EbvalloTM on Track to be the First Ever
Allogeneic T-Cell Therapy Approved
Positive Opinion Based on Pivotal Phase 3
ALLELE Study Demonstrating a Favorable Risk-Benefit Profile
European Commission Approval Expected in Q4
2022
Atara Biotherapeutics, Inc. (Nasdaq: ATRA) and Pierre Fabre
today announced the Committee for Medicinal Products for Human Use
(CHMP) of the European Medicines Agency (EMA) has adopted a
positive opinion recommending the European Commission (EC) approval
of EbvalloTM (tabelecleucel) as a monotherapy for treatment of
adult and pediatric patients two years of age and older with
relapsed or refractory 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.
“Today’s positive CHMP opinion is a major step forward for
Atara’s first-in-class product that addresses an ultra-rare and
aggressive cancer with no approved therapies while providing
further validation for our unique allogeneic EBV T-cell platform,”
said Pascal Touchon, President and CEO of Atara. “If approved,
EbvalloTM will be the first ever allogeneic T-cell therapy and has
the potential to change the treatment paradigm for patients with
relapsed or refractory EBV+ PTLD who face a poor prognosis and
dismal median survival of only weeks to a few months.”
The CHMP positive opinion is based on results from the pivotal
Phase 3 ALLELE study.1 In this study, EbvalloTM demonstrated a
favorable risk-benefit profile.
“This positive opinion is a landmark moment for patients
suffering from an extremely rare cancer,” said Eric Ducournau, CEO
of Pierre Fabre, Atara's commercialization partner in Europe.
“EbvalloTM is on track to be the first ever allogeneic T-cell
therapy approved in the European Union. Our teams are excited and
poised to bring this first-in-kind innovation to European patients,
as a testimony to our corporate purpose: every time we care for a
single person, we make the whole world better.”
“All patients undergoing transplant are at risk of developing
EBV+ PTLD during their life, and in that case, those that do not
respond to initial treatment have few treatment options left,” said
Dr. Sylvain Choquet, Head of the Clinical Hematology Department at
Pitié-Salpêtrière, APHP, France. “There is an urgent unmet need for
effective therapies for this rare B-cell lymphoproliferative
disease, with data from the pivotal study demonstrating the
potential for EbvalloTM to change the treatment of relapsed or
refractory EBV+ PTLD and provide a much-needed therapeutic solution
to both patients and physicians.”
With the CHMP positive opinion, the EC’s approval of the
EbvalloTM Marketing Authorization Application (MAA) under
exceptional circumstances is expected by the end of 2022. If
granted by the EC, the centralized marketing authorizations would
be valid in all EU Member States as well as Iceland, Liechtenstein,
and Norway. In addition, the MAA will be filed to the Medicines and
Healthcare Products Regulatory Agency (MHRA) in the UK under the EC
Decision Reliance Procedure (EC DRP) with an expected approval by
the end of 2022. Under an existing collaboration agreement, Pierre
Fabre will lead all commercialization and distribution activities
in Europe and select other markets in addition to medical and
regulatory activities after the anticipated MAA approval in
Europe.
About EbvalloTM and EBV+ PTLD
EbvalloTM is an allogeneic, EBV-specific T-cell immunotherapy
which targets and eliminates EBV-infected cells in an
HLA-restricted manner. EbvalloTM (tabelecleucel) has been granted
Breakthrough Therapy Designation for the treatment of
rituximab-refractory EBV-associated lymphoproliferative disease
(LPD) by the U.S. Food and Drug Administration (FDA) and has orphan
drug designation in the U.S. EbvalloTM (tabelecleucel) received
PRIME designation by the European Medicines Agency (EMA) for the
treatment of patients with EBV-associated PTLD in the allogeneic
hematopoietic stem cell transplant (HCT) setting who have failed on
rituximab and has orphan drug designation in the EU. EBV+ PTLD is a
rare, acute, and potentially deadly hematologic malignancy that
occurs after transplantation when a patient’s T-cell activity is
compromised by immunosuppression. It can impact patients who have
undergone solid organ transplant (SOT) or an allogeneic 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 rituximab
± chemotherapy failed, underscoring the significant need for
effective, safe, and fast-acting new therapeutic options.
About Pierre Fabre
Pierre Fabre is a French healthcare company with over 35-years
of experience in innovation, development, manufacturing and
commercialization in oncology. Its portfolio includes several
medical franchises and international brands, namely Pierre Fabre
Oncology, Pierre Fabre Dermatology, Pierre fabre Health Care, Eau
Thermale Avène, Klorane, René Furterer, A-Derma, Darrow, Glytone,
Naturactive and Pierre Fabre Oral Care. The company has declared
oncology its top priority in medical care R&D and
commercialization, focusing on targeted therapies, biotherapies and
immuno-oncology. Its portfolio covers colorectal, breast, lung
cancers, melanoma and pre-cancerous conditions like actinic
keratosis. Pierre Fabre provides specific solutions to help
patients manage adverse side effects affecting the skin and mouth
due to cancer treatment. In 2021, Pierre Fabre posted 2.5 billion
euros in revenues, 66% of which came from international sales in
over 100 countries.
Established in the South-West of France since its creation, the
group manufactures over 95% of its products in France and employs
some 9,600 people worldwide. Pierre Fabre is 86%-owned by the
Pierre Fabre Foundation, a government-recognized public-interest
foundation since 1999, and secondarily by its own employees through
an international employee stock ownership plan. Further information
about Pierre Fabre can be found at www.pierre-fabre.com,
@PierreFabre.
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. 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®, the
potential characteristics and benefits 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, and the potential financial benefits to Atara as a result of
the collaboration with 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.
___________________________ 1
https://doi.org/10.1182/blood-2021-147274
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version on businesswire.com: https://www.businesswire.com/news/home/20221013006075/en/
Atara: Investors Eric Hyllengren 805-395-9669
ehyllengren@atarabio.com Media Alex Chapman 805-456-4772
achapman@atarabio.com Pierre Fabre: Laure Sgandurra +33 6 32
54 92 01 laure.sgandurra@pierre-fabre.com
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