Methods of preventing or treating anthrax using anti-anthrax antibodies
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Publication Number
US-8617548-B2
Publication Date
2013-12-31
Expiration Date
Abstract
The present invention provides an antibody which binds to B. anthracis with toxin, formulations for administration of such antibodies intramuscularly, and methods of administering such antibodies prophylactically or therapeutically.
Core Innovation
The invention relates to antibodies that bind Bacillus anthracis toxin, including protective antigen (PA), and neutralize Bacillus anthracis toxin with high affinity. The disclosed antibodies are optimized to provide specific binding characteristics and include antibody variable regions defined using amino acid residues in SEQ ID NO:1 and SEQ ID NO:2.
The problem addressed is the prevention of inhalation anthrax and the treatment of inhalation anthrax in a human subject after exposure to Bacillus anthracis spores. The disclosed approach is to administer an antibody that neutralizes Bacillus anthracis toxin together with at least one antibiotic in order to prevent the development of inhalation anthrax or to treat inhalation anthrax.
The document describes prophylactic administration prior to exposure and therapeutic administration after exposure. It further describes antibody components including deimmunization concepts, human Fc region, and IgG1 isotype concepts, and includes experimental evidence using a rabbit spore-challenge model and nonhuman primate pharmacokinetics.
Claims Coverage
The claim set includes three independent claims that cover intramuscular administration of an anti-Bacillus anthracis toxin antibody in combination with at least one antibiotic for prophylactic and therapeutic use. The core inventive features are the dual antibody-plus-antibiotic approach, the timing relative to exposure, and sequence-defined antibody variable regions.
Intramuscular anti-toxin antibody plus antibiotic to prevent inhalation anthrax after exposure
Administering intramuscularly a composition comprising an antibody which neutralizes Bacillus anthracis toxin to a human subject exposed to Bacillus anthracis spores, and further administering at least one antibiotic to prevent the development of inhalation anthrax, wherein the antibody includes the light chain variable region of amino acid residues 1-107 in SEQ ID NO:2 and the heavy chain variable region of amino acid residues 1-119 in SEQ ID NO:1.
Intramuscular anti-toxin antibody plus antibiotic to prevent inhalation anthrax prior to exposure
Administering intramuscularly a composition comprising an antibody which neutralizes Bacillus anthracis toxin to a human subject prior to exposure to Bacillus anthracis spores, and further administering at least one antibiotic to prevent the development of inhalation anthrax prior to exposure, wherein the antibody or binding molecule includes the light chain variable region of amino acid residues 1-107 in SEQ ID NO:2 and the heavy chain variable region amino acid residues 1-119 in SEQ ID NO:1.
Intramuscular anti-toxin antibody plus antibiotic to treat inhalation anthrax after exposure
Administering intramuscularly a composition comprising an antibody which neutralizes Bacillus anthracis toxin to a human subject exposed to Bacillus anthracis spores, and further administering at least one antibiotic to treat inhalation anthrax in the exposed subject, wherein the antibody comprises the light chain variable region of amino acid residues 1-107 in SEQ ID NO:2 and the heavy chain variable region of amino acid residues 1-119 in SEQ ID NO:1.
The claims center on intramuscular administration of an antibody that neutralizes Bacillus anthracis toxin together with at least one antibiotic to prevent inhalation anthrax before or after exposure, and to treat inhalation anthrax after exposure. The claims consistently require sequence-defined light and heavy chain variable regions.
Stated Advantages
Prevent the development of inhalation anthrax in a human subject exposed to Bacillus anthracis spores.
Prevent the development of inhalation anthrax in a human subject prior to exposure to Bacillus anthracis spores.
Treat inhalation anthrax in a human subject exposed to Bacillus anthracis spores.
Documented Applications
Prophylactic administration to prevent the development of inhalation anthrax in a human subject prior to exposure to Bacillus anthracis spores, in combination with at least one antibiotic.
Therapeutic administration to prevent the development of inhalation anthrax after exposure to Bacillus anthracis spores, in combination with at least one antibiotic.
Treatment of inhalation anthrax in a human subject after exposure to Bacillus anthracis spores, in combination with at least one antibiotic.
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