Full Press Release Details
Vaccine Candidate for Malaria is Accepted for EU Regulatory Review
RTS,S is the world's first malaria vaccine candidate to undergo
a component of RTS,S and in 16 additional vaccine candidates
undergoing patient studies
triggered regulatory milestone payment; Agenus entitled to royalties
LEXINGTON, Mass.--(BUSINESS WIRE)--July 24, 2014--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
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
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.
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.
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+.
WHO policy recommendations overview found at: http://www.who.int/immunization/policy/en/.
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
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