Dynavax Reports Progress In Lupus Program With Inhibitor Of TLR7 And TLR9

Main Category: Lupus
Also Included In: Clinical Trials / Drug Trials;  Immune System / Vaccines
Article Date: 27 Nov 2007 - 0:00 PDT

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In a paper appearing online in the December issue of The European Journal of Immunology (Vol. 37, Issue 12), Dynavax scientists report the results of studies made possible under a grant from the Alliance for Lupus Research (ALR). In the article entitled, "Treatment of lupus-prone mice with a dual inhibitor of TLR7 and TLR9 leads to reduction of autoantibody production and amelioration of disease symptoms", the data show that Dynavax's proprietary IRS 954, a specific inhibitor of two Toll-like receptors, TLR7 and TLR9, can prevent progression of disease when injected in the lupus prone (NZBxNZW)F1 mice. The authors observed a significant reduction of serum levels of nucleic acid specific autoantibodies, the hallmark of systemic lupus erythematosus. IRS 954 treatment also resulted in decreased proteinuria, glomerulonephritis and end-organ damage and increased survival, compared to untreated mice.

According to Robert L. Coffman, Ph.D., Vice President and Chief Scientific Officer, "These results show that the previously reported ability of IRS 954 to block IFN-alpha translates into reduced symptoms in an animal model of lupus. The data support our hypothesis that blocking both TLR7 and TLR9 in B cells and in human plasmacytoid dendritic cells is a promising new approach for the treatment of lupus. The ability of IRS 954 to specifically intervene in the inappropriate immune signaling cascade that leads to autoimmunity may have application for other autoimmune diseases as well."

IRS 954 represents a novel class of oligonucleotides, named immunoregulatory sequences (IRS), that specifically inhibit the TLR-induced inflammatory response implicated in disease progression in lupus. In 2005, the Alliance for Lupus Research awarded to Dynavax a $500,000 grant to explore new treatment approaches for systemic lupus erythematosus based on the company's novel IRS technology. The grant was the first time ALR had provided funding to a private company.

About Dynavax

Dynavax Technologies Corporation discovers, develops, and intends to commercialize innovative TLR9 agonist-based products to treat and prevent infectious diseases, allergies, cancer, and chronic inflammatory diseases using versatile, proprietary approaches that alter immune system responses in highly specific ways. Our TLR9 agonists are based on immunostimulatory sequences, or ISS, which are short DNA sequences that enhance the ability of the immune system to fight disease and control chronic inflammation. Our product candidates include: HEPLISAVTM, a hepatitis B vaccine in Phase 3 partnered with Merck & Co. Inc.; TOLAMBATM, a ragweed allergy immunotherapy in Phase 2; a therapy for non-Hodgkin's lymphoma (NHL) in Phase 2 and for metastatic colorectal cancer in Phase 1; and a therapy for hepatitis B also in Phase 1. Our preclinical asthma and COPD program is partnered with AstraZeneca. The National Institutes of Health (NIH) partially funds our preclinical work on a vaccine for influenza. Symphony Dynamo, Inc. (SDI) funds our colorectal cancer trials and our preclinical hepatitis C therapeutic program, and Deerfield Management has committed funding for our allergy programs. While Deerfield, NIH and SDI provide program support, Dynavax has retained rights to seek strategic partners for future development and commercialization. For more information, please visit http://www.dynavax.com.

This press release contains forward-looking statements that are subject to a number of risks and uncertainties, including statements about the potential for our IRS as an approach for the treatment of lupus and multiple autoimmune diseases. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including difficulties or delays in research and development and other risks detailed in the "Risk Factors" section of our Quarterly Report on Form 10-Q. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Dynavax Technologies Corporation
http://www.dynavax.com