Dynavax and AstraZeneca to Advance TLR-9 Agonist Into Clinic for Asthma

Dynavax Technologies Corporation and AstraZeneca have amended their existing Collaboration Agreement to accelerate the initiation of clinical development of AZD 1419, a proprietary second-generation TLR-9 agonist for asthma.

Dynavax will manage the early clinical development on behalf of the collaboration, and development expenses will be fully funded by AstraZeneca. Dynavax will receive an initial payment of $3 million to begin the clinical program.

Under the terms of the 2006 research collaboration and license agreement and as now amended, AstraZeneca will provide to Dynavax approximately $20 million in payments to cover the cost of clinical development activities through Phase 2a.

If AstraZeneca chooses to advance the program following completion of Phase 2a, Dynavax will receive a $20 million milestone payment, and AstraZeneca will retain its rights to develop the candidate therapy and to commercialize the resulting asthma product.

Additional remaining milestone payments to Dynavax amount to nearly $100 million. Dynavax will receive royalties on worldwide sales of approved products and will have the opportunity to co-promote the product in the United States.

AZD 1419 has been selected as the lead clinical candidate to enter formal clinical development based on extensive preclinical studies conducted by Dynavax and AstraZeneca.

These include demonstration that AZD 1419 is capable of producing long lasting disease-modifying effects in a mouse model of atopic asthma. Initiation of a Phase 1 study is planned after regulatory requirements are met and clinical materials are released.

According to Maarten Kraan, Vice President, Head of Respiratory & Inflammation, AstraZeneca Research and Development, "New approaches to asthma that have the potential to modify the course of severe respiratory disease represent a significant clinical need. We believe that Dynavax's TLR-9 agonist has potential as an innovative, next-generation therapy that could expand and strengthen our respiratory franchise."

Dino Dina, M.D., Dynavax's Chief Executive Officer, commented, "The success of this collaborative effort confirms once more the potential of our TLR-9 based therapies. The candidate molecule represents a therapy that has been shown preclinically to modify the course of asthmatic disease and produce long term remissions. With AstraZeneca's financial support and commitments to success milestones, we can now extend our clinical portfolio with a highly innovative and differentiated drug."