Atara Biotherapeutics Provides Update on Strategic Collaboration with Bayer
May 19 2022 - 4:01PM
Business Wire
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 that it received notification
of Bayer’s intention to end the exclusive worldwide licensing
agreement for next-generation mesothelin-directed CAR T-cell
therapies.
The collaboration included the funding and development of
ATA3271, an armored allogeneic T-cell immunotherapy, and an
autologous version, ATA2271, for high mesothelin-expressing tumors
such as malignant pleural mesothelioma and non-small-cell lung
cancer. Both ATA2271 and ATA3271 incorporate Atara’s novel
inclusion of armoring in the form of a PD-1 DNR construct to
overcome checkpoint inhibition and a 1XX costimulatory domain on
the CAR to enhance expansion and functional persistence of the CAR
T-cells. ATA3271 leverages Atara’s EBV T-cell platform and is
currently in IND (Investigational New Drug)-enabling studies.
“We acknowledge Bayer’s decision to end our collaboration
following Bayer’s strategic review and asset-level prioritization
of its pipeline, including cell and gene therapy,” said Jakob
Dupont, M.D., Head of Global Research & Development at Atara.
“Based on the clinical and pre-clinical data generated to date, we
remain confident in the potential of ATA2271 and ATA3271 to address
patient need in solid tumors and are re-assessing our strategy on
how best to generate value from the programs moving forward.”
Upon termination of the agreement in September 2022, the rights
and licenses granted by Atara to Bayer under the collaboration will
be returned to Atara, and Atara will have full rights to continue
the clinical development and future commercialization of its
programs worldwide. Atara will continue to support the ongoing
ATA2271 Phase 1 study, which is being conducted by Memorial Sloan
Kettering Cancer Center (MSK) who has voluntarily paused enrollment
of new patients in the study on a temporary basis. Atara and MSK
expect to provide a Phase 1 data update for ATA2271 in H2 2022.
Atara will also continue to lead IND-enabling studies and process
development for ATA3271.
“Atara remains focused on the upcoming interim analysis of our
Phase 2 EMBOLD study of ATA188 in June, and we look forward to
continued progress with tab-cel® including EMA’s review in Europe
and further engagement with FDA on an appropriate BLA pathway,”
said Pascal Touchon, President and Chief Executive Officer of
Atara. “Given the exciting developments on ATA188 and tab-cel, and
our continued progress toward submitting an IND for ATA3219 in Q4
2022, we plan to focus our resources accordingly while we re-assess
our strategy for our mesothelin CAR T program. Consequently, we
will postpone the anticipated IND filing for ATA3271 beyond the
fourth quarter of 2022. We are also maintaining our cash runway
guidance into Q4 of 2023.”
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 timing and progress of (i) the ATA2271 and ATA3271 programs;
(ii) the ATA2271 clinical trial and preliminary clinical data;
(iii) ATA2271 and ATA3271 preclinical development and preclinical
data; (iv) the safety and efficacy of Atara’s product candidates,
including ATA2271 and ATA3271; (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,
including ATA2271 and ATA3271. 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/20220519005615/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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