Atara Biotherapeutics Submits Tabelecleucel (Tab-cel®) Biologics License Application for Treatment of Epstein-Barr Virus Positive Post-Transplant Lymphoproliferative Disease with U.S. FDA
20 Mai 2024 - 3:25PM
Business Wire
First Allogeneic T-Cell Therapy BLA Submission
to U.S. Food and Drug Administration
If Approved, Tab-cel Would be First Approved
Therapy in U.S. for EBV+ PTLD
Acceptance of BLA Will Trigger $20 Million
Milestone Payment from Pierre Fabre Laboratories, with Potential
for Additional $60 Million Milestone Upon FDA Approval
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 that
Atara has submitted a Biologics License Application (BLA) to the
U.S. Food and Drug Administration (FDA) for tabelecleucel
(tab-cel®) indicated as monotherapy for treatment of adult and
pediatric patients two years of age and older with Epstein-Barr
virus positive post-transplant lymphoproliferative disease (EBV+
PTLD) who have received at least one prior therapy. For solid organ
transplant patients, prior therapy includes chemotherapy unless
chemotherapy is inappropriate. There are no FDA approved therapies
in this treatment setting.
“The BLA submission for tab-cel represents a significant moment
for Atara, our partner Pierre Fabre, and the broader allogeneic
T-cell therapy field, and is a critical step towards our goal of
delivering this first-of-its-kind treatment to EBV+ PTLD patients
in the U.S.,” said Pascal Touchon, President and Chief Executive
Officer of Atara. “I would like to thank the patients and
physicians who participated in the tab-cel clinical trials, our
long-time collaborators at Memorial Sloan Kettering Cancer Center,
as well as our internal teams for their remarkable dedication and
hard work. We now look forward to continued collaboration with the
FDA on its review and with Pierre Fabre as they actively prepare
for the potential launch of this innovative therapy in the
U.S.”
Tab-cel is an allogeneic, EBV-specific T-cell immunotherapy
designed to target and eliminate EBV-infected cells. The BLA is
supported by pivotal and supportive data covering more than 430
patients treated with tab-cel across multiple life-threatening
diseases including the latest pivotal ALLELE study data that
demonstrated a statistically significant 48.8% Objective Response
Rate (ORR) (p<0.0001) and favorable safety profile consistent
with previous analyses.
Tab-cel has been granted Breakthrough Therapy Designation for
the treatment of rituximab-refractory EBV-associated
lymphoproliferative disease by the U.S. FDA and has orphan drug
designation.
In December 2023, Atara announced the closing of the expanded
global partnership with Pierre Fabre Laboratories for the U.S. and
remaining global commercial markets for tab-cel, building on an
initial partnership covering Europe, Middle East, Africa, and other
select emerging markets. With the completion of the tab-cel BLA
submission, Atara continues to advance the Pierre Fabre expanded
global partnership, which includes potential milestone payments of
$20 million and $60 million from Pierre Fabre contingent upon the
successful FDA acceptance and approval of the tab-cel BLA,
respectively. In addition, Pierre Fabre is reimbursing Atara for
expected tab-cel global development costs through the BLA transfer
and purchasing tab-cel inventory through the manufacturing transfer
date. Atara is also eligible to receive double-digit tiered
royalties on net sales of tab-cel in the U.S. and remaining global
commercial markets referenced above.
Tab-cel was granted marketing authorization under the brand name
Ebvallo™ in December 2022 by the European Commission. Marketing
authorization was also granted by the Medicines and Healthcare
Products Regulatory Agency in the United Kingdom in May 2023 and by
Swissmedic in Switzerland in May 2024. In all three territories,
Ebvallo is indicated as 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 that can be rapidly delivered to patients
from inventory. 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 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 hematological malignancies and B-cell driven autoimmune
diseases. Atara is headquartered in Southern California. For more
information, visit atarabio.com and follow @Atarabio on X 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 development, timing and progress of tab-cel®, including a
potential BLA acceptance, the potential characteristics and
benefits of tab-cel®, the indication(s) for which tab-cel could
potentially obtain FDA approval for, and the progress and results
of, and prospects for, the expanded global partnership with Pierre
Fabre Laboratories involving tab-cel®, including Pierre Fabre
activities relating to the potential commercialization of tab-cel,
and the potential financial benefits to Atara as a result of the
expanded global partnership with Pierre Fabre Laboratories,
including any payments thereunder. 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 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/20240520985176/en/
Investor and Media Relations Jason Awe, Ph.D. Senior
Director, Corporate Communications & Investor Relations (805)
217-2287 jawe@atarabio.com
Atara Biotherapeutics (NASDAQ:ATRA)
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