US2023094548A1PendingUtilityA1

Pneumococcal polysaccharides and their use in immunogenic polysaccharide-carrier protein conjugates

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Assignee: MERCK SHARP & DOHME LLCPriority: Sep 7, 2017Filed: Sep 27, 2022Published: Mar 30, 2023
Est. expirySep 7, 2037(~11.1 yrs left)· nominal 20-yr term from priority
Inventors:Richard J. PoramboChitrananda AbeygunawardanaLuwy MuseyMichael J. KosinskiYadong Adam CuiJulie M. Skinner
A61P 31/04C08B 37/006A61K 2039/70A61K 39/39A61P 11/00A61K 2039/6037A61K 47/646A61K 47/6415A61K 47/42A61K 2039/55505A61K 39/092A61K 2039/6031C08H 1/00C08B 37/0003
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Claims

Abstract

The present invention provides capsular polysaccharides from Streptococcus pneumoniae serotypes identified using NMR. The present invention further provides polysaccharide-protein conjugates in which capsular polysaccharides from one or more of these serotypes are conjugated to a carrier protein such as CRM197. Polysaccharide-protein conjugates from one or more of these serotypes may be included in multivalent pneumococcal conjugate vaccines having polysaccharides from multiple additional Streptococcus pneumoniae serotypes.

Claims

exact text as granted — not AI-modified
1 - 12 . (canceled) 
     
     
         13 . A polysaccharide-protein conjugate, wherein the polysaccharide has an  S. pneumoniae  serotype 23A polysaccharide repeating unit of the following structures: 
       
         
           
           
               
               
           
         
       
       wherein the carrier protein is CRM197, and further wherein the conjugate has a molecular weight from 1,000 kDa to 10,000 kDa. 
     
     
         14 - 16 . (canceled) 
     
     
         17 . The polysaccharide-protein conjugate of  claim 13 , wherein the polysaccharide-protein conjugate has a polysaccharide to protein mass ratio from 0.4 to 2.0. 
     
     
         18 . The polysaccharide-protein conjugate of  claim 13 , wherein the protein is conjugated to the serotype 23A polysaccharide through the 2 nd  or 3 rd  carbon of α-Rhap or β-Glcp. 
     
     
         19 - 34 . (canceled) 
     
     
         35 . The polysaccharide-carrier protein conjugate of  claim 13 , wherein the polysaccharide has a molecular weight of between 50 kDa and 1,000 kDa. 
     
     
         36 . The polysaccharide-carrier protein conjugate of  claim 13 , wherein the polysaccharide has a molecular weight of between 100 kDa and 800 kDa. 
     
     
         37 . The polysaccharide-carrier protein conjugate of  claim 13 , wherein the polysaccharide has a molecular weight of between 100 kDa and 300 kDa. 
     
     
         38 . The polysaccharide-carrier protein conjugate of  claim 13 , wherein the degree of conjugation of the conjugate is between 2 and 15. 
     
     
         39 . The polysaccharide-carrier protein conjugate of  claim 13 , wherein the degree of conjugation of the conjugate is between 8 and 12. 
     
     
         40 . The polysaccharide-carrier protein conjugate of  claim 13 , wherein the polysaccharide-carrier protein conjugate has a polysaccharide to carrier protein mass ratio from 0.5 to 3.0. 
     
     
         41 . The polysaccharide-carrier protein conjugate of  claim 13 , wherein the polysaccharide-carrier protein conjugate has a polysaccharide to carrier protein mass ratio from 0.5 to 1.5. 
     
     
         42 . The polysaccharide-carrier protein conjugate of  claim 13 , wherein the polysaccharide-carrier protein conjugate has a polysaccharide to carrier protein mass ratio from 0.8 to 1.2. 
     
     
         43 . The polysaccharide-carrier protein conjugate of  claim 13 , wherein the polysaccharide-carrier protein conjugate comprises less than about 30% of non-covalently associated polysaccharide compared to the total amount of polysaccharide. 
     
     
         44 . The polysaccharide-carrier protein conjugate of  claim 13 , wherein the polysaccharide-carrier protein conjugate comprises less than about 25% of non-covalently associated polysaccharide compared to the total amount of polysaccharide. 
     
     
         45 . The polysaccharide-carrier protein conjugate of  claim 13 , wherein the polysaccharide-carrier protein conjugate comprises less than about 20% of non-covalently associated polysaccharide compared to the total amount of polysaccharide. 
     
     
         46 . The polysaccharide-carrier protein conjugate of  claim 13 , wherein the polysaccharide-carrier protein conjugate comprises less than about 15% of non-covalently associated polysaccharide compared to the total amount of polysaccharide. 
     
     
         47 . The polysaccharide-carrier protein conjugate of  claim 13 , wherein the carrier protein is conjugated to the serotype 23A polysaccharide unit through the 2 nd  or 3 rd  carbon of α-Rhap or β-Glcp; wherein the polysaccharide has a molecular weight of between 100 kDa and 300 kDa; wherein the degree of conjugation of the conjugate is between is between 8 and 12; wherein the mass ratio of polysaccharide to carrier protein in the conjugate is between 0.8 and 1.2; and wherein the conjugate comprises less than about 15% of non-covalently associated polysaccharide compared to the total amount of polysaccharide. 
     
     
         48 . A polysaccharide-carrier protein conjugate, wherein the polysaccharide has an  S. pneumoniae  serotype 23A polysaccharide repeating unit of the following structure: 
       
         
           
           
               
               
           
         
       
       wherein the carrier protein is CRM197; and further wherein the wherein the polysaccharide-carrier protein conjugate has a polysaccharide to carrier protein mass ratio from 0.5 to 3.0. 
     
     
         49 . The polysaccharide-carrier protein conjugate of  claim 48 , wherein the polysaccharide-carrier protein conjugate has a polysaccharide to carrier protein mass ratio from 0.5 to 1.5. 
     
     
         50 . The polysaccharide-carrier protein conjugate of  claim 48 , wherein the polysaccharide-carrier protein conjugate has a polysaccharide to carrier protein mass ratio from 0.8 to 1.2. 
     
     
         51 . The polysaccharide-carrier protein conjugate of  claim 48 , wherein the carrier protein is conjugated to the serotype 23A polysaccharide unit through the 2 nd  or 3 rd  carbon of α-Rhap or β-Glcp. 
     
     
         52 . The polysaccharide-carrier protein conjugate of  claim 48 , wherein the polysaccharide has a molecular weight of between 50 kDa and 1,000 kDa. 
     
     
         53 . The polysaccharide-carrier protein conjugate of  claim 48 , wherein the polysaccharide has a molecular weight of between 100 kDa and 800 kDa. 
     
     
         54 . The polysaccharide-carrier protein conjugate of  claim 48 , wherein the polysaccharide has a molecular weight of between 100 kDa and 300 kDa. 
     
     
         55 . The polysaccharide-carrier protein conjugate of  claim 48 , wherein the degree of conjugation of the conjugate is between 2 and 15. 
     
     
         56 . The polysaccharide-carrier protein conjugate of  claim 48 , wherein the degree of conjugation of the conjugate is between 8 and 12. 
     
     
         57 . The polysaccharide-carrier protein conjugate of  claim 48 , wherein the polysaccharide-carrier protein conjugate comprises less than about 30% of non-covalently associated polysaccharide compared to the total amount of polysaccharide. 
     
     
         58 . The polysaccharide-carrier protein conjugate of  claim 48 , wherein the polysaccharide-carrier protein conjugate comprises less than about 25% of non-covalently associated polysaccharide compared to the total amount of polysaccharide. 
     
     
         59 . The polysaccharide-carrier protein conjugate of  claim 48 , wherein the polysaccharide-carrier protein conjugate comprises less than about 20% of non-covalently associated polysaccharide compared to the total amount of polysaccharide. 
     
     
         60 . The polysaccharide-carrier protein conjugate of  claim 48 , wherein the polysaccharide-carrier protein conjugate comprises less than about 15% of non-covalently associated polysaccharide compared to the total amount of polysaccharide. 
     
     
         61 . The polysaccharide-carrier protein conjugate of  claim 48 , wherein the polysaccharide has a molecular weight of between 100 kDa and 300 kDa; wherein the degree of conjugation of the conjugate is between is between 8 and 12; wherein the mass ratio of polysaccharide to carrier protein in the conjugate is between 0.8 and 1.2; wherein the conjugate comprises less than about 15% of non-covalently associated polysaccharide compared to the total amount of polysaccharide; and wherein the conjugate has a molecular weight from 1,000 kDa to 10,000 kDa

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