Current Report Filing (8-k)
July 24 2015 - 6:03AM
Edgar (US Regulatory)
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
July
24, 2015
Date
of Report (Date of earliest event reported)
AGENUS INC.
(Exact
name of registrant as specified in its charter)
DELAWARE
|
000-29089
|
06-1562417
|
(State or other jurisdiction
of incorporation)
|
(Commission
File Number)
|
(IRS Employer
Identification No.)
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3 Forbes Road
Lexington, MA
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02421
|
(Address
of principal executive offices)
|
(Zip
Code)
|
781-674-4400
(Registrant’s
telephone number, including area code)
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))
Agenus Inc. today announced that GlaxoSmithKline received a positive
opinion for its Malaria vaccine candidate from the Committee for
Medicinal Products for Human Use of the European Medicines Agency. 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.
The full text of the press release issued in connection with the
announcement is attached hereto as Exhibit 99.1and is incorporated
herein by reference.
Item 9.01
|
|
Financial Statements and Exhibits
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(d) Exhibits
The following exhibit is filed herewith:
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99.1 Press Release dated July 24, 2015
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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.
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AGENUS INC.
|
|
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Date: July 24, 2015
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By:
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/s/ Garo H. Armen
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Garo H. Armen
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Chief Executive Officer
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EXHIBIT INDEX
Exhibit No.
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Description of Exhibit
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|
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99.1
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Press Release dated July 24, 2015
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Exhibit 99.1
GSK’s
Malaria Vaccine Containing Agenus’ QS-21 Stimulon®
Receives Positive Opinion from European Regulators for Prevention of
Malaria in Young Children in Sub-Saharan Africa
LEXINGTON, Mass.--(BUSINESS WIRE)--July 24, 2015--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.
CONTACT:
Media:
BMC Communications
Brad Miles,
646-513-3125
bmiles@bmccommunications.com
or
Investors:
Argot
Partners
Andrea Rabney, 212-600-1902
andrea@argotpartners.com
or
Jamie
Maarten, 212-600-1902
jamie@argotpartners.com
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