Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Danish biopharmaceutical firm Bavarian Nordic has reported positive results from the first of two pivotal Phase III trials of the liquid-frozen formulation of Imvamune smallpox vaccine.
Subscribe to our email newsletter
The company said that the results support a biologics license application (BLA) for US approval of the vaccine.
A total of 4,000 vaccinia-naïve subjects were involved in the randomized, double-blind, placebo-controlled Phase III trial, of which 3,000 were vaccinated with three different manufacturing lots of the liquid-frozen Imvamune formulation, while 1,000 subjects received placebo.
According to the company, the three lots of Imvamune induced equivalent antibody responses, meeting the primary endpoint of the study, while the favorable safety profile of Imvamune was confirmed in this largest clinical study performed to date.
Additionally, the company had released results from a pivotal Phase II trial of freeze-dried Imvamune smallpox vaccine supporting the clinical requirements for an Emergency Use Authorization, which would allow for stockpiling of this next-generation of the vaccine.
The Phase II trial compared the safety and immunogenicity of a freeze-dried and a liquid-frozen formulation of Imvamune and involved 650 vaccinia-naïve healthy subjects who were randomized to receive either formulation of Imvamune.
The company said that the freeze-dried vaccine induced an equivalent antibody response as the liquid-frozen version, meeting the primary endpoint of the trial.
Bavarian Nordic president and CEO Paul Chaplin said: "Completing this pivotal Phase II study is a significant step in the transition to the freeze-dried version of the vaccine, which provides a number of advantages for the future procurement and stockpiling, thereby broadening the commercial potential.
"We remain on track to complete the transfer of the manufacturing process which will enable us to start deliveries in 2016, as we look forward to continuing our successful long-standing collaboration with the US Government on their public health preparedness."
According to the company, the results provide the final clinical data required to support stockpiling of the freeze-dried version of Imvamune in the US Strategic National Stockpile.
Supported by a contract option of $22m exercised by the Biomedical Advanced Research and Development Authority (BARDA) in 2014, the company is currently working to transfer the freeze-drying process to a new manufacturing line with a larger commercial capacity.