First-Ever Off-The-Shelf Allogeneic T-Cell
Therapy to be Reviewed by any Regulatory Agency in the World
EMA Priority Medicines (PRIME) and Orphan
Designated Tabelecleucel One Step Closer for Patients with High
Unmet Need
EU Approval Decision Anticipated for Second
Half of 2022, based on CHMP Accelerated Assessment
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell
immunotherapy, leveraging its novel allogeneic EBV T-cell platform
to develop transformative therapies for patients with cancer and
autoimmune diseases, today announced that the Marketing
Authorization Application (MAA) for tabelecleucel (tab-cel®) has
been fully validated by the European Medicines Agency (EMA).
Tab-cel is an investigational treatment for patients with
Epstein-Barr virus-positive post-transplant lymphoproliferative
disease (EBV+ PTLD) who have received at least one prior therapy
following solid organ transplant (SOT) or hematopoietic cell
transplant (HCT).
The application will be evaluated by the EMA’s Committee for
Medicinal Products for Human Use (CHMP) under the centralized
licensing procedure for all EU Member States, as well as in the
European Economic Area countries Iceland, Liechtenstein, and
Norway.
“EBV+ PTLD is a rare and aggressive cancer where the patients we
seek to treat only have weeks to a few months survival after
treatment failure, with no approved options,” said Jakob Dupont,
MD, Executive Vice President and Global Head of Research and
Development at Atara. “Tab-cel is the first-ever off-the-shelf
allogeneic T-cell therapy to be reviewed by a regulatory agency and
is a watershed moment for the field and for patients with
significant unmet need. We look forward to working with the EMA as
the agency evaluates the transformative potential of tab-cel.”
Tab-cel is Atara’s lead candidate in development for
EBV-positive cancers, including EBV+ PTLD, where it is being
investigated in adults and children in the ongoing Phase 3,
registration-enabling ALLELE study. The MAA includes positive data
from this study, which demonstrates a 50% (19/38, 95% CI: 33.4,
66.6) objective response rate (ORR) as measured by independent
oncologic response adjudication (IORA) assessment, with an ORR of
50% (12/24, 95% CI: 29.1, 70.9) in PTLD following SOT and 50%
(7/14, CI: 23.0, 77.0) in PTLD following HCT, with a best overall
response of Complete Response (CR; n=5, SOT; n=5, HCT) or Partial
Response (PR; n=7, SOT; n=2, HCT). Overall, the median time to
response (TTR) was 1.1 months (0.7-4.7). Of 19 responders, 11 had a
duration of response (DOR) lasting more than six months and median
DOR has not been reached yet. Those who responded had a longer
survival compared to the non-responders, with a one-year survival
rate of 89.2% for patients responding to tab-cel compared with
32.4% among non-responders. Safety findings were consistent with
previously published data, with no new signals. There were no
reports of tumor flare reaction, and no confirmed evidence of graft
versus host disease (GvHD), organ rejection, infusion reactions, or
cytokine release syndrome (CRS) related to tab-cel.
Atara will present findings from the ALLELE study and additional
tab-cel data in eight abstracts at the 63rd American Society of
Hematology (ASH) Annual Meeting taking place December 11-14, 2021,
in Atlanta, Georgia.
In October 2021, Atara entered into an exclusive
commercialization agreement with Pierre Fabre for tab-cel in
Europe, Middle East, Africa and other select emerging markets for
Epstein-Barr virus (EBV)-positive cancers. In addition to
responsibility for the pivotal ALLELE study in PTLD and submitting
the EU MAA, Atara also remains responsible for the Phase 2
multi-cohort study, which is evaluating tab-cel in six additional
patient populations with the goal of label expansion in other
EBV-driven cancers. Pierre Fabre will lead all commercialization
and distribution activities in the territories, as well as medical
and regulatory activities after the anticipated MAA approval in
Europe.
About Tabelecleucel
Tabelecleucel (tab‐cel) is an off-the-shelf, allogeneic T-cell
immunotherapy in development for the treatment of Epstein-Barr
virus-positive post-transplant lymphoproliferative disease (EBV+
PTLD). EBV+ PTLD is a type of lymphoma (cancer) that may occur
after a solid organ transplant (SOT) or allogeneic hematopoietic
cell transplant (HCT). There are currently no approved treatments
indicated to treat PTLD and if left untreated, PTLD can have
life-threatening consequences.
Tab-cel is currently being investigated in the Phase 3
registration-enabling ALLELE study to assess efficacy and safety
for the treatment of EBV+ PTLD in SOT and HCT after failure of
standard of care.
Tab-cel has been granted Breakthrough Therapy Designation for
EBV+ PTLD following allogeneic HCT by the U.S. Food and Drug
Administration (FDA) and PRIME designation by the European
Medicines Agency (EMA) for the same indication. Tab-cel has orphan
drug designation in the U.S. and EU.
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, 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 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
tab-cel®: the timing of, and Atara’s plans for, and potential
decision by, the EMA regarding the MAA submission for EBV+ patients
with PTLD, the development, timing and progress of tab-cel®,
including data and analyses from ALLELE study, the
investigator-initiated Phase 2 study, and the EAP, the potential
characteristics, benefits, safety and efficacy of tab-cel®, and the
progress and results of, and prospects for, any collaboration
involving tab-cel®, the commercial prospects and business
opportunity for tab-cel® in the territories licensed to Pierre
Fabre. 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/20211130005204/en/
INVESTORS & MEDIA: Investors Eric Hyllengren
805-395-9669 ehyllengren@atarabio.com Media Alex Chapman
805-456-4772 achapman@atarabio.com
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