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news.Dynavax Technologies has regained full rights to DV1179, an investigational bifunctional inhibitor of toll-like receptors (TLR) 7 and 9, after the expiration of the research and development (R&D) collaboration and license deal with GlaxoSmithKline (GSK).
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At present, Dynavax has global rights to continue the development of DV1179 and other TLR 7/9 inhibitors for all indications.
As part of the deal, Dynavax carried out a Phase I trial of DV1179 to evaluate its safety and tolerability in healthy volunteers followed by a Phase Ib/IIa trial of safety and pharmacodynamics in patients with active systemic lupus erythematosus (SLE).
In the SLE trial, doses of up to 60mg/week for eight weeks were well tolerated and the most common adverse events observed were injection site reactions.
The company said that in this trial, DV1179 did not meet the pharmacodynamic endpoints related to reduction in interferon alpha-regulated genes.
After completion of the Phase Ib/IIa trial, GSK declined to exercise its option to license DV1179.
The nonclinical data suggest that DV1179 may have utility in a range of other indications and Dynavax is actively evaluating opportunities to further develop this well-characterized therapeutic product candidate.
The company said that promising data have been generated in animal models of sterile inflammation, suggesting potential use of TLR 7 and 9 inhibitors, such as DV1179, in treatment of conditions including autoimmune pancreatitis and nonalcoholic steatohepatitis (NASH).
The company is also evaluating the potential of DV1179 in autoimmune diseases with localized rather than diffuse systemic manifestations such as scleroderma and dermatomyositis.