Full Press Release Details
Announces Clearance of Investigational New Drug Applications by the FDA
for anti-CTLA-4 and anti-GITR Antibodies
studies for both checkpoint modulator antibodies allowed to commence
LEXINGTON, Mass.--(BUSINESS WIRE)--January 21, 2016--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.
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
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.
Michelle Linn, 774-696-3803
Brad Miles, 646-513-3125