First Vaccine Candidate for Malaria is Accepted for EU Regulatory Review
July 24 2014 - 6:01AM
Business Wire
- GSK’s RTS,S is the world’s first
malaria vaccine candidate to undergo regulatory review
- Agenus’ QS-21 Stimulon® is a component
of RTS,S and in 16 additional vaccine candidates undergoing patient
studies
- Submission triggered regulatory
milestone payment; Agenus entitled to royalties on product
sales
Agenus Inc. (NASDAQ:AGEN), an immuno-oncology company developing
a portfolio of checkpoint modulators (CPMs), heat shock protein
peptide-based vaccines, and adjuvants, announced that
GlaxoSmithKline (NYSE: GSK) has submitted a regulatory application
for its malaria vaccine candidate, RTS,S, to the European Medicines
Agency (EMA), and it has been accepted for regulatory review. RTS,S
contains Agenus’ QS-21 Stimulon® adjuvant, which is part of GSK’s
AS01 proprietary adjuvant system. Adjuvants can enhance the immune
response when used in combination with antigens in vaccines.
“RTS,S has the potential to protect hundreds of thousands of
children against malaria in Sub-Saharan Africa each year and we are
proud to be part of this important program,” said Robert Stein,
Chief Scientific Officer of Agenus. “RTS,S represents real progress
in the decades of work to develop a malaria vaccine and we are
gratified that our adjuvant was a key component.”
Malaria claims over 600,000 lives a year, most of which are
children in Sub-Saharan Africa (SSA).1 Around 90 percent of
estimated deaths from malaria occur in SSA and 77 percent of these
are in children under the age of five. RTS,S is intended
exclusively for use against the Plasmodium falciparum malaria
parasite, which is most prevalent in SSA. To date, there is no
vaccine available for the prevention of malaria.
Agenus has received a milestone payment for the regulatory
submission of RTS,S, and is entitled to receive an additional
milestone payment upon approval as well as royalties on product
sales. QS-21 Stimulon is also being evaluated in 16 additional
vaccine candidates currently undergoing clinical study and is a
potential source of capital to help fund development of the
company’s checkpoint modulator product candidates.
The Phase 3 RTS,S vaccine program was conducted at 13 African
research centers in eight African countries (Burkina Faso, Gabon,
Ghana, Kenya, Malawi, Mozambique, Nigeria, and Tanzania) and
included over 16,000 infants and young children. These data have
been included to support the regulatory filing.
The EMA submission is the first step in the regulatory process
toward making the RTS,S vaccine candidate available as an addition
to existing tools currently recommended for malaria prevention. An
effective vaccine for use alongside other measures, such as bed
nets and anti-malarial medicines, would represent an advance in
malaria control.
If a positive opinion from the EMA is granted, the WHO indicated
that a policy recommendation may be possible by the end of 2015. A
policy recommendation is a formal review process by WHO designed to
assist in the development of optimal immunization schedules for
diseases that have a global public health impact, such as
malaria.2
A positive opinion from the EMA would also be the basis for
marketing authorization applications to National Regulatory
Authorities (NRAs) in SSA countries. A review by a European
medicines agency is required by the majority of African countries
prior to registration of a medicinal product manufactured in
Europe. If positive, these regulatory decisions would help pave the
way toward the large-scale implementation of the vaccine through
African national immunization programs.
Notes to Editors
About RTS,S
- RTS,S is the scientific name given to
this malaria vaccine candidate and reflects the composition of this
vaccine candidate that also contains the AS01 adjuvant
system.3
- RTS,S triggers the body’s immune system
to defend against the P falciparum malaria parasite when it first
enters the human host’s bloodstream and/or when the parasite
infects liver cells.
- The vaccine is designed to prevent the
parasite from infecting, maturing and multiplying in the liver,
after which time the parasite would re-enter the bloodstream and
infect red blood cells, leading to disease symptoms. In the Phase 3
efficacy trial, RTS,S was administered in three doses, one month
apart.
About QS-21 Stimulon
Agenus’ flagship adjuvant, QS-21Stimulon adjuvant, is a saponin
extracted from the bark of the Quillaja saponaria tree, also known
as the soap bark tree, an evergreen tree native to warm temperate
central Chile. Agenus’ QS-21 Stimulon has become a key component in
the development of investigational preventive vaccine formulations
across a wide variety of infectious diseases and in several
investigational therapeutic vaccines intended to treat cancer and
degenerative disorders. QS-21 Stimulon has been widely studied in
approximately 50,000 patients. Agenus is generally entitled to
receive milestone payments as QS-21 Stimulon containing programs
advance, as well as royalties for 10 years after commercial launch,
with some exceptions.
About Agenus
Agenus is an immuno-oncology company developing a portfolio of
checkpoint modulators (CPMs), heat shock protein vaccines and
adjuvants. Agenus’ checkpoint modulator programs target GITR, OX40,
CTLA-4, LAG-3, TIM-3 and PD-1. The company’s proprietary discovery
engine Retrocyte Display® is used to generate fully human
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’ heat shock protein vaccines for cancer and infectious
disease are in Phase 2 studies. The company’s QS-21 Stimulon®
adjuvant platform is extensively partnered with GlaxoSmithKline and
Janssen and includes several candidates in Phase 3 trials. For more
information, please visit www.agenusbio.com, or connect with the
company on Facebook, LinkedIn, Twitter and Google+.
1.
http://www.who.int/malaria/world_malaria_report_2011/en/index.html.2.
WHO policy recommendations overview found at:
http://www.who.int/immunization/policy/en/. Accessed May 2014.3.
The GSK proprietary AS01 adjuvant system contains QS-21 Stimulon®
adjuvant, MPL and liposomes.
Retrocyte Display and Stimulon are registered trademarks of
Agenus and its subsidiaries.
Forward-Looking Statement
This press release contains forward-looking statements,
including statements regarding potential regulatory activities and
timelines, the potential application product candidates containing
the Company’s QS-21 Stimulon Adjuvant in the prevention and
treatment of diseases, and revenue streams to Agenus in connection
therewith. 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
Quarterly Report on Form 10-Q filed with the Securities and
Exchange Commission for the period ended March 31, 2014. 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 document, and Agenus
undertakes no obligation to update or revise the statements. All
forward-looking statements are expressly qualified in their
entirety by this cautionary statement. Agenus’ business is subject
to substantial risks and uncertainties, including those identified
above. When evaluating Agenus’ business and securities, investors
should give careful consideration to these risks and
uncertainties.
Media and Investor:Jonae R. Barnes, 617-818-2985Vice
PresidentInvestor Relations and Corporate
Communicationsjonae.barnes@agenusbio.com
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