Full Press Release Details
GSK'S MAGE-A3 Cancer Immunotherapeutic Phase 3 Study in Non-Small Cell
LEXINGTON, Mass.--(BUSINESS WIRE)--April 2, 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 (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 DFSiii in the gene signature population, the
second co-primary endpoint in the DERMA trial. The outcome is expected
For additional information, please visit GSK's website at www.gsk.com.
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.
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