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Nature Biotechnology Reports DNA Therapeutics as Powerful New Approach to Autoimmune Disease

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August 10, 2003
Business Editors/Health/Medical Writers
Source: Bayhill Therapeutics, Inc
Business Wire
Palo Alto, Calif.

By monitoring the highly specific proteomic "fingerprints" of autoantibody responses, a multi-disciplinary team from the Stanford University School of Medicine selected and then, tested disease- and patient-specific DNA "cocktails" in experimental autoimmune encephalomyelitis (EAE), a model for multiple sclerosis (MS), demonstrating the effectiveness of these novel therapeutics in reducing epitope spreading of autoreactive B cell responses. In an article published in the September issue of Nature Biotechnology, senior author Lawrence Steinman, M.D., Professor of Neurology and Neurological Sciences, Stanford University indicated that "epitope spreading" -- the expansion of the immune response beyond the initial target of attack -- is considered by many experts to be an essential step in the cascade that results in autoimmune disease, and opined that "through 'reverse genomics,' (the authors' approach could be used) to develop and tailor disease- and patient-specific tolerizing DNA vaccines for autoimmune diseases."

The research represents what the authors describe as "an integrated approach to treat autoimmune disease using proteomic analysis of the specificity of autoantibody responses to guide development of genetic tolerizing vaccines." The team developed antigen microarrays containing up to 2323 distinct antigens to study the evolution of B cell responses in EAE. Based on that information, the team concluded that the diversity of autoreactive B cell responses in acute EAE was predictive of disease severity, and created DNA cocktails encoding multiple array-determined myelin targets to improve clinical outcomes. As compared to control therapies, the relapse rate of animals treated with DNA cocktail alone or DNA cocktail plus IL-4 was significantly reduced.

Both MS and EAE, the experimental model of MS, include a relapsing-remitting pattern of disease activity, with periodic exacerbations of neurologic dysfunction that frequently lead to accumulating disability. The authors noted that epitope spreading may actually drive clinical relapses in the disease and the model, suggesting that the high sensitivity of their antigen arrays was responsible for improved understanding of the diversity and the specificity of the autoreactive B cell response, and these observations provided a strong foundation of knowledge upon which a new generation of DNA therapeutics for autoimmune disease can be developed. This work they said, "has the potential to revolutionize care for patients with autoimmune diseases by enabling identification of 'biosignatures' for diagnosis, prognostication, and guiding tolerizing therapy."

The Steinman et al. approach is the basis of much of the work at Palo Alto, CA-based Bayhill Therapeutics, a company focused on translating promising research in autoimmune disease into commercialized therapeutics. The company has established a therapeutic platform of autoimmune modulators, in-licensed, from Stanford University, as well as proprietary combination modulators. Dr. Steinman, along with William Robinson, M.D., Ph.D., of the Department of Neurology and Neurological Sciences at Stanford University; Hideki Garren, M.D., Ph.D., Director of Immunology and Molecular Biology at Bayhill; and Paul J. Utz, M.D., Assistant Professor of Medicine, Rheumatology and Immunology at Stanford University; founded the company. To date, Bayhill Therapeutics has demonstrated proof-of-concept with these antigen specific therapies (AIMTx(TM)), as well as in combination with two of more autoimmune modulators (AIM(TM)) in the EAE model of multiple sclerosis, the NOD model of insulin-dependent diabetes mellitus and the collagen-induced arthritis model of rheumatoid arthritis. The Company plans to enter clinical studies in the first half of 2004 with an antigen specific therapy (AIMTx(TM)) for the treatment of MS. As part of the clinical outcomes measures Bayhill intends to monitor the antibody responses correlated in the EAE work published in Nature Biotechnology.

About Bayhill Therapeutics, Inc.

Bayhill Therapeutics Inc. is focused on the translation of research into therapeutics for the treatment of autoimmune diseases. The company has established a therapeutic platform of autoimmune modulators, in-licensed from Stanford University, that address the broad market of Th1 mediated autoimmune diseases. The Company's initial disease focus is multiple sclerosis, with its first product (BHT- 3009) entering Phase I/II studies in the first quarter of 2004. In addition, the Company has a strong portfolio of product programs focused around individual agents with demonstrated proof of concept as autoimmune modulators (AIM(TM)), as well as in the combination of these modulators in a proprietary manner, AIMTx(TM).

More information on Bayhill Therapeutics Inc. can be found at www.bayhilltherapeutics.com.
 

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