By Emily Greenhalgh
PBN Web Editor
PROVIDENCE – EpiVax Inc. has been awarded an additional $300,000 small business innovation research grant from the National Institutes of Health’s National Institute of Allergy and Infectious Diseases, the company announced Friday.
The Phase II grant will fund the first year of a two-year program to study the application of Tregitopes – a set of peptides that suppress autoimmune disease, allergies and the immunogenicity of co-administered proteins – to Pompe disease.
Tregitopes, which were discovered in 2008 by EpiVax founder and CEO Dr. Anne S. De Groot and the company’s COO William Martin, act as a natural “off switch” in animal models and appear to reset the immune response away from autoimmunity and towards tolerance, normalizing blood sugar levels.
Babies born with Pompe disease lack the enzyme GAA and require life-long enzyme replacement therapy treatments. Because the enzyme in the treatments is a foreign protein, some babies can develop antibodies to the drugs.
When antibodies develop, the infants – known as “CRIM-positive” – need to be treated with a combination of immunosuppressive drugs to induce immunological tolerance to the therapy. According to EpiVax, the long-term effects of these immunosuppressive drug regimens are unknown.
The biotech company will use the $300,000 NIH grant to test Tregitopes in animal models and determine if they are viable for the future treatment of babies with CRIM-positive Pompe disease.
EpiVax recently received an additional SBIR award of $757,712 for the application of Tregitope to Hemophilia. In total, the company has received more than $3.4 million from the SBIR program, broken down as follows:
According to the NIH, Phase I grants are designed “to establish the technical merit, feasibility and commercial potential of the proposed R/R&D efforts and to determine the quality of performance of the small business awardee organization.” Phase II grants are designed “to continue the R/R&D efforts initiated in Phase I. Funding is based on the results achieved in Phase I and the scientific and technical merit and commercial potential of the project proposed in Phase II.”
According to a release, the surge in funding means new hires at the Providence-based biotech company, which is considering spinning off the Tregitope technology if angel or venture funding is made available.
“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,” Richard G. Horan, managing director at the Slater Technology Fund said in prepared remarks, adding that EpiVax was a “great example of academic innovation translating into robust economic development in biotechnology.”
Anticipated uses of Tregitope technology include induction of tolerance to co-administered protein drugs, a market worth more than $100 billion globally, as well as biotherapeautics, according to EpiVax. The company added that the Tregitopes technology may have broad applications in transplants and therapy for autoimmune disease.