The Biomedical Advanced Research Development Authority (BARDA) has exercised a contract option to push on with development of Emergent BioSolutions’ PreviThrax™ (recombinant protective antigen anthrax vaccine, purified) rPA post-exposure anthrax vaccine. The firm says that since the contract was initiated in 2010 it has increased manufacturing yields over four-fold, generated a more flexible manufacturing process at its Baltimore site, and demonstrated stability for both liquid and dry formulations.
Emergent’s BioThrax is already the only FDA-approved vaccine for pre-exposure protection against anthrax. The firm’s Anthrax pipeline, which is being supported by U.S. Government funds, also includes the Phase III-stage polyclonal antibody product Anthrivig (human anthrax immunoglobulin), which is being studied for use against symptomatic anthrax infection. In contrast, PreviThrax is in development for post-exposure prophylaxis to prevent disease developing after exposure to spores of the infectious organism Bacillus anthracis.
Two additional Anthrax candidates are in Phase I development; NuThrax (anthrax vaccine adsorbed CPG 7909 adjuvant) and Thravixa™ (fully human anthrax monoclonal antibody), which is derived from an individual immunized with BioThrax and is being evaluated for use against symptomatic anthrax infection.
In June Emergent received an additional $8.43 million in BARDA funding to carry out a noninterference study that would support a post-exposure prophylaxis PEP indication for BioThrax. During the same month the two organizations agreed a public-private partnership that will establish a Center for Innovation in Advanced Development and Manufacturing. The center will work to facilitate advanced development of chemical, biological, radiological, and nuclear (CBRN) medical countermeasures, ensure domestic pandemic influenza vaccine manufacturing surge capacity, and provide workforce development training programs to address the U.S. government’s preparedness priorities and needs.