Results for Dynavax’s (NASDAQ:DVAX) Heplisav Phase 3 trial are due out imminently and the event could be a big stock-moving event for Dynavax. William Blair recently said that it believes that there is 95% probability of success in the trial and that the results will serve as a strong catalyst to the stock. If the trial goes as planned, the company will file its BLA by the end of the year.
The company’s announcement on May 25 set the catalyst in motion. Dynavax reported completing the 12-month follow-up on all of the 2,449 subjects enrolled in its large-scale Phase 3 study of Heplisav evaluating immunogenicity in comparison to Engerix, lot-to-lot consistency and safety. With the study's completion, Dynavax said it expected to be in a position to report results within eight weeks. The 8 week mark is July 20.
Heplisav is an investigational adult hepatitis B vaccine. The vaccine candidate is being evaluated in two Phase 3 studies that are directed toward fulfilling licensure requirements in the U.S., Canada and Europe. In an earlier completed pivotal Phase 3 trial, Heplisav demonstrated increased, rapid protection with fewer doses than current licensed vaccines. Dynavax has worldwide commercial rights to Heplisav and is developing the vaccine for large, high-value populations that are less responsive to current licensed vaccines, including individuals with chronic kidney disease. Heplisav combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist known as ISS to enhance the immune response.
The results for the first Phase 3 study were released in June 2009. In addition to meeting its primary endpoint in this Phase 3 trial, Heplisav provided more rapid and increased seroprotection against hepatitis B viral infection and with fewer doses than the licensed vaccine. The data showed the differences to be particularly significant in the subset of subjects over 40 years of age who are usually less likely to respond to immunization.
This Phase 3 trial referred to as PHAST (Phase 3 HeplisAv Short-regimen Trial) evaluated more than 2,400 adults. The seroprotection rate at the primary endpoint was 95% in subjects receiving 2 doses of Heplisav at 0 and 1 month, compared to 81% in subjects receiving 3 doses of licensed vaccine Engerix-B(R) at 0, 1, and 6 months. In a subanalysis of subjects over 40 years of age, at each time point during the trial there was a statistically significant (p < 0.0001) difference in the seroprotection rate for subjects receiving Heplisav or Engerix-B. The safety results from the trial demonstrated the safety profile of Heplisav and Engerix-B appeared similar.
The total worldwide market for adult monovalent hepatitis B vaccines is estimated to exceed $400 million annually. Current vaccines leave unmet needs for more rapid and increased protection, particularly for less responsive, underserved populations.
The chronic kidney disease market is a high-value segment, the chronic kidney disease market is large, growing rapidly, and is widely recommended for vaccination. In 2008, there were approximately 750,000 end-stage renal disease (ESRD) patients in the United States and major European markets and approximately 150,000 new patients are added annually. Approximately 35% of these immunocompromised ESRD patients do not respond to vaccination and approximately 27-43% require boosters. As vaccination for these patients occurs regularly at dialysis centers, this is a concentrated, renewable market that can be served by cost-effective, targeted sales distribution networks.
As of March 31, 2011, the company had cash $53.2 million, restricted cash of $0.7 million and working capital of $44.4 million. The firm then estimated that it has sufficient cash resources to meet its anticipated cash needs through the next 12 months.