Atara Biotherapeutics to Present Recent Progress and Key Upcoming Catalysts at the 40th Annual J.P. Morgan Healthcare Conference
January 10 2022 - 8:30AM
Business Wire
Significant Progress Achieved Against Strategic
Priorities for ATA188, Tab-cel® and CAR T Programs in 2021
ATA188 Granted FDA Fast Track Designation for
Both Non-Active PPMS and Non-Active SPMS in Recognition of
Potential to Address Significant Unmet Medical Need
Tab-cel® on Track to be First Ever Allogeneic
Off-The-Shelf T-cell Immunotherapy Approved in EU in 2022
Presentation on Wednesday, January 12 at 5:15
p.m. EST / 2:15 p.m. PST
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 2021 accomplishments across strategic
priorities and key upcoming catalysts at the 40th Annual J.P.
Morgan Healthcare Conference on Wednesday, January 12 at 2:15 p.m.
PST / 5:15 p.m. EST.
“Atara made significant progress in 2021, including presentation
of positive data from our pivotal Phase 3 ALLELE study and EU
regulatory submission for tab-cel; new data confirming our
conviction for ATA188 as the first investigational therapy to
potentially reverse disability in progressive multiple sclerosis,
now further validated by FDA Fast Track designation; and promising
early safety and persistence data for our potentially best-in-class
allogeneic CAR T portfolio that does not require TCR or HLA gene
editing,” said Pascal Touchon, President and Chief Executive
Officer of Atara. “With the interim analysis from our EMBOLD study
of ATA188, a planned BLA submission and the potential
groundbreaking EU approval for tab-cel, the first ever allogeneic,
off-the-shelf T-cell therapy to reach this stage, 2022 will be an
exciting year for Atara and patients in significant need.”
Tabelecleucel (tab-cel®) for Post-Transplant
Lymphoproliferative Disease (PTLD)
- Continued progress with the U.S. Food and Drug Administration
(FDA), including productive engagement with CBER and a Type B CMC
meeting scheduled for Q1 2022
- Atara plans to complete the Biologics License Application (BLA)
submission for patients with EBV+ PTLD in Q2 2022
- U.S. approval of BLA for patients with EBV+ PTLD anticipated in
H1 2023
- Following successful interactions with EMA, Atara submitted a
Marketing Authorization Application (MAA) for tab-cel in patients
with EBV+ PTLD, the first ever for an allogeneic, off-the-shelf
T-cell therapy, in November 2021. With the granting of Accelerated
Assessment, the Company anticipates a decision regarding EU
approval in Q4 2022
- First presentation of positive data from the pivotal Phase 3
ALLELE study, reinforcing the transformative potential of tab-cel,
as an oral session at the 63rd American Society of Hematology (ASH)
Annual Meeting in December 2021
- Data demonstrated a 50% objective response rate (ORR) and
durability of response with 89% of patients responding to treatment
surviving after one year, compared with 32% in non-responders
- In a second oral presentation at ASH, longer term data from
Phase 2 and Expanded Access Protocol (EAP) studies showed two-year
survival benefit of over 86% in responders whether they achieved a
complete response (CR) or partial response (PR) and median OS of
54.6 months
- Continued favorable tab-cel safety profile and no new safety
signals with more than 180 PTLD patients treated to date
- EBV+ PTLD is a rare and potentially life-threatening cancer
that may occur following a solid organ transplant (SOT) or
allogeneic hematopoietic cell transplant (HCT). For patients with
EBV+ PTLD, the median survival is only 0.7 to 4.1 months after
failure of initial therapy. There are currently no EMA- or
FDA-approved treatments indicated for these patients
Tab-cel for Potential Additional Indications
- Enrollment is continuing at sites in the potential label
expansion multi-cohort Phase 2 study evaluating six patient
populations within EBV+ immunodeficiency-associated
lymphoproliferative diseases (IA-LPDs) and other EBV-driven
diseases
- First data from the multi-cohort study planned to be presented
in 2023
ATA188 for Progressive Multiple Sclerosis (MS)
- FDA has granted Fast Track designation for ATA188 in non-active
primary progressive multiple sclerosis (PPMS) and non-active
secondary progressive multiple sclerosis (SPMS), two populations
with high unmet medical need and limited treatment options
- A Fast Track designation expedites the review of drugs filling
an unmet medical need to treat serious conditions to get important
therapies to patients faster; once received, this designation
allows early and frequent communication with FDA throughout the
development and review process
- Atara is continuing to make good progress enrolling the Phase 2
randomized, double-blind, placebo-controlled dose-expansion EMBOLD
study evaluating the efficacy and safety of ATA188 in patients with
progressive MS
- A formal interim analysis is planned for Q2 2022, including
efficacy and safety, to optimize the likelihood of success in Phase
2 and confirm current development strategy
- Following the interim analysis, the Company will communicate
next steps for the program, including rationale, while still
maintaining the integrity of the study
- Atara plans to conduct pivotal Phase 3 studies at the
conclusion of the Phase 2 study and is actively exploring
partnership opportunities
- One Phase 3 study will focus on non-active SPMS, for which no
approved therapies currently exist in U.S. or EU
- A separate study will focus on non-active PPMS, which has very
few treatment options in most countries and approved therapies are
of limited efficacy
- The vast majority of people with PPMS and SPMS have non-active
disease
- Overall, increasing research activity and support within the
academic community for the hypothesis of EBV as a driver of MS
pathogenesis
CAR T Programs
- Atara continues to advance our CAR T programs in liquid and
solid tumors, which include a differentiated approach to allogeneic
cell therapy, with no gene editing of the T-cell receptor (TCR) and
next generation CAR technologies to enhance expansion and
persistence of functional T cells
ATA2271/ATA3271 (Solid Tumors Over-Expressing
Mesothelin)
- Global strategic collaboration for ATA2271 and ATA3271 with
Bayer continues to progress well with advancement of the
mesothelin-partnered CAR T immunotherapy programs
- Data presented at ESMO-IO in December 2021 showed promising
early safety and persistence of armored CAR T, ATA2271, in patients
with advanced mesothelioma; infusions for the first two patient
cohorts have now been completed
- Atara is continuing to make progress on IND-enabling studies
for ATA3271, an off-the-shelf, allogeneic CAR-T therapy targeting
mesothelin using next-generation PD-1 dominant negative receptor
(DNR) and 1XX CAR co-stimulatory signaling domain technologies for
patients with advanced mesothelioma, and expects a filing in Q4
2022
ATA3219 (B-cell Malignancies)
- Atara continues to advance development of ATA3219, a potential
best-in-class allogeneic CD19 CAR T therapy that does not require
TCR or human leukocyte antigen (HLA) gene editing, leveraging our
next-generation 1XX CAR co-stimulatory signaling domain and
allogeneic EBV T-cell platform
- New pre-clinical data (on file) demonstrated optimized version
of ATA3219 with an enhanced memory phenotype, leads to both strong
proliferative potential and potent antitumor activity supporting a
best-in-class profile
- Atara expects to submit an IND for B-cell malignancies in Q4
2022
A live audio webcast of the presentation will be available by
visiting the Investors & Media – News & Events section of
atarabio.com on Wednesday, January 12, at 5:15 p.m. EST / 2:15 p.m.
PST. 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 10
at 8:30 a.m. EST / 5:30 a.m. PST.
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: (1) the potential
benefits, safety and efficacy of tab-cel®; the timing and progress
of tab-cel®, including (i) data and analyses from the ALLELE study,
(ii) tab-cel® clinical trials, and the timing and outcome of
Atara’s discussions with the FDA regarding a BLA submission for
tab-cel®, (iii) the timing and decision of the EMA regarding the
MAA for tab-cel®, (iv) the timing of the initiation or submission
of the BLA, (v) Atara’s ability to successfully advance the
development of tab-cel®, including for potential additional
indications, (vi) Atara’s activities in anticipation of potential
tab-cel® approval and commercial launch in the U.S., including the
timing thereof, (vii) Atara’s collaboration with Pierre Fabre for
commercializing tab-cel® in Europe, Middle East, Africa and other
emerging markets, including the timing thereof, and (viii) the
potential competition for tab-cel®; (2) the potential benefits,
safety and efficacy of ATA188; the timing and progress of ATA188,
including (i) data and analyses from the ATA188 OLE study, (ii)
data and analyses from the EMBOLD study, including from the planned
interim analysis, including the timing thereof, (iii) the timing,
design and outcome of potential additional ATA188 clinical trials,
(iv) Atara’s ability to successfully advance the development of
ATA188; and (v) partnering options for ATA188; (3) the timing and
progress of its CAR T programs, including (i) ATA2271 clinical
trial; (ii) ATA3271 and ATA3219 preclinical development, including
the timing of regulatory submissions for such product candidates,
(iii) progress of the strategic collaboration with Bayer for
ATA2271 and ATA3271, and (iv) Atara’s ability to successfully
advance the development of its CAR T programs; and (4) Atara’s
research and development activities and manufacturing activities,
including the development and progress thereof; (5) Atara’s ability
to advance development of its 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/20220109005052/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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