Atara Bio Granted Access to Priority Medicines (PRIME) Regulatory Support for Allogeneic Epstein-Barr Virus (EBV)-Specific Cy...
October 18 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) Committee for Medicinal Products for Human Use (CHMP)
and Committee for Advanced Therapies (CAT) have granted access to
the EMA’s newly established Priority Medicines (PRIME) regulatory
initiative for EBV-CTL in the treatment of patients with rituximab
refractory EBV-PTLD following hematopoietic cell transplant (HCT).
PRIME provides early and enhanced regulatory support to optimize
regulatory applications and accelerate the review of medicines that
address a high unmet need. EBV-CTL 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, as well as in autoimmune diseases.
"We are pleased to be selected by the CHMP and CAT to
participate in this innovative program designed to spur development
of therapies for patients with serious diseases that have few
therapeutic options," noted Isaac Ciechanover, M.D., President, and
Chief Executive Officer of Atara Bio. "We look forward to working
closely with the CHMP and CAT, and to seeking Scientific Advice in
the fourth quarter of this year to continue to advance our
development efforts in Europe."
Access to the Priority Medicines initiative is granted by the
EMA to support the development and accelerate the review of new
therapies to treat patients with unmet medical need. The criteria
for the Priority Medicines initiative require early clinical
evidence that the therapy offers a therapeutic advantage over
existing treatments or benefits patients without treatment options.
This designation provides appointment of a rapporteur, early
dialogue and scientific advice at key development milestones, and
the potential to qualify products for accelerated review earlier in
the application process.
The U.S. Food and Drug Administration granted Breakthrough
Therapy Designation to EBV-CTL for the treatment of patients with
rituximab refractory EBV-PTLD after HCT in February 2015. The
company anticipates the initiation of two Phase 3 trials in
rituximab refractory EBV-PTLD after HCT or solid organ transplant
(SOT) later this year.
About EBV-CTL
EBV is associated with a wide range of hematologic malignancies
and solid tumors, as well as certain autoimmune conditions such as
multiple sclerosis. In patients with weakened immune systems,
including those who have received an HCT or SOT, EBV infection can
result in an aggressive B-cell lymphoma called EBV-PTLD. 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's EBV-CTL 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, Atara's
EBV-CTL finds the cells expressing EBV and kills them. EBV-CTL is
currently being studied in ongoing Phase 2 clinical trials in
patients with EBV-associated cancers, including PTLD and
nasopharyngeal carcinoma. EBV-CTL is also available to eligible
patients with PTLD through an ongoing multicenter expanded access
protocol 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 EBV-CTL, Cytomegalovirus targeted Cytotoxic
T-cells (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 early and enhanced regulatory support to optimize regulatory
applications and accelerate the review of medicines that address a
high unmet need derived from this PRIME designation, working
closely with the CHMP and CAT, seeking Scientific Advice in the
fourth quarter of this year to continue to advance our development
efforts in Europe, and the initiation of two Phase 3 trials in
rituximab refractory EBV-PTLD after HCT or solid organ transplant
(SOT) later this year. 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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