NEW: EpiVax Gets $2.25M From National Institutes of Health
Tuesday, April 10, 2012
EpiVax's Tregitrope, shown here causing a natural regulatory T-cell to communicate differently with "effector" cells. Image: EpiVax.
Moving autoimmune disease treatment forward
The new funding from NIH will allow EpiVax to move this important treatment for autoimmune diseases forward in preclinical studies. Tregitopes were discovered in 2008 by the team of De Groot and Martin at EpiVax and the program is currently managed by Scientific Director, Leslie Cousens, Ph.D. The original discovery was published in the journal Blood in 20081. These are linear sequences contained within the framework of monoclonal antibodies and immunoglobulin G (also known as gamma globulin). The Tregitopes act as a natural ‘off switch” and have been shown in standard preclinical models, and by collaborating laboratories, to suppress and treat autoimmune disease, allergy, and to effectively suppress the imunogenicity of co-administered proteins.
Uses of Tregitope
Anticipated uses of Tregitope include induction of tolerance to co-‐administered protein drugs, a market worth more than $100B globally. Also known as biotherapeutics, drugs such as Campath, Rituximab, enzyme replacement therapies such as Myozyme, and blood factors such as FVIII often induce antibodies, rendering the drugs less effective or ineffective. In addition, Tregitopes may have broad applications in transplant, according Nader Najafian, M.D., who is using Tregitopes in research being performed at Harvard Brigham and Women’s Hospital, and therapy for autoimmune diseases such as multiple sclerosis.
GET THE LATEST BREAKING NEWS HERE -- SIGN UP FOR GOLOCAL FREE DAILY EBLASTResearcher Samia Khoury M.D., an internationally recognized MS researcher also based at Harvard Brigham and Women’s Hospital, says that pre-clinical studies of Tregitope being carried out in her laboratory are “promising”. The Tregitope technology won awards from the American Transplant Association (ATA) and from the American Association of Pharmacologists (AAPS) in 2010 and 2011.
From Phase I to II
The receipt of the original Phase I SBIR grant awarded in 2008 allowed EpiVax to generate substantial evidence that Tregitopes may explain the effectiveness of IVIG, a current leader in auto-immune treatment. In animal models, Tregitope appears to “reset” the immune response away from autoimmunity and towards tolerance, normalizing blood sugar levels. “This is another great example of the important role the SBIR program has played in helping Rhode Island small businesses,” said Senator Sheldon Whitehouse, who worked to re‐authorize the program in the Senate last year. “I commend EpiVax for its hard work and dedication over the years, and congratulate it on its SBIR grant. This funding will support Rhode Island’s knowledge economy by helping EpiVax continue its important research on the prevention and treatment of harmful diseases.”
Targeting Type 1 diabetes
The initial target for Tregitope therapy will be Type 1 diabetes (T1D). Each year more than 13,000 young people are diagnosed with T1D. Islet replacement therapy is still in the experimental stage for individuals with advanced disease, but EpiVax believes that T1D-Tregitope therapy will facilitate this novel treatment for individuals in the later stages of T1D. Furthermore, preliminary studies carried out by EpiVax and collaborators indicate that Tregitope may be useful for inducing tolerance to transplants, protein drugs, and blood replacement therapies, suggesting that Tregitope may be useful for patients with other auto-immune diseases. EpiVax will use this new round of funding to develop a dosing and delivery procedure for Tregitope therapy in preparation for an IND. Preliminary “Safety and Toxicity” studies are also supported by the NIH Phase II.
“Developing more specific therapies to promote tolerance to the beta cell antigens that trigger the autoimmune response is a critical component of a comprehensive therapeutic approach to type 1 diabetes,” said Julia Greenstein, Ph.D., assistant vice president of cure therapies for JDRF, whose previous funding for EpiVax helped the company derive preliminary data to support the new NIH funding. “It’s great to see the NIH support EpiVax’s approach as this therapy 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.”
"The endorsement, and more so the continued funding, by the National Institutes of Health of EpiVax's Tregitope program, is further validation of the promising research pioneered by Dr. De Groot and her colleagues and collaborators," said Richard G. Horan, managing director at the Slater Technology Fund. "Rhode Islanders have been well‐served by the support provided EpiVax from the Slater Fund in the company's early years. In addition to generating a return on the fund's investment, the company has generated over a decade of high value, high wage jobs funded by steadily increasing grants and contracts with pharmaceutical and biotech companies. It's a great example of academic innovation translating into robust economic development in biotechnology."
For more Health coverage, don't miss GoLocalTV, fresh every day at 4pm and on demand 24/7, here.
