Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company
focused on the discovery and development of novel cancer
immunotherapies and predictive biomarkers, today presented two
trial in progress posters, on the Phase 1 INNATE clinical trial and
the Phase 2 SELECT clinical trial, at the American Society of
Clinical Oncology (ASCO) Virtual Annual Meeting. INNATE, a
proof-of-concept (POC) trial, is evaluating Jounce’s lead
macrophage program JTX-8064 (anti-LILRB2/ILT4 inhibitor) as a
monotherapy and in combination with pimivalimab (anti-PD-1
inhibitor, formerly known as JTX-4014) in patients with a variety
of advanced solid tumors. SELECT, Jounce’s second POC trial, is
evaluating pimivalimab as a monotherapy and in combination with
vopratelimab (ICOS agonist) in a novel biomarker selection paradigm
in PD-(L)1 naïve non-small cell lung cancer patients.
“Our INNATE trial is rapidly progressing through dose escalation
and we are on-track to begin indication-specific, POC, monotherapy
and pimivalimab combination expansion cohorts in the second half of
this year,” said Elizabeth Trehu, M.D., chief medical officer
of Jounce Therapeutics. “Furthermore, we are excited to
announce the expansion cohort indications for INNATE, which were
selected using our translational data-driven approach, linking
JTX-8064’s mechanism to tumor types in three groups of patients
including: PD-(L)1 inhibitor experienced and resistant, PD-(L)1
inhibitor naïve and historically resistant, and PD-(L)1 inhibitor
and historically more sensitive. JTX-8064 is one of only two
clinical-stage LILRB2 programs in development and we expect it to
be the first program to initiate expansion cohorts in four of our
chosen tumor types. We are also pleased to see TISvopra positivity
rates tracking with expectations in our biomarker selection trial,
SELECT, and we remain on-track to report data next year.”
Poster Presentation Details:
Poster Title: Phase 1, First-in-Human trial of
JTX-8064, an anti-LILRB2/ILT4 monoclonal antibody, as monotherapy
and in combination with anti-PD-1 in adult patients with advanced
solid (INNATE)Presenter: Kyriakos P. Papadopoulos,
MD, South Texas Accelerated Research Therapeutics (START), San
Antonio, TXSession Title: Developmental
Therapeutics – ImmunotherapyAbstract Number:
TPS2672Date and Time: Friday, June 4, 2021; 9:00am
ET Highlights from the trial in progress poster include the
selection criteria for expansion cohorts in the ongoing Phase 1
INNATE trial and an outline the future biomarker plan:
- Expansion cohort
selection was informed using human histoculture and gene signature
analysis from Jounce’s Translational Science Platform and includes
PD-(L)1 naïve and experienced patients as well as PD-(L)1 sensitive
and resistant tumor types.
- The INNATE trial is divided into 4 stages with
indication-specific expansion cohorts intended to establish
proof-of-concept for JTX-8064:
- JTX-8064 monotherapy dose escalation in relapsed / refractory
solid tumors
- JTX-8064 plus
pimivalimab dose escalation in relapsed / refractory solid
tumors
- JTX-8064 monotherapy
expansion in PD-(L)1i naïve platinum resistant ovarian cancer
- JTX-8064 plus
pimivalimab expansions in:
- PD-(L)1i naïve
platinum resistant ovarian cancer
- PD-(L)1i naïve head
and neck squamous cell carcinoma (HNSCC)
- PD-(L)1i naïve
undifferentiated pleomorphic sarcoma (UPS) and liposarcoma
(LPS)
- PD-(L)1i experienced
non-small cell lung cancer (NSCLC)
- PD-(L)1i experienced
clear cell renal cell carcinoma (ccRCC)
- PD-(L)1i experienced
triple negative breast cancer (TNBC)
- PD-(L)1i experienced
cutaneous squamous cell carcinoma (cSCC).
- The dose for
expansion cohorts will be selected based on safety, pharmacokinetic
and receptor occupancy data from the monotherapy dose escalation
stage of INNATE.
- Archival and
pre-treatment tumor biopsies as well as pre- and post-treatment
blood samples will be collected to evaluate a number of potential
predictive and pharmacodynamic biomarkers using Jounce’s
Translational Science Platform.
Poster Title: Phase 2 Study of PD-1 Inhibitor
JTX-4014 (Pimivalimab) Alone and in Combination with Vopratelimab,
an ICOS Agonist, in Biomarker-selected Subjects with Metastatic
NSCLC After One Prior Platinum-containing Regimen
(SELECT)Presenter: Oleh Kobziev, MD, Regional
Center of Oncology, Kharkiv, 61070, UkraineSession
Title: Lung Cancer – Non-Small Cell
MetastaticAbstract Number: TPS9137Date and
Time: Friday, June 4, 2021; 9:00am ET
The SELECT trial is currently enrolling approximately 75
immunotherapy naïve NSCLC patients who have been pre-selected with
the TISvopra predictive biomarker
- TISvopra may serve as a unique biomarker for potential
increased benefit for both pimivalimab monotherapy as well as
pimivalimab in combination with vopratelimab.
- Data from Jounce and a third-party ICOS agonist program support
an ICOS-focused biomarker selection strategy to identify patients
that may benefit from ICOS agonism.
- Early screening data from SELECT support Jounce’s estimate that
approximately 20% of PD-(L)1i naïve non-small cell lung cancer
patients tested for TISvopra in the study would meet the TISvopra
positivity threshold.
- SELECT is on-track to report clinical data in 2022.
Both posters will be available on the “Our Pipeline” section of
the Jounce Therapeutics website under “Publications”
at www.jouncetx.com.
About JTX-8064
JTX-8064 is a humanized IgG4 monoclonal antibody designed to
specifically bind to Leukocyte Immunoglobulin Like Receptor B2
(LILRB2/ILT4) and block interactions with its ligands. JTX-8064 is
the first tumor-associated macrophage candidate developed from
Jounce’s Translational Science Platform. Preclinical data presented
at the 2020 Society for Immunotherapy of Cancer’s Annual
Meeting and the 2019 and 2021 American Association for Cancer
Research Annual Meetings support the development of JTX-8064
as a novel immunotherapy to reprogram immune-suppressive
macrophages and enhance anti-tumor immunity. A Phase 1 clinical
trial named INNATE (NCT04669899) of JTX-8064 as a monotherapy and
in combination with Jounce’s internal anti-PD-1 inhibitor,
pimivalimab (formerly JTX-4014) is currently enrolling patients
with advanced solid tumors.
About Pimivalimab
Pimivalimab (formerly JTX-4014) is a well-characterized fully
human IgG4 monoclonal antibody designed to block binding to PD-L1
and PD-L2. Pimivalimab demonstrated a 17% durable overall response
rate in a Phase 1 trial of 18 heavily pre-treated PD-(L)1 inhibitor
naïve patients, which excluded all tumor types for which PD-(L)1
inhibitors were approved. In this Phase 1 trial, pimivalimab was
shown to have an acceptable safety profile. Pimivalimab is
currently being assessed in the INNATE Phase 1 trial (NCT04669899)
in combination with JTX-8064, a LILRB2 (ILT4) inhibitor.
Pimivalimab is also being assessed in the SELECT Phase 2 clinical
trial (NCT04549025) in combination with vopratelimab, 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.
About Vopratelimab
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
SELECT Phase 2 clinical trial (NCT04549025) in combination with
Jounce’s internal investigational PD-1 inhibitor, pimivalimab
(formerly JTX-4014), compared to pimivalimab alone. The SELECT
trial is currently enrolling approximately 75 immunotherapy naïve
NSCLC patients who have been pre-selected with the
TISvopra predictive biomarker, an 18 gene RNA tumor
inflammation signature which predicted the emergence of ICOS hi CD4
T cells and clinical benefit in the ICONIC trial of vopratelimab
alone and in combination with a PD-1 inhibitor. SELECT is powered
to demonstrate the statistical superiority of the combination of
vopratelimab plus pimivalimab compared to pimivalimab.
About Jounce Therapeutics:
Jounce 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 currently has multiple
development stage programs ongoing while simultaneously advancing
additional early-stage assets from its robust discovery engine
based on its Translational Science Platform. Jounce’s highest
priority program, JTX-8064, is a LILRB2 (ILT4) receptor antagonist
shown to reprogram immune-suppressive tumor associated macrophages
to an anti-tumor state in preclinical studies. Jounce’s most
advanced product candidate, vopratelimab, is a monoclonal antibody
that binds to and activates ICOS, and is currently being studied in
the SELECT Phase 2 trial. Pimivalimab is a PD-1 inhibitor intended
for combination use in the INNATE and SELECT trials and with
Jounce’s broader pipeline. Additionally, Jounce exclusively
licensed worldwide rights to JTX-1811, a monoclonal antibody
targeting CCR8 and designed to selectively deplete T regulatory
cells in the tumor microenvironment, to Gilead Sciences, Inc. For
more information, please visit www.jouncetx.com.
Cautionary Note Regarding Forward-Looking
Statements:
Various statements in this release concerning Jounce’s future
expectations, plans and prospects, including without limitation,
Jounce’s expectations regarding the timing, progress, results and
release of data for clinical trials of vopratelimab, pimivalimab
and JTX-8064, identification, selection and enrollment of patients
for Jounce’s clinical trials, and the use of pimivalimab in
combination with Jounce’s other product candidates, 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 “expect,” “goal,” “plan,” “on track,” “will”
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 and future product candidates; the preclinical
and clinical results for its product candidates, which may not
support further development and marketing approval; the potential
advantages of Jounce’s product candidates; Jounce’s ability to
successfully manage its clinical trials; 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 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 Contacts:Mark YoreJounce
Therapeutics, Inc.+1-857-200-1255 myore@jouncetx.com
Julie SeidelStern Investor
Relations+1-212-362-1200Julie.Seidel@sternir.com
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