Celgene Corp. & bluebird bio Announce bb2121 Anti-BCMA CAR-T Cell Therapy Has Been Granted Breakthrough Therapy Designation f...
November 16 2017 - 8:30AM
Business Wire
Designations based on preliminary clinical data
from ongoing phase I study of bb2121 in heavily pre-treated
multiple myeloma
Celgene Corporation (NASDAQ:CELG) and bluebird bio, Inc.
(NASDAQ:BLUE) today announced that bb2121, a chimeric antigen
receptor T-cell (CAR-T) therapy targeting b-cell maturation antigen
(BCMA) in previously treated patients with multiple myeloma, has
been granted Breakthrough Therapy Designation (BTD) by the U.S.
Food and Drug Administration (FDA) and PRIority MEdicines (PRIME)
eligibility by the European Medicines Agency (EMA).
BTD designation and PRIME eligibility for bb2121 were based on
preliminary clinical data from the ongoing phase 1 study CRB-401.
Updated data from CRB-401 is scheduled to be presented at the 59th
annual meeting of the American Society of Hematology in Atlanta
during an oral presentation on Dec. 11.
“Receiving Breakthrough Therapy Designation and PRIME
eligibility for bb2121 further underscores the potential of this
novel cellular immunotherapy approach to multiple myeloma
treatment,” said Jay Backstrom, M.D., Chief Medical Officer and
Head of Global Regulatory Affairs for Celgene. “We will work
closely with these agencies as we accelerate development of bb2121,
a novel technology and therapy for patients with multiple
myeloma.”
“Despite recent advances, multiple myeloma remains an incurable
disease, and heavily pretreated patients have limited therapeutic
options,” said David Davidson, M.D., Chief Medical Officer for
bluebird bio. “Early data suggest that treatment with bb2121 has
the potential to induce durable responses in this patient
population. It is encouraging for both the FDA and EMA to identify
bb2121 as a candidate for accelerated development as we continue
our work with Celgene to bring this therapy to patients in need of
new options.”
Breakthrough Therapy Designation is intended to expedite the
development and review of drugs that are intended to treat serious
or life-threatening conditions. The criteria for breakthrough
therapy designation require preliminary clinical evidence that
demonstrates the drug may have substantial improvement on at least
one clinically significant endpoint over available therapy.
PRIME is a program launched by the EMA to enhance support for
the development of medicines that target an unmet medical need.
This voluntary program is based on enhanced interaction and early
dialogue with developers of promising medicines, to optimize
development plans and speed up evaluation so these medicines can
reach patients earlier. The program focuses on medicines that may
offer a major therapeutic advantage over existing treatments, or
benefit patients without treatment options. These medicines are
considered priority medicines by EMA. To be accepted for PRIME, a
medicine must show its potential to benefit patients with unmet
medical needs based on early clinical data.
About Celgene
Celgene Corporation, headquartered in Summit, New
Jersey, is an integrated global biopharmaceutical company engaged
primarily in the discovery, development and commercialization of
innovative therapies for the treatment of cancer and inflammatory
diseases through next-generation solutions in protein homeostasis,
immuno-oncology, epigenetics, immunology and neuro-inflammation.
For more information, please visit www.celgene.com. Follow
Celgene on Social
Media: @Celgene, Pinterest, LinkedIn, Facebook and YouTube.
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 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 has operations in Cambridge, Massachusetts,
Seattle, Washington and Europe.
About the bluebird bio-Celgene Collaboration
In March 2013, bluebird bio and Celgene entered into a
collaboration to develop chimeric antigen receptor (CAR) T cell
therapies to target and destroy cancer cells. In June 2015, the
collaboration was amended and restated to focus on developing
product candidates targeting B-cell maturation antigen (BCMA).
bluebird bio’s lead oncology program, bb2121, is an anti-BCMA CAR T
program currently being studied in a Phase 1 trial for the
treatment of relapsed/refractory multiple myeloma. bluebird bio and
Celgene are also working together on a second anti-BCMA CAR T
program, bb21217.
Forward-Looking Statements
This press release contains forward-looking statements within
the meaning of The Private Securities Litigation Reform Act of
1995. Such forward-looking statements include those regarding the
potential benefits of, and plans relating to the collaboration
between bluebird bio and Celgene; the potential of bb2121 as a
therapeutic drug; and the benefit of each company’s strategic plans
and focus. The words “anticipate,” “believe,” “estimate,” “expect,”
“intend,” “may,” “plan,” “predict,” “project,” “would,” “could,”
“potential,” “possible,” “hope” and similar expressions are
intended to identify forward-looking statements, although not all
forward-looking statements contain these identifying words. Such
statements are subject to numerous important factors, risks and
uncertainties that may cause actual events or results to differ
materially from current expectations and beliefs. For example,
there can be no guarantee that any product candidate will be
successfully developed or complete necessary preclinical and
clinical phases, or that development of any of product candidates
will successfully continue. There can be no guarantee that any
positive developments will result in stock price appreciation.
Management's expectations and, therefore, any forward-looking
statements in this press release could also be affected by risks
and uncertainties relating to a number of other important factors,
including: results of clinical trials and preclinical studies,
including subsequent analysis of existing data and new data
received from ongoing and future studies; the content and timing of
decisions made by the U.S. FDA and other regulatory authorities,
investigational review boards at clinical trial sites and
publication review bodies; the ability to obtain and maintain
requisite regulatory approvals and to enroll patients in planned
clinical trials; unplanned cash requirements and expenditures;
competitive factors; the ability to obtain, maintain and enforce
patent and other intellectual property protection for any product
candidates; the ability to maintain key collaborations; and general
economic and market conditions. These and other risks are described
in greater detail under the caption "Risk Factors" included in each
company’s public filings with the Securities and Exchange
Commission. Any forward-looking statements contained in this press
release speak only as of the date hereof, and neither company has
any obligation to update any forward-looking statements, whether as
a result of new information, future events or otherwise, except as
may be required by law.
Hyperlinks are provided as a convenience and for informational
purposes only. Neither Celgene nor bluebird bio bears
responsibility for the security or content of external websites or
websites outside of their respective control.
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For
Celgene:Investors:908-673-9628investors@celgene.comorMedia:908-673-2275media@celgene.comorFor
bluebird bio:Elizabeth Pingpank,
617-914-8736epingpank@bluebirdbio.com
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