Dynavax shares leap as US FDA lifts clinical hold on Heplisav

The US Food and Drug Administration has removed the clinical hold for Dynavax Technologies' Heplisav Investigational New Drug (IND) application in individuals with chronic kidney disease. The product is a Phase III investigational adult hepatitis B vaccine designed to provide increased, rapid protection with fewer doses than current licensed vaccines.

The FDA put Heplisav on hold last March after one patient developed a case of Wegener's granulomatosis, an inflammatory autoimmune disease that affects the small blood vessels and can cause extensive tissue damage. The news of the agency's change of stance will likely surprise investors, who had largely written off the vaccine, Heplisav. Last November the company's shares fell to 15 cents, down from more than $10.00 in late 2006. They rose to $3.35 in early trading on September 10 from a close of $1.75the previous day, the Reuters news service reported.

As a result of the FDA's decision, Dynavax says it now expects to initiate a Phase III trial in chronic kidney disease patients in the near-term. The firm also plans to initiate a Phase III lot-to-lot consistency trial in adults aged over 40 years in early 2010.

"The success of our scientific approach to resolving the clinical hold on Heplisav allows us to resume development of our enhanced hepatitis B vaccine," commented chief executive Dino Dina

Dynavax' global strategy as previously discussed with the FDA and the European Medicines Evaluation Agency (EMEA) is to develop Heplisav for populations that are less responsive to current licensed vaccines, including adults over 40 years of age, individuals with chronic kidney disease, and others.