Second IND Clearance for ATA3219 Following
Non-Hodgkin’s Lymphoma (NHL) and First in an Autoimmune Disease
Indication
Initial Clinical Data in NHL Anticipated in H2
2024 and for Lupus Nephritis in H1 2025
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 the
U.S. Food and Drug Administration (FDA) has cleared an
Investigational New Drug (IND) application for ATA3219, an
allogeneic, anti-CD19 chimeric antigen receptor (CAR) T-cell
monotherapy for the treatment of systemic lupus erythematosus (SLE)
with kidney involvement (lupus nephritis [LN]).
“Expanding upon an extensive clinical experience encompassing
the treatment of over 600 patients using our allogeneic T-cell
platform in both oncology and autoimmune diseases, we are excited
to clinically evaluate the potential of our differentiated
allogeneic CAR T-cell approach. We are eager to address the
significant unmet need in lupus nephritis as we initiate our Phase
1 trial,” said Pascal Touchon, President and Chief Executive
Officer of Atara. “We look forward to bringing the promise and
accessibility of a potentially curative off-the-shelf cell therapy
option to patients with severe autoimmune diseases, potentially
eliminating the burdens of autologous CAR T therapies like costly
infrastructure and treatment delays.”
The multi-center, Phase 1, open-label, single-arm,
dose-escalation study will evaluate the safety and preliminary
efficacy of ATA3219 in subjects with LN. Subjects will receive
lymphodepletion treatment followed by ATA3219 at a dose of 40, 80,
or 160 x 106 CAR+ T cells. ATA3219 is designed to be given as a
one-time infusion and followed for safety and efficacy. Each dose
level is designed to enroll 3-6 patients, with the first subject
expected to be enrolled in the second half of 2024.
“Existing therapeutic agents for lupus nephritis yield
suboptimal responses and have limitations due to their requirement
for ongoing administration, susceptibility to treatment failures,
and limited accessibility to inflamed tissues resulting in
incomplete depletion of B cells,” said Rajani Dinavahi, Chief
Medical Officer at Atara. “CAR T cells can naturally infiltrate
deep into target tissues to mediate B-cell depletion and produce
durable responses. Building on the encouraging academic data in
lupus nephritis with autologous CD19 CAR T, ATA3219 is an
off-the-shelf therapy that could significantly reduce constraints
for patients and physicians like leukapheresis and long waiting
times, therefore potentially improving access to a large population
of patients.”
Proof of concept for a CD19 CAR T approach in autoimmune disease
was first demonstrated in early academic results from an
investigator-sponsored study showing 100% (8/8) of LN patients
rapidly attaining drug-free, durable remission with an autologous
CD19-targeted CAR T therapy. The therapy eliminated the pathogenic,
autoreactive B cells and allowed healthy B cells to return after
treatment, enabling the patients’ immune system to function
normally again with associated improvement of clinical symptoms.1
These early proof of concept clinical data with CD19 targeted CAR T
support further development of CAR T for LN with differentiated and
off-the-shelf allogeneic approaches.
The ATA3219 IND submission included in vitro data reflecting the
CD19 antigen-specific functional activity of ATA3219 and
CAR-mediated activity against B cells from SLE patients. ATA3219
led to robust CD19-specific B-cell depletion compared to
controls.
LN is a serious and most common complication of SLE, a chronic
multisystem autoimmune disease. The prevalence of SLE in the U.S.
is 73 per 100,000 people, afflicting more than 200,000 U.S.
patients alone, and occurs in women much more commonly than men. Up
to 60% of adult patients with SLE develop renal disease during the
course of their illness, and up to 70% of patients with LN are
refractory to standard immunosuppressive therapies. Despite recent
advances in treatment strategies, the response rate using existing
therapies remains low, with significant risk of long-term morbidity
and mortality associated with refractory LN.
About ATA3219
ATA3219 combines the natural biology of unedited T cells with
the benefits of an allogeneic therapy. It consists of allogeneic
Epstein-Barr virus (EBV)-sensitized T cells that express a CD19 CAR
construct for the treatment of CD19+ relapsed or refractory B-cell
malignancies, including B-cell non-Hodgkin’s lymphoma and B-cell
mediated autoimmune diseases including systemic lupus erythematosus
(SLE) with kidney involvement (lupus nephritis [LN]). ATA3219 has
been optimized to offer a potential best-in-class profile,
featuring off-the-shelf availability. It incorporates multiple
clinically validated technologies including a modified CD3�
signaling domain (1XX) that optimizes expansion and mitigates
exhaustion, enrichment during manufacturing for a less
differentiated phenotype for robust expansion and persistence and
retains the endogenous T-cell receptor without gene editing as a
key survival signal for T cells contributing to persistence.
Next-Generation Allogeneic CAR T Approach
Atara is focused on applying Epstein-Barr virus (EBV) T-cell
biology, featuring experience in over 600 patients treated with
allogeneic EBV T cells, 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,
Atara’s allogeneic platform maintains expression of the native EBV
TCR 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
from inventory. 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 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 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: (1)
the ATA3219 program; (2) the potential characteristics and benefits
of ATA3219; (3) the Company’s planned clinical study of ATA3219 to
treat lupus nephritis, including the timing and enrollment thereof.
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 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.
1Mueller, F., et al. CD19-Targeted CAR-T Cells in Refractory
Systemic Autoimmune Diseases: A Monocentric Experience from the
First Fifteen Patients. Blood 2023; 142 (Supplement 1): 220.
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version on businesswire.com: https://www.businesswire.com/news/home/20240229015853/en/
Investor and Media Relations: Jason Awe, Ph.D. Senior
Director, Corporate Communications & Investor Relations (805)
217-2287 jawe@atarabio.com
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