Atara Biotherapeutics to Present Recent Progress and Key Upcoming Milestones at the 42nd Annual J.P. Morgan Healthcare Conference
08 Enero 2024 - 7:00AM
Business Wire
Closing of Transaction with Pierre Fabre
Laboratories to Expand Global Tab-cel® Partnership
Tab-cel BLA on Track for Submission in Q2 2024
Following Positive New Data from Pivotal ALLELE Study
Expansion of Next-gen Allogeneic CAR-T
Portfolio to Autoimmune Disease
ATA3219 IND in Lupus Nephritis Planned in Q1
2024
Focused Operational Activities and Associated
Strategic Restructuring Extends Cash Runway into 2027
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
Pascal Touchon, President and Chief Executive Officer of Atara,
will present the Company’s 2023 accomplishments across strategic
priorities and key upcoming milestones at the 42nd Annual J.P.
Morgan Healthcare Conference on Thursday, January 11 at 9:45 a.m.
PST / 12:45 p.m. EST.
“Our off-the-shelf, allogeneic CAR EBV T cell pipeline now spans
both oncology and autoimmune indications and is designed to
overcome current limitations of autologous CAR T and other
allogeneic cell therapy approaches. With preliminary clinical data
expected later this year for ATA3219 in lymphoma and a planned IND
in Lupus Nephritis in Q1, we enter 2024 with multiple opportunities
for a potential best-in-class allogeneic product,” said Pascal
Touchon, President and Chief Executive Officer of Atara.
“Meanwhile, we are encouraged by our latest pivotal study data for
tab-cel supporting our plan to file a BLA in Q2 2024, while our
global commercial partner Pierre Fabre is starting to prepare the
U.S. launch.”
Tabelecleucel (tab-cel® or EBVALLOTM) for Post-Transplant
Lymphoproliferative Disease (PTLD)
- Atara is advancing toward filing a Biologics License
Application (BLA) in Q2 2024, which will include the latest pivotal
ALLELE study data-cut that demonstrated a statistically significant
49% Objective Response Rate (ORR) (p<0.0001) and favorable
safety profile consistent with previous analyses
- This new data set augments the extensive database of pivotal
and supportive data as part of the upcoming BLA filing package,
collectively consisting of approximately 450 patients treated with
tab-cel across multiple life-threatening diseases
- The expanded global partnership with Pierre Fabre Laboratories
for the U.S. and remaining global commercial markets for tab-cel
closed on December 20, 2023
- Under the agreement, Atara received approximately USD 27
million in cash upfront at the closing of the deal, with the
potential to receive up to a total of USD 640 million in milestone
payments, development funding, and significant double-digit tiered
royalties on net sales
Tab-cel for Potential Indication Expansion
- Positive new clinical data from a combined analysis, including
the first reported data from the multicohort Phase 2 EBVision
trial, were presented during an oral session at the ESMO
Immuno-Oncology Annual Congress
- In the pooled analysis, an ORR of 77.8% was observed in 18
central nervous system (CNS) EBV+ PTLD patients including 1 CNS
EBV+ PTLD patient with no prior treatment, who achieved a complete
response
- One- and two-year overall survival rates were higher in
responders (85.7% and 66.7%, respectively) versus non-responders
(0% and 0%, respectively)
- Tab-cel was well tolerated, with no reports of serious
treatment-related fatal or life-threatening treatment-emergent
adverse events (TEAEs), and no reports of serious treatment-related
TEAEs of neurotoxicity, organ rejection, graft versus host disease,
or tumor flare reaction of any grade
- Enrollment is continuing at sites in the potential label
expansion multi-cohort Phase 2 EBVision trial evaluating new
patient populations, including 1L EBV+ PTLD and EBV+
immunodeficiency-associated lymphoproliferative diseases
(IA-LPDs)
CAR-T Programs (Hematological Malignancies and Autoimmune
Conditions)
ATA3219
- Atara is progressing development of ATA3219, an allogeneic,
off-the-shelf CAR T targeting CD19, optimized for a memory
phenotype and incorporating a next generation 1XX signaling
domain
- Pre-clinical data support a potential best-in-class profile
with longer persistence and superior anti-tumor efficacy compared
to an autologous CD19 CAR T benchmark
- Site selection and activation is ongoing for the Phase 1 study
in relapsed/refractory B-cell non-Hodgkin’s lymphoma (NHL) and
progressing toward enrolling the first patient in Q1 2024
- Preliminary clinical data in lymphoma anticipated H2 2024
- Planned Q1 2024 IND submission in Lupus Nephritis following
compelling clinical results from autologous CD19 CAR T academic
clinical study showing 8/8 patients attaining remission1
- Atara’s EBV CAR T cells may offer a differentiated therapeutic
approach—off-the-shelf accessibility, no requirement for gene
editing, and a less differentiated phenotype driving cellular
fitness—with the potential for rapid and deep B-cell depletion
- ATA3219 autoimmune development is building upon the favorable
safety profile of Atara's allogeneic EBV T cells in autoimmune
disease
ATA3431
- Positive preclinical data presented at ASH for ATA3431, an
allogeneic, dual-targeted CAR directed against CD20 and CD19 to
mitigate CD19 antigen escape, built on Atara’s EBV T-cell platform
with novel 1XX stimulation for enhanced persistence
- Data showed superior in vivo anti-tumor activity, survival, and
functional persistence of ATA3431 compared to an autologous CD20-
CD19 CAR-T benchmark
- Atara is advancing ATA3431 into IND-enabling studies
Strategic Restructure and Financial Impact
- Atara is undertaking a strategic restructuring and reducing its
current workforce of 225 by approximately 25% reflecting its
evolving corporate strategy and pipeline focus to progress its
potential best-in-class allogeneic CAR-T portfolio for cancer and
autoimmune diseases
- Atara will focus on executing its remaining responsibilities
under the tab-cel collaboration with Pierre Fabre Laboratories,
including filing the BLA in Q2 2024, and advancing its
differentiated allogeneic CAR-T (AlloCAR-T) ATA3219 and ATA3431
programs to key milestones in 2024
- The strategic restructuring, combined with anticipated payments
upon successful filing and approval of tab-cel BLA from our
expanded global partnership, and the Company’s existing cash, cash
equivalents and short-term investments as of September 30, 2023, is
expected to fund the Company’s planned operations into 2027
A live audio webcast of the presentation will be available by
visiting the Investors & Media – News & Events section of
atarabio.com on Thursday, January 11, at 9:45 a.m. PST / 12:45 p.m.
EST. An archived replay of the webcast will be available on the
Company's website for 30 days following the live presentation. A
new corporate presentation will be available on Monday, January 8
at 8:00 a.m. EST / 5:00 a.m. PST.
Next-Generation Allogeneic CAR-T Approach
Atara is focused on applying Epstein-Barr virus (EBV) T-cell
biology, featuring experience in over 500 patients treated, and
novel chimeric antigen receptor (CAR) technologies to meet the
current limitations of autologous and allogeneic CAR therapies
head-on by advancing a potential best-in-class CAR-T pipeline in
oncology and autoimmune disease. Unlike gene-edited approaches
aimed at inactivating T-cell receptor (TCR) function to reduce the
risk for graft-vs-host disease, EBV T cells maintain expression of
native TCRs that promote in vivo functional persistence while also
demonstrating inherently low alloreactivity due to their
recognition of defined viral antigens and partial human leukocyte
antigen (HLA) matching. A molecular toolkit of clinically-validated
technologies—including the 1XX costimulatory domain designed for
better cell fitness and less exhaustion while maintaining stemness—
offers a differentiated approach to addressing significant unmet
need with the next generation CAR T.
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
within days. 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 Epstein-Barr virus (EBV) 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 (formerly
known as 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 development, data, timing and progress, as applicable, of
Atara’s (i) tab-cel program, including a potential BLA for tab-cel
in the United States, and the amended and restated
commercialization agreement with Pierre Fabre, (ii) AlloCAR-T
programs, including the Phase 1 study of ATA3219 in
relapsed/refractory B-cell NHL, preclinical data for ATA3431, the
potential characteristics and benefits of ATA3431, and potential
IND submissions for ATA3431 and for ATA3219 to treat Lupus
Nephritis, (iii) restructuring, including the potential
cost-savings and other financial impacts related thereto and (iv)
cash runway. 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’s 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.
1Blood (2023) 142 (Supplement 1): 220.
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version on businesswire.com: https://www.businesswire.com/news/home/20240107093705/en/
Investor and Media Relations: Alex Chapman Vice
President, Corporate Communications & Investor Relations (805)
456-4772 achapman@atarabio.com
Jason Awe, Ph.D. Senior Director, Corporate Communications &
Investor Relations (805) 217-2287 jawe@atarabio.com
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