DK2334705T3 - Biologiske produkter - Google Patents

Biologiske produkter Download PDF

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Publication number
DK2334705T3
DK2334705T3 DK09736624.9T DK09736624T DK2334705T3 DK 2334705 T3 DK2334705 T3 DK 2334705T3 DK 09736624 T DK09736624 T DK 09736624T DK 2334705 T3 DK2334705 T3 DK 2334705T3
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DK
Denmark
Prior art keywords
fab
antibody
seq
dab
sequence
Prior art date
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DK09736624.9T
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English (en)
Inventor
Laura Hancock
Sam Philip Heywood
Ralph Adams
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Ucb Biopharma Sprl
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Publication date
Priority claimed from GB0817704A external-priority patent/GB0817704D0/en
Priority claimed from GB0905314A external-priority patent/GB0905314D0/en
Application filed by Ucb Biopharma Sprl filed Critical Ucb Biopharma Sprl
Application granted granted Critical
Publication of DK2334705T3 publication Critical patent/DK2334705T3/da

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/04—Drugs for disorders of the alimentary tract or the digestive system for ulcers, gastritis or reflux esophagitis, e.g. antacids, inhibitors of acid secretion, mucosal protectants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/16—Drugs for disorders of the alimentary tract or the digestive system for liver or gallbladder disorders, e.g. hepatoprotective agents, cholagogues, litholytics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P11/00—Drugs for disorders of the respiratory system
    • A61P11/06—Antiasthmatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P17/00—Drugs for dermatological disorders
    • A61P17/06—Antipsoriatics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P19/00—Drugs for skeletal disorders
    • A61P19/02—Drugs for skeletal disorders for joint disorders, e.g. arthritis, arthrosis
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P27/00—Drugs for disorders of the senses
    • A61P27/02—Ophthalmic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P29/00—Non-central analgesic, antipyretic or antiinflammatory agents, e.g. antirheumatic agents; Non-steroidal antiinflammatory drugs [NSAID]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P3/00—Drugs for disorders of the metabolism
    • A61P3/08—Drugs for disorders of the metabolism for glucose homeostasis
    • A61P3/10—Drugs for disorders of the metabolism for glucose homeostasis for hyperglycaemia, e.g. antidiabetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/08—Antiallergic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P9/00—Drugs for disorders of the cardiovascular system
    • A61P9/12—Antihypertensives
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • C07K16/245—IL-1
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2878—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • 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
    • C07K2317/50—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
    • C07K2317/569—Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/624—Disulfide-stabilized antibody (dsFv)
    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/31—Fusion polypeptide fusions, other than Fc, for prolonged plasma life, e.g. albumin

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Public Health (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • General Chemical & Material Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Pulmonology (AREA)
  • Diabetes (AREA)
  • Rheumatology (AREA)
  • Cardiology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Dermatology (AREA)
  • Hematology (AREA)
  • Pain & Pain Management (AREA)
  • Ophthalmology & Optometry (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Urology & Nephrology (AREA)
  • Neurosurgery (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Obesity (AREA)
  • Endocrinology (AREA)
  • Emergency Medicine (AREA)

Claims (9)

1. Multivalent antistoffusionsprotein, som omfatter et Fab- eller Fab'-fragment, med en første specificitet til et antigen af interesse og som yderligere omfatter to enkelt-domæne-antistoffer (dAb) med specificitet til et andet antigen af interesse, hvor de to enkelt-domæne-antistoffer er bundet af en disulfidbinding og hvor de to enkelt-domæne-antistoffer er et VH/VL-par og VH-dAb'et er genetisk splejset sammen, direkte eller via en linker til den C-terminale ende af Fab- eller Fab’-tung-kæden og VL-dAb'et er genetisk splejset sammen, direkte eller via en linker til den C-terminale ende af Fab- eller Fab'-let-kæden.
2. Multivalent antistoffusionsprotein ifølge krav 1, hvor det første antigen og andet antigen er forskellige præparater.
3. Multivalent antistoffusionsprotein ifølge krav 1 eller krav 2, hvor det andet antigen er albumin.
4. Multivalent antistoffusionsprotein ifølge krav 3, hvor albuminet er humant serumalbumin.
5. Dobbelt specificitets antistoffusionsprotein ifølge krav 1, omfattende et Fab- eller Fab'-fragment, med en første specificitet til et antigen af interesse og som yderligere omfatter to enkelt-domæne-antistoffer (dAb) med specificitet til et andet antigen af interesse, som binder humant serumalbumin og hvor de to enkelt-domæne-antistoffer er bundet af en disulfidbinding og ét af enkelt-domæne-antistofferne er et tung-kæde-VFI-enkelt-domæne-anti-stof, som omfatter mindst én af en CDR, der har sekvensen givet på figur 5 (e) SEQ ID NO:56 eller figur 5 (k) SEQ ID NO:62 for CDR-H1, en CDR, der har sekvensen givet på figur 5(f) SEQ ID NO:57 eller figur 5 (1) SEQ ID NO:63 for CDR-H2 og en CDR, der har sekvensen givet på figur 5 (g) SEQ ID NO:58 eller figur 5 (m) SEQ ID NO:64 for CDR-H3.
6. Dobbelt specificitets antistoffusionsprotein ifølge krav 1, omfattende et Fab- eller Fab'-fragment, med en første specificitet til et antigen af interesse og som yderligere omfatter to enkelt-domæne-antistoffer (dAb) med specificitet til et andet antigen af interesse, som binder humant serumalbumin og hvor de to enkelt-domæne-antistoffer er bundet af en disulfidbinding og ét af enkelt-domæne-antistofferne er et let-kæde-VL-enkelt-domæne-antistof, som omfatter mindst én af en CDR, der har sekvensen givet på figur 5 (h) SEQ ID NO:59 eller figur 5 (n) SEQ ID NO:65 for CDR-L1, en CDR, der har sekvensen givet på figur 5(i) SEQ ID NO:60 eller figur 5 (o) SEQ ID NO:66 for CDR-L2 og en CDR, der har sekvensen givet på figur 5 (j) SEQ ID NO:61 eller figur 5 (p) SEQ ID NO:67 for CDR-L3.
7. Dobbelt specificitets antistoffusionsprotein ifølge krav 1, omfattende et Fab- eller Fab'-fragment, med en første specificitet til et antigen af interesse og som yderligere omfatter to enkelt-domæne-antistoffer (dAb) med specificitet til et andet antigen af interesse, som binder humant serumalbumin og hvor de to enkelt-domæne-antistoffer er bundet af en disulfidbinding og ét af enkelt-domæne-antistofferne er et tung-kæde-VFi-enkelt-domæne-anti-stof, som omfatter sekvensen givet i SEQ ID NO: 56 for CDRH1, sekvensen givet i SEQ ID NO: 57 for CDRFI2 og sekvensen givet i SEQ ID NO: 58 for CDRH3 og det andet enkelt domæne-antistof er et let-kæde-VL-enkelt-domæne-antistof, som omfatter sekvensen givet i SEQ ID NO: 59 for CDRL1, sekvensen givet i SEQ ID NO: 60 for CDRL2 og sekvensen givet i SEQ ID NO: 61 for CDRL3.
8. Farmaceutisk sammensætning omfattende et multivalent eller dobbelt specificitets antistoffusionsprotein ifølge et hvilket som helst af krav 1 til 7 i forbindelse med ét eller flere farmaceutisk acceptable bærestoffer, excipienser eller fortyndingsmidler.
9. Multivalent eller dobbelt specificitets antistoffusionsprotein ifølge et hvilket som helst af krav 1 til 8 til anvendelse i terapi.
DK09736624.9T 2008-09-26 2009-09-25 Biologiske produkter DK2334705T3 (da)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
GB0817704A GB0817704D0 (en) 2008-09-26 2008-09-26 Biological products
GB0905314A GB0905314D0 (en) 2009-03-26 2009-03-26 Biological products
PCT/GB2009/002310 WO2010035012A1 (en) 2008-09-26 2009-09-25 Biological products

Publications (1)

Publication Number Publication Date
DK2334705T3 true DK2334705T3 (da) 2017-03-27

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US (2) US10407513B2 (da)
EP (1) EP2334705B1 (da)
JP (2) JP6063122B2 (da)
CN (2) CN102164965B (da)
BR (1) BRPI0918947A2 (da)
CA (1) CA2737241C (da)
CY (1) CY1118713T1 (da)
DK (1) DK2334705T3 (da)
EA (1) EA201100527A1 (da)
ES (1) ES2620603T3 (da)
HR (1) HRP20170374T1 (da)
HU (1) HUE033438T2 (da)
LT (1) LT2334705T (da)
PL (1) PL2334705T3 (da)
PT (1) PT2334705T (da)
SI (1) SI2334705T1 (da)
WO (1) WO2010035012A1 (da)

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CN102164965A (zh) 2011-08-24
US20110184152A1 (en) 2011-07-28
LT2334705T (lt) 2017-03-27
SI2334705T1 (sl) 2017-05-31
WO2010035012A9 (en) 2011-03-17
JP2015178536A (ja) 2015-10-08

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