Agenus’ Presentations at ASCO 2021 Demonstrate Differentiated Activity of Balstilimab and Provide Clinical Update on AGEN23...
June 04 2021 - 9:09AM
Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive
pipeline of checkpoint antibodies, cell therapies, adjuvants, and
vaccines designed to activate immune response to cancers and
infections, today presented data demonstrating the differentiation
of balstilimab as an anti-PD-1 antibody as well as data from a
Phase 1 clinical trial of AGEN2373, a CD137 agonist antibody, at
the American Society of Clinical Oncology (ASCO) Annual Meeting
2021 from June 4 – 8, 2021.
Agenus submitted a Biologics License Application (BLA) to the
U.S. Food and Drug Administration (FDA) on April 19, 2021 for the
use of balstilimab in patients with recurrent or metastatic
cervical cancer. This submission was based on data from a Phase 2
trial in patients with recurrent or metastatic cervical cancer.
These data show a response rate of 20% in PD-L1 positive tumors and
an overall response rate of 15%, with a median duration of response
of 15.4 months. Balstilimab shows responses across histology
subgroups and in populations of patients typically unresponsive to
commercially available therapies, such as patients with PD-L1
negative tumors.
Preclinical studies using Agenus’ proprietary R&D VISION
platform underscored these observed clinical data. VISION
demonstrates that balstilimab may be superior to currently approved
anti-PD-1 antibodies such as pembrolizumab and nivolumab.
Balstilimab showed superior tumor killing in both PD-L1 positive
and PD-L1 negative tumors compared to commercially available
anti-PD-1 antibodies in these studies.
“We are encouraged by the initial performance of our VISION
platform both for drug discovery and potential therapeutic
predictive modeling. It has the potential to bring effective
treatments to patients more rapidly,” said Steven O’Day, MD, Chief
Medical Officer of Agenus. “AGEN2373 continues to show no liver
toxicity in the clinic, and we expect the anticipated combination
trials to provide potential benefit to patients.”
AGEN2373 is a CD137 agonist antibody designed to overcome
limitations seen with first-generation CD137 agonist antibodies,
particularly the development of liver toxicity. In this
first-in-human study of AGEN2373 in patients with advanced solid
tumors, no dose limiting toxicities were seen at doses up to 3
mg/kg; notably, no liver toxicity has been observed well above the
threshold at which liver toxicity is usually seen with other CD-137
agonist antibodies. Five patients demonstrated stable disease out
of 22 patients treated with AGEN2373 monotherapy, with prolonged
stable disease observed in three of these patients. AGEN2373 is
expected to provide benefit especially in combination therapy, and
combination trials are in planning.
Presentation Details:
Abstract title: Differentiated activity profile
for the PD-1 inhibitor balstilimabAbstract number:
5529Poster Session: Gynecologic
CancerPresenting author: Cailin Joyce, PhD
Abstract title: Initial findings of the
first-in-human Phase I study of AGEN2373, a conditionally active
CD137 agonist antibody, in patients (pts) with advanced solid
tumorsAbstract number: 2634Poster
Session: Developmental
Therapeutics—ImmunotherapyPresenting author:
Anthony Tolcher, MD
About balstilimabBalstilimab is a novel, fully
human monoclonal immunoglobulin G4 (IgG4) designed to block PD-1
(programmed cell death protein 1) from interacting with its ligands
PD-L1 and PD-L2. PD-1 is a negative regulator of immune activation
that is considered a foundational target within the immuno-oncology
market. Balstilimab is currently in clinical trials as monotherapy
and in combination with Agenus’ anti-CTLA-4, zalifrelimab, in an
ongoing Phase 2 study for recurrent/metastatic cervical cancer. A
Biologics License Application has been submitted to the U.S. Food
and Drug Administration for the use of balstilimab to treat
recurrent/metastatic cervical cancer.
About AGEN2373AGEN2373 is a novel, fully human
monoclonal conditionally active CD137 agonist antibody designed to
selectively enhance CD137 co-stimulatory signaling in activated
immune cells while mitigating side effects associated with systemic
activation of CD137. CD137 (4-1BB) is a positive regulator of the
immune system that is highly upregulated on activated T cells
(adaptive immune cells) and NK cells (innate immune cells).
AGEN2373 is currently in a Phase 1 clinical trial against solid
tumors.
About VISIONVISION (VIrtual
Systems for
Immuno-ONcology) is an active
learning platform that mimics a patient's tumor microenvironment
and immune system in order to define predictive biomarker
signatures. VISION leverages advanced analytics to explore an
immense range of drug-biology interactions not possible via
traditional processes. Producing informative data feedback loops in
real-time, VISION enables quicker validation of drug targets,
faster optimized molecule design and drug candidate selection, and
personalized treatment regimens based on biomarker signatures.
About AgenusAgenus 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, adoptive cell
therapies (through its AgenTus Therapeutics subsidiary), and
proprietary cancer vaccine platforms. 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 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 StatementsThis press release
contains forward-looking statements that are made pursuant to the
safe harbor provisions of the federal securities laws, including
statements regarding potential therapeutic benefit and future
clinical development plans for balstilimab and AGEN2373 alone and
in combination with other agents. 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.
ContactAgenus Investor
RelationsJan Medina,
CFAAgenus781-674-4490Jan.Medina@agenusbio.com
Agenus Media RelationsKimberly HaKKH
Advisors917-291-5744kimberly.ha@kkhadvisors.com
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