Agenus Inc., an immuno-oncology company developing checkpoint modulator antibodies and cancer vaccines, 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.”
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.”
