News Release

EpiVax receives JDRF program funding to develop diabetes drug using natural 'regulatory' T-cells

Business Announcement

JDRF

October 25, 2007 (Providence, RI)--- EpiVax, Inc, a leader in the field of computational immunology, announced today that it has received funding from the Juvenile Diabetes Research Foundation (JDRF), the world’s largest charitable funder of Type 1 diabetes research, to develop “Epi-13,” a novel therapeutic for the prevention and treatment of type I diabetes, a devastating and chronic autoimmune disease that affects up to three million Americans today.

JDRF will provide EpiVax $351,000 for one year to provide a first 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.

“JDRF’s research funding provides an exciting opportunity to accelerate the proof of concept and commercial development of an immune-based therapy for Type 1 diabetes,” said Anne De Groot, M.D., President and CEO of EpiVax. “We hope to make it possible for persons living with diabetes to reduce insulin dependence and to live longer with fewer symptoms.”

“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,” said Teodora Staeva-Vieira, Ph.D., Director of the Autoimmunity Program at JDRF.

JDRF funds diabetes research across a range of scientific areas, including autoimmunity, regeneration, islet cell replacement, complications, and metabolic control. The agreement with EpiVax is a part of JDRF’s innovative Industry Discovery and Development Partnership program, through which JDRF partners with pharmaceutical, biotech, and medical device businesses who are looking to develop drugs, treatments, technologies, and other therapeutics leading to a cure, reversal, or prevention of type 1 diabetes and its complications.

In most patients with Type 1 diabetes, immune responses to the body’s insulin protein diminish insulin production; thus blood sugar is not properly regulated. The insulin protein can be produced in the laboratory and administered as therapy, but this requires frequent injections for life.

The approach used by EpiVax is called “Antigen-Specific Adaptive Tolerance Induction (ASATI™)” to specifically target and reduce 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.

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 Robert Smith of the Hallett Center for Diabetes and Endocrinology at Rhode Island Hospital. According to Dr. Smith, an 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.”

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About Type 1 Diabetes

Type 1 diabetes is an autoimmune disease in which the pancreas stops producing insulin, a hormone that enables people to convert food into energy. 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. As many as 3 million Americans have type 1 diabetes today, and approximately 30,000 children and adults are diagnosed 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 JDRF

JDRF was founded in 1970 by the parents of children with Type 1 diabetes -- a disease that strikes children, adolescents, and adults suddenly, makes them insulin dependent for life, and carries the constant threat of devastating complications. Since inception, JDRF has provided more than $1.16 billion to diabetes research worldwide. More than 85 percent of JDRF's expenditures directly support research and research-related education. JDRF's mission is constant: to find a cure for Type 1 diabetes and its complications through the support of research. For more information please visit www.jdrf.org For more information on Dr. Smith’s pioneering work in diabetes, please visit. http://umf.brownmedicine.org/physician/bio.asp?ID=631. For information on Dr. Scott’s research, please visit http://microbiology.umaryland.edu/faculty/default.asp?ID=137.

Contacts:

Andy Cutler, Cutler & Company, (401) 743-7842, andy@cutlerandcompany.com
Joana Casas, JDRF Media Relations, (212) 479-7560, mcasas@jdrf.org


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