SEATTLE--(BUSINESS WIRE)--May 17, 2017--
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:
CR Rates in Relapsed/Refractory (R/R) Aggressive B-NHL Treated with
the CD19-Directed CAR T Cell Product JCAR017 (TRANSCEND NHL 001)
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
Cytokine Release Syndrome (CRS) and Neurotoxicity (NT) after
CD19-Specific Chimeric Antigen Receptor-Modified T cells (Abstract
Presenter: Kevin Hay, M.D., MSc, Fred Hutchinson Cancer Research
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
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.
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.
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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Source: Juno Therapeutics, Inc.
Juno Therapeutics, Inc.