Update on GSK’S MAGE-A3 Cancer Immunotherapeutic Phase 3 Study in Non-Small Cell Lung Cancer
April 02 2014 - 2:01AM
Business Wire
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 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.
Media and Investor Contact:Agenus
Inc.Jonae R. Barnes, 617-818-2985Vice PresidentInvestor Relations
andCorporate Communicationsjonae.barnes@agenusbio.com
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