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Publication Number
US-11957724-B2
Publication Date
2024-04-16
Expiration Date
Abstract
The present invention relates to bacteriophage therapy. More particularly, the present invention relates to novel bacteriophages having a high specificity against Escherichia coli strains, their manufacture, components thereof, compositions comprising the same and the uses thereof in phage therapy.
Core Innovation
The document describes antibacterial compositions for Escherichia coli (E. coli) that include at least one lytic bacteriophage and a pharmaceutically acceptable excipient or carrier. The bacteriophage is selected so that its genome comprises a nucleotide sequence selected from SEQ ID NOs: 1 to 15 or a sequence having at least 99% identity thereto, and the excipient or carrier comprises a preservative in an amount effective to preserve the activity of the bacteriophage.
The core invention also specifies lytic bacteriophages and related antibacterial compositions for treating and improving outcomes in mammals, including compositions suitable for an E. coli infection and for modifying microbial flora. The compositions are defined using genome sequence criteria based on SEQ ID NOs: 1 to 15 and high-identity variants, and they are configured to provide lytic activity to an E. coli strain.
In addition, the document extends the use of the defined bacteriophage compositions to decontaminating materials contaminated with an E. coli strain, and to methods that predict or determine efficacy and susceptibility to bacteriophage therapy. Such methods involve determining in vitro lytic activity of a composition comprising at least one selected bacteriophage against an E. coli strain from a subject sample, followed by treating the subject when the lytic activity is determined.
Claims Coverage
The document includes independent claims covering an antibacterial composition and multiple uses and methods: treatment of a mammal, modifying microbial flora, decontaminating contaminated materials, preparing the composition, predicting or determining efficacy, and selecting or determining subject susceptibility. Across these independent claims, the inventive coverage centers on lytic bacteriophages against E. coli defined by genome nucleotide sequences from SEQ ID NOs: 1 to 15 or at least 99% identity variants and, for the composition, a preservative-containing pharmaceutically acceptable excipient or carrier.
Sequence-defined lytic E. coli bacteriophage composition with preservative carrier
An antibacterial composition comprising at least one bacteriophage having lytic activity to an Escherichia coli (E. coli) strain and a pharmaceutically acceptable excipient or carrier; the bacteriophage selected from those having a genome comprising a nucleotide sequence selected from any one of SEQ ID NOs: 1 to 15 or a sequence having at least 99% identity thereto; and the excipient or carrier comprising a preservative in an amount effective to preserve the activity of the bacteriophage.
Mammal treatment using sequence-selected lytic E. coli bacteriophage composition
A method of treatment of an infection in a mammal in need thereof, comprising administering to the mammal infected with an Escherichia coli (E. coli) strain an antibacterial composition in an amount effective to treat the E. coli infection, wherein said composition comprises at least one bacteriophage having lytic activity to the E. coli strain and said at least one bacteriophage being selected from the bacteriophages having a genome comprising a nucleotide sequence selected from any one of SEQ ID NOs: 1 to 15 or a sequence having at least 99% identity thereto.
Modifying mammalian microbial flora using sequence-selected lytic E. coli bacteriophage composition
A method for improving the condition of a mammal by modifying the microbial flora thereof, comprising administering to the mammal an effective amount of an antibacterial composition, wherein said composition comprises at least one bacteriophage having lytic activity to an Escherichia coli (E. coli) strain; said at least one bacteriophage being selected from the bacteriophages having a genome comprising a nucleotide sequence selected from any one of SEQ ID NOs: 1 to 15 or a sequence having at least 99% identity thereto; and said microbial flora comprises the E. coli strain.
Decontaminating E. coli-contaminated material using sequence-selected lytic E. coli bacteriophage composition
A method for decontaminating a material, comprising exposing the material to an amount of an antibacterial composition effective to decontaminate the material, wherein said composition comprises at least one bacteriophage having lytic activity to an Escherichia coli (E. coli) strain; said at least one bacteriophage being selected from the bacteriophages having a genome comprising a nucleotide sequence selected from any one of SEQ ID NOs: 1 to 15 or a sequence having at least 99% identity thereto; and said material is contaminated with the E. coli strain.
Preparing sequence-selected lytic E. coli bacteriophage composition with preservative carrier
A method for preparing an antibacterial composition, comprising producing at least one bacteriophage having lytic activity to an Escherichia coli (E. coli) strain and combining at least said bacteriophage with a pharmaceutically acceptable carrier or excipient, said pharmaceutically acceptable excipient or carrier comprising a preservative in an amount effective to preserve the activity of the bacteriophage.
Predicting and determining efficacy using in vitro lytic activity of sequence-selected lytic E. coli bacteriophage composition
A method for predicting or determining the efficacy of a bacteriophage therapy in a subject and treating said subject, wherein the method comprises determining in vitro a lytic activity of a composition comprising at least one bacteriophage to an Escherichia coli strain from a sample of said subject, said at least one bacteriophage having lytic activity to an Escherichia coli (E. coli) strain and being selected from the bacteriophages having a genome comprising a nucleotide sequence selected from any one of SEQ ID NOs: 1 to 15 or a sequence having at least 99% identity thereto, and treating the subject with the composition when lytic activity to at least one Escherichia coli strain from said sample has been determined.
Selecting susceptible subjects using in vitro lytic activity of sequence-selected lytic E. coli bacteriophage composition
A method for selecting a subject or determining whether a subject is susceptible to benefit from a bacteriophage therapy and treating said subject, wherein the method comprises determining a lytic activity of a composition comprising at least one bacteriophage to an Escherichia coli strain from a sample of said subject, said at least one bacteriophage having lytic activity to an Escherichia coli (E. coli) strain and being selected from the bacteriophages having a genome comprising a nucleotide sequence selected from any one of SEQ ID NOs: 1 to 15 or a sequence having at least 99% identity thereto, and treating the subject with the composition when lytic activity to at least one Escherichia coli strain from said sample has been determined.
Across the independent claims, the claim coverage is anchored in sequence-defined lytic bacteriophages against E. coli using genome nucleotide sequences corresponding to SEQ ID NOs: 1 to 15 or at least 99% identity variants. The composition claim further requires a preservative-containing pharmaceutically acceptable excipient or carrier, and the method claims cover treatment, modifying microbial flora, decontaminating materials, preparing the composition, and conditional therapy based on in vitro lytic activity determined from subject samples.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
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