JP2024506713A - 多糖およびそのポリペプチドコンジュゲートの精製方法 - Google Patents

多糖およびそのポリペプチドコンジュゲートの精製方法 Download PDF

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JP2024506713A
JP2024506713A JP2023549595A JP2023549595A JP2024506713A JP 2024506713 A JP2024506713 A JP 2024506713A JP 2023549595 A JP2023549595 A JP 2023549595A JP 2023549595 A JP2023549595 A JP 2023549595A JP 2024506713 A JP2024506713 A JP 2024506713A
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seq
polysaccharide
polypeptide
conjugate
gas
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JP2024506713A5 (cg-RX-API-DMAC7.html
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アール バーレンズ，クリストファー
アガルワル，パレシュ
イン，ルー
ティ デイビー，ピーター
エイ セドラ，アンジー
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Vaxcyte Inc
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Vaxcyte Inc
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    • 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
    • A61K47/64—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent
    • A61K47/646—Drug-peptide, drug-protein or drug-polyamino acid conjugates, i.e. the modifying agent being a peptide, protein or polyamino acid which is covalently bonded or complexed to a therapeutically active agent the entire peptide or protein drug conjugate elicits an immune response, e.g. conjugate vaccines
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    • A61K39/385—Haptens or antigens, bound to carriers
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    • 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
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    • 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
    • A61K47/56—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 an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/61—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 an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule the organic macromolecular compound being a polysaccharide or a derivative thereof
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    • 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
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    • 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
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    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/195—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria
    • C07K14/34—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Corynebacterium (G)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K19/00—Hybrid peptides, i.e. peptides covalently bound to nucleic acids, or non-covalently bound protein-protein complexes
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    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/48—Hydrolases (3) acting on peptide bonds (3.4)
    • C12N9/50—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25)
    • C12N9/52—Proteinases, e.g. Endopeptidases (3.4.21-3.4.25) derived from bacteria or Archaea
    • C—CHEMISTRY; METALLURGY
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    • 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
    • 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
    • C12P19/14—Preparation of compounds containing saccharide radicals produced by the action of a carbohydrase (EC 3.2.x), e.g. by alpha-amylase, e.g. by cellulase, hemicellulase
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    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12Y—ENZYMES
    • C12Y304/00—Hydrolases acting on peptide bonds, i.e. peptidases (3.4)
    • C12Y304/21—Serine endopeptidases (3.4.21)
    • C12Y304/2111—C5a peptidase (3.4.21.110)
    • A—HUMAN NECESSITIES
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    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
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    • A61K2039/555—Medicinal preparations containing antigens or antibodies characterised by a specific combination antigen/adjuvant
    • A61K2039/55505—Inorganic adjuvants
    • A—HUMAN NECESSITIES
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    • A61K2039/575—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 humoral response
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    • 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
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    • A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
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    • A61K2039/60—Medicinal preparations containing antigens or antibodies characteristics by the carrier linked to the antigen
    • A61K2039/6087—Polysaccharides; Lipopolysaccharides [LPS]
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    • C07K14/315—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from bacteria from Streptococcus (G), e.g. Enterococci

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  • Gastroenterology & Hepatology (AREA)
  • Virology (AREA)
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  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Biomedical Technology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
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JP2023549595A 2021-02-17 2022-02-16 多糖およびそのポリペプチドコンジュゲートの精製方法 Pending JP2024506713A (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202163150516P 2021-02-17 2021-02-17
US63/150,516 2021-02-17
US202163288387P 2021-12-10 2021-12-10
US63/288,387 2021-12-10
PCT/US2022/016630 WO2022178015A1 (en) 2021-02-17 2022-02-16 Purification processes for polysaccharides and polypeptide conjugates thereof

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JP2024506713A true JP2024506713A (ja) 2024-02-14
JP2024506713A5 JP2024506713A5 (cg-RX-API-DMAC7.html) 2025-02-27

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EP (1) EP4294452A4 (cg-RX-API-DMAC7.html)
JP (1) JP2024506713A (cg-RX-API-DMAC7.html)
KR (1) KR20230146620A (cg-RX-API-DMAC7.html)
AU (1) AU2022221621A1 (cg-RX-API-DMAC7.html)
CA (1) CA3208716A1 (cg-RX-API-DMAC7.html)
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JP2023538365A (ja) 2020-08-19 2023-09-07 バックスサイト・インコーポレイテッド 担体－タンパク質多糖結合方法
MX2024002779A (es) 2021-09-09 2024-06-11 Affinivax Inc Vacunas neumocócicas multivalentes.
CN115894604B (zh) * 2022-12-16 2024-01-23 康日百奥生物科技(苏州)有限公司 重组蛋白澄清纯化方法
WO2025193903A1 (en) 2024-03-15 2025-09-18 Affinivax, Inc. Pneumococcal polysaccharide compositions and uses thereof

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CN109045292A (zh) * 2018-11-08 2018-12-21 山东大学 一种a群链球菌寡糖蛋白缀合物及其制备方法与应用
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CN115175697A (zh) * 2020-02-18 2022-10-11 Vaxcyte公司 具有多糖-蛋白质缀合物的a组链球菌免疫原性组合物

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JP2007500726A (ja) * 2003-07-31 2007-01-18 カイロン コーポレイション ＳｔｒｅｐｔｏｃｏｃｃｕｓＰｙｏｇｅｎｅｓについての免疫原組成物
WO2009034473A2 (en) * 2007-09-12 2009-03-19 Novartis Ag Gas57 mutant antigens and gas57 antibodies
WO2013020090A2 (en) * 2011-08-04 2013-02-07 The Regents Of The University Of California STREPTOCOCCAL GLcNAc-LACKING GLYCOPOLYPEPTIDES, CELL WALL CARBOHYDRATES, STREPTOCOCCUS VACCINES, AND METHODS FOR MAKING AND USING THEM
WO2014136064A2 (en) * 2013-03-08 2014-09-12 Pfizer Inc. Immunogenic fusion polypeptides
JP2020504760A (ja) * 2016-12-30 2020-02-13 ストロバックス・インコーポレイテッドＳｕｔｒｏｖａｘ， Ｉｎｃ． 非天然アミノ酸とのポリペプチド抗原接合体
CN107737334A (zh) * 2017-09-05 2018-02-27 中国科学院微生物研究所 一种预防a型链球菌感染的广谱多联亚单位疫苗
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