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
dynavax.
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
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