NIH Awards HIV Grant to Antigen Express for Novel T-Helper Cell-Expanding Virus Vaccine

WORCESTER, Mass. -- This $357,000 NIH Small Business Innovative Research (SBIR) award supports pre-clinical testing of a novel HIV DNA vaccine incorporating Antigen Express proprietary platform technology for boosting antigen-specific T-helper cell responses. The grant is provided by the NIAID (National Institute of Allergy and Infectious Diseases).

The grant funds pre-clinical studies for a priority use of this HIV DNA vaccine to induce potent immune responses capable of preventing HIV infection and eradicating HIV in infected individuals.

Antigen Express scientists have pioneered strategies for enhancing helper T-cell responses to DNA vaccines by controlling the function of the immunoregulatory Ii-protein. The grant was awarded to test a novel, patented mechanism to increase the potency and repertoire of antigenic epitopes in a classical HIV DNA vaccine.

The Ii protein normally blocks the antigenic peptide binding site of MHC Class II molecules at time of synthesis in the endoplasmic reticulum of antigen-presenting cells. By suppressing the Ii protein by antisense methods, peptides which are transported into the endoplasmic reticulum to be bound by MHC Class I molecules also become bound to and presented by MHC class II molecules. Many novel epitopes also become presented, and at higher concentrations.

Antigen Express scientists and collaborators already demonstrated at least a six-fold enhancement in the immune response to an HIV gp120 DNA vaccine. This grant will expand these studies toward the completion of pre-clinical work to enable a clinical trial.

Boosting the antigen-specific T-helper cell response is critical to getting strong, prompt humoral and cytotoxic T-cell response for complete and rapid control of infection. Antibodies bind to and neutralize infectious viral particles while cytotoxic T-cells attack host cells, which synthesize the virus, before the virus is released into the circulation. In addition to increasing the immunogenecity, T-helper responses also induce immunological memory, which is very important for long-term protection.

This Ii protein immunoregulating platform technology has been also been applied by Antigen Express scientists to cure murine prostate, renal cell, and colon tumors (under other NIH SBIR grants).

Also, this platform technology is being adapted to rapid development of a novel SARS DNA vaccine in collaboration Generex Biotechnology (NASDAQ:GNBT) . Antigen Express was founded in 1995 around the laboratory group of Robert Humphreys, MD, PhD, then-professor of medicine and pharmacology, and interim chair of pharmacology at the University of Massachusetts Medical School. Humphreys trained at Yale, the National Naval Hospital in Bethesda, and Harvard. The company operated in incubator of the Massachusetts Biotech Ideas until 1997 and has had nine NIH grants.

Antigen Express holds six US and several foreign Patents covering its proprietary technologies. Humphreys has more than 60 papers on mechanisms and drug leads for current Antigen Express products in development.

Source: Antigen Express, Inc.

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