On April 2, 2019 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with a pipeline of immune-modulating antibodies, cancer vaccines, adjuvants and adoptive cell therapies1, reported that the first patient was dosed in the clinical trial of its next-generation anti-CTLA-4 antibody (AGEN1181) (Press release, Agenus, APR 2, 2019, View Source [SID1234534906]). AGEN1181, a novel ‘Fc engineered’ antibody with potential for enhanced anti-tumor functions, is specifically designed to boost cancer killing immune cells and deplete cells that block the activity of these cancer killing cells.
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The first patient in the trial was dosed by Dr. Steven J. O’Day, M.D., Executive Director of the John Wayne Cancer Institute & Cancer Clinic, and a pioneer in delivering immune therapies to patients with cancer. Dr. O’Day’s pivotal work has led to the approvals of commercial antibodies targeting CTLA-4 and PD-1. "AGEN1181 represents an important next-generation breakthrough with its potential for enhanced immune activation and tumor fighting abilities," said Dr. O’Day. "The pre-clinical data so far suggest that AGEN1181 may bring superior benefit compared to first generation anti-CTLA-4 antibodies and may be an optimal partner for combinations. I am thrilled to be working with this compound."
"AGEN1181 is a product of Agenus’ innovation engine that has been key to rapidly delivering new discoveries to patients," said Garo Armen, Ph.D., Chairman and CEO of Agenus. "AGEN1181 was developed based on a new mechanism of action discovered by our scientists. In addition to this monotherapy trial, we plan to pursue combination studies with AGEN1181 soon. Besides AGEN1181, additional important discoveries from our innovation engine are also advancing towards the clinic this year."
The Phase 1, open-label, multicenter study is designed to assess the maximum tolerated dose of AGEN1181 in subjects with advanced solid tumors. It will also evaluate the safety, tolerability, PK, and PD profiles and immunogenicity of this antibody. The outcome will determine the recommended phase II dose of AGEN1181.
AGEN1181 was developed based on a discovery made by Agenus scientists, that involves modification of a key region of an antibody, known as the "Fc region", to design next-generation, ‘Fc engineered’ antibodies that may significantly enhance functionality and antitumor immunity. To learn more about AGEN1181 and its potential advantages over first-generation anti-CTLA-4 antibodies, please see Agenus’ Newsletter here.