Dynavax Technologies Corp and AstraZeneca AB have signed an amendment regarding the Research Collaboration and License Agreement they had previously established. The partnership stipulates that AstraZeneca will be responsible for the financial support of the phase 2a trial for Dynavax’s investigational drug for treatment of asthma, AZD1419, which will be conducted by Dynavax.
AZD1419 is a proprietary, second-generation TLR9 agonist CpG oligodeoxynucleotide designed for inhalation. The trial is meant to assess the compound’s safety and efficacy and the two companies are committed to accelerating the development process through the elimination of the phase 1b of the study, which was previously scheduled.
The beginning of the phase 2a trial is planned for the first quarter of the next year, and it will include asthma patients as part of the study. AstraZeneca will make a milestone payment upon its initiation. Dynavax may potentially receive up to $100 million milestone payments, as well as royalties for the product sales worldwide, while the company would also have the opportunity to co-promote drug in the US.
Given the encouraging results of the phase 1a study conducted with 45 healthy participants, the two companies advanced to the next stage of the potential disease-modifying therapeutic development process. The results of the study revealed the therapy to be safe compared to placebo when given in four weekly doses. AZD1419 was well tolerated by the volunteers as well, with no report of serious adverse events. In addition, other endpoints that included the evaluation of pharmacodynamics were met, with dose-dependent induction of interferon-regulated genes in sputum and blood cells.
Dynavax is a clinical-stage biopharmaceutical company that uses TLR biology to investigate and create novel vaccines and therapeutics for the treatment of infectious and inflammatory diseases and oncology. Its main investigational product is HEPLISAV-B, which is a hepatitis B vaccine for adults that is currently being studied in phase 3 trials.
AstraZeneca is an innovation-driven biopharmaceutical company focused on the treatment of cardiovascular, metabolic, respiratory, inflammation, autoimmune, oncology, infection and neuroscience diseases. The company recently conducted a study in collaboration with MedImmune that revealed that between 10 and 20% of COPD patients suffer from acute exacerbations of the disease due to a certain type of specialized immune cells called eosinophils that produce eosinophilic airway inflammation.