Juno Therapeutics Places JCAR015 Phase II ROCKET Trial on Clinical Hold
November 23 2016 - 08:00AM
Business Wire
Juno Therapeutics, Inc. (Nasdaq: JUNO), a biopharmaceutical
company focused on re-engaging the body’s immune system to
revolutionize the treatment of cancer, today announced that it has
voluntarily placed on hold the Phase II clinical trial of JCAR015
in adult patients with relapsed or refractory B cell acute
lymphoblastic leukemia, known as the “ROCKET” trial. The clinical
hold was initiated after two patients suffered cerebral edema
earlier this week. One patient died and as of last night the other
is not expected to recover.
Juno has notified the Food & Drug Administration of the
voluntary hold and is working with the agency and the Data and
Safety Monitoring Board to determine next steps. The company is
assessing data from the cases and the trial and is evaluating its
options regarding the JCAR015 program.
Juno’s trials and plans for its other CD19-directed CAR T cell
product candidates, including JCAR017, are not affected.
Conference Call Information
Juno will host a conference call today to discuss today’s
announcement beginning at 5:30 a.m. Pacific Time (PT) / 8:30 a.m.
Eastern Time (ET). Analysts and investors can participate in the
conference call by dialing (855) 780-7198 for callers in the United
States and Canada and +1 (631) 485-4870 for international callers,
using the conference ID# 26549311.
The webcast can be accessed live on the Investor Relations page
of Juno's website, www.JunoTherapeutics.com, and will be
available for replay for 30 days following the call.
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, 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.
Forward-Looking Statements
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995, Section 27A of the Securities Act of 1933, and Section 21E of
the Securities Exchange Act of 1934, including statements regarding
Juno’s mission, progress, and business plans, Juno’s interactions
with the FDA and the Data and Safety Monitoring Board, Juno’s
assessments and evaluations, and the impact, if any, on Juno’s
trials and plans for its other CD19-directed product candidates.
Forward-looking statements are subject to risks and uncertainties
that could cause actual results to differ materially from such
forward-looking statements, and reported results should not be
considered as an indication of future performance. These risks and
uncertainties include, but are not limited to, risks associated
with: the success, cost, and timing of Juno's product development
activities and clinical trials; Juno's ability to obtain regulatory
approval for and to commercialize its product candidates; Juno's
ability to establish a commercially-viable manufacturing process
and manufacturing infrastructure; regulatory requirements and
regulatory developments; success of Juno's competitors with respect
to competing treatments and technologies; Juno's dependence on
third-party collaborators and other contractors in Juno's research
and development activities, including for the conduct of clinical
trials and the manufacture of Juno's product candidates; Juno's
dependence on Celgene for the development and commercialization
outside of North America and China of Juno’s CD19 product
candidates and any other product candidates for which Celgene
exercises an option; Juno’s dependence on JW Therapeutics
(Shanghai) Co., Ltd, over which Juno does not exercise complete
control, for the development and commercialization of product
candidates in China; Juno's ability to obtain, maintain, or protect
intellectual property rights related to its product
candidates; amongst others. For a further description of the
risks and uncertainties that could cause actual results to differ
from those expressed in these forward-looking statements, as well
as risks relating to Juno's business in general, see Juno's
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission on May 10, 2016 and Juno’s other periodic
reports filed with the Securities and Exchange Commission. These
forward-looking statements speak only as of the date hereof. Juno
disclaims any obligation to update these forward-looking
statements.
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version on businesswire.com: http://www.businesswire.com/news/home/20161123005289/en/
Juno TherapeuticsInvestor Relations:Nicole Keith,
206-566-5521nikki.keith@junotherapeutics.comorMedia
Relations:Christopher Williams,
206-566-5660chris.williams@junotherapeutics.com
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