Jounce Therapeutics Reports Improved PFS and OS Associated with Vopratelimab (JTX-2011) Treatment Emergent Biomarker at the 2...
April 02 2019 - 1:02PM
- Improved PFS and OS observed in patients
treated with vopratelimab who have emergence of ICOS hi CD4 T cells
compared to patients with ICOS lo CD4 T cells -
Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company
focused on the discovery and development of novel cancer
immunotherapies and predictive biomarkers, today reported new
clinical data on vopratelimab (JTX-2011) at the 2019 American
Association for Cancer Research (AACR) Annual Meeting in Atlanta,
GA. The Jounce poster presentations show that patients in the
ICONIC trial with emergence of ICOS hi CD4 T cells have improved
progression free survival (PFS) and overall survival (OS) compared
to patients with ICOS lo CD4 T cells. Data related to important
immune characteristics of ICOS hi CD4 T cells were also presented.
“We are pleased to see our initial observations of tumor
reductions associated with ICOS hi CD4 T cells now extend to
improved PFS and OS. All observed benefit in the study was in the
group of patients that showed emergence of these cells. As
vopratelimab, and not PD-1 inhibitors, is responsible for the
emergence of the ICOS hi CD4 cells, we are using this key
translational data to guide our next steps in development,” said
Elizabeth Trehu, M.D., chief medical officer of Jounce
Therapeutics. “We have further characterized the ICOS hi CD4 T
cells as activated T effector cells by flow cytometry and gene
expression profiling and demonstrated peripheral expansion of T
cell receptor (TCR) clones originally found in the matched archival
tumor. These characteristics provide additional scientific support
for clinical study designs based on the emergence of ICOS hi CD4 T
cells.”
In a poster titled “Improved progression-free and
overall survival (PFS/OS) in patients (pts) with emergence of
JTX-2011 (vopratelimab) associated biomarker (ICOS high CD4 T
cells) on the ICONIC trial,” the ICONIC investigators and
Jounce scientists describe the baseline characteristics and
clinical outcomes of patients with emergence of ICOS hi CD4 T cells
as compared to patients who did not develop this T cell
population.
Three groups of ICONIC relapsed refractory solid tumor patients
were compared in the new analysis: 1) 18 patients who have
demonstrated ICOS hi CD4 T cells in the blood, 2) 32 patients who
have demonstrated ICOS lo CD4 T cells, and 3) a group of patients
enrolled in parts A through D which includes an additional 151
patients that were not tested for ICOS status due to lack of
samples (“All Patients”). The analyses revealed:
- The emergence and persistence of the ICOS hi CD4 T cell
biomarker in the peripheral blood is associated with improved PFS
and OS:
- All benefit in the study, measured by tumor reductions, PFS and
OS, was in the ICOS hi CD4 T cell group
- PFS: median 6.2 months for patients with ICOS hi CD4 T cells vs
2 months for both patients with only ICOS lo CD4 T cells and All
Patients
- OS: median not yet reached for patients with ICOS hi CD4 T
cells vs 9 months for patients with only ICOS lo CD4 T cells and
9.1 months for All Patients
- The emergence of ICOS hi CD4 T cells is attributed to
vopratelimab and not PD-1 inhibitors
- There is no association of ICOS hi CD4 T cells with the common
predictive biomarkers microsatellite instability-high (MSI-H),
tumor mutation burden (TMB) or PD-L1 immunohistochemistry
(IHC)
- The ICOS hi CD4 T cell group included PD-1 naive and
experienced patients across multiple solid tumor types
In a poster titled “Genetic and molecular profiling of
ICOS hi CD4 T cells demonstrates clonal expansion of TH1 effector
cells following vopratelimab (JTX-2011) treatment in subjects with
solid tumors,” Jounce researchers describe the
characteristics of ICOS hi CD4 T cells associated with vopratelimab
treatment, including:
- Vopratelimab stimulates CD4 T cells with pre-existing high
levels of ICOS
- Peripheral TCR clones associated with the original matched
tumor are expanded in patients with emergent ICOS hi CD4 T
cells
- ICOS hi CD4 T cells are not T regulatory cells and display
distinct characteristics of activated T effector cells by both flow
cytometry and transcriptional profiling
“We are encouraged by the improved PFS and OS data associated
with the emergence of the ICOS hi CD4 T cell biomarker and are
convinced that meaningful advancements in immuno-oncology will
require the type of science-based translational understandings that
the Jounce team and platform have enabled to advance vopratelimab
thus far,” said Richard Murray, Ph.D., chief executive officer and
president of Jounce Therapeutics. “We have established our
translational technology base for the purpose of creating a
preclinical and, more importantly, clinical scientific
understanding of the mechanism of action of new immunotherapies and
the characteristics of responding versus non-responding patients to
focus the next steps of clinical development for vopratelimab and
our pipeline.”
The posters are available on the “Our Approach” section of the
Jounce Therapeutics website at www.jouncetx.com.
Jounce Therapeutics to Host Event and
WebcastJounce Therapeutics will host an investor and
analyst event beginning at 6:30 p.m. ET and live webcast beginning
at 7:00 p.m. ET, on Tuesday, April 2, 2019. To access the live
webcast, please visit the “Events & Presentations” page in the
Investors and Media section of the company’s website at
www.jouncetx.com. The webcast will be archived and made available
for replay on the company’s website approximately two hours after
the call and will be available for 30 days thereafter.
About Vopratelimab (JTX-2011)Jounce’s lead
product candidate, vopratelimab, is a monoclonal antibody that
binds to and activates ICOS, the Inducible T cell
COStimulator, a protein on the
surface of certain T cells. The company is developing vopratelimab
to treat solid tumors as a single agent and in combination with
other therapies.
About the ICONIC TrialThe ICONIC trial is an
adaptive, open label, dose escalation and expansion clinical study
of vopratelimab alone and in combination with nivolumab, ipilimumab
and pembrolizumab in patients with advanced solid tumors.
About Jounce TherapeuticsJounce Therapeutics,
Inc. is a clinical-stage immunotherapy company dedicated to
transforming the treatment of cancer by developing therapies that
enable the immune system to attack tumors and provide long lasting
benefits to patients. Through the use of its Translational Science
Platform, Jounce first focuses on specific cell types within the
human tumor microenvironment to prioritize targets, and then
identifies related biomarkers designed to match the right
immunotherapy to the right patient. Jounce has three
development-stage programs: its two clinical product candidates,
vopratelimab, a monoclonal antibody that binds to and activates
ICOS, and JTX-4014, a monoclonal antibody that binds to PD-1 and
for potential use in combination with Jounce’s pipeline of future
product candidates, and JTX-8064, a monoclonal antibody that binds
to LILRB2 that is currently in the IND-enabling phase. For more
information, please visit www.jouncetx.com.
Forward-Looking StatementsStatements in this
release concerning Jounce’s future expectations and plans,
including without limitation, Jounce’s expectations regarding the
timing, progress and results of the clinical development of
vopratelimab, and Jounce’s clinical development strategy may
constitute forward looking statements for the purposes of the safe
harbor provisions under The Private Securities Litigation Reform
Act of 1995 and other federal securities laws and are subject to
substantial risks, uncertainties and assumptions. You should not
place reliance on these forward looking statements, which include
words such as “on track,” “aims,” “anticipates,” “intend,” “may,”
“potential” or similar terms, variations of such terms or the
negative of those terms. Although the Company believes that the
expectations reflected in the forward-looking statements are
reasonable, the Company cannot guarantee such outcomes. Actual
results may differ materially from those indicated by these
forward-looking statements as a result of various important
factors, as well as those risks more fully discussed in the section
entitled “Risk Factors” in Jounce’s most recent annual report on
Form 10-K or quarterly report on Form 10-Q, as well as discussions
of potential risks, uncertainties, and other important factors in
Jounce’s subsequent filings with the U.S. Securities and Exchange
Commission. All such statements speak only as of the date made, and
the Company undertakes no obligation to update or revise publicly
any forward-looking statements, whether as a result of new
information, future events or otherwise.
Investor Contact:Komal JoshiJounce
Therapeutics, Inc.(857) 320-2523kjoshi@jouncetx.com
Media Contact:Gina NugentThe Yates Network(617)
460-3579gina@theyatesnetwork.com
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