According to the World Health Organization, asthma affects 300 million people worldwide. Asthma is a chronic disease of the lungs and is caused primarily by allergic inflammation of the airways.
Dynavax is developing AZD1419, a novel candidate drug for allergic asthma, under our worldwide collaboration with AstraZeneca. AZD1419 is a proprietary TLR9 agonist and represents a new strategy for the treatment of allergic respiratory diseases. Direct delivery of AZD1419 to an asthmatic patient’s lungs by inhalation is designed to modify the course of disease by changing the lung immune response to environmental allergens, such as house dust and pollens, leading to a prolonged reduction in asthma symptoms. By contrast, the current mainstays of asthma therapy, corticosteroids and bronchodilators, are only able to transiently control disease activity or briefly relieve asthma symptoms, but do nothing to address the underlying allergic disease. Preclinical studies conducted by Dynavax and AstraZeneca, have shown that AZD1419 is capable of producing long lasting disease-modifying effects in a mouse model of atopic asthma (Campbell, Kell, et al. 2014.)
Clinical Studies with DV281:
Dynavax has completed a Phase 1 study assessing the safety of AZD1419 in healthy adult subjects (Jackson, Candia et al. 2018). A Phase 2 study in patients with eosinophilic, moderate to severe asthma is currently being conducted
Title: AZD1419 Ph2a Study (INCONTRO)
Status: Active, not recruiting
More Information: ClinicalTrials.gov Identifier: NCT02898662
Collaboration Agreement with AstraZeneca
AZD1419 was discovered by Dynavax and is being developed by AstraZeneca for the treatment of asthma pursuant to a collaboration established in late 2006. AZD1419 is designed to change the basic immune response to environmental allergens, such as house dust and pollens, leading to prolonged reduction in asthma symptoms by converting the response from one primarily mediated by type-2 helper T cells to type-1 helper T cells. A Phase 1a study of AZD1419 demonstrated its safety and tolerability in healthy subjects. The study also demonstrated dose-dependent induction of genes by endogenous interferon, as measured in sputum, indicating presence of the drug at the target site and target engagement. AstraZeneca is conducting a Phase 2a trial in asthma patients. Dynavax is eligible to receive development milestone payments if additional trials are initiated, royalties on worldwide sales of approved products and has the option to co-promote the product in the United States.