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
March 20,
2014
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. today announced that GlaxoSmithKline’s MAGRITi study, a Phase 3 randomized, blinded, placebo-controlled MAGE-A3ii cancer immunotherapeutic trial in non-small cell lung cancer patients, which contains Agenus’QS-21 Stimulon® adjuvant, did not meet its first or second co-primary endpoint. The study did not significantly extend the disease-free survival (DFS)iii period when compared to placebo in the overall MAGE-A3 positive patients or patients who did not receive chemotherapy.
GSK announced that it will continue the study until an analysis of the third co-primary endpoint is complete. The third co-primary endpoint is based on predefined criterion that was discussed with regulatory authorities. This analysis is based on gene signature and designed to prospectively identify MAGE-A3 positive patients who may benefit more from treatment. If further analysis shows that the predefined gene signature subset data are successful, there is the potential for regulatory filing. GSK anticipates that these data should be available in 2015. Until then, GSK will remain blinded to all safety and efficacy data.
The Independent Data Monitoring Committee for the MAGRIT study indicated that a review of the safety information raised no specific concern for the continuation of the trial.
i A double-blind, randomised, placebo-controlled Phase III trial to
assess the efficacy of recMAGE-A3 + AS15 antigen-specific cancer
immunotherapeutic as adjuvant therapy in patients with MAGE-A3 positive
NSCLC (MAGRIT, NCT00480025).
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 DFS is defined as the time from
randomization to the date of first recurrence of the disease or death,
whichever comes first.
iv Access to a proportion of the data (the
training set) will allow for the unbiased generation of a mathematical
model to assess the third co-primary endpoint in the remainder of the
data (the test set).
Item 9.01 Financial Statements and Exhibits
(d)
Exhibits
The following exhibit is filed herewith:
99.1 Press
Release dated March 20, 2014
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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|
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Date: March 20, 2014 |
By: |
/s/ Garo H. Armen |
|
Garo H. Armen |
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Chief Executive Officer |
EXHIBIT INDEX
Exhibit No. |
Description of Exhibit |
|
99.1 |
Press Release dated March 20, 2014 |
Exhibit 99.1
GSK’s MAGE-A3 Cancer Immunotherapeutic Phase 3 Study in Non-Small Cell Lung Cancer Misses First Co-Primary Endpoints
GSK to continue study until third co-primary endpoint is assessed
LEXINGTON, Mass.--(BUSINESS WIRE)--March 20, 2014--Agenus Inc. (Nasdaq: AGEN) today announced that GlaxoSmithKline’s (NYSE: GSK) MAGRITi study, a Phase 3 randomized, blinded, placebo-controlled MAGE-A3ii cancer immunotherapeutic trial in non-small cell lung cancer patients, which contains Agenus’QS-21 Stimulon® adjuvant, did not meet its first or second co-primary endpoint. The study did not significantly extend the disease-free survival (DFS)iii period when compared to placebo in the overall MAGE-A3 positive patients or patients who did not receive chemotherapy.
GSK announced that it will continue the study until an analysis of the third co-primary endpoint is complete. The third co-primary endpoint is based on predefined criterion that was discussed with regulatory authorities. This analysis is based on gene signature and designed to prospectively identify MAGE-A3 positive patients who may benefit more from treatment. If further analysis shows that the predefined gene signature subset data are successful, there is the potential for regulatory filing. GSK anticipates that these data should be available in 2015. Until then, GSK will remain blinded to all safety and efficacy data.
The Independent Data Monitoring Committee for the MAGRIT study indicated that a review of the safety information raised no specific concern for the continuation of the trial.
About GSK’s MAGRIT Program
In this study, patients were given up to 13 intramuscular injections of either the MAGE-A3 immunotherapeutic or placebo over a period of 27 months.
GSK currently remains blinded to further details of the analysis of the first two co-primary endpoints in order to allow for the unbiased generation of a mathematical model to assess the third co-primary endpointiv, which is expected to be known in 2015. GSK is also continuing to evaluate whether a gene signature can identify a population that would benefit from the same investigational MAGE-A3 cancer immunotherapeutic in DERMA, another Phase 3 trial in melanoma, which reported on the first co-primary endpoint in September 2013.
For additional information, please visit GSK’s website at www.gsk.com.
About Agenus
Agenus is a biopharmaceutical company developing a portfolio of immuno-oncology candidates, including checkpoint modulators (CPMs), heat shock protein vaccines and adjuvants. The company’s proprietary discovery engine Retrocyte Display® is designed to rapidly generate high quality therapeutic antibody drug candidates using a high-throughput approach incorporating full-length IgG format human antibody libraries expressed in mammalian B-lineage cells. A portfolio of checkpoint modulator programs is advancing in preclinical development. The company’s heat shock protein vaccines for cancer and infectious disease are in Phase 2 studies. Agenus’ QS-21 Stimulon adjuvant platform is extensively partnered with GlaxoSmithKline and Janssen and includes several candidates in Phase 3 trials. Among Agenus and its partners, 23 programs are in clinical development. For more information, please visit www.agenusbio.com, or connect with the company on Facebook, LinkedIn, Twitter and Google+.
i A double-blind, randomised, placebo-controlled Phase III trial to assess the efficacy of recMAGE-A3 + AS15 antigen-specific cancer immunotherapeutic as adjuvant therapy in patients with MAGE-A3 positive NSCLC (MAGRIT, NCT00480025).
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 DFS is defined as the time from randomization to the date of first recurrence of the disease or death, whichever comes first.
iv Access to a proportion of the data (the training set) will allow for the unbiased generation of a mathematical model to assess the third co-primary endpoint in the remainder of the data (the test set).
Stimulon and Retrocyte Display are registered trademarks of Agenus Inc. and its subsidiaries.
Forward-Looking Statement
This press release contains forward-looking statements, including statements regarding the Company’s and/or its licensees’ clinical trial activities, the publication of data, and the potential application of 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. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our Annual Report on Form 10-K filed with the Securities and Exchange Commission for the year ended December 31, 2013. 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. 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.
CONTACT:
Media and Investor Contact:
Agenus Inc.
Jonae
R. Barnes, 617-818-2985
Vice President
Investor Relations and
Corporate Communications
jonae.barnes@agenusbio.com