LEXINGTON, Mass., Oct. 20, 2017 /PRNewswire/ -- Agenus Inc.
(NASDAQ: AGEN), an immuno-oncology company with a pipeline of
immune checkpoint antibodies and cancer vaccines, announced today
that the US Food and Drug Administration (FDA) granted marketing
authorization to GlaxoSmithKline's (GSK) herpes zoster vaccine,
SHINGRIX, containing Agenus' proprietary immune adjuvant QS-21
Stimulon®. SHINGRIX is indicated for prevention of herpes zoster
(also known as shingles) in adults aged 50 years and older. The
addition of QS-21 Stimulon helps improve the vaccine's
effectiveness by boosting immune response in older adults who often
experience age-related decline in immunity.
Shingles is a major public health issue in the US, impacting as
many as 1 in 3 older adults over the age of 50 years. Shingles is
caused by a virus called varicella zoster, which is also known as
the chicken pox virus. Nearly all older adults have the varicella
zoster virus dormant in their nervous system waiting to reactivate
with advancing age and weakened immune systems.
QS-21 Stimulon is an immune-potent adjuvant designed to boost
the immune system by helping the body generate antibodies and T
cells that guard against infection. The addition of QS-21 Stimulon
to the SHINGRIX vaccine enhances the immune response in these older
adults.
"We are delighted by the remarkable efficacy of SHINGRIX,
containing our proprietary QS-21 Stimulon adjuvant and the public
health benefit; this FDA approval marks a significant milestone for
Agenus," said Garo Armen, Ph.D.,
Chairman and CEO, Agenus. "The addition of QS-21 Stimulon enhances
the immunogenicity of SHINGRIX and is beneficial in an older adult
population who often experience a decline in immunity. Beyond
shingles, our QS-21 Stimulon is under investigation in numerous
vaccines and is a critical component of our neoantigen vaccine
formulation, which is currently advancing in a Phase 1 clinical
trial in patients with cancer."
The FDA approval of SHINGRIX was based on data pooled from two
pivotal Phase III clinical trials in more than 37,000 people, which
demonstrated an efficacy rate against shingles greater than 90%
independent of age, as well as a sustained efficacy over the
four-year follow-up period. SHINGRIX also reduced the overall
incidence of postherpetic neuralgia (PHN), the most common and
oftentimes debilitating chronic nerve pain associated with
shingles. The benefit of SHINGRIX in the prevention of PHN can be
attributed to the effect of the vaccine on the prevention of
shingles. The most common side effects reported in clinical
trials of SHINGRIX were pain, redness and swelling at the injection
site, the majority of which were transient and mild to moderate in
intensity, lasting less than three days.
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 GSK's 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