Juno Therapeutics Reports Clinical Hold on the JCAR015 Phase II ROCKET Trial
July 07 2016 - 4:05PM
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
received notice from the U.S. Food and Drug Administration (FDA)
that a clinical hold has been placed on the Phase II clinical trial
of JCAR015 in adult patients with relapsed or refractory B cell
acute lymphoblastic leukemia (r/r ALL), known as the “ROCKET”
trial. The clinical hold was initiated after two patient deaths
last week, which followed the recent addition of fludarabine to the
pre-conditioning regimen.
Juno has proposed to the FDA to continue the ROCKET trial using
JCAR015 with cyclophosphamide pre-conditioning alone. In response,
the FDA has requested that Juno submit, as a Complete Response to
the Clinical Hold: a revised patient informed consent form, a
revised investigator brochure, a revised trial protocol, and a copy
of the presentation made to the agency yesterday. Juno will submit
the requested information to the FDA this week.
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 1:30 Pacific Time (PT) / 4:30 Eastern
Time (ET). Analysts and investors can participate in the conference
call by dialing 1-800-967-7137 for callers in the United
States and Canada and +1-719-325-2434 for international
callers, using the conference ID# 4430397.
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, the proposed plan for
continuation of the ROCKET trial, the timing of Juno’s response to
the FDA, and the timing of FDA review. 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/20160707006375/en/
Juno Therapeutics, Inc.Investor Relations:Nicole Keith,
206-566-5521nikki.keith@junotherapeutics.comorJuno Therapeutics,
Inc.Media Relations:Christopher Williams,
206-566-5660chris.williams@junotherapeutics.com
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