LEXINGTON, Mass., Sept. 13, 2017 /PRNewswire/ -- Agenus Inc.
(NASDAQ: AGEN), an immuno-oncology company with a pipeline of
immune checkpoint antibodies and cancer vaccines, announced today
that GlaxoSmithKline's (GSK) shingles vaccine candidate, Shingrix,
containing Agenus' proprietary immune adjuvant, QS-21 Stimulon®,
was unanimously recommended for approval by the U.S. Food and Drug
Administration's (FDA) Vaccines and Related Biological Products
Advisory Committee.
"The Advisory Committee's recommendation for the approval of
Shingrix marks the first for a product that includes Agenus'
proprietary immune adjuvant, QS-21 Stimulon, and serves as a
significant validation," said Garo
Armen, Ph.D., Agenus CEO and Chairman of the Board. "In
addition to being studied in diverse development stage vaccines,
QS-21 Stimulon is also a critical component of our neoantigen
vaccine formulations. We believe QS-21 provides Agenus with a
competitive advantage due to its demonstrated ability to bolster
immunogenicity in diverse vaccine formulations offering potential
benefit to patients."
A Biologics License Applications (BLA) filed with the FDA by GSK
for Shingrix for the prevention of herpes zoster (also known as
shingles) in people aged 50 years and older is under regulatory
review. The FDA will consider the Advisory Committee vote as it
reviews the BLA, although it is not required to follow the
recommendation.
GSK's shingles vaccine candidate is not currently approved for
use anywhere in the world. Regulatory filings in the European
Union, Canada, Australia and Japan are underway
QS-21 Stimulon is being evaluated in various GSK development
candidates in addition to being studied in Agenus' neoantigen
vaccine, AutoSynVax™, now 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 a number of combination approaches that leverage a broad
repertoire of antibody therapeutics 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 early phase clinical
programs. Agenus is headquartered in Lexington, MA. For more
information, please visit www.agenusbio.com; information that may
be important to investors will be routinely posted on our
website.
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 FDA's pending review of GSK's BLA for
Shingrix, as well as statements regarding Agenus' product
candidates and clinical trial plans and activities. 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.
Michael
Plater
781-674-4504
michael.plater@agenusbio.com
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SOURCE Agenus Inc.