bluebird bio to Present New Data from LentiGlobinTM Clinical Studies at European Hematology Association (EHA) Annual Meeting
May 18 2017 - 6:09AM
Business Wire
– Presentations include early data from
Northstar-2 (HGB-207) study of LentiGlobin in patients with
transfusion-dependent β-thalassemia (TDT) and non-β0/β0 genotypes
and updated data from HGB-205 study in TDT and severe sickle cell
disease (SCD) –
– Encore presentation of data from CRB-401
study of bb2121 in relapsed/refractory multiple myeloma to be
presented –
bluebird bio, Inc. (Nasdaq: BLUE), a clinical-stage company
committed to developing potentially transformative gene therapies
for severe genetic diseases and T cell-based immunotherapies for
cancer, announced that data from ongoing clinical studies of
LentiGlobin drug product in transfusion-dependent β-thalassemia
(TDT) and severe sickle cell disease (SCD) will be highlighted in
oral and poster presentations at the 22nd Congress of the European
Hematology Association (EHA). An encore presentation of data from
the ongoing Phase 1 study of bb2121 in relapsed/refractory multiple
myeloma, to be debuted at ASCO 2017, will also be presented. These
abstracts became available on the EHA conference website at 12:00
pm CEST (6:00 am ET) today.
“This year at EHA, we will share the first clinical data from
our HGB-207 study of LentiGlobin in patients with TDT and non-β0/β0
genotypes, using our refined drug product manufacturing process,”
said David Davidson, M.D., chief medical officer, bluebird bio. “We
also look forward to seeing data from additional patients in the
single-center HGB-205 study in TDT and SCD, and presenting data
from our study of bb2121 in relapsed/refractory multiple myeloma to
the European hematology community.”
Oral PresentationsA Phase
3 Study to Evaluate Safety and Efficacy of LentiGlobin Gene Therapy
for Transfusion-Dependent β-thalassemia in Patients with
non-β0/β0 Genotypes: The Northstar-2
(HGB-207) Trial (Abstract S814)
Presenter: Mark C. Walters, M.D., UCSF Benioff Children’s
Hospital, Oakland, CalifDate & Time: Sunday, June 25,
8:00 a.m. CEST (2:00 a.m. EST)Location: Room N111
First-in-Human Multicenter Study of bb2121 anti-BCMA CAR T
Cell Therapy for Relapsed/Refractory Multiple Myeloma: Updated
Results. (Abstract S142)
Presenter: Yi Lin, M.D., Mayo Clinic Division of
Hematology, Rochester, MNDate & Time: Friday, June 23,
2017, 11:45 a.m. CEST (5:45 a.m. EST)Location: Room N109
Note: This will be an encore of data presented at the American
Society of Clinical Oncology (ASCO) 2017 Annual Meeting
Poster PresentationUpdate
on the First Patients with Severe Hemoglobinopathies Treated with
LentiGlobin Gene Therapy (HGB-205) (Abstract P631)
Presenter: TBDPoster Session Date & Time:
Saturday, June 24, 5:30 – 9:00 p.m. CESTLocation: Poster
area (Hall 7)
About bluebird bio, Inc.With its lentiviral-based gene
therapies, T cell immunotherapy expertise and gene editing
capabilities, bluebird bio has built an integrated product platform
with broad potential application to severe genetic diseases and
cancer. bluebird bio’s gene therapy clinical programs include its
Lenti-D™ product candidate, currently in a Phase 2/3 study,
called the Starbeam Study, for the treatment of cerebral
adrenoleukodystrophy, and its LentiGlobin™ product candidate,
currently in four clinical studies for the treatment of
transfusion-dependent β-thalassemia, and severe sickle cell
disease. bluebird bio’s oncology pipeline is built upon the
company’s leadership in lentiviral gene delivery and T cell
engineering, with a focus on developing novel T cell-based
immunotherapies, including chimeric antigen receptor (CAR T) and T
cell receptor (TCR) therapies. bluebird bio’s lead oncology
program, bb2121, is an anti-BCMA CAR T program partnered
with Celgene. bb2121 is currently being studied in a Phase 1
trial for the treatment of relapsed/refractory multiple myeloma.
bluebird bio also has discovery research programs utilizing
megaTAL/homing endonuclease gene editing technologies with the
potential for use across the company’s pipeline.
bluebird bio has operations in Cambridge,
Massachusetts, Seattle, Washington and Europe.
Forward-Looking StatementsThis release contains
“forward-looking statements” within the meaning of the Private
Securities Litigation Reform Act of 1995, including statements
regarding the Company’s research, development, manufacturing and
regulatory approval plans for its LentiGlobin product candidate to
treat transfusion-dependent ß-thalassemia and severe sickle cell
disease and its bb2121 product candidate to treat
relapsed/refractory multiple myeloma, including statements whether
the manufacturing process changes for LentiGlobin will improve
outcomes of patients with transfusion-dependent ß-thalassemia and
severe sickle cell disease, whether the planned changes to the
HGB-206 clinical trial protocol will improve outcomes in patients
with severe sickle cell disease. Any forward-looking statements are
based on management’s current expectations of future events and are
subject to a number of risks and uncertainties that could cause
actual results to differ materially and adversely from those set
forth in or implied by such forward-looking statements. These risks
and uncertainties include, but are not limited to, the risks that
the preliminary positive efficacy and safety results from our prior
and ongoing clinical trials of LentiGlobin will not continue or be
repeated in our ongoing, planned or expanded clinical trials of
LentiGlobin, the risks that the changes we have made in the
LentiGlobin manufacturing process or the HGB-206 clinical trial
protocol will not result in improved patient outcomes, risks that
the current or planned clinical trials of LentiGlobin will be
insufficient to support regulatory submissions or marketing
approval in the US and EU, the risk of a delay in the enrollment of
patients in our clinical studies, and the risk that any one or more
of our product candidates, including our bb2121 product candidate,
will not be successfully developed, approved or commercialized. For
a discussion of other risks and uncertainties, and other important
factors, any of which could cause our actual results to differ from
those contained in the forward-looking statements, see the section
entitled “Risk Factors” in our most recent Form 10-Q, as well as
discussions of potential risks, uncertainties, and other important
factors in our subsequent filings with the Securities and Exchange
Commission. All information in this press release is as of the date
of the release, and bluebird bio undertakes no duty to update this
information unless required by law.
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version on businesswire.com: http://www.businesswire.com/news/home/20170518005534/en/
bluebird bio, Inc.Investors:Manisha Pai,
617-245-2107mpai@bluebirdbio.comorMedia:Elizabeth Pingpank,
617-914-8736epingpank@bluebirdbio.com
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