Dynavax Initiates Proof of Mechanism Trial in Lupus Patients

Dynavax Technologies Corporation (NASDAQ: DVAX) announced today the initiation of a proof-of-mechanism clinical trial of the TLR7 and TLR9 inhibitor, DV1179, in systemic lupus erythematosus patients. Initiation of this trial entitles Dynavax to receive a $6 million milestone payment from GlaxoSmithKline (NYSE: GSK) under their worldwide strategic alliance. GSK has an exclusive option to obtain a license to the program following completion of this trial.

The first of two stages of the trial will evaluate ascending doses of DV1179 for safety and tolerability in SLE patients, each of whom will receive eight weekly injections of DV1179. The second stage of the trial will evaluate DV1179's mechanism of action via inhibition of type 1 interferon by enrolling additional SLE patients in selected dose groups. DV1179 was previously shown to be well-tolerated in a Phase 1 trial in healthy subjects.

"To begin the evaluation of DV1179 in lupus patients is an important achievement for Dynavax," said Tyler Martin, M.D., President and Chief Medical Officer at Dynavax. "Excessive production of type 1 interferons is thought to be a critical factor in the pathogenesis of lupus. At the completion of this trial, we will be able to determine if DV1179 can reduce interferon levels in lupus patients."