Atara Biotherapeutics Announces First Clinical Data from Ongoing Tab-cel® European Multicenter Expanded Access Program (EAP) at the 2022 American Society of Clinical Oncology (ASCO) Annual Meeting and Update on Tab-cel EMA Regulatory Progress
June 04 2022 - 9:00AM
Business Wire
Overall Response Rate (ORR) of 60% Observed in
Patients with Relapsed or Refractory (R/R) EBV+ PTLD Consistent
with Previously Reported Studies
Completion of All Pre-Approval Inspections
Required to Support EU Marketing Authorization Application;
Anticipated European Commission Approval On-Track for Q4 2022
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 EMA regulatory progress and
tabelecleucel (tab-cel®) clinical outcomes. Data is reported from
the multicenter Expanded Access Program (EAP) study in Europe for
patients with relapsed or refractory (r/r) Epstein-Barr
virus-driven post-transplant lymphoproliferative disease (EBV+
PTLD) following solid organ transplant (SOT) or hematopoietic cell
transplant (HCT) and will be featured in a poster presentation at
the 2022 American Society of Clinical Oncology (ASCO) Annual
Meeting taking place June 3-7, 2022, in Chicago, IL.
In the ongoing EAP, 22 patients from the first European centers
consented to this observational study, of which 16 patients
presented with EBV+ PTLD and six with EBV+ non-PTLD between July
2020 and November 2021. The primary objective of the study is to
describe the demographics and disease characteristics of patients
with EBV+ diseases treated with tab-cel under the EAP. Secondary
objectives are to describe the tab-cel dosing pattern, to evaluate
clinically relevant treatment outcomes, and to describe the safety
of tab-cel in patients with EBV+ diseases treated under the
EAP.
Of the 16 EBV+ PTLD patients, 15 received at least one dose of
tab-cel. Overall, nine out of 15 (60%) tab-cel treated patients
achieved a response as assessed by the treating physician, with six
complete responses (CRs) and three partial responses (PRs). Of the
nine responses, eight were observed after the first treatment cycle
of tab-cel.
Safety findings were consistent with previously published data.
All treatment-emergent events were assessed as unrelated to tab-cel
by the treating physician and were consistent with patients’
underlying diseases. Further detail on baseline demographics and
disease characteristics, and additional safety data including
tab-cel exposure details, will be presented at the conference.
“We are pleased to share the latest data from our EAP in Europe
demonstrating clinically meaningful outcomes for patients with EBV+
PTLD, a rare and aggressive disease with no approved treatment
options, in line with the favorable safety and efficacy profile
from previously reported studies including the pivotal Phase 3
ALLELE study,” said Jakob Dupont, M.D., Head of Global Research
& Development at Atara. “In addition, we now welcome the
completion of our pre-approval inspections as a key milestone on
our road to achieving approval in the EU.”
Separately, Atara announced completion of all six pre-approval
inspections required to support the Marketing Authorization
Application for tab-cel in Europe, with the Good Manufacturing
Practice (GMP) compliance certificates required to support the
filing expected by July. Combined with the recent Day 120 critical
assessment report, where the European Medicines Agency (EMA)
considered the comparability data between clinical and commercial
manufacturing versions as sufficient to demonstrate comparability,
Atara continues to expect European Commission approval in Q4
2022.
ASCO presentation details:
- Title: Demographics and treatment outcomes in patients
with EBV+ PTLD treated with off-the-shelf EBV-specific CTL
(tabelecleucel) under an ongoing expanded access program in Europe:
First analyses.
- Presenting Author: Ralf Trappe, M.D., DIAKO
Evangelisches Diakonie-Krankenhaus Bremen, Bremen, Germany
- Date & Time: Saturday, June 4, 2022, at 8-11 a.m.
CDT/6-9 a.m. PDT
- Abstract Number: 7530
- Poster Number: 184
- Session: Hematologic Malignancies—Lymphoma and Chronic
Lymphocytic Leukemia
- Location: McCormick Place Convention Center Chicago,
Hall A
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 and
currently under review to support registration in Europe, 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® (tabelecleucel) in Phase 3 development
for Epstein-Barr virus-driven post-transplant lymphoproliferative
disease (EBV+ PTLD); 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:
the potential benefits, safety and efficacy of tab-cel®; the timing
and progress of tab-cel®, including (i) data and analyses from the
EAP; (ii) the timing and outcome of the MAA for tab-cel, (iii) the
timing of the EMA’s review of the MAA for tab-cel; and (iv) Atara’s
ability to successfully advance the development of tab-cel®.
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, 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/20220604005008/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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