The same week Bavarian Nordic A/S announced its preliminary Phase 1 results for Ebola Prime-Boost Vaccine, the company also announced results from the first of two pivotal phase 3 studies of the liquid-frozen formulation of IMVAMUNE supporting a Biologics License Application for US approval of its Smallpox vaccine.
In addition, the company announced results from a pivotal Phase 2 study 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 company said, “The Phase 3 was designed as a randomized, double-blind, placebo-controlled study in 4,000 vaccinia-naïve subjects. Three thousand subjects were vaccinated with three different manufacturing lots of the liquid-frozen IMVAMUNE formulation (1,000 subjects per lot) and compared to 1,000 subjects that received a placebo.”
“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,” Bavarian Nordic said, adding that, “Despite close cardiac monitoring of all subjects, no serious adverse reactions were reported among the 3,000 subjects vaccinated with IMVAMUNE, confirming the results of a smaller Phase 2 placebo controlled study that was recently published and clearly differentiates the safety profile of IMVAMUNE when compared to traditional smallpox vaccines (e.g. ACAM2000 approved in the US) that have recorded high rates of cardiac complications in healthy vaccinees (5.73 events per thousand immunizations.”
Bavarian Nordic said, “The Phase 2 study compared the safety and immunogenicity of a freeze-dried and a liquid-frozen formulation of IMVAMUNE and enrolled 650 vaccinia-naïve healthy subjects who were randomized to receive either formulation of IMVAMUNE. The freeze-dried vaccine induced an equivalent antibody response as the liquid-frozen version, meeting the primary endpoint of the study.”
Also, both formulations recorded a similar safety profile, confirming that the clinical data generated cumulatively in more than 7,600 vaccinated subjects is relevant for both formulations of IMVAMUNE., the company announced.
“The results provide the final clinical data required to support stockpiling of the freeze-dried version of IMVAMUNE in the US Strategic National Stockpile,” Bavarian Nordic stated.
“Supported by a contract option of $22 million exercised by the Biomedical Advanced Research and Development Authority (BARDA) in 2014, Bavarian Nordic is currently working to transfer the freeze-drying process to a new manufacturing line with a larger commercial capacity,” the company’s announcement stated, adding that, “These manufacturing activities remain on-track to be finalized this year, which is the final step towards meeting the regulatory requirements to stockpile the freeze-dried version of IMVAMUNE.”
Bavarian Nordic President and Chief Executive Officer Paul Chaplin, said, "Completing this pivotal Phase 2 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.”
Chapin assured that, “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."