GlaxoSmithKline (GSK) and Dynavax Technologies Corporation announced a worldwide strategic alliance to discover, develop and commercialise novel inhibitors of endosomal Toll-like Receptors (TLRs) for the treatment of immuno-inflammatory diseases. TLRs are key receptors of the innate immune system that can induce strong inflammatory responses.

Under the terms of the alliance, Dynavax will receive an initial payment of $10 million for which GSK will receive an exclusive option over four programmes targeting autoimmune and inflammatory diseases such as lupus, psoriasis, and rheumatoid arthritis.

"Our alliance with GSK provides an opportunity to create an entirely new product franchise for Dynavax," commented Dino Dina, president and chief executive officer of Dynavax. "Our TLR inhibitors have the potential to create significant value for our newest collaborator GSK as well as for our shareholders. Alliances with major pharmaceutical companies have enabled Dynavax to establish a diverse pipeline of innovative products, while contributing valuable cash for our programmes."

Dynavax is to conduct research and early clinical development in up to four programmes and is eligible to receive future potential development and commercialisation milestones totaling approximately $200 million per programme. GSK can exercise its exclusive option to license each programme upon achievement of proof-of-concept or earlier upon certain circumstances. After exercising its option, GSK will carry out further development and commercialisation of these products. Dynavax will receive tiered, up to double-digit royalties on sales and has retained an option to co-develop and co-promote one specified product.

Dynavax has pioneered a new approach to treating autoimmune and inflammatory diseases with its first-in-class oligonucleotide-based endosomal TLR inhibitors, called immunoregulatory sequences (IRS). Dynavax's lead inhibitor drug candidate, DV1079, is a bifunctional inhibitor of TLR7 and TLR9, and is expected to enter clinical development in the fourth quarter of 2009.

"We are committed to using our expertise, in collaboration with Dynavax, to research and develop new therapeutics that can improve the lives of patients with conditions like systemic lupus erythematosus, psoriasis and rheumatoid arthritis," commented Jose Carlos Gutierrez-Ramos, senior vice president and head of the Immuno-Inflammation Centre of Excellence for Drug Discovery at GSK. "Dynavax is a recognised pioneer in the scientific community for its innovation of endosomal TLR inhibitors which prevent immune signalling in autoimmune and inflammatory diseases."

Dynavax's endosomal TLR inhibitors are a novel class of oligonucleotides, called immunoregulatory sequences (IRS), that specifically inhibit the TLR-induced inflammatory response associated with autoimmune and inflammatory diseases.

Dynavax Technologies Corporation, a clinical-stage biopharmaceutical company, discovers and develops a diversified, well-funded pipeline of novel Toll-like Receptor (TLR) product candidates.