UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
8-K
CURRENT REPORT
Pursuant
to Section 13 or 15(d) of The Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported):April
28, 2015
AGENUS
INC.
(Exact
name of registrant as specified in its charter)
DELAWARE
|
000-29089
|
06-1562417
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(State or other jurisdiction
of incorporation)
|
(Commission
File Number)
|
(IRS Employer
Identification No.)
|
3 Forbes Road
Lexington, MA
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02421
|
(Address of principal executive offices)
|
(Zip
Code)
|
Registrant’s
telephone number, including area code 781-674-4400
N/A
(Former
name or former address, if changed since last report.)
Check the appropriate box below if the Form 8-K filing is intended to
simultaneously satisfy the filing obligation of the registrant under any
of the following provisions (see General Instruction A.2. below):
⃞
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
⃞
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
⃞
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
⃞
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item 8.01 Other Events.
On April 28, 2015, Agenus Inc. issued a press release titled, “NEJM
Publishes Study Showing GSK’s Shingles Vaccine Containing Agenus' QS-21
Stimulon® Adjuvant Provides over 97% Protection in
People Over the Age of 50” (the “Press Release”). A copy of the Press
Release is attached hereto as Exhibit 99.1 and is incorporated herein by
reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
Exhibit No. Description
of Exhibit
99.1 Press Release dated April 28, 2015.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf by the
undersigned hereunto duly authorized.
Date:
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April 28, 2015
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AGENUS INC.
|
|
|
|
|
|
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By:
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/s/ Garo H. Armen
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Garo H. Armen
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Chairman and CEO
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EXHIBIT INDEX
Exhibit No. Description
of Exhibit
99.1 Press Release dated
April 28, 2015
Exhibit 99.1
NEJM
Publishes Study Showing GSK’s Shingles Vaccine Containing Agenus’ QS-21
Stimulon® Adjuvant Provides over 97% Protection in People Over the Age
of 50
-
Data
simultaneously presented at ECCMID
-
HZ/su
vaccine achieves nearly 98% protection in people 70 or older
-
This
marks the second successful Phase 3 clinical program incorporating
Agenus’ QS-21 Stimulon adjuvant
LEXINGTON, Mass.--(BUSINESS WIRE)--April 28, 2015--Agenus Inc. (NASDAQ:
AGEN), an immunology company developing innovative treatments for
cancers and other diseases, announced today that primary and secondary
endpoint data from GlaxoSmithKline’s (LSE/NYSE: GSK) randomized Phase 3
trial of HZ/su, a vaccine candidate for the prevention of shingles, was
simultaneously presented at the 25th Scientific Conference of the
European Society of Clinical Microbiology and Infectious Disease
(ECCMID) in Copenhagen, and published in the New England Journal of
Medicine. GSK’s HZ/su incorporates Agenus' QS-21 Stimulon® adjuvant,
which is designed to increase immune response to antigens.
The data show that GSK’s HZ/su reduced the risk of shingles (herpes
zoster) by 97.2% in adults aged 50 and older, compared to placebo.
Importantly, the protection was maintained across all studied age
groups, ranging from 96.6% in subjects aged 50-59, 97.4% in those aged
60-69, and 97.9% in those aged 70 or older. No major safety concerns
were identified in the study. The most common reported adverse event was
pain at injection site, fatigue and myalgia.
“The vast majority of adults over age 50 are at high risk of
reactivating the varicella zoster virus, which leads to shingles and its
painful and debilitating symptoms. These clinical results point to the
broad benefits that widespread use of this vaccine could bring to adults
over 50 worldwide,” said Garo Armen, Ph.D., Chairman and CEO of Agenus.
“These data, and those from GSK’s RTS,S malaria vaccine now undergoing
regulatory review by the EMA, highlight the importance and value that we
believe QS-21 Stimulon brings to vaccines and to Agenus.”
The HZ/su vaccine candidate combines gE, a protein that is part of the
virus that causes shingles, with the AS01 adjuvant system, which
enhances the immune response to gE. The AS01 adjuvant system contains
Agenus’ QS-21 Stimulon, MPL (3-O-desacyl-4’-monophosphoryl lipid A) and
liposomes.
Agenus is eligible to receive a milestone payment upon GSK’s first
approval of a QS-21 Stimulon-containing product and royalties from any
potential commercial product sales of HZ/su. QS-21 Stimulon is being
evaluated in more than 12 additional vaccine candidates.
The HZ/su shingles study is a randomized, observer-blind,
placebo-controlled Phase 3 trial involving over 16,000 adults aged 50
years and older. The study started in August 2010 and is still ongoing.
In addition to older adults, HZ/su is being evaluated in
immunocompromised patient populations, including solid and hematological
cancer patients, hematopoietic stem cell and renal transplant recipients
and HIV-infected people.
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 chronic pain, scarring, vision complications, secondary
infection, nerve palsies and hospitalization. A person’s risk for
shingles increases sharply after 50 years of age. The individual
lifetime risk of developing shingles is approximately one in three
people; however, for individuals aged 85 and over, this risk increases
to one in two people.i
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 patients. Agenus is generally entitled to receive
milestone payments as QS-21 Stimulon containing programs advance, as
well as royalties on potential commercial sales for 10 years after
commercial launch, if ever, with some exceptions.
About Agenus
Agenus is an immunology company developing a series of Checkpoint
Modulators for the treatment of patients with cancer, infectious
diseases, and other immune disorders, heat shock protein (HSP)-based
vaccines, and immune adjuvants. These programs are supported by three
separate technology platforms. Agenus’ internal and partnered checkpoint
modulator programs target GITR, OX40, CTLA-4, LAG-3, TIM-3, PD-1 and
other undisclosed programs. The company’s proprietary discovery engine
Retrocyte DisplayTM 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
recently acquired a powerful yeast antibody display platform termed
SECANT, developed by Celexion, LLC. SECANT allows rapid generation of
soluble, full-length human antibodies. SECANT and Agenus’ mammalian
antibody display platform have complementary strengths and further
bolster Agenus' abilities to generate and optimize fully human
monoclonal antibodies. Agenus’ heat shock protein-based vaccines have
completed Phase 2 studies in newly diagnosed glioblastoma multiforme,
and in the treatment of herpes simplex viral infection; the heat shock
protein-based vaccine platform can generate personalized as well as off
the shelf products. The company’s QS-21 Stimulon® adjuvant platform is
extensively partnered with GlaxoSmithKline and with Janssen Sciences
Ireland UC and includes several candidates in Phase 2 trials, as well as
shingles and malaria vaccines which have successfully completed Phase 3
clinical trials. For more information, please visit www.agenusbio.com,
or connect with the company on Facebook, LinkedIn, Twitter and Google+;
information that may be important to investors will be routinely posted
in these locations.
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 the potential therapeutic benefit of
GSK’s singles vaccine candidate HZ/su in adults over the age of 50
worldwide, potential commercial sales of HZ/su and the potential for
Agenus to receive milestone and royalty payments for product candidates
containing Agenus’ QS-21 Stimulon generally. 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.
i S. Pinchinat et al: Similar herpes zoster incidence across
Europe: results from a systematic literature review. BMC Infectious
Diseases 2013, 13:170
CONTACT:
Media
BMC Communications
Brad Miles,
646-513-3125
bmiles@bmccommunications.com
or
Investors
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Partners
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andrea@argotpartners.com
jamie@argotpartners.com
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