Agenus Inc., an immuno-oncology company developing antibodies including checkpoint inhibitors and other checkpoint modulators, and cancer vaccines, announced that the first patient has been dosed in a phase 1/2 clinical trial of the anti-GITR agonist antibody INCAGN1876. The trial is being conducted by, and in collaboration with, Incyte Corporation.

The open-label, dose-escalation portion of the trial will evaluate the safety and tolerability of INCAGN1876 in patients with advanced or metastatic solid tumors and determine the pharmacologically active and/or maximum tolerated dose of INCAGN1876. Part 2 of the trial is planned to further evaluate the recommended dose of INCAGN1876 in selected tumor types, including advanced or metastatic endometrial adenocarcinoma, melanoma, non-small cell lung cancer and renal cell carcinoma.

“This is the second product candidate from our antibody program that has advanced into clinical trials this year,” said Garo H. Armen, Ph.D. chairman and CEO of Agenus. “We expect to initiate additional clinical studies with antibodies as well as other immuno-oncology leads from our comprehensive pipeline in the next twelve months.”

INCAGN1876 is an agonist antibody targeting the glucocorticoid-induced TNFR-related protein, or GITR. Upon activation, GITR, a co-stimulatory receptor, can stimulate immune cells to target and potentially destroy cancer cells. This antibody was discovered during an earlier collaboration with Ludwig Cancer Research. INCAGN1876 is being co-developed with Incyte.

“Targeted immunomodulatory therapy including anti-PD-1 and CTLA-4 drugs have demonstrated unprecedented results in cancer, but there remains significant need to improve treatment in cancer patients,” said Robert B. Stein, M.D., Ph.D., Agenus’ president, Research & Development. “GITR is a unique co-stimulatory receptor which holds great promise as a new pathway for stimulating immune cells to target cancer and may be effective alone or in combination with other immuno-modulatory approaches.”

Promising clinical data from trials employing monoclonal antibodies that bind to checkpoint molecules, such as CTLA-4 and programmed death receptor-1 (PD-1), have generated considerable excitement in the field of cancer immunotherapy. These molecules serve as checks employed by the body to prevent a runaway immune response or allow rapid activation of the immune response when needed. Unfortunately, these necessary mechanisms of control can hinder the anti-cancer immune response. They can be harnessed by cancer cells as a defense against immune attack. Agenus is developing a broad pipeline of antibodies that bind to key checkpoint proteins and activate or block their activities for use in cancer therapy.