DK2664625T3 - Blod-hjerne-barrierepermeable peptidsammensætninger - Google Patents

Blod-hjerne-barrierepermeable peptidsammensætninger Download PDF

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Publication number
DK2664625T3
DK2664625T3 DK13000098.7T DK13000098T DK2664625T3 DK 2664625 T3 DK2664625 T3 DK 2664625T3 DK 13000098 T DK13000098 T DK 13000098T DK 2664625 T3 DK2664625 T3 DK 2664625T3
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polypeptide
peptide
vol
vab
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DK13000098.7T
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Ram S Bhatt
Rishi Bhatt
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Icb Int Inc
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    • 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
    • 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
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6811—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a protein or peptide, e.g. transferrin or bleomycin
    • 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
    • A61K47/6843—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 material from animals or humans
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6854—Immunoglobulins
    • G01N33/6857—Antibody fragments
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • G01N33/6896—Neurological disorders, e.g. Alzheimer's disease
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0085—Brain, e.g. brain implants; Spinal cord
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/22—Immunoglobulins specific features characterized by taxonomic origin from camelids, e.g. camel, llama or dromedary
    • 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
    • C07K2317/56—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
    • C07K2317/64—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising a combination of variable region and constant region components

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Molecular Biology (AREA)
  • Biomedical Technology (AREA)
  • General Health & Medical Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Hematology (AREA)
  • Urology & Nephrology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Organic Chemistry (AREA)
  • Cell Biology (AREA)
  • Food Science & Technology (AREA)
  • Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Microbiology (AREA)
  • Biotechnology (AREA)
  • General Physics & Mathematics (AREA)
  • Pathology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Zoology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Claims (14)

  1. Blod-hj eme-barrierepermeable peptidsammensætninger Patentkrav
    1. Polypeptid, der omfatter: (i) et variabelt antigenbindende (Vab) domæne, der består af det hele eller en væsentlig del af et kamel-Vab-domæne eller et haj-V-NAR-domæne; (ii) det hele eller en del af en hængselregion, der er afledt fra et kamelantistof, der alene består af et enkelt domæne af tung kæde, som fortrinsvis er mindst 85 % identisk med aminosyrerne 128-162 af SEQ ID NO: 11; og (iii) et konstant domæne valgt blandt et CH2- eller CH3-domæne af humant IgG og eventuelt mindst ét yderligere konstant domæne valgt fra gruppen, der består af CH2- eller CH3-domænet af humant IgG, hvor CH2-domænet fortrinsvis er mindst 85 % identisk med aminosyrerne 163-272 af SEQ ID NO: 11, eller CH3-domænet fortrinsvis er mindst 85 % identisk med aminosyrerne 273-378 af SEQ ID NO: 11 af kamel-IgG, og CH1-, CH2-, CH3-, CH4- eller CH5-domænet af haj-IgNAR, og hvor polypeptidet binder til ét eller flere mål i centralnervesystemet (CNS) hos en vertebrat.
  2. 2. Polypeptid ifølge krav 1, hvor det variable antigenbindende domæne er et kamel-V ab-domæne.
  3. 3. Polypeptid ifølge et hvilket som helst af kravene 1-2, hvor polypeptidet omfatter mindst to forskellige konstante domæner.
  4. 4. Polypeptid ifølge et hvilket som helst af kravene 1-3, hvor polypeptidet er i stand til at krydse blod-hjerne-barrieren.
  5. 5. Polypeptid ifølge et hvilket som helst af kravene 3-4, hvor mindst to af de konstante domæner stammer fra forskellige arter.
  6. 6. Polypeptid ifølge et hvilket som helst af kravene 1-5, hvor Vab-domænet omfatter mindst én aminosyre, der svarer til positionerne 37, 44, 45 og 47 af SEQ ID NO: 11, der er valgt fra gruppen, der består af serin, tyrosin, arginin, histidin, asparagin, asparaginsyre, threonin, lysin og glutaminsyre.
  7. 7. Polypeptid ifølge et hvilket som helst af kravene 1-6, hvor polypeptidet yderligere omfatter et mærke.
  8. 8. Polypeptid ifølge krav 7, hvor mærket er valgt fra gruppen, der består af en radioisotop, en fluorofor, et terapeutisk middel, et toksin, et hormon, et peptid, biotin, digoxigenin, avidin, streptavidin, en nukleinsyre og en nanopartikel.
  9. 9. Polypeptid ifølge krav 8, hvor mærket er en nanopartikel, og nanopartiklen omfatter polybutylcyanoacrylat belagt med aminodextran.
  10. 10. Polypeptid ifølge et hvilket som helst af kravene 8-9, hvor nanopartiklen har en molekylvægt på 70 kDa.
  11. 11. Polypeptid ifølge et hvilket som helst af kravene 1-10, hvor det ene eller de flere mål omfatter et mål valgt fra gruppen, der består af amyloid-beta, Tau-protein, Tau-kinaser [tyrosinkinase Fyn, glycogensyntasekinase 3 (GSK-3), cyklinafhængig proteinkinase-5, caseinkinase-1, proteinkinase-A, proteinkinase-C, calcium- og calmodulinafhængig proteinkinase-II, MAPK], ApoE4, c-terminal ApoE4, beta-secretase, gamma-secretase, translocase fra den ydre membran (TOM), GSK-3, acetylcholinesterase, NMDA (N-methyl-D-aspartat), APP (amyloidprecursorprotein), TDP43, ALZAS, alfa-synuclein (naturligt og mutant), LRRK2 (naturlig og mutant), Parkin, DJ-1, Pink 1, Synphilin, VIP (vasoaktivt intestinalpeptid), PACAP ((hypofyse-adenylatcyclaseaktiverende peptid), faktor H, NF-L (neurofilament-let kæde), NF-H (neurofilament-tung kæde), Tau, Αβ-42, antitubulin, NSE (neuronspecifik enolase), Apo-E, GAP-43 (vækstassocieret protein 43), 24S-OH-chol (24S-hydroxycholesterol), protein 14-3-3, sVCAM (opløseligt vaskulært celleadhæsionsmolekyle), sPECAM (opløseligt trombocyt-endotelcelleadhæsionsmolekyle), EGFR, HER2, PDGF (trombocytafledt vækstfaktor), FGFR (fibroblast-vækstfaktorreceptor), STATs (signaltransducere og aktivatorer af transkription), GDNF (gliacellelinjeafledt neurotrofisk faktor), mTOR (mammaliamål for rapamycin), VEGF (vaskulær endotelvækstfaktor), TGF-beta (transformerende vækstfaktor beta), P13K, Ras, Raf, MAPK, AKT (aka: proteinkinase B), MAPK, TIMP1, CD133, SPP1 (secerneret phosphoprotein 1), TP53, PTEN, TMS1, IDHI, NF1, IL-10; H2aFY, mutant HTT, 8-hydroxy-2-deoxyguanosin, kobber-Zn-superoxiddismutase, A2a-receptor, transglutaminase og polyglutamin.
  12. 12. Polypeptid ifølge et hvilket som helst af kravene 1-11, hvor det ene eller de flere mål omfatter amyloid beta-peptid.
  13. 13. Polypeptid ifølge krav 12, hvor det ene eller de flere mål omfatter amyloid plak.
  14. 14. Polypeptid ifølge krav 13, hvor den amyloide plak omfatter en opløselig, diffunderbar eller uopløselig amyloid plak.
DK13000098.7T 2012-01-09 2013-01-09 Blod-hjerne-barrierepermeable peptidsammensætninger DK2664625T3 (da)

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EP3309171A1 (en) 2018-04-18
EP2664625B1 (en) 2017-08-23
EP2754670B1 (en) 2019-05-22
EP3309171B1 (en) 2021-06-09
US20130177568A1 (en) 2013-07-11
EP2664625A3 (en) 2014-05-07
EP2754670A1 (en) 2014-07-16
EP3590963A1 (en) 2020-01-08
US10112987B2 (en) 2018-10-30

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