Dynavax, AstraZeneca To Advance AZD1419 Into Phase 2a Trial - Quick Facts

(RTTNews) - Dynavax Technologies Corp. (DVAX) announced the company and AstraZeneca AB 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, a second-generation TLR9 agonist, in patients with asthma. The company said the decision to accelerate the 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.

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. 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.