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
September 5,
2013
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.) |
3 Forbes Road Lexington, MA |
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))
Item 8.01 Other events
Agenus Inc. announced today that GlaxoSmithKline’s (NYSE: GSK) DERMAi study, a Phase 3 randomized, blinded, placebo-controlled MAGE-A3 cancer immunotherapeuticii (CI) trial, which contains Agenus’QS-21 Stimulon® adjuvantiii, a component of GSK’s novel adjuvant system AS15, did not meet its first co-primary endpoint. In an independent analysis, the study did not significantly extend the disease-free survival (DFS)iv period when compared to placebo in the overall MAGE-A3 positive trial population.
In line with the Independent Data Monitoring Committee’s (IDMC) unanimous recommendation, GSK will continue the study until the second co-primary endpoint is assessed. This co-primary endpoint is based on predefined criterion that was agreed upon by regulatory authorities. This analysis, which is based on gene signature, is designed to prospectively identify patients who may have the capability to be more immunologically responsive and therefore can potentially benefit from treatment. If further analysis shows that the predefined gene signature subset data are successful, there is the potential that a regulatory filing could be considered. GSK anticipates that these data will be available in 2015. Until then, GSK will remain blinded to all safety and efficacy data.
The full text of the press release issued in connection with the announcement is being filed as Exhibit 99.1 to this current report on Form 8-K.
i Adjuvant immunotherapy with MAGE-A3 in melanoma GSK 2132231A
Antigen-Specific Cancer Immunotherapeutic in patients with resected
melanoma.
ii MAGE-A3 cancer immunotherapeutic consists of recombinant
MAGE-A3 protein and a novel immunostimulant AS15 (a combination of QS-21
Stimulon® adjuvant, monophosphoryl lipid A, and CpG7909,
a TLR-9 agonist, in a liposomal formulation).
iii QS-21 Stimulon®
adjuvant and the related agreements, and HerpV are assets of Antigenics
Inc., a wholly owned subsidiary of Agenus Inc.
iv DFS is defined as
the time from randomization to the date of first recurrence of the
disease or of death, whichever comes first.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
The following exhibit is filed herewith:
99.1 Press Release dated September 5, 2013
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.
AGENUS INC. |
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Date: |
September 5, 2013 |
By: |
/s/ Garo H. Armen |
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Garo H. Armen |
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Chief Executive Officer |
EXHIBIT INDEX
Exhibit No. Description
of Exhibit
99.1 Press Release dated
September 5, 2013