Atara Biotherapeutics Announces Plans to Submit Tab-cel® BLA in Q2 2024 Following FDA Agreement on Comparability
20 September 2023 - 6:01AM
Business Wire
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 reported
important progress related to the regulatory pathway for
tabelecleucel (tab-cel®) in the U.S.
Following productive discussions between Atara and the U.S. Food
and Drug Administration (FDA), the FDA and Atara are now aligned on
analytical comparability between manufacturing process versions.
This alignment supports Atara's ability to pool the pivotal
clinical trial data from different process versions in the
Biologics License Application (BLA) submission.
Atara expects to submit the tab-cel BLA in Q2 2024, which will
enable Atara to incorporate the latest tab-cel pivotal trial data
from the ALLELE study into the BLA filing package.
“We are pleased with the FDA’s positive assessment and
conclusion of comparability, and we look forward to progressing to
the next stage of preparing our BLA submission for tab-cel,” said
Pascal Touchon, President and Chief Executive Officer of Atara.
“Following this clarity, we can also continue to advance our U.S.
partnership discussions with several parties, selecting the best
possible partner to bring this potentially life-saving treatment to
patients.”
Tabelecleucel is an allogeneic, EBV-specific T-cell
immunotherapy which targets and eliminates EBV-infected cells in an
HLA-restricted manner. Epstein-Barr virus-positive post-transplant
lymphoproliferative disease (EBV+ PTLD) is a rare, acute, and
potentially deadly hematologic malignancy that occurs after
transplantation when patient T-cell immune responses are
compromised by immunosuppression. It can impact patients who have
undergone solid organ transplant (SOT) or allogeneic hematopoietic
cell transplant (HCT). Poor median survival of 0.7 months and 4.1
months for HCT and SOT, respectively, is reported in EBV+ PTLD
patients for whom standard of care failed, underscoring the
significant need for new therapeutic options.
Tabelecleucel is commercialized by Pierre Fabre in Europe as
EBVALLO™ following European Commission marketing authorization in
December 2022. In Europe, EBVALLO™ is indicated as a monotherapy
for the treatment of adult and pediatric patients two years of age
and older with relapsed or refractory EBV+ PTLD who have received
at least one prior therapy. For solid organ transplant patients,
prior therapy includes chemotherapy, unless chemotherapy is
inappropriate.
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) dialogue with the FDA
regarding a potential BLA submission for tab-cel; (2) tab-cel
clinical trials, and the occurrence, timing and outcome of Atara’s
interactions and discussions with the FDA regarding a BLA
submission for tab-cel, including the pooling of pivotal clinical
trial data from different process versions in a BLA submission; (3)
the potential submission of a BLA for tab-cel; and (4) the timing
and progress of Atara’s discussions with potential commercial
partners for tab-cel in the U.S. 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 ongoing COVID-19 pandemic and the war in
Ukraine, 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.
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version on businesswire.com: https://www.businesswire.com/news/home/20230919197771/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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