Dynavax Technologies Corp. (DVAX) on Tuesday announced final data from a pivotal Phase 3 trial in patients with chronic kidney disease, or CKD, demonstrating early seroprotection and the durability of the immune response to hepatitis B vaccine Heplisav compared to Engerix-B.
In October 2011, Dynavax reported that the superiority endpoint had been met in this trial, which included 516 patients aged 18 to 75 years with CKD in the U.S., Canada and Germany. The patients received 3 doses of Heplisav at 0, 1 and 6 months or 4 double doses of Engerix-B at 0, 1, 2 and 6 months.
The final data showed that Heplisav provided seroprotection to 90 percent of patients compared to 82 percent for Engerix-B at the primary endpoint of 7 months, 1 month after the 3rd dose of Heplisav and the 8th dose of Engerix-B.
The vaccine provided seroprotection to more than twice as many patients at 2 months, 1 month after the 2nd dose of Heplisav and the 4th dose of Engerix-B.
The geometric mean concentration of antibody, which is commonly used to predict the duration of protection in patients with CKD, was around four-fold higher in the Heplisav group compared to the Engerix-B group.
In a separate trial, in CKD non-responder patients on hemodialysis who had failed to develop seroprotection after two or more previous vaccination series with the licensed vaccines, new data showed a higher seroprotection rate for Heplisav compared to Fendrix and Engerix-B.
Dynavax plans to submit a U.S. Biologics License Application for Heplisav by the middle of May for an indication in healthy adults 18-70 years of age for a 2-dose vaccination regimen at 0 and 1 month.
A supplemental BLA with an indication and 3-dose primary vaccination regimen for patients with CKD will be filed when the initial BLA is approved.
by RTT Staff Writer
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