Benzinga | Jan 7, 2021 08:05AM EST

Dynavax Announces Final Immunogenicity And Interim Safety Results From Clinical Trial Evaluating HEPLISAV-B In Patients Undergoing Hemodialysis

EMERYVILLE, Calif., Jan. 7, 2021 /PRNewswire/ -- Dynavax Technologies Corporation (NASDAQ:DVAX), a biopharmaceutical company focused on developing and commercializing vaccines, today announced final immunogenicity and interim safety results of the ongoing clinical trial evaluating HEPLISAV-B(r) [Hepatitis B Vaccine (Recombinant), Adjuvanted] in patients undergoing hemodialysis.

Final immunogenicity data in 119 patients in this clinical trial evaluating a 4-dose regimen of HEPLISAV-B in adults with end-stage renal disease (ESRD) undergoing hemodialysis, demonstrated a seroprotection rate of 89.3% with high levels of anti-HBs antibodies, which are critical to maintain protection in patients undergoing hemodialysis. Interim safety data showed HEPLISAV-B is well tolerated and no safety concerns were observed. Full safety data are expected by the end of 2021.

"We are pleased with these positive results from the ongoing hemodialysis trial which reinforce the existing clinical data regarding the safety and ability of HEPLISAV-B to provide high rates of protection," commented Robert Janssen, MD, Chief Medical Officer at Dynavax. "We believe the 4-dose regimen of HEPLISAV-B, we are evaluating in this study, can provide an important hepatitis B vaccination alternative for patients undergoing hemodialysis by delivering high levels of protection with fewer doses compared to the current standard of care which requires up to 8 injections to complete the regimen."

The study, HBV-24, is an ongoing, open-label, single-arm trial being conducted in the United States to evaluate a new 4-dose regimen of HEPLISAV-B in adults with ESRD who are undergoing hemodialysis and have not previously received a hepatitis B vaccine. The study is designed to evaluate the immunogenicity of HEPLISAV-B at study week 20 and safety over the 68-week study duration. Safety and effectiveness of HEPLISAV-B have not been established in adults on hemodialysis.

Please see Important Safety Information below.

For more information about HEPLISAV-B, visit http://heplisavb.com