Download Agenus` (AGEN) IND for AGEN1884 Cleared by FDA

21/01/2016
Agenus' (AGEN) IND for AGEN1884 Cleared by FDA
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Agenus' (AGEN) IND for AGEN1884 Cleared by FDA
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January 21, 2016 8:00 AM EST
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Agenus Inc. (Nasdaq: AGEN) announced 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.”
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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.
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“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
Acquisition - Piper Jaffray
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.”
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