Dynavax Technologies has announced that the company and AstraZeneca have signed an amendment to their existing research collaboration and license agreement under which, based on the strategic priorities of the two companies, AstraZeneca will now conduct a Phase IIa safety and efficacy trial of AZD1419 in asthma patients that was originally to be conducted by Dynavax.
In a previously reported Phase Ia study of the safety of 4 weekly doses of AZD1419 compared with a placebo in 45 healthy volunteers, 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.
On the basis of these encouraging results, the companies decided to bypass a planned Phase Ib trial and proceed to Phase IIa, a study that was to be conducted by Dynavax. As trial design progressed, AstraZeneca elected, with Dynavax’s full support, to conduct the study in house, consistent with AstraZeneca’s commitment to respiratory disease, one of the company’s three main therapy areas, and Dynavax’s increasing strategic focus on vaccines and immuno-oncology.
“Our partnership with AstraZeneca is focused on the advancement of AZD1419. This amendment will promote that objective by leveraging AstraZeneca’s expertise in international clinical development of respiratory products,” said Eddie Gray, Chief Executive Officer of Dynavax.
AZD1419 is a proprietary, second-generation TLR9 agonist CpG oligodeoxynucleotide formulated for inhalation use. The Phase IIa study is planned to be initiated in 2016. For more information on this project, click here.