Immunogenic multiple hetero-antigen polysaccharide-protein conjugates and uses thereof
Inventors
Prasad, Avvari Krishna • Gu, Jianxin • Kim, Jin-Hwan • Singh, Suddham
Assignees
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Publication Number
US-12773447-B2
Publication Date
2026-10-27
Expiration Date
Abstract
The present invention relates to new glycoconjugates comprising Streptococcus pneumoniae capsular saccharide antigens and uses thereof. Glycoconjugates of the present invention will typically comprise 2 or more saccharides antigens conjugated to the same molecule of the protein carrier. The invention also relates to vaccination of human subjects, in particular infants and elderly, against pneumoccocal infections using immunogenic compositions comprising said novel glycoconjugates.
Core Innovation
The invention provides multivalent Streptococcus pneumoniae glycoconjugates wherein at least two capsular saccharides selected from specified serotype groups are conjugated to the same carrier protein molecule. The specified serotype groups include serotypes 10A, 22F, 33F, and 35B; serotypes 8, 11A, 12F, 23A, and 23B; or serotypes 8, 15A, 15B, 23A, and 23B. Each conjugated saccharide possesses a molecular weight of 20 kDa to 4000 kDa, covalently linked to carrier proteins such as CRM197, diphtheria toxoid, tetanus toxoid, or protein D.
The disclosure describes conjugate compositional characteristics including degree of conjugation, saccharide-to-protein and inter-saccharide weight ratios, size-exclusion distribution, acetate content, and free saccharide limits. Preparation approaches include selective-saccharide-reactivity pooling strategies and reductive amination, with [procedural detail omitted for safety]. Disclosed formulations encompass liquid or lyophilized immunogenic compositions intended for vaccination against S. pneumoniae infection across infant, older adult, and immunocompromised subject populations.
Claims Coverage
The relevant claims identify three inventive features across three independent claims covering multivalent glycoconjugates conjugated to the same carrier protein molecule.
Glycoconjugate comprising saccharides from serotypes 10A, 22F, 33F, and 35B
The claim covers a glycoconjugate comprising at least two saccharides selected from S. pneumoniae serotypes 10A, 22F, 33F, and 35B, wherein each saccharide is conjugated to the same carrier protein molecule and has a molecular weight of 20 kDa to 4000 kDa.
Glycoconjugate comprising saccharides from serotypes 8, 11A, 12F, 23A, and 23B
The claim covers a glycoconjugate comprising at least two saccharides selected from S. pneumoniae serotypes 8, 11A, 12F, 23A, and 23B, wherein each saccharide is conjugated to the same carrier protein molecule and has a molecular weight of 20 kDa to 4000 kDa.
Glycoconjugate comprising saccharides from serotypes 8, 15A, 15B, 23A, and 23B
The claim covers a glycoconjugate comprising at least two saccharides selected from S. pneumoniae serotypes 8, 15A, 15B, 23A, and 23B, wherein each saccharide is conjugated to the same carrier protein molecule and has a molecular weight of 20 kDa to 4000 kDa.
The three independent claims define distinct serotype groups for glycoconjugates sharing the claim element that at least two selected saccharides are conjugated to the same carrier protein molecule with a molecular weight of 20 kDa to 4000 kDa.
Stated Advantages
The 10A/22F/33F/35B conjugate exhibits a reported free saccharide level below 5%.
Mouse OPA responses for the 10A/22F/33F/35B conjugate are comparable to those for a mixture of four separately conjugated serotypes.
The selective-saccharide-reactivity pooling strategy enables multi-serotype, one-pot conjugation, reducing conjugation steps, individual conjugates, manufacturing steps, carrier dose, and required drug substance.
The pooling strategy facilitates vaccine customization.
Vaccination is proposed to extend protection against pneumococcal disease, including in infants and elderly people.
The disclosed conjugation approach is stated to better preserve saccharide O-acetylation than aqueous conditions; [procedural detail omitted for safety].
Documented Applications
Conjugate formulations and immunogenic compositions comprising the glycoconjugate and an adjuvant.
Vaccines and immunogenic compositions to prevent, treat, or ameliorate S. pneumoniae infection and induce an immune response, including in infants, older adults, and immunocompromised subjects.
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