Completion of Balstilimab BLA Filing Extended To 1H2021
December 03 2020 - 7:45AM
Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a broad
pipeline which includes checkpoint antibodies, cell therapies,
adjuvants, and vaccines designed to activate immune response to
cancers and infections, today announced updated timing of the
balstilimab BLA filing to meet the FDA feedback to follow all
patients for a median of 12 months and responders for a minimum of
6 months. Due to two newly-identified late responses in the trial,
the completion of the BLA filing is planned for the first half of
2021. In parallel, Agenus is working with the FDA to clarify
diagnostic requirements for PD-L1 testing.
The additional follow-up is required to present data on two
patients who experienced durable disease stabilization and
converted to confirmed responses on long-term balstilimab
therapy.
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 regulatory timelines for the BLA filings of
balstilimab alone and in combination with zalifrelimab. 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. Caroline
Bafundo212-994-8209Caroline.Bafundo@agenusbio.com
Agenus (NASDAQ:AGEN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Agenus (NASDAQ:AGEN)
Historical Stock Chart
From Apr 2023 to Apr 2024