DK3059246T3 - Modificeret konstant region i et antistof - Google Patents

Modificeret konstant region i et antistof Download PDF

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Publication number
DK3059246T3
DK3059246T3 DK15200628.4T DK15200628T DK3059246T3 DK 3059246 T3 DK3059246 T3 DK 3059246T3 DK 15200628 T DK15200628 T DK 15200628T DK 3059246 T3 DK3059246 T3 DK 3059246T3
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DK15200628.4T
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Tomoyuki Igawa
Hirotake Shiraiwa
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Chugai Pharmaceutical Co Ltd
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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2866Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for cytokines, lymphokines, interferons
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/524CH2 domain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/526CH3 domain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/53Hinge
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/71Decreased effector function due to an Fc-modification
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

Claims (7)

1. Konstant region i et humant antistof, som omfatter deletioner af såvel Gly ved position 329 (position 446 i EU nummereringssystemet) som Lys ved position 330 (position 447 i EU nummereringssystemet) i aminosyresekvensen ifølge SEQ ID NO: 1. hvor amidieringen af C-terminal aminosyren i den konstante region af det humane lgG1 antistof undertrykkes.
2. Konstant region i et antistof ifølge krav 1, hvor aminosyren Asn ved position 317 (position 434 i EU nummereringssystemet) i aminosyresekvensen ifølge SEQ ID NO: 1 er erstattet med en anden aminosyre.
3. Fremgangsmåde til reduktion af C-terminal heterogeniteten for et antistof omfattende et trin med deletering af Gly ved position 329 (position 446 i EU nummereringssystemet) og Lys ved position 330 (position 447 i EU nummereringssystemet) i aminosyresekvensen ifølge SEQ ID NO: 1, hvor amidieringen af C-terminal aminosyren i den konstante region af det humane IgG 1 antistof undertrykkes.
4. Konstant region i et antistof, som er kendetegnet ved, at have en reduceret C-terminal heterogenitet som opnåelig ved fremgangsmåden ifølge krav 3.
5. Konstant region i et humant antistof ifølge krav 1 eller krav 4, eller som opnåelig ved fremgangsmåden ifølge krav 3, som omfatter aminosyresekvensen ifølge SEQ ID NO: 43.
6. Et antistof, et anti-IL-6 receptorantistof, et anti-IL-31 receptorantistof, et anti-RANKL antistof, eller en farmaceutisk sammensætning omfattende et antistof med den konstante region ifølge ethvert af kravene 1,2, 4 eller 5, eller som opnåelig ved fremgangsmåden ifølge krav 3.
7. Antistof eller farmaceutisk sammensætning omfattende et antistof, som omfatter to konstante regioner i et antistof ifølge ethvert af kravene 1,2,4 eller 5, eller som opnåeligt ved fremgangsmåden ifølge krav 3.
DK15200628.4T 2007-09-26 2008-09-26 Modificeret konstant region i et antistof DK3059246T3 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2007250147 2007-09-26
EP08834649.9A EP2194066B1 (en) 2007-09-26 2008-09-26 Modified antibody constant region

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DK3059246T3 true DK3059246T3 (da) 2018-10-01

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US (3) US9688762B2 (da)
EP (4) EP3415529B1 (da)
JP (8) JP5484060B2 (da)
KR (6) KR101680906B1 (da)
CN (1) CN101874041B (da)
AR (4) AR068563A1 (da)
AU (1) AU2008304748C1 (da)
BR (1) BRPI0817273A2 (da)
CA (5) CA2700394C (da)
CL (1) CL2008002886A1 (da)
DK (2) DK2194066T3 (da)
ES (2) ES2566957T3 (da)
HK (1) HK1146728A1 (da)
IL (1) IL204537A0 (da)
MX (2) MX342551B (da)
MY (3) MY163473A (da)
PE (1) PE20090711A1 (da)
PH (2) PH12014502106A1 (da)
PL (1) PL3059246T3 (da)
RU (2) RU2526512C2 (da)
SG (2) SG193868A1 (da)
TW (2) TWI563002B (da)
WO (1) WO2009041613A1 (da)
ZA (1) ZA201002422B (da)

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