Glycoconjugate vaccines comprising basic units of a molecular construct expressing built-in multiple epitopes for the formulation of a broad-spectrum vaccine against infections due to enteropathogenic bacteria
Inventors
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Assignees
Member
BiosYnth s.r.l.BiosYnth s.r.l. is a biotechnology firm specializing in the research, development, and innovation of bacterial and viral vaccine platforms. With over 40 years of expertise, the company focuses on glycoconjugate, nanostructured vector, and synthetic peptide technologies to address invasive infectious diseases and antibiotic resistance. Operations comply with GLP and GMP standards and are supported by a robust patent portfolio and international collaborations.
BiosYnth s.r.l. is a biotechnology firm specializing in the research, development, and innovation of bacterial and viral vaccine platforms. With over 40 years of expertise, the company focuses on glycoconjugate, nanostructured vector, and synthetic peptide technologies to address invasive infectious diseases and antibiotic resistance. Operations comply with GLP and GMP standards and are supported by a robust patent portfolio and international collaborations.
Publication Number
US-10500263-B2
Publication Date
2019-12-10
Expiration Date
Abstract
The present invention refers to new glycoconjugate antigens expressing built-in multiple epitopes and to polyvalent glycoconjugate vaccines intended for the protection of mammalians, and particularly for the protection of the human population from enteropathogenic bacteria, such as the Gram-positive anaerobic bacterium Clostridium difficile and the Gram-negative bacteria Salmonella typhi, Escherichia Coli, Vibrio Cholerae, Shigella flexneri, Salmonella typhimurium, Salmonella enteritidis, Salmonella paratyphi A, Shigella sonnei, Shigella dysenteriae, Salmonella cholerasuis, Klebsiella, Enterobacter, Pseudomonas aeruginosa and/or from viral gastrointestinal infections due to human noroviruses.
Core Innovation
The invention relates to an antigenic multivalent molecular construct for a broad-spectrum enteric vaccine. It is formed from helper-T dependent carrier detoxified proteins selected between Enterotoxoid A and Cytotoxoid B from Clostridium difficile covalently bound to at least three carbohydrate structures from enteropathogenic bacteria. The carbohydrate structures include at least one repeating basic epitope consisting of a minimum of five to twelve monosaccharide residues, and each carbohydrate structure contributes different serological specificity.
The construct requires a molar relationship in which at least one mole of carrier protein is bound to at least one mole of each of the at least three carbohydrate structure or their molar sum. The carbohydrate structures are selected between bacterial polysaccharides or detoxified lipopolysaccharides of different serological specificity, with the antigenically defined repeating epitopes serving as carried carbohydrate structures.
The invention further addresses detoxified carrier and carbohydrate compatibility, including detoxified proteins and detoxified lipopolysaccharides/endotoxoids. Detoxified lipopolysaccharides are provided by clearing Lipid A through cleavage of the Lipid A moiety or by saturating the Lipid A-binding site using Synthetic Anti-Endotoxin Peptides (SAEP). Conjugation is described as covalent formation between carrier amino groups and derivatized carbohydrates to form carried antigenic multivalent constructs containing repeating basic epitopes.
Claims Coverage
The patent includes one independent claim. It defines a multivalent antigenic construct built from helper-T dependent carrier detoxified proteins covalently bound to at least three carbohydrate structures from enteropathogenic bacteria with different serological specificities, using repeating basic epitopes of five to twelve monosaccharide residues and a defined carrier-to-carbohydrate molar binding relationship.
Helper-T dependent carrier detoxified proteins covalently bound to at least three carbohydrate structures of different serological specificity
An antigenic multivalent molecular construct comprising helper-T dependent carrier detoxified proteins selected between Enterotoxoid A and Cytotoxoid B from Clostridium difficile covalently bound to a minimum of three carbohydrate structures from enteropathogenic bacteria selected between bacterial polysaccharides or detoxified lipopolysaccharides of different serological specificity, wherein each carbohydrate structure comprises at least one repeating basic epitope consisting of a minimum of five to twelve monosaccharide residues, and wherein at least one mole of carrier protein is bound to at least one mole of each of the at least three carbohydrate structure or their molar sum to form carried carbohydrate structures of different serological specificity.
Overall, the claim coverage centers on a single antigenic multivalent molecular construct in which Enterotoxoid A or Cytotoxoid B are covalently bound to at least three different carbohydrate structures, each containing repeating basic epitopes of five to twelve monosaccharide residues, and arranged with a specified molar binding relationship to achieve different serological specificities across the construct.
Stated Advantages
Broad-spectrum enteric vaccine.
Documented Applications
Enteric vaccine.
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