Juno Therapeutics Highlights Key Translational Insights with JCAR017 in Patients with DLBCL
December 09 2017 - 2:00PM
Business Wire
— Patient factors may impact safety and
efficacy outcomes—
—JCAR017 cells infiltrated tumors, more
infiltration trended with better response—
—At disease progression, tumors tended to
express CD19 and lack CAR T cells—
Juno Therapeutics, Inc. (NASDAQ:JUNO), a biopharmaceutical
company developing innovative cellular immunotherapies for the
treatment of cancer, today presented new translational insights on
clinical outcomes with its investigational CAR T product candidate
JCAR017 at the 59th American Society of Hematology (ASH) Annual
Meeting and Exposition.
Juno also announced that JCAR017, a defined composition
CD19-directed CAR T cell product candidate using a 4-1BB
costimulatory domain, had received the United States Adopted Name
lisocabtagene maraleucel (liso-cel).
"Today’s presentations suggest that the defined composition of
JCAR017 supports a potential best-in-class clinical profile and
helps to unlock key translational insights,” said Sunil Agarwal,
M.D., Juno's President of Research and Development. “These insights
will help guide our next generation strategies to further improve
durable responses.”
Tanya Siddiqi, M.D., of City of Hope National Medical Center
presented insights from ASH Abstract #193, which analyzed patients
enrolled in the diffuse large B-cell lymphoma (DLBCL) cohort of the
TRANSCEND trial of JCAR017.
Results from these exploratory analyses suggest that patient
factors may impact safety and efficacy for DLBCL patients. These
factors included:
- Baseline patient characteristics,
including high tumor burden and markers of inflammation, were
associated with high CAR T cell expansion and increased rates of
cytokine release syndrome (CRS) and neurotoxicity (NT).
- Data showed an approximately 8-fold
increased risk for CRS and NT in patients with high baseline tumor
burden.
- Baseline markers of inflammation were
associated with more durable responses; with respect to tumor
burden the association was less pronounced.
In a separate analysis, Howard Stern, M.D., Ph.D. of Juno
Therapeutics, presented findings from ASH Abstract #194, examining
JCAR017 infiltration into tumor tissue and exploring potential
mechanisms of resistance and relapse. Results showed that JCAR017
CD4 and CD8 CAR T cells infiltrated tumors post-treatment. CAR T
cell infiltration trended higher in patients who achieved a
response. At disease progression, CAR T cells were rare or absent
in tumor tissue despite the presence of CD19 and persistence of
peripheral blood CAR T cells in most patients. There does not yet
appear to be a singular resistance pathway upregulated in the tumor
at the time of progression, but well-known pathways such as PD-L1
and IDO were upregulated in different patients. These data suggest
that combinations with other immunotherapies may be beneficial to
further improve outcomes with JCAR017 therapy. Juno and Celgene are
conducting an ongoing combination trial with JCAR017 and
durvalumab, an anti-PD-L1 antibody.
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 and
multiple myeloma. 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 (lisocabtagene maraleucel; liso-cel) was
developed in collaboration with SCRI and others. JCAR017 is an
investigational CAR T therapy and is not approved for use in any
country.
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, and business plans; clinical or
translational data and the implications thereof; the potential
best-in-class profile for JCAR017 (liso-cel); the importance of
controlling product composition; and the potential of Juno to apply
these learnings to further improve durable responses.
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
ability to attract and retain key scientific, quality
control/assurance, manufacturing or management personnel; 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 and its affiliates 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 November 1, 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/20171209005021/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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