Positive Outcome of Phase 3 Study of GSK Shingles Vaccine Containing Agenus Adjuvant
December 18 2014 - 7:00AM
- GSK's ZOE-50 Phase 3 study meets primary endpoint of reducing
the risk of shingles in people aged 50 and older
- Agenus is entitled to receive royalties on potential commercial
sales of HZ/su
Agenus Inc. (Nasdaq:AGEN), an immuno-oncology company developing a
broad portfolio of checkpoint modulators (CPMs) and heat shock
protein peptide-based vaccines as well as adjuvants, announced that
its partner GlaxoSmithKline (NYSE:GSK) reported that the ZOE-50
Phase 3 study met its primary endpoint. Analysis of the primary
endpoint showed that HZ/su reduced the risk of shingles by 97.2 per
cent in adults aged 50 years and older compared to placebo.
HZ/su is a novel candidate vaccine that combines gE, a protein
found on the varicella-zoster virus that causes shingles, with
GSK's Adjuvant System, AS01B, which serves to stimulate a stronger
immunological response to the vaccine. Agenus' QS-21 Stimulon®
adjuvant is one of the key components of AS01, which is used in
other vaccine candidates undergoing clinical development.
Agenus is entitled to receive royalties on potential commercial
sales of HZ/su.
"We are thrilled with the results of this important study," said
Garo Armen, Ph.D., Chief Executive Officer of Agenus, "The results
indicate unprecedented protection against shingles. HZ/su is
the second candidate vaccine containing QS-21 saponin to produce
positive phase 3 results."
The study, which started in August 2010, is a randomized,
placebo-controlled, multicenter, international study involving
16,136 adults aged 50 and older. An additional GSK trial to
evaluate the ability of HZ/su to prevent shingles is underway in
adults aged 70 and older (ZOE-70). This study will provide
additional information on the efficacy of HZ/su vaccine candidate
in preventing some of the complications of shingles, the most
common being chronic neuropathic pain, also known as post-herpetic
neuralgia (PHN)i.
Data from GSK's ZOE-50 study are expected to be presented at a
forthcoming scientific conference and will be submitted for
publication in a peer-reviewed journal.
About shingles
Shingles typically presents as a painful, itchy rash that
develops on one side of the body, as a result of reactivation of
latent chickenpox virus (varicella-zoster virus, VZV).
Complications from shingles can include scarring, vision
complications, secondary infection, nerve palsies and PHN, the most
common complication. The lifetime risk of developing shingles is
approximately 1 in 3.
About QS-21 Stimulon
Agenus' flagship adjuvant, QS-21 Stimulon® 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 people. 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 peptide-based
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 and humanized 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 vaccine candidates
in Phase 2 and Phase 3 clinical trials. For more information,
please visit www.agenusbio.com, or connect with the company on
Facebook, LinkedIn, Twitter and Google+.
Forward-Looking Statement
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the federal
securities laws, including statements regarding research and
development and clinical trial activities and results, the
presentation and publication of data, potential revenue streams,
and the potential application of the Company's and its licensee's
technologies and product candidates in the prevention and treatment
of diseases. These forward-looking statements are subject to risks
and uncertainties that could cause actual results to differ
materially from those projected. These risks and uncertainties
include, among others, the factors described under the Risk Factors
section of our most recently filed Quarterly Report on Form 10-Q
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 document, 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.
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.
Agenus includes its affiliates for purposes of this press
release. Retrocyte Display and Stimulon are registered trademarks
of Agenus Inc. and its subsidiaries.
i Johnson, RW et al N Engl J Med 2014;371:1526-33
CONTACT: Brad Miles
BMC Communications
646-513-3125
bmiles@bmccommunications.com
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