Dynavax/AstraZeneca Form Alliance to Develop TLR Drugs

BERKELEY, Calif., Sept. 6 /PRNewswire-FirstCall/ -- Dynavax Technologies Corporation (Nasdaq: DVAX - News) has entered into a research collaboration and license agreement with AstraZeneca for the discovery and development of TLR-9 agonist-based therapies for the treatment of asthma and chronic obstructive pulmonary disease (COPD). The collaboration will utilize Dynavax's proprietary second-generation TLR-9 agonist immunostimulatory sequences or ISS.

Under the terms of the agreement, Dynavax and AstraZeneca will collaborate to identify lead TLR-9 agonists and conduct appropriate research phase studies. AstraZeneca will be responsible for any development and worldwide commercialization of products arising out of the research program. Dynavax may also have the opportunity to co-promote in the United States products arising from the collaboration.

Financial terms of the collaboration include an upfront fee of $10 million plus research funding and preclinical milestones that could bring the total committed funding to $27 million, resulting in a total potential deal value of approximately $136 million. Upon commercialization, Dynavax is also eligible to receive royalties based on product sales.

"The management of respiratory diseases such as asthma and COPD remains a major health challenge affecting 150 million people worldwide and representing a significant financial burden to the global healthcare system," said Claude Bertrand, Vice President Respiratory and Inflammation Research at AstraZeneca. "New approaches that have the potential to reverse the course of respiratory disease are needed. AstraZeneca believes that Dynavax's ISS-based technology represents an innovative, next-generation therapeutic intervention that could potentially expand and strengthen AstraZeneca's strong position in the respiratory disease field."

"We believe that AstraZeneca is the ideal partner for the development of asthma and COPD ISS-based therapies, as they have one of the most widely respected and commercially successful respiratory product portfolios in the industry," said Dino Dina, MD, Dynavax's chief executive officer. "We appreciate AstraZeneca's recognition of the innovative, disease-modifying potential of our TLR-9 agonist based approaches and are optimistic that with our combined resources and know-how, we will be able to create novel therapeutics that may provide benefit to patients suffering from these diseases."

Continued Dr. Dina: "The clinical data generated by our four Phase 2 clinical trials for the treatment of ragweed-induced allergic rhinitis provide a strong foundation for applying ISS-based agonists to treat asthma and COPD. We are hopeful that this collaboration, the goal of which is to explore the potential of ISS alone to treat respiratory diseases, will help to expand our existing portfolio of ISS-based products."


So What does this mean? What are "TLRs" Anyway! --->About TLR-9 TLR is an acronym for Toll Like Receptor. Toll receptors were first characterized in the fly (Drosophilia) and more recently a related family of Toll like receptors in the vertebrate genome. They play a central role in innate immunity and are required for the adaptive immune response. [innate immunity is non-cell mediated, adaptive is mediated by cells of the immune system.] These receptors respond and recognize molecules from bacterial, viral and fungal pathogens. For example; if you eat bacterial contaminated food, the TLR receptors in your gut will recognize specific parts of the bacterial cell wall and essentially "yell for help". Other cells, such as natural killer and dendritic, then bolster the immune response by cytokine release.