On May 13, 2020 Agenus Inc. (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of agents designed to activate immune response to cancers and infectious diseases, reported the FDA acceptance of the IND application for an allogeneic iNKT therapy, agenT-797, submitted by its subsidiary, AgenTus Therapeutics. A clinical trial for the treatment of patients with cancer is expected to commence 2H2020 (Press release, Agenus, MAY 13, 2020, View Source [SID1234557874]). AgenTus has also submitted a separate IND for the treatment of COVID-19, which is expected to clear soon.
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"We are extremely pleased to rapidly advance our proprietary iNKT cell therapy to the clinic to combat cancer and also address the urgent COVID-19 pandemic," said Dr. Walter Flamenbaum, CEO of AgenTus Therapeutics. "We expect our clinical trials to demonstrate the key features of agent-797 and the benefits of combinations of our allogeneic iNKTs with Agenus’ pipeline of checkpoint antibodies in solid tumors."
"I am heartened by our team’s efforts to rapidly advance our allogeneic iNKT cells to treat patients with cancer and COVID-19," said Dr. Garo Armen, Chairman and CEO of Agenus and Chairman of AgenTus Therapeutics. "Our iNKTs are streamlined for treating large numbers of patients from a single batch. They are manufactured without the need for genetic manipulation, are expected to suppress graft-versus-host disease, can be manufactured affordably, and are designed for quick access by patients."
Separately, Agenus indicated that it is contemplating several options with regard to its AgenTus Therapeutics subsidiary. This is given its previous guidance and the advancement of AgenTus’ first cell therapy candidates towards the clinic. These options include the potential spinning out of AgenTus and issuing a portion of its holdings in AgenTus to Agenus shareholders in the form of a stock dividend. Agenus expects that such a decision will be made by the end of this year.