GSK’s Malaria Vaccine Containing Agenus’ QS-21 Stimulon® Receives Positive Opinion from European Regulators for Preventi...
July 24 2015 - 1:08AM
Business Wire
Agenus Inc. (NASDAQ:AGEN), an immunology company discovering and
developing innovative treatments for cancers and other diseases,
today announced that GlaxoSmithKline (NYSE: GSK) received a
positive opinion for its Malaria vaccine candidate from the
Committee for Medicinal Products for Human Use (CHMP) of the
European Medicines Agency (EMA). The vaccine candidate, named
Mosquirix™ (RTS,S) is the first QS-21 Stimulon containing product
to receive a positive regulatory decision. Agenus’ adjuvant QS-21
is designed to increase immune response to antigens in vaccines.
The positive opinion signals that Mosquirix meets the necessary
quality, safety and efficacy requirements according to EU
standards.
“This is a significant milestone for the field of Malaria
and our QS-21 Stimulon, which is an integral component of the
adjuvant contained in Mosquirix, the first malaria candidate
vaccine to generate positive Phase 3 data, now awaiting the World
Health Organization’s recommendations and approvals by African
Health authorities,” commented Garo Armen, Ph.D., Chairman and CEO
of Agenus. “We look forward to seeing Mosquirix achieve the
required final clearances so it can begin benefiting children at
risk of contracting and dying from Malaria.”
The CHMP scientific opinion is a key step in the regulatory
process toward making a vaccine against Malaria available. The
positive opinion follows review by the CHMP of the candidate
vaccine’s safety, efficacy and quality. Clinical data supporting
the filing were mainly from a Phase 3 clinical program involving
more than 16,000 infants and young children.
Following the CHMP positive opinion, two of the World Health
Organization’s (WHO) independent advisory groups, the Strategic
Advisory Group of Experts (SAGE) on Immunization and the Malaria
Policy Advisory Committee (MPAC), will now jointly review the
evidence base for the vaccine candidate and make a joint policy
recommendation for how the vaccine should be used in the event that
it ultimately is approved by the national regulatory authorities in
the sub-Saharan African countries for which the vaccine is
intended. The WHO has indicated that such a policy recommendation
may be possible by end of this year.
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 individuals and patients.
Agenus is entitled to receive a modest milestone payment upon
approval of the first licensed product with GSK, as well as low
single digit royalties on potential commercial sales for 10 years
after commercial launch, with some exceptions.
About Agenus
Agenus is an immunology company engaged in the discovery and
development of novel checkpoint modulators, vaccines and adjuvants
to treat cancer and other diseases. Using its proprietary platforms
Retrocyte Display™ and SECANT®, the Company is discovering and
developing novel antibodies to target GITR, OX40, CTLA-4, LAG-3,
TIM-3, PD-1 and other undisclosed checkpoints in partnered and
internal programs. Agenus’ heat shock protein vaccine, Prophage,
has successfully completed Phase 2 studies in newly diagnosed
glioblastoma multiforme. The Company’s QS-21 Stimulon® adjuvant is
extensively partnered with GlaxoSmithKline and Janssen Sciences
Ireland UC, and two vaccine candidates containing QS-21 have
successfully completed Phase 3 trials. For more information, please
visit www.agenusbio.com, or follow the company on Twitter
@Agenus_Bio; information that may be important to investors will be
routinely posted in these locations.
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 expected
benefit from GSK’s Mosquirix™ vaccine, the potential milestone and
royalties payable to Agenus and the Company’s potential to create
best-in-class combination therapies for treating patients with
cancer. 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 Agenus’ Prospectus
Supplement filed with the Securities and Exchange Commission on May
21, 2015. 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20150723006695/en/
Media:BMC CommunicationsBrad Miles,
646-513-3125bmiles@bmccommunications.comorInvestors:Argot
PartnersAndrea Rabney, 212-600-1902andrea@argotpartners.comorJamie
Maarten, 212-600-1902jamie@argotpartners.com
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