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Providence, RI, December 17, 2004—EpiVax, Inc, a leading provider of protein and genome analysis services, vaccine components, and vaccine candidates to researchers, government agencies, universities, and pharmaceutical companies, has been awarded a BioDefense Phase I Small Business Innovation Research (SBIR) grant by the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH), for developing a genome-derived, epitope-driven smallpox vaccine.

The NIAID/NIH award for $993,771 will be used to screen the genomes of variola (smallpox) and vaccinia (cowpox) for common elements, also known as epitopes that drive protective immunity. However, EpiVax researchers will not be using the actual smallpox virus in conducting their research.

Safer, Faster Smallpox Vaccine Development

Having successfully proven that EpiVax can accurately identify epitopes directly from genome data using proprietary bioinformatics tools, EpiVax will now have two years to prove these epitopes can be used to make a safe and effective smallpox vaccine. EpiVax specializes in developing vaccines based on filtering the genome sequence, and as a result, does not need to handle dangerous pathogens in its vaccine development programs. This new vaccine will be developed using molecular biology techniques, and will not involve working with the actual
smallpox virus.

“This project will again demonstrate our technique for making safer vaccines for the entire world.

What we learn from this project we plan to apply to the development of better vaccines for a range of infectious diseases, including avian flu” said Anne De Groot, M.D., President and CEO of EpiVax. “This grant also highlights the tremendous work being done in the fields of science and technology in the State of Rhode Island.” In September 2004, EpiVax was awarded a similar biodefense grant in the amount of $859,773 to develop a novel vaccine for Tularemia, an
agent that could also be used as a bioterrorism agent. Recently, EpiVax relocated and expanded its corporate and research headquarters within the “Jewelry District” of Providence, Rhode Island.

Smallpox – a presumed bioterror agent

This research project is supported by the NIAID’s new biodefense grant program.
(http://www2.niaid.nih.gov/biodefense/) In the 1970’s, the world was declared free of the naturally occurring form of the smallpox disease, with the last U.S. case reported in 1949.

Unfortunately, smallpox still poses a very real threat as a bioterror weapon—a threat that the majority of Americans under 30 years old have not been vaccinated against (Source: Vaccine Technology & Development News, November/December 2003). Smallpox is one of the most feared and potentially devastating of all bioterrorist agents for three reasons: (1) the virus is highly infectious when distributed by aerosol; (2) there is a high case fatality rate associated with
infection (30%) and (3) there is great potential for dissemination from person to person, which would amplify the impact of a terrorist event. Smallpox virus is also considered to be a significant threat because it can be manufactured in large quantities and can be stored for long periods of time. On average, each person infected with smallpox may infect three to five other people. Currently, there is no method to treat smallpox. Modern medication can only help to control the pain and fever (Source: http://www.smallpox.mil/).

About existing Smallpox vaccines

Smallpox (variola) immunity is achieved by vaccination with a live, related virus (vaccinia, or cowpox), using methods that were first described by Jenner in the late 1800’s. Newer versions of the Jenner vaccine are being developed by other biotech companies (Acambis, Dynport) but these vaccines are also based on live attenuated (weakened) vaccinia viruses. Because the smallpox vaccine is a live vaccine, the vaccine strain can be passed from person to person, which can be a significant problem for individuals who have immunosuppressive conditions, eczema, or autoimmune disease. Cardiac events including myocarditis and dilated
cardiomyopathy have been reported following smallpox immunization.

As a result of these complications, there is renewed interest in the development of new smallpox vaccines. EpiVax is the only biotech company using a bioinformatics approach to derive a safe new smallpox vaccine directly from the variola and vaccinia genomes.

For more information on smallpox, please visit:
http://www.hhs.gov/smallpox/ or
http://www.bt.cdc.gov/agent/smallpox/vaccination/facts.asp

About EpiVax:

Based in Providence, EpiVax, Inc. is dedicated to the Intelligent Design® of new vaccines and therapeutics. EpiVax merges in vitro immunology research with bioinformatics to generate new vaccines for infectious diseases such as HIV, TB, hepatitis and avian influenza, new therapeutics for cancer and autoimmune diseases, and new protein therapeutics for treatment of cancer and autoimmune diseases. Epitope mapping, the selection of target peptides from an antigen, is a powerful resource for the development of novel vaccines. EpiVax research shows that peptides chosen by EpiMatrix™ for synthesis and testing are highly likely to provoke an immune response when presented to T cells. Epitopes are the most concise piece of information required by the T cell to generate an immune response. EpiVax tools and products are improved versions of tools derived from research initially carried out at the TB/HIV Research Laboratory at Brown University. For more information of EpiVax, please visit www.epivax.com.