Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading
off-the-shelf, allogeneic T-cell immunotherapy company developing
novel treatments for patients with cancer, autoimmune and viral
diseases, today announced results presented by collaborators at the
60th American Society of Hematology (ASH) Annual Meeting. One study
presents details of a next-generation CAR T technology that
increases T cell persistence and decreases T cell exhaustion.
Another important study presents positive Phase 2 clinical results
in patients with EBV+ PTLD involving the CNS. PTLD patient
treatment patterns and health outcomes are described in additional
ASH presentations.
“Our highlighted ASH presentations this year demonstrate the
promise of Atara’s next-generation CAR T and off-the-shelf,
allogeneic T-cell immunotherapy pipeline,” said Dietmar
Berger, M.D., Ph.D., Global Head of Research and Development
of Atara Biotherapeutics. “Cutting-edge CAR T discoveries by
our Moffitt Cancer Center collaborators may have wide applications
including as a component of our CAR T programs in acute myeloid
leukemia (AML) and B-cell malignancies. Our collaborating
investigators at Memorial Sloan Kettering also showed promising
Phase 2 clinical results for patients with EBV+ PTLD involving the
CNS, a difficult-to-treat and often lethal complication of bone
marrow and organ transplantation. We are encouraged by these robust
results and the broad potential of our CAR T technologies and T
cell immunotherapy platform.”
60th American Society of Hematology (ASH) Annual Meeting
Summary:
Abstract 966: Mutation of the CD28
Costimulatory Domain Confers Increased CAR T Cell Persistence and
Decreased ExhaustionSession: 703. Adoptive
Immunotherapy: Preclinical Studies to Improve Safety and Efficacy
of CAR-T CellsOral Presentation Date and Time:
Monday, December 3, 2018 at 5:45 pm PST Location:
Marriott Marquis San Diego Marina, San Diego Ballroom
BAuthors: Justin C Boucher, Gongbo Li, Bishwas
Shrestha, Maria L Cabral, Dylan Morrissey, Lawrence Guan, Marco L
DavilaAffiliations: Moffitt Cancer Center
Abstract 4590: Adoptive Therapy with
EBV-Specific T Cells for Treatment of CNS EBV Post-Transplant
Lymphoproliferative Disease Arising after Hematopoietic Stem Cell
Transplant or Solid Organ TransplantSession: 723.
Clinical Allogeneic and Autologous Transplantation: Late
Complications and Approaches to Disease Recurrence: Poster III
Poster Presentation Date & Time: Monday,
December 3, 2018 from 6:00 pm – 8:00 pm
PSTLocation: San Diego Convention Center, Hall
GHAuthors: Susan Prockop, MD, Stephanie Suser,
Ekaterina Doubrovina, MD, PhD, Hugo R. Castro-Malaspina, MD,
Esperanza B. Papadopoulos, MD, James W. Young, MD, Victoria Szenes,
PNP, Alison Slocum, MA, Karim Baroudy, MS and Richard J. O'Reilly,
MDAffiliations: Memorial Sloan Kettering Cancer
CenterOverview:
- This poster presentation evaluated EBV-specific T-cells
generated from primary and third party (tab-cel®) donors.
- Patients with EBV+ PTLD involving the CNS following allogeneic
hematopoietic stem cell transplant (HCT) or solid organ transplant
(SOT) who failed prior rituximab from the Phase 2 studies 95-024
(NCT00002663) and 11-130 (NCT01498484) were included in the
analysis.
Abstract 4777: Treatment Patterns for Patients
with Post-Transplant Lymphoproliferative Disorder Who Fail
Rituximab after Allogeneic Hematopoietic Stem Cell Transplantation:
Findings from a Systematic Literature
ReviewSession: 902. Health Services
Research—Malignant Diseases: Poster IIIPoster Presentation
Date & Time: Monday, December 3, 2018 from 6:00 pm –
8:00 pm PSTLocation: San Diego Convention Center,
Hall GHAuthors: Hairong Xu, MD, PhD, Crystal
Watson, MS, Shan Ashton Garib, MA, Anna Forsythe, PharmD, MSc, MBA
and Arie Barlev, PharmDAffiliations: Atara
Biotherapeutics, Purple Squirrel Economics
Abstract 3556: Estimating Long-Term Survival in
a Cohort of Allogeneic Hematopoietic Stem Cell Transplant
PatientsSession: 902. Health Services
Research—Malignant Diseases: Poster IIPoster Presentation
Date & Time: Sunday, December 2, 2018 from 6:00 pm –
8:00 pm PSTLocation: San Diego Convention Center,
Hall GHAuthors: Stephen Palmer, MSc, Casey Quinn,
PhD, MPhil, Crystal Watson, MS and Arie Barlev,
PharmDAffiliations: Centre for Health Economics,
University of York, PRMA Consulting Ltd., Atara Biotherapeutics
Abstract 4596: Dual-Sensitized T-Cells
Responding to EBV Blcl and Either CMVpp65 or WT-1 Peptide Pools
Have Distinct or Shared HLA Restrictions That May Depend on the
Presenting HLA AllelesSession: 723. Clinical
Allogeneic and Autologous TransplantationPoster
Presentation Date & Time: Monday, December 3, 2018
from 6:00 pm – 8:00 pm PSTLocation: San Diego
Convention Center, Hall GHAuthors: Ekaterina
Doubrovina, MD, PhD, Aisha N. Hasan, MD, Susan Prockop, MD, Karim
Baroudy, MS, and Richard O’Reilly, MD
Affiliations: Memorial Sloan Kettering Cancer
Center
Abstract 5839: A Systematic Literature Review
of Real-World Evidence in Post-Transplant Lymphoproliferative
DisorderAuthors: Hairong Xu, MD, PhD, Anna
Forsythe, PharmD, MSc, MBA, Arie Barlev, PharmD, Nazia Rashid,
PharmD and Crystal Watson, MS Affiliations: Atara
Biotherapeutics, Purple Squirrel Economics
Abstract 5841: Younger Patients Are Impacted By
Post-Transplant Lymphoproliferative Disorder: Findings from a
Systematic Literature Review of Real-World
EvidenceAuthors: Crystal Watson, MS, Hairong Xu,
MD, PhD, Anna Forsythe, PharmD, MSc, MBA, Shan Ashton Garib, MA and
Arie Barlev, PharmDAffiliations: Atara
Biotherapeutics, Purple Squirrel Economics
Abstract 5840: Risk of Patients Developing
Post-Transplant Lymphoproliferative Disorder within the First Year
after an Allogeneic Hemopoietic Stem Cell Transplant, 2011 to 2016:
A US Claims Database AnalysisAuthors: Arie Barlev,
PharmD, Hairong Xu, MD, PhD, Nicole Fulcher, MA, Crystal Watson,
MS, Ila Sruti, MPH and Akshay Sudhindra,
MDAffiliations: Atara Biotherapeutics, IBM Watson
Health
About EBV+ PTLDSince its discovery as the first
human oncovirus, Epstein-Barr virus (EBV) has been implicated in
the development of a wide range of lymphoproliferative disorders,
including lymphomas, and other cancers. EBV is widespread in all
human populations and persists as a lifelong, asymptomatic
infection. In immunocompromised patients, such as those undergoing
allogeneic hematopoietic cell transplants (HCT) or solid organ
transplants (SOT), EBV-associated post-transplant
lymphoproliferative disorder (EBV+ PTLD) represents a
life-threatening condition. The expected median survival for
patients with EBV+ PTLD following HCT who have failed rituximab
first line therapy is 16-56 days. In EBV+ PTLD following SOT,
patients failing rituximab are considered to have increased risk
for chemotherapy-induced treatment-related mortality compared to
other lymphoma patients. One- and two-year survival in patients
with high-risk EBV+ PTLD following SOT is estimated to be 36% and
0%, respectively.
About tab-cel® (tabelecleucel)Atara's most
advanced T-cell immunotherapy in development, tab-cel®, is a
potential treatment for patients with Epstein-Barr virus (EBV)
associated post-transplant lymphoproliferative disorder (EBV+ PTLD)
who have failed rituximab, as well as other EBV-associated
hematologic and solid tumors, including nasopharyngeal carcinoma
(NPC). In February 2015, the FDA granted tab-cel®
Breakthrough Therapy Designation for EBV+ PTLD following allogeneic
hematopoietic cell transplant (HCT), and in October 2016, tab-cel®
was accepted into the EMA Priority Medicines (PRIME) regulatory
pathway for the same indication, providing enhanced regulatory
support. In addition, tab-cel® has orphan status in the U.S. and
EU. Tab-cel® is in Phase 3 clinical development for the treatment
of EBV+ PTLD following an allogeneic hematopoietic cell transplant
(MATCH study) or solid organ transplant (ALLELE study), and Atara
recently initiated a Phase 1/2 study in NPC.
About Atara Biotherapeutics, Inc.Atara
Biotherapeutics, Inc. (@Atarabio) is a leading off-the-shelf,
allogeneic T-cell immunotherapy company developing novel treatments
for patients with cancer, autoimmune and viral diseases. Atara’s
most advanced T-cell immunotherapy, tab-cel® (tabelecleucel), is in
Phase 3 development for patients with Epstein-Barr virus associated
post-transplant lymphoproliferative disorder (EBV+ PTLD), as well
as other EBV associated hematologic and solid tumors, including
nasopharyngeal carcinoma (NPC). Atara is also developing T-cell
immunotherapies targeting EBV antigens believed to be important for
the potential treatment of multiple sclerosis (MS). Atara's
pipeline also includes next generation chimeric antigen receptor
T-cell (CAR T) immunotherapies for patients with hematologic and
solid tumors, autoimmune and infectious diseases. The company was
founded in 2012 and is headquartered in South San Francisco,
California.
Forward Looking StatementsThis 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
Company’s ability to advance a next-generation CAR T and
off-the-shelf, allogeneic T-cell immunotherapy pipeline; the
potential wide applications of the Company’s collaborators’
discoveries, including as a component of the Company’s CAR T
programs AML and B-cell malignancies; promising clinical results;
and the Company’s ability to realize the broad potential of its CAR
T technologies and T cell immunotherapy platform. Because such
statements deal with future events and are based on Atara
Biotherapeutics' current expectations, they are subject to
various risks and uncertainties and actual results, performance or
achievements of Atara Biotherapeutics 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 in Atara
Biotherapeutics' 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
Biotherapeutics 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 CONTACTS:
Investors:John Craighead, Atara
Biotherapeutics650-410-3012jcraighead@atarabio.com
John Grimaldi, Burns McClellan212-213-0006
x362jgrimaldi@burnsmc.com
Media:Nancie Steinberg, Burns
McClellan212-213-0006 x318nsteinberg@burnsmc.com
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