Dynavax Technologies and AstraZeneca signed an amendment to the existing Research Collaboration and License Agreement under which AstraZeneca will fully fund and Dynavax will conduct a Phase 2a safety and efficacy trial of AZD1419 in patients with asthma.
AZD1419 is a proprietary, second-generation TLR9 agonist CpG oligodeoxynucleotide formulated for inhalation use. The decision to accelerate this potential disease-modifying therapeutic into Phase 2, eliminating the previously planned Phase 1b study, was based on the positive results of a Phase 1a study in 45 healthy volunteers. The primary study objective was assessment of the safety of 4 weekly doses of AZD1419 or placebo. Ascending doses were well tolerated with no serious adverse events observed in treated subjects. Additional endpoints assessing pharmacodynamics were met, with dose-dependent induction of interferon-regulated genes in sputum and blood cells.
Dynavax intends to initiate the Phase 2a study in asthma patients in the first half of 2015 and a milestone is payable on its initiation. Remaining potential milestone payments to Dynavax total approximately $100 million. In addition, Dynavax will receive royalties on worldwide sales of any approved products resulting from the collaboration and will have the opportunity to co-promote in the United States.