Dynavax Technologies has regained full rights to DV1179, an investigational bifunctional inhibitor of toll-like receptors (TLR) 7 and 9.
This resulted from the expiration of the Research and Development Collaboration and License Agreement with GSK originally executed in 2008.
Dynavax will now have global rights to continue the development of DV1179 and other TLR 7/9 inhibitors for all indications.
Under the collaboration, Dynavax conducted a Phase 1 study of DV1179 to assess 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 (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.
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