Dynavax Presents Phase 2 Clinical Data On Heplisav

At its initiation, the Phase 2 single blind study in chronic kidney disease patients called for the comparison of two different Heplisav regimens, a single-dose vaccine and a double-dose vaccine, at 0, 1, and 6 months.

A total of 41 subjects with progressive loss of renal function and between 40-70 years of age were enrolled. The vast majority of patients had received only the first two immunizations when the study was prematurely discontinued due to an FDA-imposed clinical hold on Heplisav. The clinical hold was subsequently removed.

In the poster entitled, ‘Safety and Immunogenicity of a Novel hepatitis B Vaccine Adjuvanted with Immunostimulatory Sequence (ISS) in Renal Predialysis and Dialysis Patients,’ Dynavax has presented safety and immunogenicity data for time points 4 weeks after the first immunization and 8 and 20 weeks after the second immunization.

Heplisav is currently being evaluated in a Phase 3 study in subjects with chronic kidney disease at multiple centers in the US, Canada and Germany. An additional Phase 3 study in subjects over the age of 40 is being conducted to demonstrate lot-to-lot consistency and complete the safety database for Heplisav. Dynavax anticipates submitting the initial BLA for Heplisav in 2011.

Tyler Martin, chief medical officer at Dynavax, said: “Chronic Kidney Disease patients undergoing hemodialysis are at high risk of HBV infection, are hyporesponsive to current HBV vaccines, and have a worse prognosis if infected with HBV. These results demonstrate that Heplisav can effectively protect this susceptible patient population.”