iTeos Therapeutics, Inc. (Nasdaq: ITOS), a clinical-stage
biopharmaceutical company pioneering the discovery and development
of a new generation of highly differentiated immuno-oncology
therapeutics for patients, today announced new clinical data from
its ongoing Phase 1/2a clinical trial of inupadenant (EOS-850), a
next-generation adenosine receptor (A2AR) antagonist, at the
American Society of Clinical Oncology (ASCO) Annual Meeting 2021.
Updated results from the single-agent dose-escalation and expansion
portions of the trial provided evidence of durable antitumor
activity in patients with advanced solid tumors and indicated
safety consistent with previously reported results. Three serious
adverse events considered possibly related to treatment with
inupadenant had plausible alternate causes and do not represent a
new safety concern for the program. Additionally, preliminary
analyses of pre-treatment tumor biopsies indicated that the
expression of A2AR is associated with clinical outcomes in patients
with solid tumors treated with single agent inupadenant.
“We are pleased with the durability of the anti-tumor responses
we have observed to date with our highly selective A2AR antagonist,
inupadenant, in patients with advanced cancers. These early-stage
results support the development for the treatment of cancer of
inupadenant, a selective inhibitor of A2AR, which is known to play
a crucial role in immunosuppression in the tumor microenvironment.”
said Joanne Jenkins Lager, M.D., chief medical officer of iTeos
Therapeutics. “We have used a proprietary assay to identify A2AR
expression as a biomarker that may be predictive of clinical
benefit. These new biomarker findings provide insight into the
mechanism of action of inupadenant, informing our selection of
potential indications, and may allow us to identify patients more
likely to benefit from inupadenant. We are continuing to evaluate
combinations with pembrolizumab and chemotherapy in our ongoing
Phase 1b/2a trial with the goal of improving outcomes for
patients.”
Phase 1/2a monotherapy Study Design and Results
The ongoing Phase 1/2a trial is evaluating the safety,
tolerability, pharmacokinetics (PK), pharmacodynamics (PD) and
antitumor activity of inupadenant monotherapy to define the maximum
tolerated dose (MTD) and recommended Phase 2 dose of inupadenant as
a single agent and in combination with pembrolizumab and/or
chemotherapy in patients with advanced solid tumors. As of the data
cut-off (February 26, 2021), 43 patients had enrolled in the
single-agent dose-escalation and expansion parts of the study.
Results presented at ASCO 2021 provided an update on 21 patients
enrolled in the single-agent dose-escalation and new data on 22
patients enrolled in the dose expansion.
Durable responses and stable disease greater than six months
were observed in five patients with advanced solid tumors,
including:
- previously reported partial responses: ongoing for more than 12
months in one patient with castrate-resistant prostate cancer, and
lasting for more than 8 months in one patient with melanoma
resistant to both pembrolizumab and ipilimumab; and
- stable disease in a patient with non-small cell lung cancer
enrolled in the expansion, with ongoing treatment for more than 10
months.
The safety of inupadenant monotherapy was consistent with
previously presented data. The most frequent adverse events were
fatigue, anemia, decreased appetite and constipation. Drug-related
serious adverse events (acute myocardial infarction, atrial
fibrillation, and pericardial effusion) were reported in three of
the 43 enrolled patients.
Evaluation of pre-treatment biopsies indicated that higher
expression of A2AR was associated with longer survival and either
tumor regression or stable tumor size in patients with solid tumors
treated with single agent inupadenant.
The e-poster and abstract can be accessed on the ASCO conference
website. The abstract and presentation details are as follows:
Title: Phase 1 trial of
the adenosine A2A receptor antagonist inupadenant (EOS-850): Update
on tolerability, and antitumor activity potentially associated with
the expression of the A2A receptor within the
tumor.Session Title: Developmental
Therapeutics—ImmunotherapyAbstract
#: 2562Authors: Laurence
Buisseret, et al.
Further Clinical Development of
InupadenantBased on the promising Phase 1/2a data to date,
iTeos plans to further evaluate inupadenant in combination with
pembrolizumab and in combination with chemotherapy in Phase 1b/2
studies, with an initial focus on patients with castrate-resistant
prostate cancer, anti-PD-1-resistant melanoma and triple negative
breast cancer. iTeos will continue to evaluate A2AR and other
potential predictive biomarkers in the inupadenant clinical
development program to ensure optimal therapeutic combinations and
identify patients most likely to benefit from treatment.
About InupadenantElevated levels of adenosine
found in the tumor microenvironment are known to be
immunosuppressive, by inhibiting A2AR, the only high-affinity
adenosine receptor expressed on different immune cells found in the
tumor micro-environment. Inupadenant (EOS-850) is the first
insurmountable A2AR antagonist tailored for application in
immuno-oncology, currently in clinical development. Inupadenant was
designed by iTeos’ scientists to remain potent at the high
adenosine concentrations found in the tumor micro-environment and
maintain continuous target coverage in multiple tumor types.
Inupadenant has a very high selectivity for A2AR compared to the
other adenosine receptors and is non brain penetrant, two
characteristics that should improve its safety. With this profile,
we believe that inupadenant has the potential for enhanced
antitumor activity as compared to other A2AR antagonists currently
in clinical development.
About iTeos Therapeutics, Inc.iTeos
Therapeutics is a clinical-stage biopharmaceutical company
pioneering the discovery and development of a new generation of
highly differentiated immuno-oncology therapeutics for patients.
iTeos Therapeutics leverages its deep understanding of the tumor
microenvironment and immunosuppressive pathways to design novel
product candidates with the potential to fully restore the immune
response against cancer. The Company’s innovative pipeline includes
two clinical-stage programs targeting novel, validated
immuno-oncology pathways designed with optimized pharmacologic
properties for improved clinical outcomes. The initial antibody
product candidate, EOS-448, is a high affinity, potent, anti-TIGIT
antibody with a functional Fc domain, designed to enhance the
anti-tumor response through a multifaceted immune modulatory
mechanism. An open-label Phase 1/2a clinical trial of EOS-448 is
ongoing in adult cancer patients with advanced solid tumors with
preliminary data indicating clinical activity as a monotherapy and
a favorable tolerability profile. The Company is also advancing
inupadenant, a next-generation adenosine A2A receptor antagonist
tailored to overcome cancer immunosuppression. iTeos is conducting
an open-label, multi-arm Phase 1/2a clinical trial of inupadenant
as a single-agent and in combinations in adult cancer patients with
advanced solid tumors. Preliminary results indicate encouraging
single-agent activity in the dose escalation portion of the trial.
iTeos Therapeutics is headquartered in Cambridge, MA, with a
research center in Gosselies, Belgium.
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For further information, please contact:
Investor Contact:Ryan BakeriTeos Therapeutics,
Inc.Ryan.Baker@iteostherapeutics.com
Media Contact: media@iteostherapeutics.com
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