Agenus Announces Clearance of Investigational New Drug Applications by the FDA for anti-CTLA-4 and anti-GITR Antibodies
January 21 2016 - 7:59AM
Business Wire
Clinical studies for both checkpoint modulator
antibodies allowed to commence
Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company
developing checkpoint modulator antibodies and cancer vaccines,
announced today that the U.S. Food and Drug Administration (FDA)
cleared the company's investigational new drug (IND) application
for AGEN1884, an immune checkpoint modulator (CPM) antibody that
binds to cytotoxic T-lymphocyte antigen-4 (CTLA-4). Clearance was
also received for a second CPM antibody partnered with Incyte
(NASDAQ: INCY) for INCAGN1876, which targets glucocorticoid-induced
TNFR-related protein (GITR). Clinical trials for both candidates
are expected to begin in the first half of 2016.
“We are pleased with the prospects of both CTLA-4 and GITR
moving rapidly into and through the clinic, and in our efforts to
bring profoundly effective medicines to cancer patients,” said Garo
Armen, PhD, Chairman and CEO of Agenus. “We are also diligently
advancing several other product candidates into the clinic and are
aiming to begin a number of clinical trials in 2016.”
These two compounds were developed utilizing Agenus’
state-of-the-art monoclonal antibody platform capabilities and
leverage the company's world-class expertise in immuno-oncology and
related drug discovery and development. The antibodies were
discovered during an earlier collaboration with Ludwig Cancer
Research. Recepta, a Brazilian biotech company, was also involved
in the collaboration that led to the discovery of AGEN1884, which
is partnered with Recepta for certain South American rights.
INCAGN1876 is now being co-developed with Incyte.
“CTLA-4 is emerging as an important foundational target for
immuno-oncology combination regimens, showing terrific promise when
used with other CPMs and cancer vaccines. Our CTLA-4 antagonist
antibody, AGEN1884, is a natural potential fit with our expanding
vaccine portfolio. This includes Prophage™, slated to enter a
randomized placebo-controlled study in newly diagnosed GBM in the
second half of 2016, and AutoSynVax™, which we also plan to take
into the clinic in the second half of 2016,” said Robert B. Stein,
MD, PhD, Agenus’ President, Research & Development. “I would
like to acknowledge the research and development teams at Agenus,
and Incyte for GITR, for their tireless efforts to achieve our goal
of filing these INDs by the end of 2015.”
About Checkpoint Modulators
Promising clinical data from studies employing monoclonal
antibodies that bind to checkpoint molecules, such as cytotoxic
T-lymphocyte antigen-4 (CTLA-4) and programmed death receptor-1
(PD-1), have generated considerable excitement in the field of
cancer immunotherapy. These molecules serve as checks employed by
the body to prevent a runaway immune response, which can be
debilitating, and even deadly. Unfortunately, these necessary
mechanisms of control can hinder the anti-cancer immune response.
They can be harnessed by cancer cells as a defense against immune
attack. Agenus is developing a broad pipeline of antibodies that
bind to key checkpoint proteins and activate or block their
activities for use in cancer therapy.
About Agenus
Agenus is an immunotherapy company focused on the discovery and
development of revolutionary new treatments that engage the body’s
immune system to benefit patients suffering from cancer. By
combining multiple powerful platforms, Agenus has established a
highly integrated approach to target identification and validation,
and for the discovery, development and manufacturing of monoclonal
antibodies that modulate targets of interest. The company’s broad
portfolio of novel checkpoint modulator and other immuno-modulatory
monoclonal antibodies, vaccines and adjuvants, work in combination
to provide the opportunity to create best-in-class therapeutic
regimens. Agenus’ heat shock protein-based vaccine, Prophage™, has
successfully completed Phase 2 studies in newly-diagnosed
glioblastoma. The company is collaborating with Merck and Incyte to
discover and develop multiple checkpoint modulators. For more
information, please visit www.agenusbio.com; information that
may be important to investors will be routinely posted on our
website.
Forward-Looking Statement
This press release contains forward-looking statements that are
made pursuant to the safe harbor provisions of the federal
securities laws, including statements regarding planned clinical
trial activities of Agenus and its partners, as well as the
efficacy of certain product candidates. 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 Agenus’ Form 10-Q filed with the Securities and Exchange
Commission on November 4, 2015. 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 press release, and Agenus undertakes no obligation to
update or revise the statements, other than to the extent required
by law. All forward-looking statements are expressly qualified in
their entirety by this cautionary statement.
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version on businesswire.com: http://www.businesswire.com/news/home/20160121005696/en/
Agenus:Agenus Inc.Michelle Linn,
774-696-3803michelle.linn@agenusbio.comorMedia:BMC
CommunicationsBrad Miles,
646-513-3125bmiles@bmccommunications.com
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