LEXINGTON, Mass., Jan. 8, 2020 /PRNewswire/ -- Agenus Inc. (NASDAQ:
AGEN), an immuno-oncology company with an extensive pipeline of
agents that activate immune response to cancers, announced the
dosing of the first patient with AGEN1223. AGEN1223 is a novel
bi-specific antibody discovered by Agenus and designed to deplete
regulatory T cells in the tumor microenvironment. The first patient
was infused in December 2019 and the
trial is underway with a plan to initiate combinations with
balstilimab, Agenus' investigational PD-1 inhibitor, in 2020.
Dr. Anthony El-Khoueiry of the
USC Norris Comprehensive Cancer Center
and Keck School of Medicine was the clinical investigator dosing
this first patient. Dr. El-Khoueiry is the phase I program director
and a recognized expert in early drug development and translational
medicine with a focus in hepatobiliary (liver, gall bladder, and
bile duct) and pancreatic cancers.
"AGEN1223 is a novel bispecific antibody designed to selectively
deplete specific immune-suppressive cells called regulatory T
cells. The ability to deplete these cells in the tumor
microenvironment may be an important treatment advantage for
patients with cancer," said Dr. Anna
Wijatyk, Head of Clinical Development at Agenus. "AGEN1223
is designed to eliminate the escape pathways that tumors use to
continue to grow beyond multiple lines of therapy, including
anti-PD-1 therapy. We believe that AGEN1223, due to its
design to both selectively deplete intratumoral Tregs while sparing
peripheral Tregs and to activate effector immune cells, represents
an important novel therapy and promising combination agent for
patients with aggressive tumors."
The Phase 1, open-label, multicenter study is designed to assess
the maximum tolerated dose of AGEN1223 in subjects with advanced
solid tumors. It will also evaluate the safety, tolerability, PK,
and PD profiles and immunogenicity of this bi-specific
antibody.
AGEN1223 was discovered by Agenus scientists and engineered to
enhance immune functionality and immunogenicity. Our
preclinical data show that AGEN1223 simultaneously engages two
antigens that are co-expressed specifically on tumor-infiltrating
Tregs thereby prompting their depletion. These data further show
that cancer-fighting effector T cells and essential peripheral
Tregs, which do not sufficiently co-express these targets, are
largely spared from destruction. In addition to its Treg depleting
capabilities, AGEN1223 can co-stimulate antigen-specific effector T
cells that are essential for tumor killing in preclinical assays.
Overall, AGEN1223 may represent a promising combination partner for
a range of other therapeutic interventions – which could include
checkpoint inhibitors, vaccines, or cell therapy. Gilead Sciences,
Inc. has an exclusive option to license AGEN1223 as part of our
December 2018 collaboration agreement
with the company. Agenus is currently responsible for the
development of AGEN1223. AGEN1223 and balstilimab are
investigational agents. Their safety and efficacy are being
evaluated in a Phase 1 clinical trial.
About Agenus
Agenus is a clinical-stage immuno-oncology company focused on the
discovery and development of therapies that engage the body's
immune system to fight cancer. The Company's vision is to expand
the patient populations benefiting from cancer immunotherapy by
pursuing combination approaches that leverage a broad repertoire of
antibody therapeutics, proprietary cancer vaccine platforms, and
adoptive cell therapies (through its AgenTus Therapeutics
subsidiary). The Company is equipped with a suite of antibody
discovery platforms and a state-of-the-art GMP manufacturing
facility with the capacity to support early phase clinical
programs. Agenus is headquartered in Lexington, MA. For more information, please
visit www.agenusbio.com and our twitter handle @agenus_bio.
Information that may be important to investors will be routinely
posted on our website and twitter.
Forward-Looking Statements
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the federal
securities laws, including statements regarding: the clinical
utility of AGEN1223; expectations regarding the results of the
Phase 1 study of AGEN1223; expectations for future clinical trial
plans and development activities of AGEN1223; our clinical trial
plans and activities, research and development plan and activities
for antibodies other than AGEN1223; and the anticipated operations
and benefits of AGEN1223 and our other programs. These
forward-looking statements are subject to risks and uncertainties
that could cause actual results to differ materially. These risks
and uncertainties include, among others, the factors described
under the Risk Factors section of our most recent Quarterly Report
on Form 10-Q or Annual Report on Form 10-K filed with the
Securities and Exchange Commission. Agenus cautions investors not
to place considerable reliance on the forward-looking statements
contained in this release. These statements speak only as of the
date of this press release, and Agenus undertakes no obligation to
update or revise the statements, other than to the extent
required by law. All forward-looking statements are expressly
qualified in their entirety by this cautionary statement.
Contact:
Agenus Inc.
Jennifer Buell, PhD
781-674-4420
Jennifer.Buell@agenusbio.com
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SOURCE Agenus Inc.