Juno Therapeutics’ & Celgene Corporation’s Investigational Drug JCAR017 Granted Breakthrough Therapy Designation from FDA...
December 20 2016 - 9:00AM
Business Wire
-- Early results recently announced with
JCAR017 in non-Hodgkin lymphoma and pediatric acute lymphoblastic
leukemia
-- Pivotal DLBCL trial expected to begin in
2017
Juno Therapeutics, Inc. (NASDAQ: JUNO) and Celgene Corporation
(NASDAQ: CELG), today announced that the U.S. Food and Drug
Administration (FDA) has granted Breakthrough Therapy designation
to investigational drug JCAR017 for the treatment of patients with
relapsed/refractory (r/r) aggressive large B-cell non-Hodgkin
lymphoma (NHL), including diffuse large B-cell lymphoma (DLBCL),
not otherwise specified (de novo or transformed from indolent
lymphoma), Primary Mediastinal B-cell Lymphoma (PMBCL) or Grade 3B
Follicular Lymphoma. In addition, the European Medicines Agency
(EMA) Committee for Medicinal Products for Human Use (CHMP) and
Committee for Advanced Therapies (CAT) have granted JCAR017 access
to the Priority Medicines (PRIME) scheme for r/r DLBCL.
JCAR017 uses a defined CD4:CD8 cell composition and 4-1BB as the
costimulatory domain, which differentiates it from other
CD19-directed CAR T product candidates in clinical development.
Earlier this month, data from multiple phase I studies with JCAR017
in non-Hodgkin lymphoma and pediatric acute lymphoblastic leukemia
were presented at the 58th American Society of Hematology Annual
Meeting.
“The Breakthrough Therapy designation from the FDA and PRIME
eligibility from EMA for JCAR017 highlight the need for new
treatment options for patients with DLBCL, particularly for the
significant number of patients who do not respond to initial
therapy or with relapsed disease,” said Mark J. Gilbert, M.D.,
Juno’s Chief Medical Officer. “Early data with JCAR017 in a range
of B-cell malignancies has been encouraging and we look forward to
initiating a pivotal trial in patients with relapsed or refractory
DLBCL in the U.S. in 2017.”
“The encouraging news of the FDA Breakthrough Therapy and EMA
PRIME designations reflect the agencies’ emphasis on accelerating
the development and assessment of potential new options for serious
blood cancers like DLBCL,” said Jay Backstrom, M.D., Chief Medical
Officer and Head of Global Regulatory Affairs for Celgene. “We will
continue to work closely with our partners at Juno and with the
agencies to move the JCAR017 program forward in the interest of
patients with relapsed or refractory DLBCL.”
The Breakthrough Therapy designation and PRIME eligibility were
granted by the FDA and EMA, respectively, on the basis of early
clinical results with JCAR017 in r/r DLBCL. According to the FDA,
Breakthrough Therapy designation is intended to expedite the
development and review of medicines with early evidence of
potential clinical benefit in serious diseases. PRIME was launched
by the EMA earlier this year and enables accelerated assessment of
therapeutic applications that target an unmet medical need,
focusing on medicines that may offer a major therapeutic advantage
over existing treatments, or benefit patients with no treatment
options.
JCAR017 is not approved in any country. FDA’s Breakthrough
Therapy designation and access to EMA’s Priority Medicines scheme
does not constitute or guarantee a future approval.
ABOUT JUNO
Juno Therapeutics is building a fully integrated
biopharmaceutical company focused on re-engaging the body’s immune
system to revolutionize the treatment of cancer. Founded on the
vision that the use of human cells as therapeutic entities will
drive one of the next important phases in medicine, Juno is
developing cell-based cancer immunotherapies based on chimeric
antigen receptor and high-affinity T cell receptor technologies to
genetically engineer T cells to recognize and kill cancer. Juno is
developing multiple cell-based product candidates to treat a
variety of B-cell malignancies as well as solid tumors. Several
product candidates have shown compelling clinical responses in
clinical trials in refractory leukemia and lymphoma conducted to
date. Juno's long-term aim is to leverage its cell-based platform
to develop new product candidates that address a broader range of
cancers and human diseases. Juno brings together innovative
technologies from some of the world's leading research
institutions, including the Fred Hutchinson Cancer Research
Center, Memorial Sloan Kettering Cancer Center, Seattle
Children's Research Institute, the University of California,
San Francisco, and The National Cancer Institute. Juno
Therapeutics has an exclusive license to the St. Jude
Children’s Research Hospital patented technology for
CD19-directed product candidates that use 4-1BB, which was
developed by Dario Campana, Chihaya Imai, and St. Jude
Children’s Research Hospital.
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 THE JUNO-CELGENE COLLABORATION
Celgene Corporation and Juno Therapeutics formed a collaboration
in June 2015 under which the two companies will leverage T cell
therapeutic strategies to develop treatments for patients with
cancer and autoimmune diseases with an initial focus on chimeric
antigen receptor (CAR) and T cell receptor (TCR) technologies. In
April 2016, Celgene exercised its option to develop and
commercialize the Juno CD19 program outside North America and
China.
FORWARD-LOOKING STATEMENTS
This press release contains forward-looking statements, which
are generally statements that are not historical facts.
Forward-looking statements can be identified by the words
"expects," "anticipates," "believes," "intends," "estimates,"
"plans," "will," “outlook” and similar expressions. Forward-looking
statements are based on management’s current plans, estimates,
assumptions and projections, and speak only as of the date they are
made. Celgene and Juno undertake no obligation to update any
forward-looking statement in light of new information or future
events, except as otherwise required by law. Forward-looking
statements involve inherent risks and uncertainties, most of which
are difficult to predict and are generally beyond the control of
either company. Actual results or outcomes may differ materially
from those implied by the forward-looking statements as a result of
the impact of a number of factors, many of which are discussed in
more detail in the public reports of each company filed with the
Securities and Exchange Commission.
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version on businesswire.com: http://www.businesswire.com/news/home/20161220005299/en/
For Juno:Investor Relations:Nicole Keith,
206-566-5521nikki.keith@junotherapeutics.comorMedia:Christopher
Williams, 206-566-5660chris.williams@junotherapeutics.comorFor
Celgene:Investor Relations:Patrick Flanigan,
908-673-9969pflanigan@celgene.comorMedia:Greg Geissman,
908-673-9854ggeissman@celgene.com
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