BR112021024393A2 - Um conjugado de polissacarídeo-proteína pneumocócico de sorotipo 35b imunogênico e processo de conjugação para fabricar o mesmo - Google Patents

Um conjugado de polissacarídeo-proteína pneumocócico de sorotipo 35b imunogênico e processo de conjugação para fabricar o mesmo

Info

Publication number
BR112021024393A2
BR112021024393A2 BR112021024393A BR112021024393A BR112021024393A2 BR 112021024393 A2 BR112021024393 A2 BR 112021024393A2 BR 112021024393 A BR112021024393 A BR 112021024393A BR 112021024393 A BR112021024393 A BR 112021024393A BR 112021024393 A2 BR112021024393 A2 BR 112021024393A2
Authority
BR
Brazil
Prior art keywords
serotype
protein
manufacture
same
polysaccharide conjugate
Prior art date
Application number
BR112021024393A
Other languages
English (en)
Other versions
BR112021024393A8 (pt
Inventor
N Santiago-Miranda Adriana
Jian He
M Phillips Katherine
Patrick Mchugh
Original Assignee
Merck Sharp & Dohme
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Merck Sharp & Dohme filed Critical Merck Sharp & Dohme
Publication of BR112021024393A2 publication Critical patent/BR112021024393A2/pt
Publication of BR112021024393A8 publication Critical patent/BR112021024393A8/pt

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Classifications

    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/385Haptens or antigens, bound to carriers
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/62Medicinal 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
    • A61K47/64Drug-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
    • A61K47/6415Toxins or lectins, e.g. clostridial toxins or Pseudomonas exotoxins
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/62Medicinal 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
    • A61K47/64Drug-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
    • A61K47/646Drug-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
    • 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
    • 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
    • A61K2039/60Medicinal 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
    • A61K2039/62Medicinal preparations containing antigens or antibodies characterised by the link between antigen and carrier

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Communicable Diseases (AREA)
  • Oncology (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Virology (AREA)
  • Toxicology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)

Abstract

um conjugado de polissacarídeo-proteína pneumocócico de sorotipo 35b imunogênico e processo de conjugação para fabricar o mesmo. a presente invenção fornece uma melhoria de processo relacionada à conjugação de polissacarídeos capsulares de streptococcus pneumoniae (s. pneumoniae) de sorotipo 35b para uma proteína carreadora. o conjugado de polissacarídeo-proteína de sorotipo 35b, preparado pelo processo revelado, é, entre outras coisas, mais imunogênico do que conjugados semelhantes feitos por métodos do estado da técnica. os conjugados de polissacarídeo-proteína de sorotipo 35b de s. pneumoniae preparados usando os processos da invenção podem ser incluídos em composições de vacina conjugada pneumocócica multivalente.
BR112021024393A 2019-06-05 2020-06-01 Um conjugado de polissacarídeo-proteína pneumocócico de sorotipo 35b imunogênico e processo de conjugação para fabricar o mesmo BR112021024393A8 (pt)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US201962857524P 2019-06-05 2019-06-05
PCT/US2020/035509 WO2020247299A1 (en) 2019-06-05 2020-06-01 An immunogenic serotype 35b pneumococcal polysaccharide-protein conjugate and conjugation process for making the same

Publications (2)

Publication Number Publication Date
BR112021024393A2 true BR112021024393A2 (pt) 2022-01-18
BR112021024393A8 BR112021024393A8 (pt) 2023-01-31

Family

ID=73652261

Family Applications (1)

Application Number Title Priority Date Filing Date
BR112021024393A BR112021024393A8 (pt) 2019-06-05 2020-06-01 Um conjugado de polissacarídeo-proteína pneumocócico de sorotipo 35b imunogênico e processo de conjugação para fabricar o mesmo

Country Status (10)

Country Link
US (1) US20220233674A1 (pt)
EP (1) EP3980055A4 (pt)
JP (1) JP2022535063A (pt)
KR (1) KR20220017996A (pt)
CN (1) CN114025790A (pt)
AU (1) AU2020286360A1 (pt)
BR (1) BR112021024393A8 (pt)
CA (1) CA3142692A1 (pt)
MX (1) MX2021014710A (pt)
WO (1) WO2020247299A1 (pt)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN116870144A (zh) 2017-01-31 2023-10-13 默沙东有限责任公司 制备多糖-蛋白缀合物的方法
US11090374B2 (en) 2017-02-24 2021-08-17 Merck Sharp & Dohme Corp. Enhancing immunogenicity of Streptococcus pneumoniae polysaccharide-protein conjugates
CN116898959A (zh) 2017-09-07 2023-10-20 默沙东有限责任公司 肺炎球菌多糖及其在免疫原性多糖-载体蛋白缀合物中的用途
BR112020004502A8 (pt) 2017-09-07 2022-11-01 Merck Sharp & Dohme Polissacarídeos pneumocócicos e uso dos mesmos em conjugados imunogênicos polissacarídeo-proteína carreadora
CN111683678B (zh) 2017-12-06 2024-01-26 默沙东有限责任公司 包含肺炎链球菌多糖蛋白缀合物的组合物及其使用方法
US11896656B2 (en) 2018-04-30 2024-02-13 Merck Sharp & Dohme Llc Methods for providing a homogenous solution of lyophilized mutant diptheria toxin in dimethylsulfoxide
CN112074293A (zh) 2018-04-30 2020-12-11 默沙东公司 生产肺炎链球菌荚膜多糖载体蛋白缀合物的方法
SG11202106541WA (en) 2018-12-19 2021-07-29 Merck Sharp & Dohme Compositions comprising streptococcus pneumoniae polysaccharide-protein conjugates and methods of use thereof
CN118510548A (zh) 2022-01-13 2024-08-16 辉瑞公司 包含缀合的荚膜糖抗原的免疫原性组合物及其用途
WO2024116096A1 (en) 2022-12-01 2024-06-06 Pfizer Inc. Pneumococcal conjugate vaccine formulations

Family Cites Families (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TW201136603A (en) * 2010-02-09 2011-11-01 Merck Sharp & Amp Dohme Corp 15-valent pneumococcal polysaccharide-protein conjugate vaccine composition
EP3104886B1 (en) * 2014-02-14 2018-10-17 Pfizer Inc Immunogenic glycoprotein conjugates
EA201792470A1 (ru) * 2015-06-08 2018-10-31 Серум Инститьют Оф Индия Прайват Лтд. Способы улучшения адсорбции полисахарид-белковых конъюгатов и полученная из них композиция поливалентной вакцины
BR112019006278A2 (pt) * 2016-09-30 2019-07-02 Biological E Ltd composições de vacina pneumocócica multivalente que compreendem conjugados de polissacarídeo-proteína
US11090374B2 (en) * 2017-02-24 2021-08-17 Merck Sharp & Dohme Corp. Enhancing immunogenicity of Streptococcus pneumoniae polysaccharide-protein conjugates
WO2018227177A1 (en) * 2017-06-10 2018-12-13 Inventprise, Llc Multivalent conjugate vaccines with bivalent or multivalent conjugate polysaccharides that provide improved immunogenicity and avidity
WO2020157772A1 (en) * 2019-01-28 2020-08-06 Biological E Limited Multivalent pneumococcal polysaccharide-protein conjugate vaccine compositions

Also Published As

Publication number Publication date
CA3142692A1 (en) 2020-12-10
JP2022535063A (ja) 2022-08-04
WO2020247299A1 (en) 2020-12-10
BR112021024393A8 (pt) 2023-01-31
KR20220017996A (ko) 2022-02-14
EP3980055A1 (en) 2022-04-13
EP3980055A4 (en) 2023-07-26
US20220233674A1 (en) 2022-07-28
MX2021014710A (es) 2022-01-18
CN114025790A (zh) 2022-02-08
AU2020286360A1 (en) 2021-12-23

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Owner name: MERCK SHARP AND DOHME LLC (US)