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Px563L is a next-generation recombinant protein subunit anthrax vaccine candidate developed to improve upon the safety and immunogenicity of currently licensed anthrax vaccines. It consists of a mutant recombinant protective antigen (mrPA; SNKE167-ΔFF-315-E308D) combined with a liposome-embedded monophosphoryl lipid A (MPLA) adjuvant. The vaccine is administered intramuscularly in two doses 28 days apart and has demonstrated good tolerability and robust immunogenicity in Phase 1 clinical trials. Px563L elicits protective toxin-neutralizing antibody responses that exceed thresholds associated with survival in animal models of Bacillus anthracis exposure. The product was originally developed by Pfenex using its proprietary expression technology platform and has been supported by the US Department of Health and Human Services for potential use as a medical countermeasure to meet Strategic National Stockpile requirements[1][2][4][5][7].
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