PE20240090A1 - Composiciones inmunogenas que comprenden antigenos de sacarido capsular conjugados y sus usos - Google Patents

Composiciones inmunogenas que comprenden antigenos de sacarido capsular conjugados y sus usos

Info

Publication number
PE20240090A1
PE20240090A1 PE2023003151A PE2023003151A PE20240090A1 PE 20240090 A1 PE20240090 A1 PE 20240090A1 PE 2023003151 A PE2023003151 A PE 2023003151A PE 2023003151 A PE2023003151 A PE 2023003151A PE 20240090 A1 PE20240090 A1 PE 20240090A1
Authority
PE
Peru
Prior art keywords
glycoconjugate
carrier protein
alkyne
reacting
streptococcus pneumoniae
Prior art date
Application number
PE2023003151A
Other languages
English (en)
Inventor
Annaliesa Sybil Anderson
Caitlyn Gallagher
Jianxin Gu
Isis Kanevsky
Jin-Hwan Kim
Justin Keith Moran
Suddham Singh
Naveen Surendran
Original Assignee
Pfizer
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 Pfizer filed Critical Pfizer
Publication of PE20240090A1 publication Critical patent/PE20240090A1/es

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Classifications

    • 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
    • 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
    • A61K2039/57Medicinal 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
    • 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
    • A61K2039/62Medicinal preparations containing antigens or antibodies characterised by the link between antigen and carrier
    • A61K2039/627Medicinal preparations containing antigens or antibodies characterised by the link between antigen and carrier characterised by the linker

Landscapes

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

Abstract

La presente invencion se refiere a un metodo para elaborar un glicoconjugado de serotipo 3 de Streptococcus pneumoniae, que comprende las etapas de: (a) hacer reaccionar un polisacarido capsular de serotipo 3 de Streptococcus pneumoniae aislado con un derivado de acido carbonico tal como 1,1'-carbonildiimidazol (CDI), 1,1'-carbonil-di-(1,2,4-triazol) (CDT), carbonato de disuccinimidilo (DSC) o N-hidroxisuccinimidil cloroformiato y un ligador azido de formula H2N-X-N3, donde: X se selecciona de CH2(CH2)n, (CH2CH2O)mCH2CH2, entre otros, n es 1 a 10 y m es 1 a 4, en un solvente aprotico para producir un polisacarido azido activado; (b) hacer reaccionar una proteina portadora con un agente que tiene una porcion N-hidroxisuccinimida (NHS) y un grupo alquino de formula III, donde: X se selecciona de CH2O(CH2)nCH2C=O y CH2O(CH2CH2O)m(CH2)nCH2C=O, n es 0 a 10 y m es 0 a 4, en donde la porcion NHS reacciona con los grupos amino para formar un enlace amida para asi obtener una proteina portadora funcionalizada de alquino; (c) hacer reaccionar el polisacarido azido activado de la etapa (a) con la proteina portadora de alquino activada de la etapa (b) mediante reaccion de cicloadicion de azida-alquino mediada por Cu+1 para formar un glicoconjugado. Tambien se refiere a un glicoconjugado de serotipo 3 de Streptococcus pneumoniae conjugado de manera covalente con una porteina portadora (CP), tal como CRM197 o SCP, a traves de un espaciador, donde el glicoconjugado tiene la formula VII, donde X se selecciona de CH2(CH2)n', (CH2CH2O)mCH2CH2, entre otros; n' es 1 a 10; m es 1 a 4; X' es CH2O(CH2)n"CH2C=O y CH2O(CH2CH2O)m'(CH2)n"CH2C=O, n" es 0 a 10 y m' es 0 a 4.
PE2023003151A 2021-05-28 2022-05-25 Composiciones inmunogenas que comprenden antigenos de sacarido capsular conjugados y sus usos PE20240090A1 (es)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202163194641P 2021-05-28 2021-05-28
US202163228763P 2021-08-03 2021-08-03
PCT/IB2022/054914 WO2022249106A2 (en) 2021-05-28 2022-05-25 Immunogenic compositions comprising conjugated capsular saccharide antigens and uses thereof

Publications (1)

Publication Number Publication Date
PE20240090A1 true PE20240090A1 (es) 2024-01-16

Family

ID=82019939

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2023003151A PE20240090A1 (es) 2021-05-28 2022-05-25 Composiciones inmunogenas que comprenden antigenos de sacarido capsular conjugados y sus usos

Country Status (11)

Country Link
US (1) US20220387613A1 (es)
EP (1) EP4346892A2 (es)
KR (1) KR20230175284A (es)
AU (1) AU2022281543A1 (es)
BR (1) BR112023023671A2 (es)
CA (1) CA3221074A1 (es)
CO (1) CO2023016246A2 (es)
IL (1) IL308902A (es)
PE (1) PE20240090A1 (es)
TW (1) TW202304503A (es)
WO (1) WO2022249106A2 (es)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2023135515A1 (en) * 2022-01-13 2023-07-20 Pfizer Inc. Immunogenic compositions comprising conjugated capsular saccharide antigens and uses thereof

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Also Published As

Publication number Publication date
KR20230175284A (ko) 2023-12-29
IL308902A (en) 2024-01-01
TW202304503A (zh) 2023-02-01
BR112023023671A2 (pt) 2024-02-06
AU2022281543A1 (en) 2023-11-23
CO2023016246A2 (es) 2024-02-26
CA3221074A1 (en) 2022-12-01
AU2022281543A9 (en) 2023-11-30
WO2022249106A3 (en) 2023-03-09
WO2022249106A2 (en) 2022-12-01
EP4346892A2 (en) 2024-04-10
US20220387613A1 (en) 2022-12-08

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