NEJM Publishes Study Showing GSK’s Shingles Vaccine Containing Agenus’ QS-21 Stimulon® Adjuvant Provides over 97% Protec...
April 28 2015 - 7:00AM
Business Wire
- Data simultaneously presented at
ECCMID
- HZ/su vaccine achieves nearly 98%
protection in people 70 or older
- This marks the second successful Phase
3 clinical program incorporating Agenus’ QS-21 Stimulon
adjuvant
Agenus Inc. (NASDAQ: AGEN), an immunology company developing
innovative treatments for cancers and other diseases, announced
today that primary and secondary endpoint data from
GlaxoSmithKline’s (LSE/NYSE: GSK) randomized Phase 3 trial of
HZ/su, a vaccine candidate for the prevention of shingles, was
simultaneously presented at the 25th Scientific Conference of the
European Society of Clinical Microbiology and Infectious Disease
(ECCMID) in Copenhagen, and published in the New England Journal of
Medicine. GSK’s HZ/su incorporates Agenus' QS-21 Stimulon®
adjuvant, which is designed to increase immune response to
antigens.
The data show that GSK’s HZ/su reduced the risk of shingles
(herpes zoster) by 97.2% in adults aged 50 and older, compared to
placebo. Importantly, the protection was maintained across all
studied age groups, ranging from 96.6% in subjects aged 50-59,
97.4% in those aged 60-69, and 97.9% in those aged 70 or older. No
major safety concerns were identified in the study. The most common
reported adverse event was pain at injection site, fatigue and
myalgia.
“The vast majority of adults over age 50 are at high risk of
reactivating the varicella zoster virus, which leads to shingles
and its painful and debilitating symptoms. These clinical results
point to the broad benefits that widespread use of this vaccine
could bring to adults over 50 worldwide,” said Garo Armen, Ph.D.,
Chairman and CEO of Agenus. “These data, and those from GSK’s RTS,S
malaria vaccine now undergoing regulatory review by the EMA,
highlight the importance and value that we believe QS-21 Stimulon
brings to vaccines and to Agenus.”
The HZ/su vaccine candidate combines gE, a protein that is part
of the virus that causes shingles, with the AS01 adjuvant system,
which enhances the immune response to gE. The AS01 adjuvant system
contains Agenus’ QS-21 Stimulon, MPL (3-O-desacyl-4’-monophosphoryl
lipid A) and liposomes.
Agenus is eligible to receive a milestone payment upon GSK’s
first approval of a QS-21 Stimulon-containing product and royalties
from any potential commercial product sales of HZ/su. QS-21
Stimulon is being evaluated in more than 12 additional vaccine
candidates.
The HZ/su shingles study is a randomized, observer-blind,
placebo-controlled Phase 3 trial involving over 16,000 adults aged
50 years and older. The study started in August 2010 and is still
ongoing. In addition to older adults, HZ/su is being evaluated in
immunocompromised patient populations, including solid and
hematological cancer patients, hematopoietic stem cell and renal
transplant recipients and HIV-infected people.
About Shingles
Shingles typically presents as a painful, itchy rash that
develops on one side of the body, as a result of reactivation of
latent chickenpox virus (varicella zoster virus, VZV).
Complications from shingles can include chronic pain, scarring,
vision complications, secondary infection, nerve palsies and
hospitalization. A person’s risk for shingles increases sharply
after 50 years of age. The individual lifetime risk of developing
shingles is approximately one in three people; however, for
individuals aged 85 and over, this risk increases to one in two
people.i
About QS-21 Stimulon®
QS-21 Stimulon is a saponin extracted from the bark of the
Quillaja saponaria tree, an evergreen also known as the soap bark
tree. The adjuvant is a key component of investigational vaccines
to prevent a wide variety of infectious diseases, and therapeutic
vaccines for cancer and degenerative disorders. QS-21 Stimulon has
been evaluated in approximately 50,000 patients. Agenus is
generally entitled to receive milestone payments as QS-21 Stimulon
containing programs advance, as well as royalties on potential
commercial sales for 10 years after commercial launch, if ever,
with some exceptions.
About Agenus
Agenus is an immunology company developing a series of
Checkpoint Modulators for the treatment of patients with cancer,
infectious diseases, and other immune disorders, heat shock protein
(HSP)-based vaccines, and immune adjuvants. These programs are
supported by three separate technology platforms. Agenus’ internal
and partnered checkpoint modulator programs target GITR, OX40,
CTLA-4, LAG-3, TIM-3, PD-1 and other undisclosed programs. The
company’s proprietary discovery engine Retrocyte DisplayTM is used
to generate fully human and humanized therapeutic antibody drug
candidates. The Retrocyte Display platform uses a high-throughput
approach incorporating IgG format human antibody libraries
expressed in mammalian B-lineage cells. Agenus recently acquired a
powerful yeast antibody display platform termed SECANT, developed
by Celexion, LLC. SECANT allows rapid generation of soluble,
full-length human antibodies. SECANT and Agenus’ mammalian antibody
display platform have complementary strengths and further bolster
Agenus' abilities to generate and optimize fully human monoclonal
antibodies. Agenus’ heat shock protein-based vaccines have
completed Phase 2 studies in newly diagnosed glioblastoma
multiforme, and in the treatment of herpes simplex viral infection;
the heat shock protein-based vaccine platform can generate
personalized as well as off the shelf products. The company’s QS-21
Stimulon® adjuvant platform is extensively partnered with
GlaxoSmithKline and with Janssen Sciences Ireland UC and includes
several candidates in Phase 2 trials, as well as shingles and
malaria vaccines which have successfully completed Phase 3 clinical
trials. For more information, please visit www.agenusbio.com, or
connect with the company on Facebook, LinkedIn, Twitter and
Google+; information that may be important to investors will be
routinely posted in these locations.
Forward-Looking Statement
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
therapeutic benefit of GSK’s singles vaccine candidate HZ/su in
adults over the age of 50 worldwide, potential commercial sales of
HZ/su and the potential for Agenus to receive milestone and royalty
payments for product candidates containing Agenus’ QS-21 Stimulon
generally. 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.
i S. Pinchinat et al: Similar herpes zoster incidence across
Europe: results from a systematic literature review. BMC Infectious
Diseases 2013, 13:170
MediaBMC CommunicationsBrad Miles,
646-513-3125bmiles@bmccommunications.comorInvestorsArgot
PartnersAndrea Rabney/Jamie Maarten,
212-600-1902andrea@argotpartners.comjamie@argotpartners.com
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