GSK’s older adult RSV vaccine candidate, containing Agenus’ QS-21 STIMULON™, shows 94.1% reduction in severe RSV disease and overall vaccine efficacy of 82.6% in pivotal trial
October 13 2022 - 7:32AM
Agenus Inc. (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 GSK
has disclosed positive pivotal phase III trial results for its
respiratory syncytial virus (RSV) vaccine candidate for adults aged
60 years and above and plans to present full data at ID Week on
October 20th. The vaccine candidate was highly efficacious,
demonstrating overall vaccine efficacy of 82.6% (96.95% CI,
57.9–94.1) against RSV lower respiratory tract disease (RSV-LRTD),
meeting the trial’s primary endpoint.
Consistent high vaccine efficacy was also observed across a
range of pre-specified secondary endpoints, highlighting the impact
the vaccine could have on the populations most at risk of the
severe adverse outcomes of RSV. Efficacy against severe RSV-LRTD,
defined as LRTD with at least two lower respiratory signs or
assessed as severe by the investigator and confirmed by the
external adjudication committee, was 94.1% (95% CI, 62.4–99.9),
while efficacy against RSV-LRTD in participants with pre-existing
comorbidities and adults aged 70-79 years was 94.6% (95% CI,
65.9–99.9) and 93.8% (95% CI, 60.2-99.9), respectively.
Vaccine efficacy against LRTD was consistent across both RSV-A
and RSV-B subtypes, consistent with the robust neutralizing
antibody response generated against both subtypes. The
vaccine was well tolerated with a favorable safety profile.
“These are exceptional results, particularly for high-risk
populations such as older adults and those with pre-existing
co-morbidities. The effectiveness and durability of vaccines
containing QS-21 STIMULON has been demonstrated in Shingrix, with
best-in-class protection exceeding 9 years,” said Dr. Garo H.
Armen, Chief Executive Officer of Agenus Inc. “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.”
QS-21 STIMULON is a key component of GSK’s AS01 adjuvant derived
from saponin extracts. It is approved for use in both GSK’s
shingles vaccine, Shingrix1, and malaria vaccine, Mosquirix,1 which
have generated significant immune responses and a favorable safety
profile. Vaccine adjuvants may play an important role in vaccine
supply in the future, as they can improve antigen stability and
increase immunogenicity in populations with lower levels of natural
immunity.
Agenus’ subsidiary, SaponiQx, was formed in 2021 to pursue
scalable, sustainable, and cost-effective production of adjuvants,
including saponins. The company expects to be able to supply its
first GMP material by the end of 2022. 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 GSK vaccines Shingrix and
Mosquirix and GSK RSV older adult vaccine candidate 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 infectious
disease; 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 Officer
339.927.1763
ethan.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.
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