Tolerx Presents Preclinical Data on Novel T-cell Modulator, TRX518, for Antitumor Immune Response at Federation of Clinical Immunology Societies Scientific Meeting

CAMBRIDGE, Mass., June 25 /PRNewswire/ -- 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."

About TRX518

TRX518 is a targeted T-cell immunomodulator that binds to the glucocorticoid-induced tumor necrosis factor receptor (GITR) found on multiple types of T cells and other immune cells. Activated GITR plays a role in directing the antitumor immune response via activating tumor-antigen-specific T effector cells, as well as abrogating the suppression induced by inappropriately activated T regulatory cells. In preclinical studies, TRX518 achieved its targeted effect without compromising normal immune function and preclinical models suggest TRX518 may have a reduced risk of causing the serious inflammatory side effects that can result from cytokine release.

About Tolerx

Tolerx, Inc., a world leader in the understanding of T cell function, is developing novel therapies intended to treat autoimmune diseases, diabetes, and cancer by specifically modulating T cell activity. The company's pipeline includes its lead candidate, otelixizumab, a targeted T cell immunomodulator in Phase 3 development for the treatment of type 1 diabetes that is partnered with GlaxoSmithKline. TRX1, a Phase 1 candidate, is a nonlytic anti-CD4 antibody that is being developed for the treatment of aberrant or untoward immune responses. The company also has three preclinical candidates, TRX518, TRX585, and TRX385, which enhance immune responses and as such are being evaluated for potential benefit in the treatment of cancer and chronic infections. Tolerx is a privately held company headquartered in Cambridge, MA USA. For more information, please visit www.tolerx.com.

SOURCE Tolerx, Inc.

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