Navigation Links
Tolerx Presents Preclinical Data on Novel Anti-GITR Cancer Immunotherapeutic Demonstrating Enhanced Anti-Tumor Responses

CAMBRIDGE, Mass., April 5, 2011 /PRNewswire/ -- Tolerx, Inc., a biopharmaceutical company developing novel therapies to treat autoimmune diseases and cancer by normalizing the immune response, today presented results from preclinical studies with 2F8, a murine analog of TRX518, a first-in-class immunomodulatory agent currently in a Phase 1 clinical study for the treatment of cancer. Preclinical data demonstrated anti-tumor efficacy in a murine model as a monotherapy, and further enhanced efficacy when used in combination with multiple classes of chemotherapeutics and with biologic agents such as anti-CTLA4.  Both TRX518, and its murine analog, 2F8, are monoclonal antibodies reactive with the glucocorticoid-induced tumor necrosis factor receptor (GITR) and are designed to enhance the immune system's anti-tumor response by enabling T lymphocytes and other cells to more effectively attack cancer cells. The preclinical data were presented as a poster and invited talk at the Keystone Symposia "Immunoregulatory Networks" meeting held in Breckenridge, Colorado.

"These data underscore the exciting promise of our anti-GITR program, highlighting the potential efficacy of TRX518's unique and powerful mechanism of action," said Tony deFougerolles, Tolerx's Chief Scientific Officer. "The preclinical data suggest that anti-GITR may have similar efficacy to anti-CTLA4, and that the combination of anti-GITR with anti-CTLA4 and chemotherapy may result in dramatic regression of established tumors."

The preclinical studies included combinations of an anti-GITR monoclonal antibody, chemotherapeutic drugs (including gemcitabine, cyclophosphamide, 5-fluorouracil, and doxorubicin), and an anti-CTLA4 monoclonal antibody.  These agents were evaluated for their anti-tumor efficacy against established tumors using a colon carcinoma model in mice.  Results and data included:

  • The combination of anti-GITR and chemotherapeutic 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.

About Tolerx

Tolerx, Inc., a biotechnology company and a leader in immunology, has a portfolio of innovative, first-in-class therapeutic candidates to treat autoimmune diseases, cancer and viral infections by normalizing immune responses. Tolerx is a privately held company headquartered in Cambridge, MA USA. For more information, please visit

SOURCE Tolerx, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related biology technology :

1. Laureate Announces Manufacturing Agreement with Tolerx
2. Tolerx Expands Phase 3 DEFEND Trial of Otelixizumab in Europe
3. Tolerx Announces Amendment to Phase 3 DEFEND Protocol
4. Tolerx Presents Otelixizumab Phase 2 Dose Optimization Data At The IDFs 20th World Diabetes Congress
5. Tolerx Initiates Phase 1 Clinical Trial of TRX518, a First-in-Class anti-GITR Antibody for the Treatment of Cancer
6. Bluestar Silicones Presents Adhesive Gels for Wound Care at Medical Grade Polymers Conference
7. Acologix Presents Preclinical Data on Cartilage Regeneration by AC-100 at the 30th ASBMR Annual Meeting
8. Enobia Pharma Presents PreClinical Data Showing ENB-0040 Significantly Improved Survival and Healed Skeletal Manifestations of Severe Hypophosphatasia in Mice
9. MedImmune Presents Data at AAP National Conference & Exhibition Demonstrating Burden of RSV Disease
10. GeoVax Presents Data at AIDS Vaccine 2008 Conference
11. Dendreon Presents Preclinical Data Validating Anti-Tumor Activity of D-3263, a Trp-p8 Agonist
Post Your Comments:
(Date:6/23/2016)... 2016   Boston Biomedical , an industry ... to target cancer stemness pathways, announced that its ... Drug Designation from the U.S. Food and Drug ... including gastroesophageal junction (GEJ) cancer. Napabucasin is an ... cancer stemness pathways by targeting STAT3, and is ...
(Date:6/23/2016)... June 23, 2016 A person commits a crime, ... scene to track the criminal down. An outbreak ... and Drug Administration (FDA) uses DNA evidence to track down ... Sound far-fetched? It,s not. The FDA has increasingly used ... investigations of foodborne illnesses. Put as simply as possible, whole ...
(Date:6/23/2016)... ... June 23, 2016 , ... Charm Sciences, Inc. is ... has received AOAC Research Institute approval 061601. , “This is another AOAC-RI approval ... Bob Salter, Vice President of Regulatory and Industrial Affairs. “The Peel Plate methods ...
(Date:6/23/2016)... 23, 2016  The Biodesign Challenge (BDC), a university ... to harness living systems and biotechnology, announced its winning ... New York City . ... showcased projects at MoMA,s Celeste Bartos Theater during the ... MoMA,s senior curator of architecture and design, and ...
Breaking Biology Technology:
(Date:6/22/2016)... , June 22, 2016 On Monday, the ... to industry to share solutions for the Biometric Exit ... Customs and Border Protection (CBP), explains that CBP intends ... departing the United States , in ... to defeat imposters. Logo - ...
(Date:6/20/2016)... 20, 2016 Securus Technologies, a leading ... for public safety, investigation, corrections and monitoring announced ... it has secured the final acceptance by all ... Managed Access Systems (MAS) installed. Furthermore, Securus will ... be installed by October, 2016. MAS distinguishes between ...
(Date:6/15/2016)... ALBANY, New York , June 15, 2016 ... published a new market report titled "Gesture Recognition Market ... Trends and Forecast, 2016 - 2024". According to the ... at USD 11.60 billion in 2015 and is ... and reach USD 48.56 billion by 2024.  ...
Breaking Biology News(10 mins):