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GEN News Highlights : Feb 18, 2010

Dynavax and GSK Choose Clinical Candidate from Endosomal TLR Inhibitor Program

Bifunctional TLR inhibitor could move into Phase I trials later this year.

Dynavax and GlaxoSmithKline (GSK) confirmed the selection of a clinical candidate from their endosomal toll-like receptor (TLR) inhibitor alliance. The molecule called DV1179 is a bifunctional TLR inhibitor that could start in clinical development later this year, the firms suggest. IND-enabling preclinical work is currently in progress.

Dynavax and GSK initiated their multiprogram partnership to develop inhibitors of endosomal TLRs in 2008. The will focus on autoimmune diseases and inflammatory disorders, such as lupus, psoriasis, and rheumatoid arthritis.

The collaboration is based on Dynavax’ immunoregulatory sequence oligonucleotides, which are designed to specifically inhibit the TLR-induced inflammatory response associated with autoimmune and inflammatory diseases. Under the terms of the deal, Dynavax is carrying out research and early clinical development on up to four programs.

GSK has an exclusive option to license each program on the achievement of proof-of-concept or earlier in certain circumstances. Once GSK has licensed a candidate it will be responsible for all further development and commercialization. In addition to its initial $10 million fee, Dynavax is eligible to receive development and commercialization milestones totaling approximately $200 million per program.