Dynavax Stock Soars: Shares up 55% on Ragweed Trial Results

The New England Journal of Medicine Reports Positive Results From Dynavax Technologies Corporation (DVAX) Ragweed Allergy Therapy Trial; Dynavax Stock Soars

BERKELEY, Calif.,-- The NEW ENGLAND JOURNAL OF MEDICINE (Vol. 355, October 5, 2006, No.14), today reported that a new approach to allergy therapy not only reduced the acute allergic responses of individuals with ragweed allergies but also sustained that effect for over 12 months. The novel treatment, called "AIC" in the paper, is a TLR9 agonist linked to ragweed allergen, developed by Dynavax Technologies Corporation .

Dr. Peter Creticos, principal investigator and lead author of the paper, entitled, "Immunotherapy with a Ragweed-Toll-like Receptor 9 Agonist Vaccine for Allergic Rhinitis," said that the pilot study "appears to offer a means of achieving long-term clinical efficacy in ragweed allergic rhinitis as the clinical effects suggest the induction of long-lasting disease modification. Furthermore, the demonstrated therapeutic properties and safety pave the way for a therapeutic intervention that is qualitatively superior to standard immunotherapy." Dr. Creticos is Associate Professor of Medicine and Clinical Director of the Division of Clinical Immunology of The Johns Hopkins University School of Medicine. He serves as Medical Director of the Johns Hopkins Asthma and Allergy Center in Baltimore, Maryland.

In the paper, Dr. Creticos pointed to statistically significant efficacy results including peak Nasal Symptom Complex Score (NSCS) reductions in AIC-treated patients of 55% (p=0.03) in 2001 which persisted through the 2002 ragweed season (53% reduction in NSCS, p=0.02) with no additional therapy. Additionally, the AIC-treated group used no relief medication at all during the second season, while placebo patients used antihistamines for 8 days (average) and decongestants for 4 days (average) of the two-week peak season. The intervention also generated clinically significant quality of life improvements for patients. Dr. Creticos added that the intervention was safely tolerated as no treatment-associated serious adverse reactions were reported, nor did any lab tests show abnormalities in the patients tested.


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. This is "bigtime news" and I hope the stock reflects this in the future. I will be in this as well.

BTW, there are numerous companies that use novel TLR agonists as drug therapies such as 3M, Coley and Anadys. Check them out.