Dynavax Technologies will now have global rights to continue the development of DV1179 and other TLR 7/9 inhibitors for all indications.
Under the terms of the agreement with GlaxoSmithKline, 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 up to 60 mg/week for eight weeks were well tolerated and the most frequent side effects were injection site reactions. However, DV1179 did not meet the pharmacodynamic goals related to reduction in interferon alpha-regulated genes. After the Phase Ib/IIa trial was completed, GlaxoSmithKline declined to exercise its option to license DV1179.
Non-clinical findings suggest that DV1179 may have utility in a range of other indications. Dynavax is actively evaluating opportunities for further development of this well-characterised therapeutic product candidate. Notably, promising results 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 non-alcoholic steatohepatitis (NASH). The company is also evaluating the potential of DV1179 in autoimmune diseases with localised rather than diffuse systemic manifestations such as scleroderma and dermatomyositis.
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