GSK’s RSV vaccine candidate for older adults, containing Agenus’ QS-21 STIMULON™ as part of GSK’s AS01 adjuvant, reports positive pivotal data supporting initiation of global regulatory submissions
June 10 2022 - 8:00AM
Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive
pipeline of therapies and adjuvants designed to activate the immune
response to cancer and infections, today shared that partner GSK
announced positive headline results from a pre-specified efficacy
interim analysis of the AReSVi 006 phase III trial evaluating their
investigational RSV vaccine in adults aged 60 years and above. The
primary endpoint was exceeded with no unexpected safety concerns
observed. Engagement with regulators is planned to start
immediately with anticipated regulatory submissions in H2 2022.
“The need for vaccines offering long-lasting efficacy and
scalable production processes has been amplified by the current
pandemic. The effectiveness and durability of vaccines containing
QS-21 STIMULON has been demonstrated in Shingrix, with
best-in-class protection exceeding 9 years. Our subsidiary,
SaponiQx, is developing a proprietary plant cell culture
manufacturing process designed to enable broader use of QS-21
STIMULON through a sustainable, eco-friendly production method
scalable to address pandemic and other vaccine needs,” said Dr.
Garo H. Armen, Chief Executive Officer of Agenus Inc.
GSK’s RSV vaccine candidate contains Agenus’ proprietary QS-21
STIMULON within its AS01 adjuvant, which – in the context of other
antigens – has already demonstrated positive immune responses as
well as a favorable safety profile. QS-21 STIMULON is a critical
component of the AS01 adjuvant used in multiple GSK vaccines,
including GSK’s FDA approved Shingrix shingles vaccine, and the
world’s first malaria vaccine Mosquirix, endorsed by the
WHO.1,2
Agenus’ subsidiary, SaponiQx, has developed a plant cell culture
method of manufacturing QS-21 STIMULON, which is designed to
support its broader use based on sustainable, scalable, and
cost-effective supply. SaponiQx expects to generate GMP material
using this process before the end of the year to enable partner
clinical trials. Once SaponiQx’s plant cell culture process is
fully scaled, Agenus’ wholly-owned manufacturing campus is designed
to support the capacity for broad use across disease settings, as
well as scalability to address future pandemic threats.
About Agenus
Agenus is a clinical-stage immuno-oncology company focused on
the discovery and development of therapies that engage the body's
immune system to fight cancer and infections. The Company's vision
is to expand the patient populations benefiting from cancer
immunotherapy by pursuing combination approaches that leverage a
broad repertoire of antibody therapeutics, adoptive cell therapies
(through its subsidiary MiNK Therapeutics), and adjuvants (through
its subsidiary SaponiQx). The Company is equipped with a suite of
antibody discovery platforms and a state-of-the-art GMP
manufacturing facility with the capacity to support clinical
programs. Agenus is headquartered in Lexington, MA. For more
information, please visit www.agenusbio.com and our Twitter handle
@agenus_bio. Information that may be important to investors will be
routinely posted on our website and Twitter.
Statement Regarding 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 QS-21 STIMULON
adjuvant, alone and formulated in vaccines and vaccine candidates
such as GSK’s RSV vaccine candidate, Shingrix and Mosquirix, for
instance, statements regarding vaccine efficacy, safety, mechanism
of action and durability; clinical development and regulatory plans
and timelines; current and future manufacturing capabilities,
including our ability to scale-up manufacturing and to manufacture
in a consistent, sustainable, eco-friendly, and cost effective
manner; the ability of QS-21 STIMULON adjuvant to be used in
effective and safe vaccines for the prevention and/or treatment of
Covid-19 and other infectious disease; anticipated corporate
milestones, including our ability to partner, license and/or
otherwise monetize the QS-21 STIMULON adjuvant; and any other
statements containing the words "may," "believes," "expects," "is
designed to,” "estimates," "will," “establish,” “validated,” “best
in class,” and similar expressions are intended to identify
forward-looking statements. 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 further information, please contact
Agenus Inc.Ethan Lovell
Chief External Affairs & Communications
Officer339.927.1763ethan.lovell@agenusbio.com
___________________________1 Shingrix and Mosquirix trade marks
are owned by or licensed to the GSK group of companies. QS-21
STIMULON trade mark is owned by Agenus,
Inc.2 https://www.who.int/news/item/06-10-2021-who-recommends-groundbreaking-malaria-vaccine-for-children-at-risk
Agenus (NASDAQ:AGEN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Agenus (NASDAQ:AGEN)
Historical Stock Chart
From Sep 2023 to Sep 2024