Primary Endpoint of Confirmed Disability
Improvement at 12 Months Not Achieved
Company to Further Analyze Data and Evaluate
Strategic Options for ATA188 Program with Focusing of Resources and
Planned Expense Reductions Expected to Extend Cash Runway Beyond Q3
2025
Allogeneic CAR-T Portfolio Advancing with
Several Catalysts Anticipated in the Next 18 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
primary analysis data from its Phase 2 EMBOLD study of ATA188 in
non-active progressive multiple sclerosis (PMS). The study did not
meet the primary endpoint of confirmed disability improvement (CDI)
by expanded disability status scale (EDSS) at 12 months compared to
placebo. In addition, fluid and imaging biomarkers did not provide
further supportive evidence.
"We are surprised and deeply disappointed with the results of
EMBOLD, particularly for the MS patient community which is in
urgent need of new treatment options. We are grateful to the
patients and investigators who participated in the study, and to
colleagues at Atara for their steadfast work,” said Pascal Touchon,
President and Chief Executive Officer of Atara. “We are further
evaluating the EMBOLD data as we continue to believe in the
critical role EBV plays in MS pathogenesis, however we anticipate
stopping the study as no treatment benefit was observed.”
Preliminary safety data showed there were no new safety signals
in the EMBOLD study, reinforcing the favorable safety profile
observed with ATA188 to date.
Atara is actively reviewing the totality of the data, including
a 6 percent disability improvement in the treatment arm compared to
33 percent disability improvement observed in the Phase 1 study, in
addition to identifying the factors related to a substantially
greater than expected placebo rate of 16 percent for CDI at 12
months compared with an expected rate of 4-6 percent in non-active
PMS patients. These evaluations will help Atara determine the next
steps for the program.
“Looking ahead, we maintain our strong conviction in the
potential of our pipeline reinforced by the first ever regulatory
approval of an allogeneic T-cell immunotherapy, EBVALLOTM, in
Europe,” Dr. Touchon continued. “Following anticipated additional
payments and significant double-digit royalties from the recently
expanded tab-cel® partnership with Pierre Fabre, we are currently
well positioned with a cash runway well beyond upcoming milestones,
including pre-clinical data for ATA3431 at ASH in December,
preliminary clinical data from our Phase 1 study of ATA3219 in
relapsed/refractory B-cell non-Hodgkin’s lymphoma anticipated in
the second half of 2024, and expanding ATA3219 development into
autoimmune disease.”
Going forward, the Company plans to significantly reduce its
expenses on ATA188 and further focus resources on advancing its
differentiated allogeneic CAR-T pipeline, in addition to executing
the expanded tab-cel partnership with Pierre Fabre through the
Biologics License Application (BLA) transfer. These future actions
are expected to meaningfully extend our cash runway beyond Q3 of
2025.
About EMBOLD
EMBOLD is a multi-national, randomized, double-blind,
placebo-controlled study with an open-label extension to evaluate
the safety and efficacy of ATA188 in participants with non-active
progressive multiple sclerosis. The study primary analysis at 12
months included 103 adult participants with progressive multiple
sclerosis (non-active PPMS and non-active SPMS).
In year one, study participants received two cycles of treatment
(ATA188 or placebo) at the recommended part two dose, which was
identified in part one, and were followed for 12 months, which is
the timepoint for the primary endpoint. In year two, all patients
received two cycles of therapy to maintain the blinding – those
initially receiving placebo received ATA188 (two cycles) and those
initially receiving ATA188 received one cycle of ATA188 followed by
one cycle of placebo. After year two, all participants can continue
into a three-year open-label extension during which they will
receive annual treatment with ATA188.
About Atara Biotherapeutics, Inc.
Atara is harnessing the natural power of the immune system to
develop off-the-shelf cell therapies for difficult-to-treat cancers
and autoimmune conditions, including multiple sclerosis, that can
be rapidly delivered to patients within days. With cutting-edge
science and differentiated approach, Atara is the first company in
the world to receive regulatory approval of an allogeneic T-cell
immunotherapy. Our advanced and versatile Epstein-Barr virus (EBV)
T-cell platform does not require T-cell receptor or HLA gene
editing and forms the basis of a diverse portfolio of
investigational therapies that target EBV, the root cause of
certain diseases, in addition to next-generation AlloCAR-Ts
designed for best-in-class opportunities across a broad range of
non-EBV-associated liquid and solid tumors. Atara is headquartered
in Southern California. For more information, visit atarabio.com
and follow @Atarabio on X (formerly known as 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:
(1) the development, timing and progress of tab-cel®, including a
potential BLA, the potential characteristics and benefits of
tab-cel®, and the progress and results of, and prospects for,
Atara’s expanded global partnership with Pierre Fabre Laboratories
involving tab-cel®, and the potential financial benefits to Atara
as a result of the expanded global partnership with Pierre Fabre
Laboratories; (2) Atara’s expected cash runway; (3) the development
of ATA188, including Atara’s review of the data and analyses from
the EMBOLD study; (4) the role of EBV in the pathogenesis of
multiple sclerosis; and (5) the development, timing and progress of
Atara’s AlloCAR-T programs, including the timing of the start of
any clinical trials, and the safety and efficacy of product
candidates emerging from such programs, including ATA3219 and
ATA3431. 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 and the wars in Ukraine and the Middle East,
which may significantly impact (i) our business, research, clinical
development plans and operations, including our operations in
Southern California and Denver 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 , 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.
View source
version on businesswire.com: https://www.businesswire.com/news/home/20231108902565/en/
Investor and Media Relations: Alex Chapman Vice
President, Corporate Communications & Investor Relations (805)
456-4772 achapman@atarabio.com Jason Awe, Ph.D. Senior Director,
Corporate Communications & Investor Relations (805) 217-2287
jawe@atarabio.com
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