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): July
20, 2015
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
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(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.
Agenus Inc. (“Agenus”) announced today that it has acquired rights to
antibodies targeting Carcinoembryonic Antigen Cell Adhesion Molecule 1
(“ceaCAM1”), a glycoprotein expressed on T cell and NK cell lymphocytes
from Diatheva s.r.l., an Italian biotech company controlled by SOL S.p.A.
ceaCAM1 is overexpressed in melanoma, bladder, lung, colon,
pancreas, and gastric cancers and has been shown to modulate innate and
adaptive immune suppression in pre-clinical studies. Antibodies
targeting ceaCAM1 are thought to have the potential to effectively treat
cancer alone or in combination with other checkpoint modulator
antibodies, including those in Agenus’ development pipeline. Under the
license agreement, Agenus receives exclusive, worldwide rights for
development and commercialization of ceaCAM1 antibodies from
Diatheva. Agenus is responsible for certain upfront, early development,
clinical trial and regulatory milestone payments for the successful
development of ceaCAM1 antibodies totaling as much as $44 million.
Diatheva is also eligible to receive additional sales milestones and
royalties.
The full text of the press release issued in connection with the
announcement is attached hereto as Exhibit 99.1 and is incorporated
herein by reference.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits
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 20, 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.
Date:
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July 20, 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.
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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 20, 2015.
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Exhibit 99.1
Agenus
Acquires Novel Antibodies to Immuno-oncology Target CEACAM1
Target
Expressed on Lymphocytes and Tumors Offers Unique Advantages for
Unlocking the Immune Response to Fight Cancer
LEXINGTON, Mass.--(BUSINESS WIRE)--July 20, 2015--Agenus Inc. (NASDAQ:
AGEN), an immunology company developing innovative treatments for
cancers and other diseases, today announced that it has acquired rights
to antibodies targeting Carcinoembryonic Antigen Cell Adhesion Molecule
1 (CEACAM1), a glycoprotein expressed on T cell and NK cell lymphocytes
from Diatheva s.r.l., an Italian biotech company controlled by SOL S.p.A.
CEACAM1 is overexpressed in melanoma, bladder, lung, colon,
pancreas, and gastric cancers and has been shown to modulate innate and
adaptive immune suppression in pre-clinical studies. Antibodies
targeting CEACAM1 are thought to have the potential to effectively treat
cancer alone or in combination with other checkpoint modulator
antibodies, including those in Agenus’ development pipeline.
“CEACAM1 is emerging as a powerful immune modulator, with significant
evidence that blocking its interactions could strengthen immune cells’
attack on cancer,” said Robert Stein, M.D., Ph.D., Chief Scientific
Officer of Agenus. “Diatheva’s anti-CEACAM1 monoclonal antibodies expand
and complement our broad portfolio of checkpoint modulators and
personalized cancer vaccines, with the potential to create best-in-class
combination therapies for treating patients with cancer.”
Under the license agreement, Agenus receives exclusive, worldwide rights
for development and commercialization of CEACAM1 antibodies from
Diatheva. Agenus is responsible for certain upfront, early development,
clinical trial and regulatory milestone payments for the successful
development of CEACAM1 antibodies totaling as much as $44 million.
Diatheva is also eligible to receive additional sales milestones and
royalties.
Professor Mauro Magnani, Ph.D., Founder and Scientific Director of
Diatheva, stated, “Agenus’ proven immuno-oncology and development
capabilities, represents an exciting opportunity for Diatheva’s most
advanced human monoclonal antibodies. Agenus’ selection of our
anti-CEACAM1 antibodies is indicative of the quality of Diatheva’s
research and will support reinvestment in our company’s pipeline.”
About Agenus
Agenus is an immunology company developing novel
checkpoint modulators, vaccines and adjuvants to treat cancer,
infectious diseases and other immune disorders. Using its proprietary
platforms Retrocyte DisplayTM 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.
About Diatheva
DIATHEVA s.r.l., was founded in 2002 by
researchers and angel investors as a spin off of the University of
Urbino in Italy. In 2012 the SOL Group acquired a majority stake in
Diatheva and has since continued to invest in the company’s operations.
Diatheva’s mission is to translate research into industrial products
through collaborations with industry partners as well as with public and
private research institutions. Diatheva is focused on the development,
production and commercialization of new and innovative biotechnology
products (antibodies, recombinant proteins, immunoassays and molecular
diagnostic kits) for research and therapeutic applications in the fields
of cancer, microbial detection and pharmacogenetics based on its
significant preclinical pipeline of patented antibodies. Diatheva’s
capabilities include a GMP-certified facility for production of API
material intended for preclinical and clinical studies, with a special
emphasis on therapeutic antibodies, recombinant enzymes and immunogens.
Diatheva is an ISO 9001 /UNI EN ISO 9001:2008 certified company.
SOL is an Italian multinational group which operates in Europe, Morocco,
Turkey and India in two distinct sectors: the production, applied
research and marketing of technical, pure and medicinal gases and in
respiratory home care. SOL employs more than 3,000 people in 26
countries. Its parent company, SOL S.p.A has been listed on the Italian
Stock Exchange since 1998. Group revenues for the fiscal year ending
December 31st 2014 were €636 million. Healthcare-focused biotechnology
research represents a new area of focus for the SOL Group.
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 the acquisition of Diatheva’s rights
to antibodies targeting CEACAM1, the potential milestone payments and
royalties payable to Diatheva 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’ Quarterly Report on Form 10-Q filed with
the Securities and Exchange Commission for the period ended March 31,
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/Jamie Maarten, 212-600-1902
andrea@argotpartners.com
jamie@argotpartners.com
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