HRP20211288T1 - Kapsularni polisaharidi bakterije streptococcus pneumoniae i njihovi konjugati - Google Patents

Kapsularni polisaharidi bakterije streptococcus pneumoniae i njihovi konjugati Download PDF

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HRP20211288T1
HRP20211288T1 HRP20211288TT HRP20211288T HRP20211288T1 HR P20211288 T1 HRP20211288 T1 HR P20211288T1 HR P20211288T T HRP20211288T T HR P20211288TT HR P20211288 T HRP20211288 T HR P20211288T HR P20211288 T1 HRP20211288 T1 HR P20211288T1
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serotype
capsular polysaccharide
immunogenic
immunogenic conjugate
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HRP20211288TT
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Mingming Han
Avvari Krishna PRASAD
David Cooper
Wendy Jo Watson
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Pfizer Inc.
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Publication of HRP20211288T1 publication Critical patent/HRP20211288T1/hr

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/09Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
    • A61K39/092Streptococcus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/70Carbohydrates; Sugars; Derivatives thereof
    • A61K31/715Polysaccharides, i.e. having more than five saccharide radicals attached to each other by glycosidic linkages; Derivatives thereof, e.g. ethers, esters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/02Bacterial antigens
    • A61K39/09Lactobacillales, e.g. aerococcus, enterococcus, lactobacillus, lactococcus, streptococcus
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/385Haptens or antigens, bound to carriers
    • AHUMAN NECESSITIES
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    • A61K39/39Medicinal preparations containing antigens or antibodies characterised by the immunostimulating additives, e.g. chemical adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00Drugs for disorders of the respiratory system
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • A61P31/04Antibacterial agents
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    • C08ORGANIC MACROMOLECULAR COMPOUNDS; THEIR PREPARATION OR CHEMICAL WORKING-UP; COMPOSITIONS BASED THEREON
    • C08BPOLYSACCHARIDES; DERIVATIVES THEREOF
    • C08B37/00Preparation of polysaccharides not provided for in groups C08B1/00 - C08B35/00; Derivatives thereof
    • C08B37/0003General processes for their isolation or fractionation, e.g. purification or extraction from biomass
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12PFERMENTATION OR ENZYME-USING PROCESSES TO SYNTHESISE A DESIRED CHEMICAL COMPOUND OR COMPOSITION OR TO SEPARATE OPTICAL ISOMERS FROM A RACEMIC MIXTURE
    • C12P19/00Preparation of compounds containing saccharide radicals
    • C12P19/04Polysaccharides, i.e. compounds containing more than five saccharide radicals attached to each other by glycosidic bonds
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/555Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505Inorganic adjuvants
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/57Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • A61K2039/575Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 humoral response
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/60Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031Proteins
    • A61K2039/6037Bacterial toxins, e.g. diphteria toxoid [DT], tetanus toxoid [TT]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/60Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6031Proteins
    • A61K2039/6068Other bacterial proteins, e.g. OMP
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/70Multivalent vaccine

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  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
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Claims (22)

1. Postupak priprave imunogenog konjugata koji sadrži kapsularni polisaharid serotipa 15B bakterije Streptococcus pneumoniae, kovalentno vezan na proteinski nosač, naznačen time što se postupak sastoji u koracima: (a) vezanja aktiviranog kapsularnog polisaharida serotipa 15B na proteinski nosač, gdje se navedeni aktivirani polisaharid dobiva postupkom koji se sastoji u koracima reakcije izoliranog kapsularnog polisaharida serotipa 15B bakterije Streptococcus pneumoniae, koji sadrži najmanje 0,6 mM acetata po mM navedenog kapsularnog polisaharida serotipa 15B, s oksidirajućim sredstvom, gdje navedeni aktivirani polisaharid ima molekulsku težinu između 100 i 300 kDa; i (b) reakcije vezanog, aktiviranog polisaharida i proteinskog nosača s reducirajućim sredstvom kako bi se dobilo konjugat kapsularnog polisaharida serotipa 15B s proteinskim nosačem; gdje se korak (a) i korak (b) provodi u DMSO-u.
2. Postupak u skladu s patentnim zahtjevom 1, naznačen time što je proteinski nosač CRM197.
3. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 2, naznačen time što je koncentracija aktiviranog kapsularnog polisaharida serotipa 15B u koraku (b) između 0,1 i 10 mg/ml, 0,5 i 5 mg/ml ili 0,5 i 2 mg/ml.
4. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačen time što je početni ulazni omjer između aktiviranog kapsularnog polisaharida serotipa 15B 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, 0,6:1 i 1:1, ili 0,6:1 i 1,5:1.
5. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačen time što u koraku (b) aktivirani polisaharid reagira s između 1 i 2 molarna ekvivalenta natrijevog cijanoborohidrida u trajanju od 40 do 50 sati na temperaturi između 20 do 26 °C.
6. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 5, naznačen time što navedeni postupak uključuje dodatni sljedeći korak: (c) zatvaranja neizreagiranog aldehida dodavanjem NaBH4.
7. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačen time što je navedeno oksidirajuće sredstvo perjodat.
8. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačen time što je navedeno oksidirajuće sredstvo natrijev perjodat.
9. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačen time što je navedeno oksidirajuće sredstvo natrijev metaperjodat.
10. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 9, naznačen time što je prinos u koraku konjugacije (b) veći od 50%.
11. Postupak u skladu s bilo kojim od patentnih zahtjeva 1 do 10, naznačen time što navedeni postupak dodatno uključuje korak formuliranja konjugata u polivalentno cjepivo.
12. Imunogeni konjugat, naznačen time što ga se dobiva postupkom u skladu s bilo kojim od patentnih zahtjeva 1 do 11.
13. Imunogeni konjugat u skladu s patentnim zahtjevom 12, naznačen time što navedeni imunogeni konjugat sadrži manje od 40% slobodnog kapsularnog polisaharida serotipa 15B u usporedbi s ukupnom količinom kapsularnog polisaharida serotipa 15B.
14. Imunogeni konjugat u skladu s patentnim zahtjevom 12 ili 13, naznačen time što imunogeni konjugat ima molekulsku težinu između: 3000 i 20000 kDa; 5000 i 10000 kDa; 5000 i 20000 kDa; 8000 i 20000 kDa; 8000 i 16000 kDa; ili 10000 i 16000 kDa.
15. Imunogeni konjugat u skladu s bilo kojim od patentnih zahtjeva 12 do 14, naznačen time što je omjer između kapsularnog polisaharida serotipa 15B i proteinskog nosača u konjugatu između 0.4 i 2.
16. Imunogeni konjugat u skladu s bilo kojim od patentnih zahtjeva 12 do 15, naznačen time što najmanje 40% imunogenog konjugata ima Kd manji ili jednak 0,3 na stupcu CL-4B.
17. Imunogeni konjugat u skladu s bilo kojim od patentnih zahtjeva 12 do 16, naznačen time što je stupanj konjugacije između: 2 i 15; 2 i 13; 2 i 10; 2 i 8; 2 i 6; 2 i 5, 2 i 4; 3 i 15; 3 i 13; 3 i 10; 3 i 8; 3 i 6; 3 i 5; 3 i 4; 5 i 15; 5 an 10; 8 i 15; 8 i 12; 10 i 15; ili 10 i 12.
18. Imunogeni konjugat u skladu s bilo kojim od patentnih zahtjeva 12 do 17, naznačen time što je omjer između mM acetata po mM kapsularnog polisaharida serotipa 15B u imunogenom konjugatu i mM acetata po mM kapsularnog polisaharida serotipa 15B u aktiviranom polisaharidu najmanje 0,6, 0,65, 0,7, 0,75, 0,8, 0,85, 0,9, ili 0,95, po mogućnosti najmanje 0,7 ili najmanje 0,9.
19. Imunogeni pripravak, naznačen time što sadrži imunogeni konjugat u skladu s bilo kojim od patentnih zahtjeva 12 do 18 i fiziološki prihvatljivi vehikulum.
20. Cjepivo, naznačeno time što sadrži imunogeni pripravak u skladu s patentnim zahtjevom 19.
21. Imunogeni pripravak u skladu s patentnim zahtjevom 19, ili cjepivo u skladu s patentnim zahtjevom 20, naznačeni time što su namijenjeni upotrebi u postupku zaštite subjekta od infekcije serotipom 15B bakterije Streptococcus pneumoniae.
22. Imunogeni pripravak u skladu s patentnim zahtjevom 19, ili cjepivo u skladu s patentnim zahtjevom 20, naznačeni time što su namijenjeni upotrebi u postupku liječenja ili sprječavanja infekcije bakterijom Streptococcus pneumoniae, bolesti ili stanja povezanog sa serotipom 15B bakterije Streptococcus pneumoniae kod subjekta, gdje se navedeni postupak sastoji u koraku primjene terapijski ili profilaktički djelotvorne količine imunogenog pripravka ili navedenog cjepiva.
HRP20211288TT 2014-01-21 2021-08-11 Kapsularni polisaharidi bakterije streptococcus pneumoniae i njihovi konjugati HRP20211288T1 (hr)

Applications Claiming Priority (3)

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US201461929561P 2014-01-21 2014-01-21
EP15708581.2A EP3096786B1 (en) 2014-01-21 2015-01-15 Streptococcus pneumoniae capsular polysaccharides and conjugates thereof
PCT/IB2015/050316 WO2015110942A2 (en) 2014-01-21 2015-01-15 Streptococcus pneumoniae capsular polysaccharides and conjugates thereof

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US (3) US20160324949A1 (hr)
EP (3) EP3096786B1 (hr)
JP (3) JP6585624B2 (hr)
KR (4) KR102619514B1 (hr)
CN (2) CN112336854A (hr)
AU (3) AU2015208822B2 (hr)
BR (2) BR112016016580B1 (hr)
CA (1) CA2937190A1 (hr)
DK (2) DK3583947T3 (hr)
ES (2) ES2883571T3 (hr)
FI (1) FI3583947T3 (hr)
FR (1) FR22C1041I2 (hr)
HK (1) HK1232133A1 (hr)
HR (2) HRP20231504T1 (hr)
HU (2) HUE055553T2 (hr)
IL (2) IL311385A (hr)
MX (2) MX371453B (hr)
PL (2) PL3096786T3 (hr)
PT (2) PT3583947T (hr)
RU (2) RU2688831C2 (hr)
SI (2) SI3096786T1 (hr)
WO (1) WO2015110942A2 (hr)

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