FDA Accepts IND Application for Agenus’ iNKT Therapy agenT-797

Biopharmaceutical company Agenus (NASDAQ: AGEN) has announced the acceptance of an IND application for its allogeneic invariant natural killer T cell (iNKT) cancer therapy, agenT-797, by the United States Food and Drug Administration (FDA), with human trials of the treatment anticipated to begin in the second half of 2020.

CEO of AgenTus Therapeutics Walter Flamenbaum, MD, stated, “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. 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. Our iNKTs are streamlined for treating large numbers of patients from a single batch,” stated Garo Armen, PhD, Chairman and CEO of Agenus and Chairman of AgenTus Therapeutics.

“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,” Dr. Armen continued.

iNKT cells are an immune cell subset thought to have significance in the regulation of cancer and autoimmunity. By producing a variety of immune-modulatory signaling molecules known as cytokines, including interleukins and tumor necrosis factor alpha, iNKT cells influence the anti-cancer response of T lymphocytes and other immune cell populations.

Agenus indicates that their iNKT technology may have advantages over other immune cell therapeutics, including T cells, natural killer cells, and gamma-delta T cells, due to iNKT cells’ relative resistance to exhaustion, ease of mass production, and efficacy without modification, among other reasons.

The FDA approval of the IND application for agenT-797 will enable the technology to progress to human trials. However, whether iNKT cells are superior to other immune cell-based therapeutics remains to be determined.

Immuno-oncology company NantKwest is also developing a cell-based therapy for solid tumors, but utilizing natural killer cells instead of iNKT cells. NantKwest’s therapy has shown promise for the treatment of pancreatic cancer and is currently anticipated to enter phase 2 clinical trials.