Agenus Submits Balstilimab Biologics License Application to the U.S. FDA for Patients with Recurrent or Metastatic Cervical C...
April 19 2021 - 8:30AM
Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an
extensive pipeline of agents which includes checkpoint antibodies,
cell therapies, adjuvants, and vaccines designed to activate immune
response to cancers and infections, today announced the submission
of a Biologics License Application (BLA) to the U.S. Food and Drug
Administration (FDA). The BLA has been submitted for the
accelerated approval of balstilimab, Agenus’ anti-PD-1 antibody,
for the treatment of patients with recurrent or metastatic cervical
cancer with disease progression on or after chemotherapy, and
includes data from its pivotal Phase 2 single-arm clinical trial,
presented at the European Society for Medical Oncology (ESMO)
Virtual Congress 2020. These clinical data, along with preclinical
data, suggest that balstilimab demonstrates differentiated features
from other anti-PD-1 antibodies.
“Women with recurrent or metastatic cervical cancer have a very
poor prognosis and limited treatment options. Data suggest
balstilimab may bring benefit to patients beyond what is available
in this disease setting today,” said Jennifer Buell, PhD, President
and Chief Operating Officer at Agenus. “This submission also marks
a significant step in our transition to a commercial company and
the advancement of our oncology combination strategy.”
The balstilimab BLA submission is based on an update to data
presented at the ESMO Virtual Congress 2020 and published in an
Oncogene editorial, which demonstrate that balstilimab shows
potential differentiation from other anti-PD-1 antibodies. This
updated dataset includes maturation of late patient responses, with
the overall data showing response rates of 20% in PD-L1 positive
tumors, 15% in all tumors (PD-L1 positive and negative), and a
median duration of response of 15.4 months.
“We expect that the potential approval of balstilimab will
enable us to better pursue our oncology combination strategy for
our own extensive pipeline of agents as well as for existing and
future partner products,” said Steven O’Day, MD, Chief Medical
Officer at Agenus. “In particular, we hope to use this potential
approval to allow us to rapidly proceed with our anti-CTLA-4
combination strategy, which we believe can add significantly to the
benefit provided by our anti-PD-1 agent. There are currently
limited treatment options available for recurrent or metastatic
cervical cancer patients, and our vision is to bring effective
treatments to these patients.”
In April 2020, the FDA granted Fast Track designation for
balstilimab in recurrent or metastatic cervical cancer based on its
potential to provide benefit to patients with a serious condition
and unmet medical need.
A global, randomized, Phase 3 confirmatory clinical trial
designed to support global registration is planned.
About Cervical CancerNearly 14,000 women are
expected to be diagnosed with invasive cervical cancer in the
United States this year and more than 4,000 are expected to die.
Cervical cancer remains one of the leading causes of cancer death
in women globally, annually killing more than 300,000 women
worldwide.1 Despite advances in routine medical examinations and
HPV vaccines, cervical cancer remains prevalent. When left
undetected, recurrent or metastatic cervical cancer often develops,
for which there are limited treatment options and a low chance of
survival. Current therapies for recurrent or metastatic cervical
cancer are limited to a small subset of patients with limited
benefit.
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.
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 future clinical trials, potential clinical
benefit of our products, and future product development plans for
balstilimab 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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1
https://acsjournals.onlinelibrary.wiley.com/doi/10.3322/caac.21660
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