|Dynavax Says Phase 3 Data on HEPLISAV; Novavax to Initiate Seasonal and Pandemic Influenza Trials|
|By Staff and Wire Reports|
|Tuesday, 24 September 2013 18:44|
Dynavax Technologies Corporation (NASDAQ: DVAX) announced immunogenicity and safety results of two Phase 3 trials (HBV-16 and HBV-17) of HEPLISAV(TM) investigational hepatitis B vaccine were published in the journal VACCINE accompanied by a Commentary from Drs. Stanley Plotkin and William Schaffner. The Commentary emphasizes the effect of 1018, the novel adjuvant contained in HEPLISAV, and concludes that the "results from these trials add to the body of evidence that 1018 can be an important new adjuvant for immunization against hepatitis B." These HEPLISAV data have been previously reported at medical conferences.
The article entitled "Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared to a licensed hepatitis B vaccine in healthy adults 40-70 years of age" by Dr. William Heyward and colleagues, describes the results from a Phase 3 clinical trial of HEPLISAV conducted in the US and Canada in over 2,400 subjects. The article concludes that HEPLISAV induced significantly higher seroprotection rates in all groups (including hyporesponsive populations) than the licensed comparator hepatitis B vaccine in a shorter two-dose schedule over one month while maintaining a similar safety profile.
The article entitled "Immunogenicity and safety of an investigational hepatitis B vaccine with a Toll-like receptor 9 agonist adjuvant (HBsAg-1018) compared with a licensed hepatitis B vaccine in patients with chronic kidney disease" by Dr. Robert Janssen and colleagues, describes the results from a Phase 3 clinical trial of HEPLISAV in over 500 participants with CKD in the US, Canada and Germany. The article concludes that three doses of HEPLISAV provided significantly higher seroprotection rates and earlier and more persistent seroprotection than the licensed comparator hepatitis B vaccine while maintaining a similar safety profile.
Novavax (Nasdaq: NVAX) a clinical-stage vaccine company, announced it is finalizing details on costs and timelines for their next round of clinical studies with the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) following successful completion of process improvement studies. Novavax is preparing to move forward with these next clinical trials for its quadrivalent seasonal influenza vaccine candidate and its pandemic influenza vaccine candidate, both under U.S. INDs. The pandemic study will include the use of Novavax' proprietary saponin-based adjuvant, Matrix-M™.
"Novavax is committed to moving these two vaccine candidates through to licensure. The clinical trials we have planned for 2014 are important steps in the completion of that goal," said Stanley C. Erck, President and Chief Executive Officer, "Given the shift in the global disease focus from the H5N1 avian influenza strain to the H7N9 avian influenza strain we have expanded our pandemic program to include H7N9. We are especially pleased with BARDA's interest in the development of both of our pandemic vaccine candidates with the Matrix-M adjuvant, along with our seasonal vaccine program."
About the Novavax BARDA Contract--In February 2011, Novavax was awarded a contract valued at up to $179 million by BARDA for the advanced development of recombinant influenza vaccine products and manufacturing capabilities for pandemic preparedness. Throughout the contract's 3-year base period, valued at $97 million, Novavax has been developing and testing its novel recombinant virus-like particle (VLP) influenza vaccines to address BARDA's commitment to advancing recombinant-based technology as a component of pandemic preparedness. Upon satisfaction of established milestones, the contract can expect to be extended for an additional 24 months, upon execution by BARDA of an Option One period, valued at $79 million in additional funding. The milestones under the Option One period would focus on completion of the pathway to product licensures from the U.S. Food and Drug Administration (FDA), including support for manufacturing scale-up. There is an additional contract option for vaccine production ($3 million).
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