DNA vaccines for autoimmune diseases

Abstract

Autoimmune diseases represent a group of disorders in which there exists a large unmet medical need for effective treatments, but also where there exists a tremendous responsibility among physicians and drug developers to maintain adequate and acceptable patient safety. Several drugs have been approved and many others are about to be approved for the treatment of autoimmune diseases, but in pushing the envelope of therapeutic efficacy, concerns have been raised about the long-term safety of these new therapies. DNA vaccines provide a method of treating autoimmune diseases in a highly specific manner, and could therefore overcome these safety concerns while still maintaining comparable efficacy. The numerous reports of DNA vaccines in animal models of autoimmune diseases and results from three recent human trials of DNA vaccines in autoimmune diseases are reviewed here.

Keywords::

• autoimmune disease
• BHT-3009
• BHT-3021
• DNA vaccine
• multiple sclerosis
• Type 1 diabetes

Acknowledgements

Hideki Garren gratefully acknowledges the contributions of Stanford University colleagues Lawrence Steinman, William Robinson and PJ Utz, who were involved in the discovery and development of DNA vaccines for autoimmune disease, as well as all of the investigators involved in the clinical trials of BHT-3009 and BHT-3021.

Financial & competing interests disclosure

The Juvenile Diabetes Research Foundation has provided partial financial support for the BHT-3021 trial. Hideki Garren has received salary, stock and stock options from Bayhill Therapeutics, developers of BHT-3009 and BHT-3021. The author has no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

No writing assistance was utilized in the production of this manuscript.