Atara Bio Receives Positive Opinion from EMA on Orphan Drug Designation for Allogeneic Cytomegalovirus (CMV)-specific Cytotox...
October 11 2016 - 8:00AM
Atara Biotherapeutics, Inc. (Nasdaq:ATRA), a biopharmaceutical
company developing meaningful therapies for patients with severe
and life-threatening diseases that have been underserved by
scientific innovation, today announced that the European Medicines
Agency (EMA) issued a positive opinion for orphan drug designation
for the Company's CMV-CTL product candidate for the treatment of
CMV infection in patients with impaired cell-mediated immunity.
"The positive opinion from EMA to designate CMV-CTLs as an
orphan medicinal product in the European Union (EU) demonstrates
the compelling need for new treatments to combat this viral
infection in patients with few therapeutic options," said Isaac
Ciechanover, M.D., President and Chief Executive Officer of Atara
Bio. "We look forward to the presentation of additional clinical
data at upcoming scientific congresses on the use of CMV-CTL to
treat refractory CMV infection in patients who have received an
allogeneic hematopoietic cell transplant, and to continuing our
discussions with both FDA and EMA on late phase development to
support registration of CMV-CTL."
Orphan drug designation in the EU provides regulatory and
financial incentives for companies to develop and market therapies
that treat a life-threatening or chronically debilitating
conditions affecting no more than five in 10,000 persons in the EU,
and where no satisfactory treatment is available. In addition to a
10-year period of marketing exclusivity in the EU after product
approval, orphan drug designation provides incentives for companies
seeking protocol assistance from the EMA during the product
development phase and direct access to the centralized procedure
for authorizing medicinal products.
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 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 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 Epstein Barr virus targeted Cytotoxic T-cells
(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
the presentation of additional clinical data at upcoming scientific
congresses on the use of CMV-CTL to treat refractory CMV infection
in patients who have received an allogeneic hematopoietic cell
transplant, continued discussions with both FDA and EMA on late
phase development to support registration of CMV-CTL and the
marketing exclusivity derived from this orphan designation. 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 August 8, 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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