RU2015102069A - Антитела к биотину и способы их применения - Google Patents

Антитела к биотину и способы их применения Download PDF

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RU2015102069A
RU2015102069A RU2015102069A RU2015102069A RU2015102069A RU 2015102069 A RU2015102069 A RU 2015102069A RU 2015102069 A RU2015102069 A RU 2015102069A RU 2015102069 A RU2015102069 A RU 2015102069A RU 2015102069 A RU2015102069 A RU 2015102069A
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amino acid
seq
antibody
acid sequence
hvr
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RU2015102069A
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Ульрих БРИНКМАНН
Ги ЖОРЖ
Майкл ГРОТЕ
Айке ХОФФМАНН
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Ф. Хоффманн-Ля Рош Аг
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/44—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material not provided for elsewhere, e.g. haptens, metals, DNA, RNA, amino acids
    • 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
    • A61K47/68—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 antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • 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
    • A61K47/68—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 antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—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 antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2299/00—Coordinates from 3D structures of peptides, e.g. proteins or enzymes
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (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)
  • Heterocyclic Carbon Compounds Containing A Hetero Ring Having Oxygen Or Sulfur (AREA)

Abstract

1. Гуманизированное антитело к биотину, включающее: (a) HVR-H3, содержащий аминокислотную последовательность SEQ ID NO: 11, (b) HVR-L3, содержащий аминокислотную последовательность SEQ ID NO: 15, и (с) HVR-H2, содержащий аминокислотную последовательность SEQ ID NO: 10.2. Антитело по п. 1, где антитело включает: (a) HVR-H1, содержащий аминокислотную последовательность SEQ ID NO: 09, (b) HVR-H2, содержащий аминокислотную последовательность SEQ ID NO: 10, и (с) HVR-H3, содержащий аминокислотную последовательность SEQ ID NO: 11.3. Антитело согласно любому из пп. 1-2, где антитело включает: (а) HVR-L1, содержащий аминокислотную последовательность SEQ ID NO: 13; (b) HVR-L2, содержащий аминокислотную последовательность SEQ ID NO: 14; и (с) HVR-L3, содержащий аминокислотную последовательность SEQ ID NO: 15.4. Антитело по п. 1, содержащее в позиции 24 вариабельного домена тяжелой цепи, пронумерованной согласно Kabat, аминокислотный остаток серина и/или содержащее в позиции 73 вариабельного домена тяжелой цепи, пронумерованной согласно Kabat, аминокислотный остаток треонина.5. Антитело согласно п. 1, содержащее в позиции 60 вариабельного домена тяжелой цепи, пронумерованной согласно Kabat, аминокислотный остаток аланина и в позиции 61 вариабельного домена тяжелой цепи, пронумерованной согласно Kabat, аминокислотный остаток глутамина.6. Антитело согласно п. 1, содержащее:(a) VH-последовательность, по меньшей мере на 95% идентичную аминокислотной последовательности SEQ ID NO: 12;(b) VL-последовательность, по меньшей мере на 95% идентичную аминокислотной последовательности SEQ ID NO: 16; или(c) VH-последовательность, как определено в (а), и VL-последовательность, как определено в (b),где аминокислотный остаток в позиции 24 вариабельного домена тяжелой цепи, пронумерованной согласно Kabat, представляет собой серин, и/или аминокислотный остаток в позиции 73 вариабельного домена тяжелой цепи,

Claims (15)

1. Гуманизированное антитело к биотину, включающее: (a) HVR-H3, содержащий аминокислотную последовательность SEQ ID NO: 11, (b) HVR-L3, содержащий аминокислотную последовательность SEQ ID NO: 15, и (с) HVR-H2, содержащий аминокислотную последовательность SEQ ID NO: 10.
2. Антитело по п. 1, где антитело включает: (a) HVR-H1, содержащий аминокислотную последовательность SEQ ID NO: 09, (b) HVR-H2, содержащий аминокислотную последовательность SEQ ID NO: 10, и (с) HVR-H3, содержащий аминокислотную последовательность SEQ ID NO: 11.
3. Антитело согласно любому из пп. 1-2, где антитело включает: (а) HVR-L1, содержащий аминокислотную последовательность SEQ ID NO: 13; (b) HVR-L2, содержащий аминокислотную последовательность SEQ ID NO: 14; и (с) HVR-L3, содержащий аминокислотную последовательность SEQ ID NO: 15.
4. Антитело по п. 1, содержащее в позиции 24 вариабельного домена тяжелой цепи, пронумерованной согласно Kabat, аминокислотный остаток серина и/или содержащее в позиции 73 вариабельного домена тяжелой цепи, пронумерованной согласно Kabat, аминокислотный остаток треонина.
5. Антитело согласно п. 1, содержащее в позиции 60 вариабельного домена тяжелой цепи, пронумерованной согласно Kabat, аминокислотный остаток аланина и в позиции 61 вариабельного домена тяжелой цепи, пронумерованной согласно Kabat, аминокислотный остаток глутамина.
6. Антитело согласно п. 1, содержащее:
(a) VH-последовательность, по меньшей мере на 95% идентичную аминокислотной последовательности SEQ ID NO: 12;
(b) VL-последовательность, по меньшей мере на 95% идентичную аминокислотной последовательности SEQ ID NO: 16; или
(c) VH-последовательность, как определено в (а), и VL-последовательность, как определено в (b),
где аминокислотный остаток в позиции 24 вариабельного домена тяжелой цепи, пронумерованной согласно Kabat, представляет собой серин, и/или аминокислотный остаток в позиции 73 вариабельного домена тяжелой цепи, пронумерованной согласно Kabat, представляет собой треонин.
7. Антитело по п. 4, содержащее VH-последовательность SEQ ID NO: 12.
8. Антитело по любому из пп. 4 или 7, содержащее VL последовательность SEQ ID NO: 16.
9. Антитело, содержащее VH-последовательность SEQ ID NO: 12 и VL последовательность SEQ ID NO: 16.
10. Антитело по п. 1, являющееся полноразмерным антителом IgG1 или полноразмерным антителом IgG4.
11. Антитело по п. 1 или 9, являющееся моноклональным антителом.
12. Антитело по п. 1 или 9, представляющее собой фрагмент антитела, связывающий биотин.
13. Фармацевтический препарат, включающий антитело по любому из пп. 1-12, и фармацевтически приемлемый носитель.
14. Антитело по п. 1 или 9 для применения в качестве лекарственного препарата.
15. Применение антитела по любому из пп. 1-12 при производстве лекарственного препарата.
RU2015102069A 2012-07-04 2013-07-04 Антитела к биотину и способы их применения RU2630296C2 (ru)

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EP12174957 2012-07-04
EP12174957.6 2012-07-04
PCT/EP2013/064099 WO2014006123A1 (en) 2012-07-04 2013-07-04 Anti-biotin antibodies and methods of use

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