LEXINGTON, Mass., Oct. 13, 2017 /PRNewswire/ -- Agenus Inc.
(NASDAQ: AGEN), an immuno-oncology company with a pipeline of
immune checkpoint antibodies and cancer vaccines, announced today
that Health Canada granted marketing authorization to
GlaxoSmithKline's (GSK) shingles vaccine, Shingrix, that contains
Agenus' proprietary immune adjuvant QS-21 Stimulon®
adjuvant. The approval in Canada
marks the first approval for Shingrix and the first approval of a
vaccine containing QS-21 Stimulon.
In September of this year, Shingrix, was unanimously recommended
for approval by the FDA Vaccines and Related Biological Products
Advisory Committee. A decision by FDA on whether to approve
Shingrix in the United States is
anticipated in the coming weeks.
QS-21 Stimulon is an immune-potent adjuvant designed to help the
body generate antibodies and T cells, which guard against infection
with viruses, parasites and bacteria. The approval of Shingrix in
Canada is based on efficacy data
collected in more than 37,000 people which demonstrated an efficacy
rate against shingles greater than 90%,and this is
independent from age (≥50 and ≥70 years of age), as well as a
sustained efficacy over the entire follow-up period. Most common
side effects reported in clinical trials were pain, redness and
swelling at the injection site and the majority of which were
transient and mild to moderate in intensity, lasting less than
three days.
"The approval of the Shingrix vaccine containing Agenus' QS-21
Stimulon is a major and most exciting development for the eligible
population for GSK, and for Agenus. This approval confirms our
belief that the addition of our proprietary immune adjuvant
improves vaccine effectiveness and, ultimately, brings benefit to
patients," said Garo Armen, Ph.D.,
Chairman and CEO, Agenus. "The Canadian approval marks the first of
further decisions on approvals for Shingrix. We look forward to the
FDA decision in the near future."
The addition of QS-21 Stimulon is being studied to determine its
potential to help a diverse range of vaccines work more effectively
to treat or cure difficult-to-treat diseases, like cancer. QS-21
Stimulon is currently being used in combination with Agenus'
neoantigen vaccine, AutoSynVax™, now in a Phase 1 clinical trial in
cancer.
QS-21 Stimulon is also currently being evaluated in numerous GSK
vaccine development candidates for both therapeutic and
prophylactic applications.
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 and further regulatory decisions
on approvals for Shingrix, as well as statements regarding Agenus'
product candidates and clinical trial plans and activities,
including the potential for QS-21 Stimulon to help a diverse range
of neoantigen vaccines work more effectively to potentially cure
difficult-to-treat diseases like cancer. 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
781-674-4420
Jennifer.Buell@agenusbio.com
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SOURCE Agenus Inc.