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EpiVax-Novozymes Tregitope-Albumin Fusion Moves 'Paradigm-Shifting' Treatment for Diabetes Closer to Clinical Trials

PROVIDENCE, R.I., Feb. 12, 2013 /PRNewswire/ -- EpiVax, Inc. is pleased to announce a new Collaborative Research Agreement with Novozymes Biopharma. The collaboration will enable EpiVax to rapidly advance its Tregitope immune-modulating technology as a potential treatment for autoimmune diseases. When used as a buffering agent, albumin has excellent safety and pharmacokinetic profiles. Fusing Tregitopes to Novozymes' proven albumin-based half-life extension platform will create a safe and effective vehicle for the application of Tregitopes to multiple problems in the areas of autoimmunity, transplantation, and allergy.

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Tregitopes, discovered by Anne De Groot and Bill Martin at EpiVax, are linear sequences of amino acids contained within the framework of monoclonal antibodies and immunoglobulin G; the original finding was published in the journal Blood in 2008. Since their discovery, EpiVax has compiled substantial evidence linking Tregitopes to the activation of natural regulatory T cells. By selectively activating these natural regulatory T cells, Tregitopes can dampen unwanted immune responses. Preliminary studies carried out by EpiVax and collaborators indicate that Tregitopes may be useful for inducing tolerance to transplants, protein drugs, and blood replacement therapies, as well as for the treatment of allergies. EpiVax believes Tregitopes may explain the effectiveness of intravenous immunoglobulin G (IVIG), widely utilized as an autoimmune treatment (a $4B annual market).

The initial disease target for Tregitope therapy with the albumin-Tregitope fusion will be Type 1 diabetes (T1D). Each year, more than 13,000 young people are diagnosed with T1D. Islet replacement therapy is in the experimental stage for individuals with advanced disease, and EpiVax believes the albumin-Tregitope fusion will facilitate this novel treatment for individuals in later stages of T1D.

Tregitopes act as a natural immune system "off switch" and have been shown in standard preclinical models to "reset" immune responses away from autoimmunity and towards tolerance. "Developing more specific therapies to promote tolerance … is a critical component of a comprehensive approach to T1D," said Julia L. Greenstein , Ph.D., VP of Cure Therapies for JDRF, whose previous funding helped EpiVax derive preliminary data to support recent NIH awards.  "[Tregitopes] may have the potential to reduce the harmful immune responses to the insulin-producing beta cells, thereby preserving the body's ability to make its own insulin." 

NIH SBIR grants coupled with private foundation funds have brought total pre-clinical funding for Tregitopes to more than $6M in the past 4 years.


Anthony Marcello

SOURCE EpiVax, Inc.
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