Dynavax Regains Full Rights To DV1179, Investigational TLR 7/9 Inhibitor

(RTTNews) - Dynavax Technologies Corp. (DVAX) has regained full rights to DV1179, an investigational bifunctional inhibitor of toll-like receptors or TLR 7 and 9, resulting from the expiration of the Research and Development Collaboration and License Agreement with GSK originally executed in 2008. Dynavax would now have global rights to continue the development of DV1179 and other TLR 7/9 inhibitors for all indications.

As part of the collaboration, Dynavax conducted a Phase 1 trial of DV1179 to evaluate its safety and tolerability in healthy volunteers followed by a Phase 1b/2a study of safety and pharmacodynamics in patients with active systemic lupus erythematosus or SLE. In the SLE study, doses up to 60 mg/week for 8 weeks were well tolerated and the most common adverse events were injection site reactions, but DV1179 did not meet the pharmacodynamic endpoints related to reduction in interferon alpha-regulated genes. Following completion of the Phase 1b/2a study, GSK declined to exercise its option to license DV1179.

Nonclinical data suggest that DV1179 may have utility in a range of other indications and Dynavax is actively assessing opportunities for further development of this well-characterized therapeutic product candidate. Particularly, 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.

Further, Dynavax is assessing the potential of DV1179 in autoimmune diseases with localized rather than diffuse systemic manifestations like scleroderma and dermatomyositis.