Tolerx presents preclinical data on TRX518 anti-GITR immunotherapy for cancer

Tolerx, Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by modulating T cell activity, presented results from preclinical studies with TRX518, an early-stage agent Tolerx is developing as a treatment for cancer. TRX518 is a monoclonal antibody to glucocorticoid-induced tumor necrosis factor receptor (GITR) and is designed to enhance the immune system's ability to attack tumors by activating and rendering T effector cells resistant to T regulatory cell suppression. Anti-GITR agents have been identified by the National Cancer Institute as having high potential for treating cancer.  The preclinical data were presented and recognized as a distinguished abstract at the annual meeting of the Federation of Clinical Immunology Societies in Boston, Massachusetts.

The data included in the presentation demonstrated that a murine analog of TRX518, which is an anti-GITR antibody, resulted in pronounced and durable immune responses to several antigens in mice. These data also showed that the TRX518 analog, when combined with gemcitabine, a standard chemotherapeutic, significantly reduced tumor burden (p<0.001) and prolonged survival (p<0.001) in the mouse model when compared with gemcitabine alone. In particular, of the mice treated with the combination therapy, 65% had a complete remission. Similar findings were observed when the TRX518 analog was combined with cyclophosphamide. The humanized monoclonal antibody, TRX518, blocked the interaction of GITR with its ligand, enhanced the cytotoxicity of human natural killer cells, downmodulated GITR on peripheral blood lympocytes, did not induce appreciable cytokine release, and was well tolerated and safe at high doses in non-human primates.

"We are highly encouraged by the preclinical results with anti-GITR immunotherapy. This approach appears to induce unique mechanisms for augmenting antitumor immune responses and holds promise for treating malignancies in man," said Louis Vaickus, MD, Chief Medical Officer at Tolerx. "In a murine model of established colon cancer, the results, especially the complete remissions, were striking and these findings represent preclinical proof of concept for TRX518."

SOURCE Tolerx, Inc.