HRP20201493T1 - Anti-alfa-sinukleinska protutijela i postupci uporabe - Google Patents

Anti-alfa-sinukleinska protutijela i postupci uporabe Download PDF

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HRP20201493T1
HRP20201493T1 HRP20201493TT HRP20201493T HRP20201493T1 HR P20201493 T1 HRP20201493 T1 HR P20201493T1 HR P20201493T T HRP20201493T T HR P20201493TT HR P20201493 T HRP20201493 T HR P20201493T HR P20201493 T1 HRP20201493 T1 HR P20201493T1
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seq
antibody
human
constant region
synuclein
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HRP20201493TT
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Markus Britschgi
Sylwia Huber
Klaus Kaluza
Thomas Kremer
Olaf Mundigl
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F. Hoffmann-La Roche Ag
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    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • 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
    • A61K47/6849—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 the antibody targeting a receptor, a cell surface antigen or a cell surface determinant
    • 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
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • 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
    • A61P25/14—Drugs for disorders of the nervous system for treating abnormal movements, e.g. chorea, dyskinesia
    • A61P25/16—Anti-Parkinson drugs
    • 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
    • A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], 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 [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2881—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD71
    • 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
    • C07K2317/32—Immunoglobulins specific features characterized by aspects of specificity or valency specific for a neo-epitope on a complex, e.g. antibody-antigen or ligand-receptor
    • 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
    • C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • 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
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51—Complete heavy chain or Fd fragment, i.e. VH + CH1
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515—Complete light chain, i.e. VL + CL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • 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
    • C07K2317/622—Single chain antibody (scFv)
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • 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
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/01—Fusion polypeptide containing a localisation/targetting motif
    • C07K2319/02—Fusion polypeptide containing a localisation/targetting motif containing a signal sequence
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/33—Fusion polypeptide fusions for targeting to specific cell types, e.g. tissue specific targeting, targeting of a bacterial subspecies

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
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  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
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  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
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  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Cell Biology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Hospice & Palliative Care (AREA)
  • Psychiatry (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Claims (8)

1. Anti-humano alfa-sinukleinsko protutijelo, naznačeno time, da obuhvaća: (a) HVR-H1 koji sadrži aminokiselinski slijed od SEQ ID NO: 21; (b) HVR-H2 koji sadrži aminokiselinski slijed od SEQ ID NO: 22; (c) HVR-H3 koji sadrži aminokiselinski slijed od SEQ ID NO: 17; (d) HVR-L1 koji sadrži aminokiselinski slijed od SEQ ID NO: 23; (e) HVR-L2 koji sadrži aminokiselinski slijed od SEQ ID NO: 24; i (f) HVR-L3 koji sadrži aminokiselinski slijed od SEQ ID NO: 25.
2. Anti-humano alfa-sinukleinsko protutijelo prema patentnom zahtjevu 1, naznačeno time, da je anti-alfa sinukleinsko protutijelo humanizirano.
3. Anti-humano alfa-sinukleinsko protutijelo prema jednom od patentnih zahtjeva 1 do 2, naznačeno time, da anti-humano alfa-sinukleinsko protutijelo nadalje sadrži humani akceptorski okvir.
4. Anti-humano alfa-sinukleinsko protutijelo prema jednom od patentnih zahtjeva 1 do 3, naznačeno time, da: a) protutijelo sadrži dva teška lanca protutijela od kojih svaki sadrži varijabilnu domenu teškog lanca i konstantnu regiju teškog lanca, pri čemu: i) varijabilna domena obuhvaća hipervarijabilne regije slijedova od SEQ ID NO: 21, SEQ ID NO: 22 i SEQ ID NO: 17, ii) konstantna regija je konstantna regija humanog IgG1, pri čemu C-terminalni ostatak lizina može biti prisutan ili odsutan, i iii) konstantna regija obuhvaća promjene aminokiselina L234A, L235A i P329G, b) protutijelo sadrži dva laka lanca protutijela od kojih svaki lanac sadrži varijabilnu domenu lakog lanca i konstantnu domenu lakog lanca, pri čemu: i) varijabilna domena obuhvaća hipervarijabilne regije slijedova od SEQ ID NO: 23, SEQ ID NO: 24 i SEQ ID NO: 25, ii) konstantna regija je konstantna regija humanog lakog lanca kapa ili konstantna regija humanog lakog lanca lambda, i c) protutijelo i) inhibira alfa-sinukleinom uzrokovanu citotoksičnost u ljudskim neuronima i glija stanicama, i/ili ii) inhibira međustanični prijenos oligomernog humanog alfa-sinukleina između neurona i glija stanica, i/ili iii) smanjuje alfa-sinukleinom uzrokovanu aktivnost kaspaze u Lundovim ljudskim mezencefalnim stanicama (LHUMES), pri čemu je numeriranje u Fc-regiji sukladno Kabat EU indeksu.
5. Anti-humano alfa-sinukleinsko protutijelo prema jednom od patentnih zahtjeva 1 do 3, naznačeno time da: a) protutijelo sadrži dva teška lanca protutijela od kojih svaki u smjeru od N- do C-terminalnog kraja, sadrži varijabilnu domenu teškog lanca, konstantnu regiju teškog lanca, peptidni povezivač i fragment protutijela scFab ili scFv, koji se specifično veže na humani transferinski receptor, pri čemu: i) varijabilna domena obuhvaća hipervarijabilne regije slijedova od od SEQ ID NO: 21, SEQ ID NO: 22 i SEQ ID NO: 17, ii) konstantna regija je konstantna regija humanog IgG1, pri čemu C-terminalni ostatak lizina može biti prisutan ili odsutan, i iii) konstantna regija obuhvaća promjene aminokiselina L234A, L235A i P329G, b) protutijelo sadrži dva laka lanca protutijela od kojih svaki lanac sadrži varijabilnu domenu lakog lanca i konstantnu domenu lakog lanca, pri čemu: i) varijabilna domena obuhvaća hipervarijabilne regije slijedova od SEQ ID NO: 23, SEQ ID NO: 24 i SEQ ID NO: 25, ii) konstantna regija je konstantna regija humanog lakog lanca kapa ili konstantna regija humanog lakog lanca lambda, i c) protutijelo i) inhibira alfa-sinukleinom uzrokovanu citotoksičnost u ljudskim neuronima i glija stanicama, i/ili ii) inhibira međustanični prijenos oligomernog humanog alfa-sinukleina između neurona i glija stanica, i/ili iii) smanjuje alfa-sinukleinom uzrokovanu aktivnost kaspaze u LHUMES stanicama, pri čemu je numeriranje u Fc-regiji sukladno Kabat EU indeksu.
6. Farmaceutska formulacija, naznačena time, da sadrži protutijelo prema jednom od patentnih zahtjeva 1 do 5 i farmaceutski prihvatljiv nosač.
7. Protutijelo prema jednom od patentnih zahtjeva 1 do 5, naznačeno time, da se upotrebljava kao lijek.
8. Protutijelo prema jednom od patentnih zahtjeva 1 do 5, naznačeno time, da se upotrebljava u liječenju Parkinsonove bolesti.
HRP20201493TT 2013-11-21 2014-11-18 Anti-alfa-sinukleinska protutijela i postupci uporabe HRP20201493T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP13193892 2013-11-21
EP14799764.7A EP3071597B1 (en) 2013-11-21 2014-11-18 Anti-alpha-synuclein antibodies and methods of use
PCT/EP2014/074840 WO2015075011A1 (en) 2013-11-21 2014-11-18 ANTI-alpha-SYNUCLEIN ANTIBODIES AND METHODS OF USE

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US (5) US9493553B2 (hr)
EP (2) EP3071597B1 (hr)
JP (3) JP2017504566A (hr)
KR (3) KR102399292B1 (hr)
CN (3) CN105722857B (hr)
AR (2) AR098465A1 (hr)
AU (3) AU2014351996B2 (hr)
CA (1) CA2924268C (hr)
ES (1) ES2821904T3 (hr)
HR (1) HRP20201493T1 (hr)
HU (1) HUE051982T2 (hr)
IL (1) IL244495B (hr)
LT (1) LT3071597T (hr)
MX (3) MX375020B (hr)
MY (1) MY176237A (hr)
NZ (1) NZ717673A (hr)
PL (1) PL3071597T3 (hr)
PT (1) PT3071597T (hr)
RS (1) RS60882B1 (hr)
RU (2) RU2718990C1 (hr)
SG (1) SG10202007189VA (hr)
SI (1) SI3071597T1 (hr)
TW (1) TW201609804A (hr)
WO (1) WO2015075011A1 (hr)

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