Jounce Therapeutics Presents New Vopratelimab Predictive Biomarker Data Supporting Use in the Upcoming SELECT Trial at the 20...
February 06 2020 - 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 new data
on the identification of the predictive biomarker to be used for
patient selection in the SELECT clinical trial of vopratelimab
(vopra), in addition to a research collaboration with NanoString
(NASDAQ: NSTG). The new data introduces TISvopra, a baseline RNA
signature with a threshold optimized for the emergence of ICOS hi
CD4 T cells, a vopratelimab pharmacodynamic biomarker not
associated with PD-1 inhibitor therapy. When applied to ICONIC
clinical data, TISvopra predicted clinical outcomes from the ICONIC
trial better than PD-L1 immunohistochemistry (IHC). These results
are being presented today at the 2020 ASCO-SITC Clinical
Immuno-Oncology Symposium Annual Meeting in Orlando, Florida.
“We are excited to announce these two new developments
supporting our upcoming SELECT clinical trial of vopratelimab and
our own PD-1 inhibitor. The new data presented today at ASCO-SITC
reveal the identification of TISvopra as a baseline predictive
biomarker associated with the emergence of ICOS hi CD4 T cells.
When applied to ICONIC clinical data, TISvopra then predicted
clinical benefit in patients who received vopratelimab alone or in
combination with nivolumab. This, coupled with our new research
collaboration with NanoString, reflects our commitment to patient
selection strategies to identify those most likely to benefit from
our novel immunotherapies,” said Elizabeth Trehu, M.D., chief
medical officer of Jounce Therapeutics. “The identification of
TISvopra is a crucial step forward in the development of
vopratelimab, and we plan to initiate the Phase 2 SELECT trial
using this biomarker in mid-2020.”
Key highlights from the poster, titled “Association of a
Predictive RNA Signature (RS) With Emergence of ICOS hi CD4 T Cells
and Efficacy Outcomes for the ICOS Agonist Vopratelimab (vopra) and
Nivolumab (nivo) in Patients (pts) on the ICONIC trial”
include:
- TISvopra is an 18 gene RNA Tumor Inflammation Signature (TIS),
utilized with a vopratelimab-specific threshold and was identified
as a biomarker predictive of ICOS hi CD4 T cell emergence. TISvopra
positive patients treated with vopratelimab alone or in combination
with nivolumab also showed improved clinical benefit (response
rate, six month and nine month landmark progressive free survival
and overall survival) as compared with TISvopra negative patients
in the ICONIC trial.
- TIS includes genes associated with integral elements of CD4 T
cell activation that may contribute to a more comprehensive immune
response.
- The TISvopra threshold was chosen to optimize prediction of
ICOS hi CD4 T cell emergence and was more predictive of clinical
benefit than PD-L1 IHC in the ICONIC trial.
- The emergence of ICOS hi CD4 T cells is a vopratelimab, but not
a PD-1 inhibitor, pharmacodynamic biomarker linked to clinical
benefit in the ICONIC trial.
- In the upcoming SELECT trial, TISvopra will be used to select
patients for treatment with vopratelimab and JTX-4014, Jounce’s
PD-1 inhibitor.
The poster is available in the “Our Pipeline” section of the
Jounce Therapeutics website under “Publications” at
www.jouncetx.com.
Jounce also announced a research collaboration with NanoString
to support the application of the predictive biomarker to be used
in the SELECT trial. Under the terms of the collaboration, Jounce
and NanoString will apply an optimized selection threshold of the
TIS based on the emergence of ICOS hi CD4 T cells (TISvopra). The
TISvopra clinical trial assay will be implemented on the nCounter®
Dx Analysis System.
About the Phase 2 SELECT Clinical TrialThe
Phase 2 SELECT clinical trial is a randomized, ex-U.S. trial to
evaluate the efficacy of JTX-4014 alone and in combination with
vopratelimab. The trial is powered to show statistical superiority
of vopratelimab plus JTX-4014 compared to JTX-4014 alone in a
biomarker-selected patient population. Jounce expects to enroll
approximately 75 immunotherapy naïve second-line non-small cell
lung cancer (NSCLC) patients. Patients will be prescreened for the
TISvopra biomarker. Jounce estimates that approximately 20% of the
prescreened NSCLC patients will be above the TISvopra threshold and
potentially eligible for the trial. Jounce expects to initiate the
SELECT trial in mid-2020 and report preliminary efficacy and
biomarker relationships to clinical outcomes from up to 75 patients
in 2021.
About VopratelimabJounce’s lead product
candidate, vopratelimab, is a clinical-stage monoclonal antibody
that binds to and activates ICOS, the Inducible T
cell CO-Stimulator, a protein on
the surface of certain T cells commonly found in many solid tumors.
Vopratelimab is currently being assessed in the Phase 2 EMERGE
clinical trial in a sequenced combination with ipilimumab in
patients with NSCLC who were previously treated with PD-1/PD-L1
inhibitor therapies. Jounce is also planning to initiate the Phase
2 SELECT clinical trial of vopratelimab with its investigational
PD-1 inhibitor, JTX-4014, in TISvopra biomarker-selected patients.
Vopratelimab was previously assessed in the Phase 1/2 ICONIC trial
and was found to be safe and well-tolerated, alone and in
combination with each of the anti-PD-1 antibodies nivolumab and
pembrolizumab, as well as with ipilimumab, an antibody that binds
to CTLA-4.
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 a biomarker-driven approach. Jounce
has three development-stage programs, two of which are
clinical-stage programs, vopratelimab, a monoclonal antibody that
binds to and activates ICOS, and JTX-4014, a PD-1 inhibitor
intended for potential combination use with Jounce’s broader
pipeline. Vopratelimab is currently being assessed in a Phase 2
clinical trial, and an additional trial to assess vopratelimab in
combination with JTX-4014 is planned. Phase 1 data for JTX-4014
were reported in November 2019. The next development candidate to
emerge from Jounce’s Translational Science Platform is JTX-1811, a
monoclonal antibody designed to deplete T regulatory cells in the
tumor microenvironment. JTX-1811 is currently in IND-enabling
activities. In addition, Jounce has exclusively licensed worldwide
rights to JTX-8064, a LILRB2 receptor antagonist, to Celgene
Corporation, a wholly-owned subsidiary of Bristol-Myers Squibb
Company. For more information, please visit www.jouncetx.com.
Cautionary Note Regarding Forward-Looking
StatementsVarious statements in this release concerning
Jounce’s future expectations, plans and prospects, including
without limitation, Jounce’s expectations regarding the timing,
progress and results of the EMERGE and SELECT clinical trials 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 often
include words such as “expects,” “plan,” “potential” or similar
terms, variations of such terms or the negative of those terms.
Although Jounce believes that the expectations reflected in the
forward-looking statements are reasonable, Jounce cannot guarantee
such outcomes. Actual results may differ materially from those
indicated by these forward-looking statements as a result of
various important factors, including, without limitation, Jounce’s
ability to successfully demonstrate the efficacy and safety of its
product candidates; the clinical results for its product
candidates, which may not support further development and marketing
approval; Jounce’s ability to enroll patients in its clinical
trials; the potential advantages of Jounce’s product candidates;
the development plans of its product candidates and any companion
or complementary diagnostics; actions of regulatory agencies, which
may affect the initiation, timing and progress of preclinical
studies and clinical trials of Jounce’s product candidates; and
those risks more fully discussed in the section entitled “Risk
Factors” in Jounce’s most recent Annual Report on Form 10-K filed
with the Securities and Exchange Commission as well as discussions
of potential risks, uncertainties, and other important factors in
Jounce’s subsequent filings with the Securities and Exchange
Commission. All such statements speak only as of the date made, and
Jounce undertakes no obligation to update or revise publicly any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Investor and Media Contact: Komal Joshi Jounce
Therapeutics, Inc. (857) 320-2523 kjoshi@jouncetx.com
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