GSK’s Malaria Vaccine Phase 3 Study Containing Agenus’ QS-21 Published in The Lancet
April 24 2015 - 7:00AM
Business Wire
- Final study results show significant
reduction in malaria cases
- EMA currently reviewing the
regulatory application
Agenus Inc. (NASDAQ: AGEN), an immunology company developing
innovative treatments for cancers and other diseases, announced
today that final results from a large-scale Phase 3 study of
GlaxoSmithKline’s (NYSE: GSK) malaria vaccine candidate, RTS,S,
were published in The Lancet. The study demonstrated a
statistically significant reduction against malaria in children who
received RTS,S followed by a booster shot of the vaccine at 18
months. RTS,S incorporates QS-21 Stimulon®, Agenus’ adjuvant
designed to increase the immune response to antigens in
vaccines.
The study results also showed:
- RTS,S reduced the number of cases of
clinical malaria in young children (aged 5-17 months at first
vaccination) by 36%, and in infants (aged 6-12 weeks) by 26% over
an average follow-up period of 48 months.
- This resulted in an average reduction
of 1,774 cases of clinical malaria for every 1,000 children
vaccinated (aged 5-17 months), and an average reduction of 983
cases of clinical malaria for every 1,000 infants vaccinated over
an average 36-month follow-up. Children receiving the vaccine
candidate but not a booster dose had lower rates of protection. The
study showed that RTS,S averted even more cases of malaria in areas
with higher transmission rates.
“We’re proud to be a part of this malaria vaccine initiative,
which has the potential to save tens of thousands of lives each
year,” said Garo Armen, Ph.D., Chairman and CEO of Agenus. “These
compelling results demonstrate for the first time that a vaccine
and adjuvant can significantly reduce suffering by young children
in areas hardest hit by malaria. We look forward to RTS,S
potentially achieving regulatory approval and being made available
to the millions of children who are at risk of severe malaria in
sub-Saharan African countries.”
Agenus is eligible for a milestone payment upon approval of
RTS,S and royalties from potential commercial sales. QS-21 Stimulon
is being evaluated in more than 12 additional vaccine
candidates.
RTS,S trial data were submitted to the European Medicines Agency
(EMA) in June 2014 for review by their Committee for Medicinal
Products for Human Use (CHMP). A positive opinion from the CHMP,
together with a potential policy recommendation from the World
Health Organization (anticipated by the end of 2015), would be the
basis for licensure applications to the National Regulatory
Authorities (NRAs) in sub-Saharan African countries.
Eleven research centers in seven African countries conducted the
trial, in partnership with GSK and the Path Malaria Vaccine
Initiative (MVI), with grant funding from the Bill & Melinda
Gates Foundation to MVI. The trial, launched in 2009 and concluded
in January 2014, enrolled 15,459 young child (5-17 months) and
infant (6-12 weeks) participants.
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 AgenusAgenus 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 StatementThis 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 regulatory approval of GSK’s
malaria vaccine candidate, RTS,S, the potential for RTS,S to save
lives each year, potential commercial sales of RTS,S and the
potential for Agenus to receive milestone and royalty payments for
product candidates containing Agenus’s 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.
For AgenusMediaBMC CommunicationsBrad Miles,
646-513-3125bmiles@bmccommunications.comorInvestorsArgot
PartnersAndrea Rabney/Jamie Maarten,
212-600-1902andrea@argotpartners.comjamie@argotpartners.com
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