Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
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-11547755-B2
Publication Date
2023-01-10
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. aereus, 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 relates to multivalent glycoconjugate vaccine antigens in which a helper-T dependent carrier protein is covalently bound to multiple capsular polysaccharide carbohydrate structures of different serological specificity on a single carrier. The vaccine construction includes a basic unit with the carrier covalently bound to a minimum of three different carbohydrate structures via a linker comprising imine reduced bonds and amide bonds, and each carbohydrate structure comprises at least one repeating basic epitope consisting of a minimum of five to twelve monosaccharide residues.
The carrier protein is selected from CRM197, diphtheria toxoid, tetanus toxoid, Protein D from Haemophilus influenzae, pneumococcal surface proteins, pneumococcal toxin, and derivatives thereof including tetanus toxoid derivatized by an adipic acid dihydrazide spacer. The antigenic multivalent molecular construct is provided in a physiologically acceptable vehicle optionally with an adjuvant or pharmaceutically acceptable excipients.
The document further describes broad multivalent coverage by combining at least three type-specific carbohydrate antigens covalently associated on the same carrier, including examples oriented to protecting against pulmonary and systemic infections for bacterial antigens of Streptococcus pneumoniae or Neisseria meningitidis.
Claims Coverage
The claims cover a multivalent vaccine formulation built on one helper-T dependent carrier protein covalently bound to at least three different type-specific capsular polysaccharide carbohydrate antigens, with linker chemistry including imine reduced bonds and amide bonds and carbohydrate repeating basic epitopes of at least five to twelve monosaccharide residues. The claim set also recites carrier selection, physiologically acceptable vehicle, optional adjuvant or excipients, and further dependent limitations on dose, adjuvant, and administration routes.
Multivalent construct on a helper-T carrier for pulmonary and systemic infection protection
A vaccine formulation for use in humans or in a veterinary field for protection against pulmonary and systemic infections, comprising at least one antigenic multivalent molecular construct for bacterial antigens of Streptococcus pneumoniae or Neisseria meningitidis, wherein the vaccine consists of a basic unit comprising a helper-T dependent carrier protein covalently bound to a minimum of three carbohydrate structures which are capsular polysaccharides of different serological specificity.
Imine reduced/amide bonded linkage to repeating carbohydrate epitopes
The linker comprises imine reduced bonds and amide bonds, and each carbohydrate structure comprises at least one of the repeating basic epitopes consisting of a minimum of five to twelve monosaccharide residues.
Selected helper-T dependent carrier protein set
The carrier protein is selected from the group consisting of natural diphtheria mutant 6 protein CRM197, diphtheria toxoid, tetanus toxoid, Protein D from Haemophilus influenzae, pneumococcal surface proteins, pneumococcal toxin and derivatives thereof including tetanus toxoid derivatized by an adipic acid dihydrazide spacer.
Carrier loading of each type-specific carbohydrate antigen
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 in a physiologically acceptable vehicle, optionally together with an adjuvant or pharmaceutically acceptable excipients.
Quantitative vaccine dose range
A vaccine formulation characterized by a vaccine dose ranging from 0.1 to 10 μg.
Enumerated adjuvant selection
A vaccine formulation in which the adjuvant is selected from listed mineral, organic, or biological adjuvants including aluminium phosphate, aluminium hydroxide, squalene-based adjuvants, monophosphoryl-lipid A, and trehalose dicorynomycolate.
Quantitative adjuvant amount range per dose
A vaccine formulation further specifies that the adjuvant amount ranges from 0.1 to 1 mg per dose.
Specified administration routes
The vaccine formulation is adapted for administration by subcutaneous, intramuscular, intracutaneous, or transcutaneous routes.
Broad-spectrum inclusion of Neisseria meningitidis antigens
A broad-spectrum polyvalent vaccine formulation that includes bacterial antigens from Neisseria meningitidis.
The claims center on multivalent glycoconjugate vaccine formulations in which a helper-T dependent carrier protein covalently presents at least three different capsular polysaccharide carbohydrate structures of different serological specificity, using a linker comprising imine reduced bonds and amide bonds and carbohydrate repeating basic epitopes of at least five to twelve monosaccharide residues. Dependent claims further specify dose, adjuvant selection and amount, administration routes, and inclusion of Neisseria meningitidis antigens.
Stated Advantages
Not explicitly described in patent.
Documented Applications
Not explicitly described in patent.
Interested in licensing this patent?