Pipeline :: Autoimmunity / Inflammation

Dynavax has pioneered a new approach to treating autoimmune and inflammatory diseases with its oligonucleotide-based Toll-like Receptor (TLR) inhibitors, called immunoregulatory sequences (IRS). TLRs are key receptors of the innate immune system that can induce strong inflammatory responses. Under our worldwide strategic alliance with GSK, we are developing DV1179, a bifunctional inhibitor of TLR7 and TLR9. Our IRS program is focused on novel TLR inhibitors for diseases such as lupus, psoriasis, and rheumatoid arthritis.

In April 2011, we announced the start of dosing in the first human clinical trial in our lupus program. The Phase 1 study will assess the safety of DV1179 in multiple ascending doses. A total of 24 healthy subjects, divided into three dose groups, will each receive four weekly injections of DV1179. Data from this study is expected later this year. Following successful completion of the trial, Dynavax expects to initiate a proof-of-mechanism study in lupus patients.

In the June 16, 2010 issue of NATURE, Dynavax scientists showed that activation of cells of the innate immune system by two key receptors, TLR7 and TLR9, can cause glucocorticoid resistance in lupus patients. In the paper, "TLR Recognition of Self Nucleic Acids Hampers Glucocorticoid Activity in Lupus," the data also demonstrated that this resistance can be reversed by Dynavax's novel TLR7/TLR9 inhibitors in human blood cells and animal models of lupus.

Since late 2008, Dynavax and GlaxoSmithKline have had a worldwide strategic alliance to discover, develop, and commercialize novel TLR inhibitors. We are conducting research and early clinical development in up to four programs and are eligible to receive future potential development and commercialization milestones totaling approximately $200 million per program. GSK can exercise its exclusive option to license each program upon achievement of proof-of-concept or earlier upon certain circumstances. After exercising its option, GSK will carry out further development and commercialization of these products. We will receive tiered, up to double-digit royalties on sales and have retained an option to co-develop and co-promote one product.

Commercial Opportunity

Over 20 million individuals in the U.S. and Europe have autoimmune diseases such as lupus, psoriasis, and rheumatoid arthritis. Key biologic drugs used to treat these conditions generate over $15 billion in worldwide sales each year.

Our TLR inhibitors have demonstrated a highly targeted effect on key immune cells and pathways that play a role in multiple autoimmune and inflammatory diseases. In contrast, currently marketed and pipeline products are broadly immunosuppressive with variable efficacy and substantial toxicity.