Atara Bio Announces Collaboration with Merck to Evaluate KEYTRUDA® (pembrolizumab) in Combination with ATA129 in Nasopharyng...
April 21 2017 - 8:00AM
Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical
company focused on developing meaningful therapies for patients
with severe and life-threatening diseases, today announced that it
has entered into a clinical trial collaboration agreement with
Merck (known as MSD outside the United States and Canada), to
evaluate Atara Bio’s allogeneic Epstein-Barr virus (EBV)-specific
cytotoxic T lymphocytes (CTL), or ATA129, in combination with
Merck’s anti-PD-1 (programmed death receptor-1) therapy, KEYTRUDA®
(pembrolizumab), in patients with platinum resistant or recurrent
EBV-associated NPC. The Phase 1/2 trial will evaluate the safety,
pharmacokinetics, pharmacodynamics, and preliminary efficacy of the
combination and is planned for initiation in 2018.
Atara Bio’s ATA129 is an investigational therapy in which a
healthy donor’s T-cells are stimulated to recognize EBV antigens,
or viral proteins, expressed in the cells of certain liquid and
solid tumors. ATA129 has previously been evaluated as a single
agent in Phase 1 and 2 trials that enrolled patients with a variety
of EBV-positive malignancies including 14 patients with
chemotherapy refractory, metastatic NPC. In these trials, evidence
of radiographic response was observed and EBV-CTLs were also shown
to expand after administration without concomitant lymphodepleting
chemotherapy. Recent studies suggest that EBV upregulates the
transcription of PD-L1 in EBV-associated solid tumors such as NPC
and gastric cancer, suggesting the potential for synergy in
combination with anti-PD-1 therapies, such as KEYTRUDA.
KEYTRUDA is a humanized monoclonal antibody that works by
increasing the ability of the body’s immune system to help detect
and fight tumor cells. KEYTRUDA blocks the interaction between PD-1
and its ligands, PD-L1 and PD-L2, thereby activating T lymphocytes
which may affect both tumor cells and healthy cells.
“Both ATA129 and KEYTRUDA have shown evidence of objective
radiographic responses in NPC, and there is a strong biologic
rationale to combine these therapies as their complementary
mechanisms of action may enhance the anti-tumor activity,” said
Chris Haqq, M.D., Ph.D., Executive Vice President of Research and
Development and Chief Scientific Officer of Atara Bio.
The collaboration agreement is between Atara Biotherapeutics,
Inc. and Merck Sharp & Dohme B.V. Under the agreement, the
trial will be sponsored by Atara Bio. Additional details of the
collaboration were not disclosed.
About ATA129
EBV is associated with a wide range of hematologic malignancies
and solid tumors, as well as certain autoimmune conditions such as
multiple sclerosis. T-cells are a critical component of the body's
immune system and can be harnessed to counteract viral infections
and some cancers. By focusing the T-cells on specific proteins
involved in the cancers and infections, the power of the immune
system can be employed to combat these diseases. Atara Bio’s ATA129
utilizes a technology in which T-cells are collected from the blood
of third-party donors and then exposed to EBV antigens. The
resulting activated T-cells are then expanded, characterized, and
stored for future therapeutic use in an appropriate partially human
leukocyte antigen, or HLA, matched patient, providing an
allogeneic, cellular therapeutic option for patients. In the
context of EBV infection, ATA129 finds the cells expressing EBV and
kills them. ATA129 is currently being studied in ongoing Phase 2
clinical trials in patients with EBV-associated cancers, including
EBV-associated post-transplant lymphoproliferative disorders
(EBV-PTLD) and NPC. ATA129 is also available to eligible patients
with EBV-positive tumors through an ongoing multicenter expanded
access protocol trial. Atara Bio is planning to initiate two Phase
3 trials of ATA129 in patients with rituximab-refractory EBV-PTLD
following either hematopoietic cell transplant (HCT) or solid organ
transplant (SOT).
About Atara Biotherapeutics’ Allogeneic Cellular Therapy
Platform
Atara Bio's cellular therapy platform provides healthy immune
capability to a patient and arms the immune system to precisely
target and combat disease. Cells derived from healthy donors are
manufactured in advance and stored as inventory so that a
customized unit of cells can be chosen for each patient. The cells
are ready to infuse in approximately 3 to 5 days. Once
administered, the cells home to their target, expand in-vivo to
eliminate diseased cells, and eventually recede. This versatile
platform can be directed towards a broad array of disease causing
targets and has demonstrated clinical proof of concept across both
viral and non-viral targets in conditions ranging from liquid and
solid tumors to infectious and autoimmune diseases. The Company has
pursued prospective feedback from health authorities on both
manufacturing and clinical trial design. Atara Bio’s lead product
candidate, ATA129, has the potential to be the first commercial
allogeneic T-cell therapy for a viral target implicated in
cancer.
About Atara Biotherapeutics, Inc.
Atara Biotherapeutics, Inc. is a biopharmaceutical company
developing meaningful therapies for patients with severe and
life-threatening diseases that have been underserved by scientific
innovation, with an initial focus on allogeneic T-cell therapies
for cancer, autoimmune, and infectious disease. Atara Bio's T-cell
product candidates harness the power of the immune system to
recognize and attack cancer cells and cells infected with certain
viruses. The Company's initial clinical stage T-cell product
candidates include ATA129, Cytomegalovirus targeted Cytotoxic
T-cells (CMV-CTL), or ATA230, and Wilms Tumor 1 targeted Cytotoxic
T-cells (WT1-CTL), or ATA520. These product candidates have
demonstrated the potential to have therapeutic benefit in a number
of clinical indications including hematologic malignancies, solid
tumors, and refractory viral infections. The Company is also
developing a next generation of allogeneic T-cell product
candidates utilizing a technology to selectively enhance a T-cell's
ability to target specific viral proteins implicated in disease.
Initial clinical investigations employing this approach will focus
on multiple sclerosis and other virally mediated cancers and
infections.
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 the statements
regarding the design of the Phase 1/2 trial to evaluate the safety,
pharmacokinetics, pharmacodynamics, and preliminary efficacy of the
combination; the planned initiation of the trial in 2018; and the
complementary mechanisms of action which may enhance the anti-tumor
activity. Because such statements deal with future events and are
based on Atara Bio's current expectations, they are subject to
various risks and uncertainties and actual results, performance, or
achievements of Atara Bio 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 those discussed under the heading "Risk
Factors" in Atara Bio's annual report on Form 10-K filed with the
SEC on March 9, 2017, including the documents incorporated by
reference therein, and subsequent filings with the SEC. Except as
otherwise required by law, Atara Bio 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.
KEYTRUDA® is a registered trademark of Merck Sharp & Dohme
Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ,
USA
INVESTOR & MEDIA CONTACT:
Investors:
John Craighead, Atara Bio
650-491-5806
jcraighead@atarabio.com
Steve Klass, Burns McClellan
212-213-0006 x331
sklass@burnsmc.com
Media:
Justin Jackson
212-213-0006 x327
jjackson@burnsmc.com
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