on the unmet
need in patients with non-active secondary progressive multiple
sclerosis (SPMS) in the U.S. and the study design, patient
demographics, and healthcare resource utilization of patients with
active and non-active PMS in a novel, patient-centered real-world
evidence study.
Poster Presentation
Details:
EP1242: Long-term disability improvement during
EBV-targeted T-cell immunotherapy ATA188 is related to brain volume
change and normalised magnetisation transfer ratio in T2
lesions
- Presenting Author: Samantha Noteboom, MS Center
Amsterdam, Anatomy and Neurosciences, Vrije Universiteit Amsterdam,
Amsterdam Neuroscience, Amsterdam UMC location VUmc, Amsterdam,
Netherlands
- Date & Time: Wednesday, October 26, 2022, at 8 a.m.
CEST / 2 a.m. EDT / 11 p.m. PDT on Tuesday, October 25, 2022
EP1070: Unmet Need of Current Disease-modifying
Treatments Reported by Physicians in Patients with Non-active
Secondary Progressive Multiple Sclerosis in the United States
- Presenting Author: Kiren Kresa-Reahl, MD, Atara
Biotherapeutics, South San Francisco, CA, United States
- Date & Time: Wednesday, October 26, 2022, at 8 a.m.
CEST / 2 a.m. EDT / 11 p.m. PDT on Tuesday, October 25, 2022
EP1190: A Novel, Patient-Centred Real-World Evidence
Study Designed to Better Understand Active and Non-active
Progressive Multiple Sclerosis Using Health Records in the United
States
- Presenting Author: Kiren Kresa-Reahl, MD, Atara
Biotherapeutics, South San Francisco, CA, United States
- Date & Time: Wednesday, October 26, 2022, at 8 a.m.
CEST / 2 a.m. EDT / 11 p.m. PDT on Tuesday, October 25, 2022
About ATA188
Epstein-Barr virus (EBV) is the leading cause of multiple
sclerosis (MS) from onset to progression of the disease and is both
necessary for and precedes diagnosis of MS, with prior EBV
infection increasing susceptible individuals’ risk of developing MS
32-fold. EBV-infected B cells drive pathology in MS by stimulating
autoreactive T cells, and by differentiating into autoreactive
plasma cells. These EBV-infected B cells present in the central
nervous system (CNS), driving chronic inflammation and the
generation of reactive antibodies against some brain proteins.
Specifically targeting EBV infected immune cells represents a new
targeted approach. ATA188, Atara’s investigational off-the-shelf,
allogeneic T-cell immunotherapy aims to specifically target
EBV-infected B cells and plasma cells for progressive forms of MS.
ATA188 is currently in a Phase 2 EMBOLD clinical study for the
treatment of patients with progressive forms of MS and has met
target enrollment, with final data and communication expected in
October 2023.
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 receiving a CHMP positive opinion
for a marketing authorization in Europe, 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, which
does not require TCR or HLA gene editing, to create a robust
pipeline including: tab-cel in Phase 3 development for Epstein-Barr
virus-driven post-transplant lymphoproliferative disease (EBV+
PTLD) and other EBV-driven diseases; 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, USA.
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
ATA188, the development, timing and progress of ATA188, the
potential characteristics and benefits of ATA188, the potential
safety, efficacy, duration of response and tolerability of ATA188,
including as measured by SDI or EDSS, clinical trials and data
relating to ATA188, and the potential link between ATA188 and brain
structural changes or remyelination. Because such statements deal
with future events and are based on Atara’s current expectations,
they are subject to various risks and uncertainties and actual
results, performance or achievements of Atara 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’s 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 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20221025006149/en/
Investors Eric Hyllengren 805-395-9669
ehyllengren@atarabio.com Media Alex Chapman 805-456-4772
achapman@atarabio.com
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