HRP20211337T1 - Kapsularni polisaharidi bakterije streptococcus pneumoniae i njihovi konjugati - Google Patents
Kapsularni polisaharidi bakterije streptococcus pneumoniae i njihovi konjugati Download PDFInfo
- Publication number
- HRP20211337T1 HRP20211337T1 HRP20211337TT HRP20211337T HRP20211337T1 HR P20211337 T1 HRP20211337 T1 HR P20211337T1 HR P20211337T T HRP20211337T T HR P20211337TT HR P20211337 T HRP20211337 T HR P20211337T HR P20211337 T1 HRP20211337 T1 HR P20211337T1
- Authority
- HR
- Croatia
- Prior art keywords
- serotype
- polysaccharide
- activated
- protein carrier
- molar equivalents
- Prior art date
Links
- 229920001282 polysaccharide Polymers 0.000 title claims 20
- 239000005017 polysaccharide Substances 0.000 title claims 20
- 150000004676 glycans Chemical class 0.000 title claims 16
- 241000193998 Streptococcus pneumoniae Species 0.000 title claims 3
- 229940031000 streptococcus pneumoniae Drugs 0.000 title claims 2
- 238000000034 method Methods 0.000 claims 20
- OWBTYPJTUOEWEK-UHFFFAOYSA-N butane-2,3-diol Chemical compound CC(O)C(C)O OWBTYPJTUOEWEK-UHFFFAOYSA-N 0.000 claims 8
- 238000006243 chemical reaction Methods 0.000 claims 5
- 108090000623 proteins and genes Proteins 0.000 claims 5
- 102000004169 proteins and genes Human genes 0.000 claims 5
- -1 33F polysaccharide Chemical class 0.000 claims 4
- 238000007254 oxidation reaction Methods 0.000 claims 4
- KHIWWQKSHDUIBK-UHFFFAOYSA-N periodic acid Chemical compound OI(=O)(=O)=O KHIWWQKSHDUIBK-UHFFFAOYSA-N 0.000 claims 4
- 238000010791 quenching Methods 0.000 claims 4
- 230000000171 quenching effect Effects 0.000 claims 4
- IAZDPXIOMUYVGZ-UHFFFAOYSA-N Dimethylsulphoxide Chemical compound CS(C)=O IAZDPXIOMUYVGZ-UHFFFAOYSA-N 0.000 claims 3
- 108010071134 CRM197 (non-toxic variant of diphtheria toxin) Proteins 0.000 claims 1
- 150000001299 aldehydes Chemical class 0.000 claims 1
- 239000007864 aqueous solution Substances 0.000 claims 1
- 239000003638 chemical reducing agent Substances 0.000 claims 1
- 230000002163 immunogen Effects 0.000 claims 1
- 229940031348 multivalent vaccine Drugs 0.000 claims 1
- BEOOHQFXGBMRKU-UHFFFAOYSA-N sodium cyanoborohydride Chemical compound [Na+].[B-]C#N BEOOHQFXGBMRKU-UHFFFAOYSA-N 0.000 claims 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/02—Bacterial antigens
- A61K39/09—Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
- A61K39/092—Streptococcus
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/385—Haptens or antigens, bound to carriers
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/39—Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
- A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
- A61K47/62—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being a protein, peptide or polyamino acid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
- A61P31/04—Antibacterial agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
- A61P37/04—Immunostimulants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- C—CHEMISTRY; METALLURGY
- C08—ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
- C08B—POLYSACCHARIDES; DERIVATIVES THEREOF
- C08B37/00—Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
- C08B37/0003—General processes for their isolation or fractionation, e.g. purification or extraction from biomass
-
- C—CHEMISTRY; METALLURGY
- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
- C12P—FERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
- C12P19/00—Preparation of compounds containing saccharide radicals
- C12P19/04—Polysaccharides, i.e. compounds containing more than five saccharide radicals attached to each other by glycosidic bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
- A61K2039/55505—Inorganic adjuvants
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
- A61K2039/575—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 humoral response
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
- A61K2039/6031—Proteins
- A61K2039/6037—Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
- A61K2039/6031—Proteins
- A61K2039/6068—Other bacterial proteins, e.g. OMP
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K2039/70—Multivalent vaccine
Claims (13)
1. Postupak priprave imunogenog konjugata koji sadrži polisaharid serotipa 10A, 22F ili 33F iz bakterije Streptococcus pneumoniae kovalentno vezan na proteinski nosač, naznačen time što se postupak sastoji u koracima:
(a) vezanja aktiviranog polisaharida serotipa 10A, 22F ili 33F na proteinski nosač, gdje se navedeni aktivirani polisaharid serotipa 10A, 22F ili 33F dobiva postupkom koji se sastoji u koracima:
(i) reakcije izoliranog kapsularnog polisaharida serotipa 10A, 22F ili 33F s perjodatom; i
(ii) gašenja reakcije oksidacije dodavanjem butan-2,3-diola, čime se dobije aktivirani Streptococcus pneumoniae polisaharid serotipa 10A, 22F ili 33F; i
(b) reakcije vezanog, aktiviranog polisaharida serotipa 10A, 22F ili 33F i proteinskog nosača s reducirajućim sredstvom kako bi se dobilo konjugat polisaharid serotipa 10A, 22F ili 33F-proteinski nosač.
2. Postupak u skladu s patentnim zahtjevom 1, naznačen time što se temperaturu reakcije u koraku (i) i (ii) održava između 2 i 8 °C.
3. Postupak u skladu s patentnim zahtjevom 1, naznačen time što navedeni aktivirani polisaharid serotipa 10A se dobiva postupkom koji se sastoji u koracima:
(i) reakcije izoliranog polisaharida serotipa 10A s 0,2 do 0,3 molarna ekvivalenta perjodata na temperaturi između 2 i 8 °C; i
(ii) gašenja reakcije oksidacije dodavanjem 0,5 do 2 molarna ekvivalenta butan-2,3-diola na temperaturi između 2 i 8 °C, čime se dobije aktivirani polisaharid serotipa 10A.
4. Postupak u skladu s patentnim zahtjevom 1, naznačen time što se navedeni aktivirani polisaharid serotipa 22F dobiva postupkom koji se sastoji u koracima:
(i) reakcije izoliranog polisaharida serotipa 22F s 0,05 do 0,2 molarna ekvivalenta perjodata na temperaturi između 2 i 8 °C; i
(ii) gašenja reakcije oksidacije dodavanjem od 2 do 3, po mogućnosti 2, molarna ekvivalentia butan-2,3-diola na temperaturi između 2 i 8 °C, čime se dobije aktivirani polisaharid serotipa 22F.
5. Postupak u skladu s patentnim zahtjevom 1, naznačen time što se navedeni aktivirani polisaharid serotipa 33F dobiva postupkom koji se sastoji u koracima:
(i) reakcije izoliranog polisaharida serotipa 33F s 0,05 do 0,2 molarna ekvivalenta perjodata na temperaturi između 2 i 8 °C; i
(ii) gašenja reakcije oksidacije dodavanjem 0,5 do 1,5 molarnih ekvivalenata butan-2,3-diola na temperaturi između 2 i 8 °C, čime se dobije aktivirani polisaharid serotipa 33F.
6. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačen time što navedeni postupak dodatno uključuje korak:
(c) zatvaranja neizreagiranih aldehida u konjugatu polisaharid serotipa 10A, 22F ili 33F-proteinski nosač.
7. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačen time što se korake (a) i (b) provodi u DMSO-u ili u vodenoj otopini.
8. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što je koncentracija aktiviranog polisaharida u koraku (b) između 0,1 i 10 mg/ml 0,5 i 5 mg/ml ili 0,5 i 2 mg/ml.
9. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 8, naznačen time što je početni omjer između aktiviranog polisaharida serotipa 10A, 22F ili 33F i proteinskog nosača između 5:1 i 0,1:1, 2:1 i 0,1:1, 2:1 i 1:1, 1,5:1 i 1:1, 0,1:1 i 1:1, 0,3:1 i 1:1 ili 0,6:1 i 1,2:1.
10. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačen time što, u koraku (b), aktivirani polisaharid reagira s između 0,5 i 2,5 molarnih ekvivalenata natrijevog cijanoborohidrida.
11. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 10, naznačen time što dodatno uključuje korak pročišćavanja konjugata polisaharid-proteinski nosač.
12. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 11, naznačen time što je proteinski nosač CRM197.
13. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 11, naznačen time što navedeni postupak dodatno uključuje korak formuliranja konjugata u polivalentno cjepivo.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201461929598P | 2014-01-21 | 2014-01-21 | |
PCT/IB2015/050314 WO2015110940A2 (en) | 2014-01-21 | 2015-01-15 | Streptococcus pneumoniae capsular polysaccharides and conjugates thereof |
EP15708579.6A EP3096783B1 (en) | 2014-01-21 | 2015-01-15 | Streptococcus pneumoniae capsular polysaccharides and conjugates thereof |
Publications (1)
Publication Number | Publication Date |
---|---|
HRP20211337T1 true HRP20211337T1 (hr) | 2021-11-26 |
Family
ID=52630419
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
HRP20211337TT HRP20211337T1 (hr) | 2014-01-21 | 2021-08-20 | Kapsularni polisaharidi bakterije streptococcus pneumoniae i njihovi konjugati |
Country Status (21)
Country | Link |
---|---|
US (4) | US10105431B2 (hr) |
EP (2) | EP3957321A3 (hr) |
JP (4) | JP6612260B2 (hr) |
KR (2) | KR102099741B1 (hr) |
CN (2) | CN112168957A (hr) |
AU (2) | AU2015208820B2 (hr) |
BR (1) | BR112016015835B1 (hr) |
CA (1) | CA2937184A1 (hr) |
DK (1) | DK3096783T3 (hr) |
ES (1) | ES2883343T3 (hr) |
FR (1) | FR22C1039I2 (hr) |
HK (1) | HK1223273A1 (hr) |
HR (1) | HRP20211337T1 (hr) |
HU (1) | HUE055408T2 (hr) |
IL (5) | IL283554B (hr) |
MX (1) | MX371454B (hr) |
PL (1) | PL3096783T3 (hr) |
PT (1) | PT3096783T (hr) |
RU (1) | RU2710393C2 (hr) |
SI (1) | SI3096783T1 (hr) |
WO (1) | WO2015110940A2 (hr) |
Families Citing this family (32)
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AU2015208820B2 (en) * | 2014-01-21 | 2020-05-14 | Pfizer Inc. | Streptococcus pneumoniae capsular polysaccharides and conjugates thereof |
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BR122021023687A8 (pt) | 2017-12-06 | 2023-02-07 | Merck Sharp & Dohme | Usos de composições imunogênicas multivalentes compreendendo conjugados de proteína carreadora e polissacarídeo de s. pneumoniae |
MX2020007939A (es) | 2018-02-05 | 2020-09-03 | Sanofi Pasteur Inc | Composicion del conjugado proteina-polisacarido multivalente nuemococica. |
EP3749357A4 (en) | 2018-02-05 | 2022-04-20 | Sanofi Pasteur, Inc. | POLYVALENT PNEUMOCOCCAL POLYSACCHARIDE PROTEIN CONJUGATE COMPOSITION |
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