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Tolerx Presents Preclinical Data on Novel Anti-GITR Cancer Immunotherapeutic Demonstrating Enhanced Anti-Tumor Responses
Date:4/5/2011

eutic drugs showed potent anti-tumor activity against established tumors and were efficacious across multiple classes of drugs including alkylating agents, DNA intercalators, and pyrimidine analogs.  
  • The combination of anti-GITR and gemcitabine showed anti-tumor activity against established tumors comparable to a combination consisting of anti-CTLA4 and gemcitabine.
  • The use of a triple combination (anti-GITR, anti-CTLA4, and gemcitabine) demonstrated the greatest anti-tumor results, with complete tumor regression observed in greater than 73% of mice (P<0.01).

    • A Phase 1, first-in-human, open label, dose escalation safety study of TRX518 in adults with Stage III/IV metastatic melanoma was initiated in December 2010 and is currently underway.

    About TRX518

    TRX518 is an investigational immunotherapy designed to activate GITR (glucocorticoid-induced tumor necrosis factor receptor) found on multiple types of T cells and other immune cells. GITR plays a role in directing the anti-tumor immune response via a multifaceted mechanism of action that includes activating tumor antigen-specific T effector cells, abrogating the suppression induced by T regulatory cells, and activating NK cells. In preclinical studies, TRX518 achieved its effect without compromising normal immune function, and preclinical models suggest TRX518 to have a favorable safety profile. A Phase 1 clinical study of TRX518, a first-in-class anti-GITR monoclonal antibody, has been initiated to assess the safety, tolerability, pharmacokinetic, and pharmacodynamic profiles of ascending single doses in patients with malignant melanoma. TRX518 is designed to have activating and sustaining effects on T lymphocytes and other cells for enhancing the immune system's responses against cancer cells, including responses that may occur with TRX518 alone, as well as complementary responses in combination with other cancer therapies including cancer vaccines. <
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    SOURCE Tolerx, Inc.
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