Atara Bio Announces Results from Ongoing Phase 2 Trial of Allogeneic Cytomegalovirus (CMV)-specific Cytotoxic T Lymphocytes (...
December 03 2016 - 10:30AM
Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical
company focused on developing meaningful therapies for patients
with unmet medical needs in diseases that have seen limited
therapeutic innovation, today announced that its collaborating
investigators at Memorial Sloan Kettering Cancer Center (MSK) are
reporting Phase 2 results for Atara’s allogeneic T-cell product
candidate, CMV-CTL, during the 58th ASH Annual Meeting being held
in San Diego, California. Data from the Phase 2 trial describe the
efficacy and safety of CMV-CTL in the treatment of 15 patients with
documented CMV mutations conferring resistance to anti-viral
therapies. Patients had received a median of 3 prior therapies
before receiving allogeneic CMV-CTL. CMV-CTL is an investigational
therapy in which a healthy donor’s T-cells are stimulated to
recognize CMV antigens, or viral proteins, expressed in the cells
of patients infected with CMV.
Dr. Susan Prockop, M.D. and colleagues are reporting the
following clinical results from the trial:
- Response Rate: 73.3% with 6 complete responses (CR) and 5
partial responses (PR).
- 6-month Overall Survival: 72.7% in responders (CR+PR) versus
25% in non-responders.
- Safety: 16 grade ≥ 3 serious adverse events (SAE) deemed
possibly related to CMV-CTL among 66 patients.
"We are encouraged by the efficacy and safety results reported
at ASH on the use of CMV-CTL in patients with genetically resistant
CMV infection," said Chris Haqq M.D., Ph.D., Executive Vice
President of Research and Development and Chief Scientific Officer
of Atara Bio. "These results support late stage development of
CMV-CTL for patients with few therapeutic options."
The ASH 2016 oral presentation, titled "Third Party CMV-Specific
Cytotoxic T Cells for Treatment of Antiviral Resistant CMV
Infection after Hematopoietic Stem Cell Transplant," will take
place this morning, Saturday, December 3, at 7:30 a.m. PT in Grand
Hall B of the Manchester Grand Hyatt in San Diego, CA.
About CMV-CTL
In patients with weakened immune systems, CMV infection can
result in a range of symptoms including blindness, brain damage,
difficulty breathing, or even death, depending on which organ is
affected. 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
cancers and infections, the power of the immune system can be
employed to combat these diseases. Atara's CMV-CTL utilizes a
technology in which T-cells are collected from the blood of
third-party donors and then exposed to CMV 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 CMV
infection, Atara's CMV-CTL finds the cells expressing CMV and kills
them. CMV-CTL is currently being studied in an ongoing Phase 2
clinical trial.
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’s
lead product candidate derived from this platform, Epstein Barr
virus targeted Cytotoxic T-cells (EBV-CTL), is expected to enter
pivotal trials in 2016. The company has pursued prospective
feedback from health authorities on both manufacturing and clinical
trial design. Its lead product candidate 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 immunotherapy and oncology.
Atara Bio's programs include T-cell product candidates and
molecularly targeted product candidates. The T-cell product
candidates include EBV-CTL, CMV-CTL, and Wilms Tumor 1 targeted
Cytotoxic T-cells (WT1-CTL) and harness the power of the immune
system to recognize and attack cancer cells and cells infected with
certain viruses. The molecularly targeted product candidates
include STM 434. These product candidates target activin and
myostatin, members of the TGF-beta family of proteins, and have
demonstrated the potential to have therapeutic benefit in a number
of clinical indications.
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
late stage development of CMV-CTL for patients with few therapeutic
options. 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-Q filed with the
Securities and Exchange Commission (SEC) on November 4, 2016,
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.
INVESTOR & MEDIA CONTACT:
Investors:
Steve Klass
212-213-0006 x331
sklass@burnsmc.com
Media:
Justin Jackson
212-213-0006 x327
jjackson@burnsmc.com
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