Jounce Therapeutics Initiates Phase 2 EMERGE Study of Vopratelimab in Combination with Ipilimumab in Patients with Non-Small ...
June 18 2019 - 8:00AM
Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company
focused on the discovery and development of novel cancer
immunotherapies and predictive biomarkers, today announced that it
has initiated dosing in the Phase 2 EMERGE clinical trial of its
lead product candidate, vopratelimab, in combination with
ipilimumab in patients with non-small cell lung cancer (NSCLC) or
urothelial cancer who have progressed on or after PD-1/PD-L1
inhibitor therapies. These patient populations represent a rapidly
growing area of unmet need as PD-1 inhibitors move into earlier
lines of therapy, with few options and no established standard of
care for patients who progress after a PD-1/PD-L1 inhibitor.
“The Phase 2 EMERGE clinical trial of vopratelimab and
ipilimumab builds upon the original science from our founders as
well as the reverse translational subset analysis from patients who
benefitted in our ICONIC trial versus those who did not.
Vopratelimab treatment resulted in the emergence of ICOS hi CD4 T
effector cells in the peripheral blood and emergence of these cells
was associated with response and improvements in progression free
survival and overall survival, as presented at the 2019 American
Association for Cancer Research Annual Meeting,” said Beth Trehu,
M.D., chief medical officer of Jounce Therapeutics. “Ipilimumab is
known to induce a population of ICOS hi CD4 T cells, making it a
scientifically logical combination partner for vopratelimab in the
EMERGE study, as we have shown vopratelimab stimulates, expands and
sustains ICOS hi CD4 T cells. We are pleased to have begun
enrollment in the EMERGE clinical trial and expect to report
preliminary efficacy data in 2020.”
About the Phase 2 EMERGE Clinical TrialThe
Phase 2 EMERGE clinical trial is an open-label, multi-center study
to evaluate the efficacy of vopratelimab in combination with
ipilimumab. In the initial stage, Jounce expects to enroll
approximately 40 patients with NSCLC and approximately 40 patients
with urothelial cancer. The primary endpoint is overall response
rate (ORR) and secondary endpoints include safety, duration of
response, progression free survival (PFS) and overall survival
(OS). Additional important assessments will include close
monitoring of ICOS hi CD4 T cell emergence, and a range of other
biomarkers, including exploratory assessment of potential
predictive biomarkers. Jounce expects to report preliminary
efficacy and biomarker relationships to clinical outcomes on up to
80 patients in 2020.
Patients and physicians interested in the Phase 2 EMERGE trial
can contact EMERGE@jouncetx.com. For more information on this
trial, please visit https://clinicaltrials.gov (Identifier:
NCT03989362).
About Vopratelimab Jounce’s lead product
candidate, vopratelimab (formerly JTX-2011), is a clinical-stage
monoclonal antibody that binds to and activates ICOS,
the Inducible T
cell COStimulator, a
protein on the surface of certain T cells commonly found in many
solid tumors. Vopratelimab was assessed in a Phase 1/2 clinical
trial that we refer to as ICONIC. In the initial Phase 1/2 portion
of ICONIC, vopratelimab was found to be safe and well-tolerated,
both alone and in combination with nivolumab, an anti-PD-1
antibody. At the June 2018 annual meeting of the American Society
of Clinical Oncology, we reported Response Evaluation Criteria in
Solid Tumors, or RECIST, responses and other tumor reductions as
determined by investigator assessment that were associated with an
ICOS pharmacodynamic biomarker. We subsequently reported that these
responses were durable, lasting six or more months and that all
responders, as determined by investigator assessments, remained on
study for more than one year. ICONIC also included dose-escalation
Phase 1 portions to assess vopratelimab in combination with
pembrolizumab, an anti-PD-1 antibody, and in combination with
ipilimumab, an antibody that binds to CTLA-4 on certain T cells.
This Phase 1 portion established the safety of vopratelimab in
combination with each of ipilimumab and pembrolizumab.
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 Leukocyte Immunoglobulin Like Receptor B2 (LILRB2)
that is currently in the IND-enabling phase. In addition, Jounce is
progressing numerous novel discovery stage programs. For more
information, please visit www.jouncetx.com.
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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