Atara Biotherapeutics Provides Update on ATA2271 Autologous CAR T Trial
February 18 2022 - 8:00AM
Business Wire
Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leader in T-cell
immunotherapy, developing transformative therapies for patients
with cancer and autoimmune diseases, today reported Memorial Sloan
Kettering Cancer Center’s (MSK) notification to the U.S. Food and
Drug Administration (FDA) of a fatal serious adverse event (SAE)
associated with a patient treated in the ongoing Phase 1,
MSK-conducted dose-escalation clinical study of autologous
mesothelin CAR T, ATA2271. MSK has voluntarily paused enrollment of
new patients in the study on a temporary basis while additional
information regarding the case is gathered and reviewed. The FDA
has notified MSK of its agreement with this approach.
ATA2271 is a next-generation, autologous chimeric antigen
receptor (CAR) T-cell therapy targeting mesothelin currently under
clinical investigation in patients with malignant pleural
mesothelioma. The single case involved a patient with a history of
multiple malignancies and other comorbidities undergoing treatment
for advanced recurrent mesothelioma. MSK is in the process of
further evaluating the occurrence, including the extent of the
relationship of the event to ATA2271.
“The safety of every patient participating in studies we are
funding or conducting is of the utmost priority for Atara,” said
Jakob Dupont, MD, Head of Global Research & Development at
Atara. “Clinical evaluation of the case remains ongoing, and we are
working closely with investigators at MSK, who are conducting the
ATA2271 study under their IND, to establish the underlying causes
of the event. We anticipate providing a further update in the
coming weeks following further discussion and consultation with
MSK.”
The median survival of treated patients with malignant pleural
mesothelioma is 9-17 months even with successful completion of a
combination of chemotherapy, aggressive surgical resection, and
radiation therapy. The first six patients enrolled in the two
lowest dose cohorts received either 1x106 cells/kg (patients 1-3)
or 3x106 cells/kg (patient 4-6) intrapleural ATA2271. Within these
two cohorts, no dose limiting toxicities have been reported to
date. The patient event being reported relates to the first patient
in a third, higher-dose cohort (6x106 cells/kg).
The temporary pause in ATA2271 study enrollment does not impact
the IND-enabling work currently underway to advance ATA3271, a
separate, off-the-shelf, allogeneic CAR-T therapy targeting
mesothelin using next-generation PD1DNR and 1XX CAR technologies
for patients with advanced mesothelioma. ATA3271, ATA3219, tab-cel,
and ATA188 all utilize Atara’s allogeneic EBV T-cell platform, the
safety and tolerability of which has been validated by clinical
studies and experience in approximately 400 patients in various
disease areas with no observed cytokine release syndrome (CRS) to
date.
MSK Disclosure: MSK has intellectual property rights and
associated interests by virtue of licensing agreements between MSK
and Atara.
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 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:
the timing and progress of (i) the ATA2271 program; (ii) the
ATA2271 clinical trial, and preliminary clinical data; (iii)
ATA2271 preclinical development and preclinical data; (iv) the
safety and efficacy of Atara’s product candidates, including
ATA2271; (v) MSK’s ability to successfully advance the development
of ATA2271; and (vi) Atara’s ability to successfully advance the
development of its CAR T programs. 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/20220217006012/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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