Jounce Therapeutics Presents Phase 1 Data from ICONIC Study of JTX-2011 in Patients with Advanced Solid Tumors at 2017 ASCO A...
June 05 2017 - 9:00AM
-- ICOS Agonist Antibody Well Tolerated Alone and
as Combination Immunotherapy --
Jounce Therapeutics, Inc. (NASDAQ:JNCE), a clinical-stage company
focused on the discovery and development of novel cancer
immunotherapies and predictive biomarkers for patient enrichment,
today announced that Phase 1 data from the Company’s ICONIC study
of JTX-2011 were presented in a poster (Abstract #192770) at the
2017 American Society of Clinical Oncology (ASCO) Annual Meeting.
JTX-2011 is a monoclonal antibody targeting ICOS, a protein found
on the surface of certain T cells within many solid tumors. The
preliminary data show JTX-2011 to be well-tolerated in doses up to
0.3 mg/kg as a monotherapy and in combination with nivolumab in
patients with advanced solid tumors.
“We are very encouraged by the safety and pharmacodynamic data
from the ICONIC study, which showed JTX-2011 to be well-tolerated
as a monotherapy and in combination with nivolumab,” said Beth
Trehu, M.D., FACP, chief medical officer of Jounce Therapeutics.
“The JTX-2011 Phase 1 data in this poster is the first clinical
data to be presented with an ICOS agonist antibody, and includes
the safety, PK and PD data, as well as the selected dose for the
Phase 2 monotherapy portion of the trial that was initiated in
April of this year.”
The Phase 1 portion of the Phase 1/2 ICONIC (ICOS AgONist
Antibody for Immunotherapy in Cancer Patients) study was a
dose-escalation study to assess safety and tolerability of JTX-2011
and to determine the recommended Phase 2 dose (RP2D) of JTX-2011 as
a monotherapy and in combination with nivolumab. The study enrolled
patients with any advanced solid tumor who had disease progression
after treatment with all available therapies known to confer
clinical benefit. Unlike the ongoing Phase 2 study, the Phase 1
study did not include enrichment for patients with the ICOS
biomarker.
A summary of results as of May 12, 2017, is as follows:
- Forty-six subjects were dosed in six cohorts of escalating
doses of JTX-2011 alone every three weeks and four cohorts of
escalating doses of JTX-2011 plus nivolumab 240 mg IV every three
weeks
- Most adverse events were Grade 1 or 2, with the most common
being chills, decreased appetite, nausea and fever
- Infusion-related adverse events were reported in 10
participants at doses 0.003 mg/kg through 0.3 mg/kg in both
monotherapy and combination
- Immune related adverse events not associated with drug infusion
were reported in six participants at doses at or above 0.03 mg/kg,
including two dose-limiting toxicities at 1 mg/kg, resulting in a
maximum tolerated dose for JTX-2011 monotherapy of 0.3 mg/kg
- 0.3 mg/kg was selected as the recommended Phase 2 dose for
JTX-2011 monotherapy based on safety and tolerability, target
engagement, PK and peripheral blood immunophenotyping
- Nine out of 12 monotherapy participants at the RP2D and 10 out
of 12 combination therapy participants at all dose levels remain on
study with limited duration of follow-up
“These early data are promising and support our advancement to
the Phase 2 portion of the ICONIC study. As we shift our focus to
look at measures of preliminary efficacy, we will be utilizing the
biomarker enrichment strategy that defines Jounce’s translational
approach, and enroll a certain number of patients with a high
percentage of ICOS-expressing immune cells in their tumors into the
Phase 2 cohorts. We look forward to gaining important insights on
how JTX-2011 may benefit patients that have not had success with
currently available therapies,” said Richard Murray, Ph.D.,
chief executive officer of Jounce Therapeutics.
Phase 2 Portion of ICONIC Study:
In April 2017, Jounce announced the initiation of the Phase 2
portion of the ICONIC trial, which consists of two parts evaluating
preliminary efficacy. Patient enrollment is ongoing in the
monotherapy (Part C) portion of the study. The Phase 2 study
evaluates JTX-2011 as a monotherapy across more than three
disease-specific expansion cohorts in solid tumors, including
patients with head and neck squamous cell cancer (HNSCC) and
non-small cell lung cancer (NSCLC) and in combination with
nivolumab and in over five cohorts, including HNSCC, NSCLC, triple
negative breast cancer, melanoma and gastric cancer. Each of these
indications was identified by Jounce’s Translational Science
Platform as having tumors displaying high percentages of
ICOS-expressing infiltrating immune cells, the target of JTX-2011.
In addition, individual patients will be stratified for the ICOS
biomarker, which measures the percentage of ICOS-expressing immune
cells in their tumors, to ensure that sufficient numbers of
patients with high ICOS expression, who may be more likely to
respond, are enriched into each cohort.
About the ICONIC StudyThe ICONIC study
(ICOS AgONist Antibody for
Immunotherapy in Cancer Patients)
is an open label, dose-escalation and expansion clinical study of
JTX-2011 alone or in combination with a fixed dose of nivolumab in
subjects with advanced solid tumors . The four-part, adaptive
design includes Parts A, B, C and D. Parts A and B comprise the
Phase 1 portion of the study and are designed to provide safety, PK
and PD data in both the monotherapy (Part A) and combination
therapy (Part B) settings. Parts C (monotherapy) and D (combination
therapy) are designed to provide preliminary efficacy
proof-of-concept data. For more information on the ICONIC trial,
visit clinicaltrials.gov.
About JTX-2011 Jounce’s lead product candidate,
JTX-2011, is a monoclonal antibody that binds to and
activates ICOS, a protein on the surface of certain T
cells. Preclinical data support that JTX-2011 may have a dual
mechanism of action that stimulates anti-tumor T effector cells,
and also reduces the immunosuppressive T regulatory cells in the
tumor microenvironment. The company is developing JTX-2011 to treat
solid tumors as a single agent and in combination with other
therapies.
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 the use of its Translational Science
Platform, Jounce first focuses on specific cell types within tumors
to prioritize targets, and then identifies related biomarkers
designed to match the right therapy to the right patient. Jounce’s
lead product candidate, JTX-2011, is a monoclonal antibody that
binds to and activates ICOS and is currently in a Phase 1/2 trial.
For more information, please visit http://jouncetx.com/.
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 preclinical studies
and clinical trials for Jounce’s product candidates and any future
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 “anticipate,”
“estimate,” “expect,” “intend,” “may,” “on track,” “plan,”
“predict,” “target,” “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, 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.
Media Contact:
Katie Engleman
Pure Communications, Inc.
(919) 333-7722
katie@purecommunicationsinc.com
Investor Contact:
Beth DelGiacco
Stern Investor Relations, Inc.
(212) 362-1200
beth@sternir.com
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