LEXINGTON, Mass., Oct. 25, 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 Centers for Disease Control and Prevention's (CDC)
Advisory Committee on Immunization Practices (ACIP) voted in favor
of three recommendations for the use of Shingrix (Zoster Vaccine
Recombinant, Adjuvanted) containing QS-21 Stimulon® for the
prevention of shingles (herpes zoster):
- Herpes Zoster subunit vaccine (Shingrix) is recommended for the
prevention of herpes zoster and related complications for
immunocompetent adults age 50 year and older.
- Herpes Zoster subunit vaccine (Shingrix) is recommended for the
prevention of herpes zoster and related complication for
immunocompetent adults who previously received Zoster
Vaccine Live (Zostavax).
- Herpes Zoster subunit vaccine (Shingrix) is
preferred over Zoster Vaccine Live (Zostavax) for the
prevention of herpes zoster and related complications.
"The Advisory Committee's vote to recommend Shingrix enhanced
with QS-21 Stimulon on three different counts further confirms our
belief in the vaccine's efficacy and its potential to extend
immunization for up to 62 million adults in the United States," remarked Garo Armen, Ph.D., Chairman and CEO, Agenus.
"Today's vote confirms the importance of ensuring that millions of
at-risk adults are protected against shingles with Shingrix."
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
enhances the immunogenicity of Shingrix by boosting immune
response, which is critically important for older adults, the
population most vulnerable to shingles and the painful and often
debilitating consequences of the virus.
Shingrix was approved by the US Food and Drug Administration
(FDA) on October 20, 2017 for use in
adults aged 50 years and older. Data from studies of people
vaccinated with Shingrix, who were previously vaccinated with
Zostavax, have been presented previously to the ACIP and have been
published in peer-reviewed journals, but have not yet been reviewed
by the
FDA.[i],[ii]
The most common side effects of Shingrix are pain, redness, and
swelling at the injection site, muscle pain, tiredness, headache,
shivering, fever, and upset stomach, which are related to the
immune system responding to the vaccine. Based on available data,
the majority of reactions to the vaccine were transient and mild to
moderate in intensity, lasting less than three days.
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.
The ACIP recommendations will be forwarded to the director of
the CDC and the US Department of Health and Human Services for
review and approval. Once approved, the final recommendations will
be published in a future Morbidity and Mortality Weekly Report
(MMWR).
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 potential for
Shingrix to extend immunization for up to 62 million adults in
the United States. 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
i
https://www.cdc.gov/vaccines/acip/meetings/downloads/slides-2017-06/zoster-03-colindres.pdf
ii
https://academic.oup.com/jid/article/doi/10.1093/infdis/jix482/4209275/Immunogenicity-and-Safety-of-the-HZ-su-Adjuvanted
View original content with
multimedia:http://www.prnewswire.com/news-releases/shingrix-with-qs-21-stimulon-receives-positive-recommendation-from-cdcs-advisory-committee-on-immunization-practices-as-preferred-vaccine-for-prevention-of-shingles-300543490.html
SOURCE Agenus Inc.