Escherichia coli compositions and methods thereof
Inventors
Donald, Robert G. K. • Pan, Rosalind
Assignees
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Publication Number
US-12458689-B2
Publication Date
2025-11-04
Expiration Date
Abstract
This invention provides a polypeptide derived from E. coli or a fragment thereof, including compositions and methods thereof. In one embodiment, the compositions comprise a polypeptide derived from E. coli or a fragment thereof, and modified O-polysaccharide molecules derived from E. coli lipopolysaccharides or conjugates thereof. In a further aspect, the compositions further comprise modified O-polysaccharide molecules derived from Klebsiella pneumoniae or conjugates thereof.
Core Innovation
The document describes compositions and methods for eliciting an immune response against Escherichia coli and Klebsiella pneumoniae in a subject by administering an effective amount of a composition comprising two saccharide components. One component comprises an Escherichia coli-derived saccharide selected from Formula O1A, Formula O2, Formula O6: K2, Formula O6: K13, Formula O6: K15, Formula O6: K54, Formula O25b, and Formula O75, where n is an integer consisting of 31 to 100 in the Formula for each saccharide molecule. The other component comprises a saccharide derived from a Klebsiella pneumoniae type selected from O3, O4, O5, O7, O8, and O12.
The elicited immune response can include opsonophagocytic antibodies against Escherichia coli and can be protective against an Escherichia coli infection in the subject. Additional refinements specify inclusion of an Escherichia coli saccharide moiety comprising 3-deoxy-d-manno-oct-2-ulosonic acid (KDO).
Carrier protein conjugation is described for saccharides using a carrier protein conjugate concept with an enumerated list of carrier proteins, including CRM197 and toxin-related or detoxified toxin components. The disclosure additionally provides refinement options in which particular Klebsiella pneumoniae type saccharides, including Klebsiella pneumoniae type O4, are used.
Claims Coverage
1 independent claim is present in the partial content and contains 8 explicitly listed inventive structural features for the administered composition. The claim covers a method of eliciting an immune response against both E. coli and K. pneumoniae by administering an effective amount of a composition comprising specified E. coli-derived saccharides and specified K. pneumoniae-derived saccharides.
Administered dual-species saccharide composition for eliciting an immune response
A method of eliciting an immune response against Escherichia coli and Klebsiella pneumoniae in a subject by administering an effective amount of a composition comprising a saccharide derived from E. coli and a saccharide derived from a K. pneumoniae type.
E. coli saccharide with enumerated Formula O structures and n constraint
The E. coli-derived saccharide is selected from Formula O1A, Formula O2, Formula O6: K2, Formula O6: K13, Formula O6: K15, Formula O6: K54, Formula O25b, and Formula O75, wherein n is an integer consisting of 31 to 100 in the Formula for each saccharide molecule.
K. pneumoniae saccharide derived from selected O types
The K. pneumoniae-derived saccharide is selected from K. pneumoniae type O antigens consisting of O3, O4, O5, O7, O8, and O12.
KDO moiety in the E. coli saccharide
The E. coli saccharide includes a 3-deoxy-d-manno-oct-2-ulosonic acid (KDO) moiety.
Specific K. pneumoniae type O4 saccharide
The K. pneumoniae saccharide is derived from K. pneumoniae type O4.
Carrier protein conjugate selection for a K. pneumoniae saccharide
The carrier protein conjugated to a saccharide derived from K. pneumoniae is selected from a listed group of specific carrier proteins and toxin-derived fragments.
Immune response includes opsonophagocytic antibodies against E. coli
The immune response comprises opsonophagocytic antibodies against E. coli.
Protection from E. coli infection
The method generates an immune response that protects a subject from an E. coli infection.
The claim scope centers on combining a specifically defined E. coli-derived saccharide, with n from 31 to 100 and optional KDO, with a specifically defined K. pneumoniae saccharide from selected O types, optionally narrowed to type O4. The disclosure also covers immune-response characterization as opsonophagocytic antibodies against E. coli and protection from E. coli infection, with additional refinement through selected carrier protein conjugation options for K. pneumoniae saccharide conjugates.
Stated Advantages
Elicits an immune response against Escherichia coli and Klebsiella pneumoniae in a subject.
Generates an immune response that protects a subject from an E. coli infection.
Immune response comprises opsonophagocytic antibodies against E. coli.
Documented Applications
Use in a method of eliciting an immune response against Escherichia coli and Klebsiella pneumoniae in a subject.
Protection of a subject from an E. coli infection via an immune response generated by the administered composition.
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