Update on GSK’S MAGE-A3 Cancer Immunotherapeutic Phase 3 Study in Non-Small Cell Lung Cancer

  Update on GSK’S MAGE-A3 Cancer Immunotherapeutic Phase 3 Study in Non-Small
  Cell Lung Cancer

Business Wire

LEXINGTON, Mass. -- April 2, 2014

Agenus Inc. (Nasdaq: AGEN) today announced  that GlaxoSmithKline’s (NYSE: GSK)
MAGRIT^i study, a Phase 3 randomized, blinded, placebo-controlled MAGE-A3^ii
cancer immunotherapeutic trial in non-small cell lung cancer (NSCLC) patients,
which contains Agenus’QS-21 Stimulon^® adjuvant, will be stopped. GSK
announced that it will not be possible to identify a sub-population of
gene-signature positive NSCLC patients that may benefit from the treatment.

The Independent Data Monitoring Committee (IDMC) indicated that its review of
the current safety information revealed no specific safety concern and the
data is in line with the known safety information for the MAGE-A3 cancer
immunotherapeutic.

Update on GSK’s Phase 3 DERMA Program in Melanoma

GSK is continuing another Phase 3 clinical trial (DERMA) to evaluate whether a
gene signature can identify a sub-population of melanoma patients that would
benefit from the same investigational MAGE-A3 cancer immunotherapeutic. This
follows the read-out of the first co-primary endpoint in September 2013 of
disease free survival in the overall MAGE-A3 positive population, which was
not met. Work is progressing on the mathematical model (the gene signature
classifier) to allow assessment of DFS^iii in the gene signature population,
the second co-primary endpoint in the DERMA trial. The outcome is expected in
2015.

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 preclinical checkpoint modulator programs of
GITR and OX40 agonists and CTLA-4, LAG-3, TIM-3 and PD-1 antagonists is
advancing in 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.

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
 
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