Designations based on preliminary clinical data from ongoing phase I
study of bb2121 in heavily pre-treated multiple myeloma
SUMMIT, N.J. & CAMBRIDGE, Mass.--(BUSINESS WIRE)--
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.
View source version on businesswire.com: http://www.businesswire.com/news/home/20171116005818/en/
For Celgene:
Investors:
908-673-9628
investors@celgene.com
or
Media:
908-673-2275
media@celgene.com
or
For
bluebird bio:
Elizabeth Pingpank, 617-914-8736
epingpank@bluebirdbio.com
Source: Celgene Corporation
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