Juno Therapeutics to Present Key Clinical Data Updates on JCAR017 & JCAR014 at the 2017 American Society of Clinical Oncology...
May 17 2017 - 5:00PM
Business Wire
Juno Therapeutics, Inc. (NASDAQ: JUNO), a biopharmaceutical
company developing innovative cellular immunotherapies for the
treatment of cancer, today announced that it will present key
clinical updates in partnership with its collaborators on its
investigational products JCAR017 and JCAR014 at the upcoming
American Society of Clinical Oncology (ASCO) Annual Meeting 2017 in
Chicago, Illinois, June 2-6.
JCAR017 and JCAR014 are chimeric antigen receptor (CAR) T cell
product candidates that target CD19, a protein expressed on the
surface of almost all B cell malignancies, including non-Hodgkin
lymphoma (NHL), chronic lymphocytic leukemia (CLL), and acute
lymphoblastic leukemia (ALL). While the manufacturing process and
final cell product differ, both product candidates utilize the
4-1BB co-stimulatory domain and use a defined cell manufacturing
process, controlling the type of cells a patients receives with the
goal of delivering an improved therapeutic benefit. Insights from
studies of the translational product JCAR014 are being applied to
the development of JCAR017.
New data from the ongoing Phase I TRANSCEND NHL 001 trial
(NCT02631044) evaluating JCAR017 in adult patients with relapsed or
refractory aggressive NHL [diffuse large B cell lymphoma (DLBCL),
primary mediastinal B cell lymphoma (PMBCL), follicular lymphoma
Grade 3B, and mantle cell lymphoma (MCL)] will be presented, with
increased patient numbers and longer duration of follow-up reported
at two dose levels as compared to previous presentations. Updated
safety data will also be presented from the ongoing Phase I trial
(NCT01865617) evaluating JCAR014 in adult patients with relapsed or
refractory ALL, NHL, or CLL. The JCAR014 presentation will also
include data on clinical and laboratory biomarkers that may allow
early identification of cytokine release syndrome (CRS) and
neurotoxicity (NT).
Key data presentations at ASCO include:
JCAR017
- CR Rates in Relapsed/Refractory
(R/R) Aggressive B-NHL Treated with the CD19-Directed CAR T Cell
Product JCAR017 (TRANSCEND NHL 001) (Abstract #7513)
- Presenter: Jeremy Abramson, M.D.,
Massachusetts General Hospital
- Poster Display & Location: Monday,
June 5, 2017: 8:00 – 11:30 a.m. Central Time; Hall A, Poster Board
#275
- Poster Discussion & Location:
Monday, June 5, 2017: 1:15 – 2:30 p.m. Central Time; Room
E354b
JCAR014
- Cytokine Release Syndrome (CRS) and
Neurotoxicity (NT) after CD19-Specific Chimeric Antigen
Receptor-Modified T cells (Abstract #3020)
- Presenter: Kevin Hay, M.D., MSc, Fred
Hutchinson Cancer Research Center
- Poster Display & Location: Monday,
June 5, 2017: 8:00 – 11:30 a.m. Central Time; Hall A, Poster Board
#115
- Poster Discussion & Location:
Monday, June 5, 2017: 4:45 – 6:00 p.m. Central Time; Hall D1
About Juno’s Chimeric Antigen Receptor and T Cell Receptor
Technologies
Juno’s CAR and TCR technologies genetically engineer T cells to
recognize and kill cancer cells. Juno’s CAR T cell technology
inserts a gene for a particular CAR into the T cell, enabling it to
recognize cancer cells based on the expression of a specific
protein located on the cell surface. Juno’s TCR technology provides
the T cells with a specific T cell receptor to recognize protein
fragments derived from either the surface or inside the cell. When
either type of engineered T cell engages the target protein on the
cancer cell, it initiates a cell-killing response against the
cancer cell. JCAR014 and JCAR017 are investigational product
candidates and their safety and efficacy have not been established.
They are not approved by any regulatory authority.
About Juno
Juno Therapeutics is building a fully integrated
biopharmaceutical company focused on developing innovative cellular
immunotherapies for 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 multiple 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 (SCRI), 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. Juno’s product candidate JCAR017 was
developed in collaboration with SCRI and others.
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” 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, clinical benefits, clinical trial results
and the implications thereof, planned presentations at ASCO,
clinical trial plans, emerging medical trends, and the potential of
biomarkers to allow early identification of serious toxicities.
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 Biotechnology
(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 4, 2017 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/20170517006004/en/
Juno Therapeutics, Inc.Investor Relations:Nicole Keith,
206-566-5521nikki.keith@junotherapeutics.comorMedia:Christopher
Williams, 206-566-5660chris.williams@junotherapeutics.com
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