EpiVax, Inc, a leader in the field of computational immunology, announced today that it has received a grant from the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), a division of the National Institutes of Health (NIH), to develop “Epi-13”, a novel therapeutic for the prevention and treatment of Type 1 diabetes, a devastating and chronic autoimmune disease that affects three million Americans.

NIDDK will provide EpiVax $600,000 over two years to reach proof-of-principle for the drug that will focus on the natural “regulatory T cells” and their protective role in the diabetes patient. The studies are anticipated to show that the drug reduces harmful immune responses to insulin-producing cells, preserving the body’s ability to make its own insulin.

“EpiVax is grateful to the NIH and other funding sources in allowing our scientific team to conduct further research on a treatment for a disease that affects the health of so many young persons.” said Dr. Annie De Groot, CEO and CSO of the company. “The grant from NIH will build on our current work funded by the Juvenile Diabetes Research Foundation (JDRF), and with these two sources of funding in-hand, we expect to be ready to consider clinical trials for treatment of juvenile diabetes, beginning in two to three years”.

"As antigen specific tolerance continues to be a major goal area in Autoimmunity for JDRF, the proposal from EpiVax presents a novel approach that could potentially generate or restore immune regulation in Type 1 diabetes and we are pleased to see the NIH/NIDDK follow-on funding to support this important project," said Teodora Staeva, Ph.D., Director of the Autoimmunity Program at JDRF.

The approach used by EpiVax is called “Antigen-Specific Adaptive Tolerance Induction (ASATI™)”; it specifically targets and reduces undesirable immune responses. EpiVax used its proprietary computer algorithms to identify the molecules that induce ASATI. Because ASATI uses the body’s own natural responses, this intervention has the potential to be far safer than immunosuppressive drugs that are now being studied. The promising treatment, called Epi-13, may have application to a broad range of auto-immune disorders. An article about Epi-13 has been accepted to the prestigious journal Blood and will be published later on this year.

EpiVax is pioneering the use of immunoinformatics for making safer, more effective human therapeutics. This approach also offers hope for individualizing therapies, also known as “immuno-pharmacogenomics”.

The EpiVax research program will be carried out in collaboration with Dr. David Scott of the University of Maryland and with Dr. Robert Smith of the Hallett Center for Diabetes and Endocrinology at Rhode Island Hospital. According to Dr. Smith, a leading expert in the treatment of Type 1 diabetes, “This research deals with a critically important clinical problem and the approach EpiVax is taking in developing new diabetes therapies holds great promise.”

About Type 1 Diabetes
Type 1 diabetes is an autoimmune disease in which a person’s pancreas stops producing insulin, a hormone that enables people to get energy from food. Type 1 diabetes usually strikes in childhood, adolescence, or young adulthood, but lasts a lifetime. People with type 1 diabetes must take multiple injections of insulin daily or continuous infusion of insulin through a pump just to survive. An estimated 3 million Americans are diagnosed with Type 1 diabetes today, and approximately 15,000 children and young adults are diagnosed with Type 1 diabetes every year. Taking insulin does not cure any type of diabetes nor prevent the possibility of its eventual and devastating effects: kidney failure, blindness, nerve damage, amputation, heart attack, and stroke.

About Epi-13
Epi-13 is a peptide that induces the body’s own natural regulatory T cells. When administered in conjunction with other antigens or protein immunogens, the response to these immunogens is diminished and altered if the antigen/immunogens are co-administered with Epi-13. Preliminary in vitro and in vivo studies indicate that the modification of the immune response is due to the induction of natural T reg cells.

About EpiVax
EpiVax, Inc. is dedicated to merging in vitro immunology research with bioinformatics to generate new therapeutics for cancer and autoimmune diseases as well as new vaccines for infectious diseases such as HIV, TB, and hepatitis. T cell epitope mapping, the selection of target peptides from any protein sequence, is a powerful resource for the development of novel protein therapeutics. EpiVax research shows that peptides chosen by EpiMatrix™ software are highly likely to provoke an immune response when presented to T cells. EpiVax tools can also accurately deimmunize proteins. For more information about EpiVax, please visit www.epivax.com.

About National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
The National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) conducts and supports research on many of the most serious diseases affecting public health. The Institute supports much of the clinical research on the diseases of internal medicine and related subspecialty fields, as well as many basic science disciplines. The Institute supports basic and clinical research through investigator-initiated grants, program project and center grants, and career development and training awards. The Institute also supports research and development projects and large-scale clinical trials through contracts. For more information about NIDDK, please visit https://www2.niddk.nih.gov/.

About Juvenile Diabetes Research Foundation (JDRF)
JDRF is the leading charitable funder and advocate of Type 1 (juvenile) diabetes research worldwide. The mission of JDRF is to find a cure for diabetes and its complications through the support of research. Type 1 diabetes is a disease which strikes suddenly and requires multiple injections of insulin daily or a continuous infusion of insulin through a pump. Insulin, however, is not a cure for diabetes, nor does it prevent its eventual and devastating complications which may include kidney failure, blindness, heart disease, stroke, and amputation.

Since its founding in 1970 by parents of children with type 1 diabetes, JDRF has awarded more than $1.16 billion to diabetes research, including more than $137 million in FY2007. In FY2007, the Foundation funded 700 centers, grants and fellowships in 20 countries. For more information about JDRF, please visit https://www.jdrf.org/.

About David Scott and Robert Smith
For more information on Dr. Smith’s pioneering work in diabetes, please visit. https://umf.brownmedicine.org/physician/bio.asp?ID=631. For information on Dr. Scott’s research, please visit https://microbiology.umaryland.edu/faculty/default.asp?ID=137.