LEXINGTON, Mass., Dec. 19,
2019 /PRNewswire/ -- Agenus Inc. (NASDAQ: AGEN), an
immuno-oncology (I-O) company with a pipeline of immune checkpoint
antibodies, adoptive cell therapies1 and cancer
vaccines, today announced the first patient dosed with AGEN1181, an
anti-CTLA-4 antibody, in combination with balstilimab, Agenus' PD-1
inhibitor. Agenus began this study as a monotherapy in patients
with advanced solid tumors within a Phase 1 dose escalation study
(NCT03860272) in April 2019.
The first patients to be treated with AGEN1181 as a monotherapy
as well as the combination trial with PD-1 were dosed by Dr.
Steven O'Day, Executive Director of
the John Wayne Cancer Institute & Cancer Clinic, and a pioneer
in delivering immune therapies to patients with cancer.
"AGEN1181, with its potential for enhanced immune activation and
tumor fighting abilities, may bring superior benefit to a broader
group of patients compared to first generation anti-CTLA-4
antibodies," said Dr. O'Day. "The pre-clinical data suggest
the superiority of this molecule as a monotherapy and in
combination with anti-PD-1, like balstilimab. Furthermore,
AGEN1181 was designed to bring benefit to a broad population of
patients both who respond to first generation molecules and those
who do not respond due to a genetic polymorphism. Expanding
the important immune priming benefit of CTLA-4 to a broad group of
patients would be outstanding. I am thrilled to be working
with this compound."
Balstilimab, the company's proprietary anti-PD-1 antibody, is
currently being evaluated as a monotherapy and in combination with
zalfrelimab (a first generation CTLA-4) in trials designed to
support a planned BLA filing in 2020 for patients with
relapsed/refractory cervical cancer.
This expanded trial is another example of Agenus' ability to
rapidly advance its novel pipeline. Next-Gen CTLA-4 is a novel
antibody from Agenus' discovery engine, and with its own PD-1
molecule, Agenus has been able to move this important combination
into the clinic with a high sense of urgency.
About AGEN1181
AGEN1181, a novel 'Fc engineered'
antibody with potential for enhanced anti-tumor functions, is
specifically designed to boost cancer killing immune cells and
deplete intratumoral regulatory T cells that promote immune
evasion. By enhancing binding to a specific Fc receptor, FcγRIIIA,
on antigen-presenting cells or natural killer cells, AGEN1181
significantly enhances the therapeutic potential of anti-CTLA-4
therapy leveraging novel mechanisms that are not captured by the
first-generation anti-CTLA-4 therapies. AGEN1181's Fc engineered
backbone improves the cross-talk between antigen-presenting cells
and T cells, to enable optimal T cell priming, activation and
formation of durable memory responses. Moreover, AGEN1181 enhanced
binding to FcγRIIIA, significantly increases the potential to
deplete intratumoral regulatory T cells, a significant barrier to
successful anti-cancer immune responses. Notably, AGEN1181 is
engineered to strongly bind both the low affinity and high affinity
FcγRIIIA polymorphisms, unlike first generation molecules which
weakly bind the low affinity polymorphism. AGEN1181 is designed to
expand the benefit to an additional ~40% of patients with the low
affinity polymorphism and enhance the benefits of CTLA-4 in all
patients.
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 with combination approaches that leverage
a broad repertoire of antibody therapeutics, adoptive cell
therapies (through its AgenTus Therapeutics subsidiary) and its
proprietary cancer vaccine platforms. Agenus has 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 Agenus' clinical development and regulatory
plans and timelines and the potential therapeutic benefit of
AGEN1181. 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
Jennifer.Buell@agenusbio.com
1Through AgenTus Therapeutics,
a subsidiary of Agenus
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SOURCE Agenus