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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-10300135-B2
Publication Date
2019-05-28
Expiration Date
Abstract
The present invention refers to new conjugate antigens expressing built-in multiple epitopes and to polyvalent glycoconjugate vaccines and formulations containing the same. In addition, the present invention concerns the use of these vaccines in particular for the protection of the human population, and in particular for the protection of the paediatric population from pulmonary and systemic infections due to S. pneumoniae, N. meningitidis, H. influenzae, K. pneumoniae, M. tuberculosis, S. aureus, or from intestinal infections due to S. typhi, V. cholerae and E. coli. The present invention additionally refers to new polyvalent glycoconjugate vaccines for the protection from C. albicans and E. coli systemic and genitourinary infections or for the protection from M. bovis infections in veterinary medicine.
Core Innovation
The invention is an antigenic multivalent molecular construct consisting of a helper-T dependent carrier protein covalently bound to a minimum of three carbohydrate structures. The carbohydrate structures are capsular polysaccharides of different serological specificity, and each carbohydrate comprises at least one repeating basic epitope consisting of a minimum of five to twelve monosaccharide residues. The linker comprises imine reduced bonds and amide bonds to connect the carrier and carbohydrates.
A key aspect is that the carrier protein carries at least one mole or fraction thereof of each of the at least three different type-specific carbohydrate antigens. The carrier protein is selected from natural diphtheria mutant protein CRM197, diphtheria toxoid, tetanus toxoid, Protein D from Haemophilus influenzae, Pneumococcal surface proteins, Pneumococcal toxin, and derivatives thereof. The construct is characterized by a helper-T dependent presentation with multivalent carbohydrate content corresponding to different serological specificities.
The concept encompasses linked carbohydrate structures that include capsular polysaccharides presented as different serological specificities and selected from multiple pathogen-derived antigen sets. The document describes forming an antigenic multivalent construct for vaccine protection against infections caused by specified pathogens using the covalently bound helper-T dependent carrier and the repeating basic epitopes of the carbohydrate antigens.
Claims Coverage
The claim coverage includes one independent claim defining the multivalent glycoconjugate construct and dependent claims refining composition and vaccine use. Across the inventive scope, the coverage includes the helper-T dependent carrier covalently bound to at least three different capsular polysaccharide antigens, together with the linker chemistry defined by imine reduced bonds and amide bonds and repeating basic epitopes defined by five to twelve monosaccharide residues.
Multivalent glycoconjugate construct with helper-T dependent carrier and at least three capsular polysaccharides
An antigenic multivalent molecular construct consisting of a helper-T dependent carrier protein covalently bound to a minimum of three carbohydrate structures which are capsular polysaccharides of different serological specificity by a linker comprising imine reduced bonds and amide bonds, wherein each carbohydrate structure comprises at least one repeating basic epitope consisting of a minimum of five to twelve monosaccharide residues.
Carrier selection and coordinated multivalent loading of type-specific carbohydrate antigens
The carrier protein is selected from the group consisting of natural diphtheria mutant protein CRM197, diphtheria toxoid, tetanus toxoid, Protein D from Haemophilus influenzae, Pneumococcal surface proteins, Pneumococcal toxin and derivatives thereof, and at least one mole or fraction thereof of protein carrier carries at least one mole or fraction thereof of each of the at least three different type-specific carbohydrate antigens.
Repeating basic epitope size constraint
The repeating basic epitope is made up of at least eight to twelve monosaccharide residues.
Different serological specificity carbohydrate antigens
Carbohydrate antigens with different serological specificity are selected from Streptococcus pneumoniae, Neisseria meningitidis, Haemophilus influenzae, Klebsiella pneumoniae, Staphylococcus aureus, Mycobacterium tuberculosis, Salmonella typhi, Escherichia coli, Vibrio cholerae, Candida albicans, and Mycobacterium bovis, including combinations thereof.
At least three capsular polysaccharides from enumerated sets
The multivalent antigenic molecular construct carries at least three carbohydrate capsular polysaccharides selected from the enumerated polysaccharide antigens including specific types for Streptococcus pneumoniae, polysaccharides of group A, C, W135, and Y, polysaccharide of type b, K polysaccharide antigens, and additional listed pathogen polysaccharide antigens, or a combination thereof.
CRM197 with triad sets of Streptococcus pneumoniae capsular polysaccharides
The antigenic multivalent molecular construct comprises the carrier protein CRM197 and three Streptococcus pneumoniae capsular polysaccharides selected from specified triad sets of serotypes including 3, 6A, 7F and other enumerated triads.
Vaccine protection using the multivalent antigenic molecular construct
A vaccine uses an antigenic multivalent molecular construct to protect a subject against infections caused by at least one specified pathogen selected among Streptococcus pneumoniae, Neisseria meningitidis, Haemophilus influenzae, Klebsiella pneumoniae, Staphylococcus aureus, Salmonella typhi, Escherichia coli, Vibrio cholerae, Mycobacterium tuberculosis, Mycobacterium bovis, and Candida albicans.
Overall, the claim coverage centers on a covalently linked helper-T dependent multivalent glycoconjugate where a selected carrier protein carries at least three different type-specific capsular polysaccharide antigens connected via imine reduced bonds and amide bonds, with repeating basic epitopes of defined monosaccharide length and dependent claims specifying particular epitope length constraints, enumerated antigen sets and serotypes, and vaccine protection against infections caused by specified pathogens.
Stated Advantages
Documented Applications
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