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HRP20201156T1 - Zajednički laki lanci i postupci primjene - Google Patents

Zajednički laki lanci i postupci primjene Download PDF

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Publication number
HRP20201156T1
HRP20201156T1 HRP20201156TT HRP20201156T HRP20201156T1 HR P20201156 T1 HRP20201156 T1 HR P20201156T1 HR P20201156T T HRP20201156T T HR P20201156TT HR P20201156 T HRP20201156 T HR P20201156T HR P20201156 T1 HRP20201156 T1 HR P20201156T1
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Croatia
Prior art keywords
antigen
activates
binding
bispecific
cell
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HRP20201156TT
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English (en)
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Christian Klein
Ekkehard Moessner
Ralf Hosse
Peter Bruenker
Pablo Umana
Christiane Jaeger
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F. Hoffmann - La Roche Ag
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Publication of HRP20201156T1 publication Critical patent/HRP20201156T1/hr

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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
    • C07K16/461—Igs containing Ig-regions, -domains or -residues form different species
    • C07K16/464—Igs containing CDR-residues from one specie grafted between FR-residues from another
    • 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
    • A61K39/0005—Vertebrate antigens
    • A61K39/0011—Cancer antigens
    • A61K39/001102—Receptors, cell surface antigens or cell surface determinants
    • 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
    • A61K39/0005—Vertebrate antigens
    • A61K39/0011—Cancer antigens
    • A61K39/001169—Tumor associated carbohydrates
    • A61K39/00117—Mucins, e.g. MUC-1
    • 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
    • A61K39/385—Haptens or antigens, bound to carriers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • C07K16/2803—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 immunoglobulin superfamily
    • C07K16/2809—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 immunoglobulin superfamily against the T-cell receptor (TcR)-CD3 complex
    • 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
    • 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
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • 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
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • C12N15/70—Vectors or expression systems specially adapted for E. coli
    • C12N15/73—Expression systems using phage (lambda) regulatory sequences
    • 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
    • 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
    • A61K2039/51—Medicinal preparations containing antigens or antibodies comprising whole cells, viruses or DNA/RNA
    • A61K2039/515—Animal cells
    • A61K2039/5158—Antigen-pulsed cells, e.g. T-cells
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • 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
    • C07K2317/30—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
    • C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41—Glycosylation, sialylation, or fucosylation
    • 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
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/71—Decreased effector function due to an Fc-modification
    • 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
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • 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

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  • Chemical Kinetics & Catalysis (AREA)
  • Peptides Or Proteins (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
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Claims (19)

1. Bispecifična molekula vezana na antigen koji aktivira T stanicu, naznačena time, da sadrži prvu i drugu funkcionalnu skupinu koja vezuje antigen, pri čemu prva funkcionalna skupina koja vezuje antigen sadrži prvi laki lanac i pri čemu je prva funkcionalna skupina koja vezuje antigen sposobna za specifično vezanje na antigen koji aktivira T stanicu, gdje je antigen koji aktivira T-stanicu CD3, dok druga funkcionalna skupina koja vezuje antigen sadrži drugi laki lanac i pri čemu je druga funkcionalna skupina koja vezuje antigen sposobna za specifično vezanje na antigen ciljne stanice, s time, da je antigen ciljne stanice receptor 1 folata (FolR1), pri čemu je aminokiselinska sekvenca prvog i drugog lakog lanca identična, gdje prvi i drugi laki lanac sadrže CDR-ove lakog lanca identifikacijskog broja sekvence: 32, identifikacijskog broja sekvence: 33 i identifikacijskog broja sekvence: 34, pri čemu je prva funkcionalna skupina koja vezuje antigen Fab i druga funkcionalna skupina koja vezuje antigen je Fab. 
2. Bispecifična molekula vezana na antigen koji aktivira T stanicu prema patentnom zahtjevu 1, naznačena time, da nadalje sadrži treću funkcionalnu skupinu koja vezuje antigen, sposobnu za specifično vezanje na antigen ciljne stanice. 
3. Bispecifična molekula vezana na antigen koji aktivira T stanicu prema patentnom zahtjevu 1, naznačena time, da nadalje sadrži Fc domenu sastavljenu od prve i druge podjedinice sposobne za stabilno udruživanje. 
4. Bispecifična molekula vezana na antigen koji aktivira T stanicu prema bilo kojem od patentnih zahtjeva 1 do 3, naznačena time, da prvi i drugi laki lanac sadrže aminokiselinsku sekvencu identifikacijskog broja sekvence: 31. 
5. Bispecifična molekula vezana na antigen koji aktivira T stanicu prema patentnom zahtjevu 4, naznačena time, da prvi i drugi laki lanac sadrže aminokiselinsku sekvencu identifikacijskog broja sekvence: 35. 
6. Bispecifična molekula vezana na antigen koji aktivira T stanicu prema bilo kojem od patentnih zahtjeva 1 do 5, naznačena time, da navedena funkcionalna skupina koja vezuje antigen, sposobna za specifično vezanje na antigen koji aktivira T stanicu, sadrži teški lanac koji sadrži CDR-ove teškog lanca identifikacijskog broja sekvence: 37, identifikacijskog broja sekvence: 38 i identifikacijskog broja sekvence: 39. 
7. Bispecifična molekula vezana na antigen koji aktivira T stanicu prema patentnom zahtjevu 2, naznačena time, da je prva, druga i treća funkcionalna skupina koja vezuje antigen svaka Fab molekula koja sadrži identičan laki lanac VLCL. 
8. Bispecifična molekula vezana na antigen koji aktivira T stanicu prema patentnom zahtjevu 2 ili 7, naznačena time, da je prva, druga i treća funkcionalna skupina koja vezuje antigen svaka Fab molekula koja sadrži CDR-ove lakog lanca identifikacijskog broja sekvence: 32, identifikacijskog broja sekvence: 33 i identifikacijskog broja sekvence: 34. 
9. Bispecifična molekula vezana na antigen koji aktivira T stanicu prema patentnom zahtjevu 2 ili 7, naznačena time, da je prva, druga i treća funkcionalna skupina koja vezuje antigen svaka Fab molekula koja sadrži laki lanac koji čini aminokiselinska sekvenca identifikacijskog broja sekvence: 31. 
10. Bispecifična molekula vezana na antigen koji aktivira T stanicu prema bilo kojem od patentnih zahtjeva 2 ili 7 do 9, naznačena time, da je svaka prva i treća funkcionalna skupina koja vezuje antigen na C-terminalnom kraju Fab teškog lanca spojena za N-terminalni kraj jedne od podjedinica Fc domene, a druga funkcionalna skupina koja vezuje antigen je na C-terminalnom kraju Fab teškog lanca spojena za N-terminalni kraj Fab teškog lanca prve funkcionalne skupine koja vezuje antigen. 
11. Bispecifična molekula vezana na antigen koji aktivira T stanicu prema bilo kojem od patentnih zahtjeva 3 do 10, naznačena time, da Fc domena je IgG, osobito IgG1 ili IgG4, Fc domena. 
12. Bispecifična molekula vezana na antigen koji aktivira T stanicu prema bilo kojem od patentnih zahtjeva 3 do 10, naznačena time, da Fc domena je ljudska Fc domena. 
13. Izolirani polinukleotid, naznačen time, da kodira bispecifičnu molekulu vezanu na antigen koji aktivira T stanicu prema bilo kojem od patentnih zahtjeva 1 do 12. 
14. Vektor, posebice vektor ekspresije, naznačen time, da sadrži izolirani polinukleotid prema patentnom zahtjevu 13. 
15. Stanica domaćina, naznačena time, da sadrži izolirani polinukleotid prema patentnom zahtjevu 13 ili vektor prema patentnom zahtjevu 14. 
16. Postupak proizvodnje bispecifične molekule vezane na antigen koji aktivira T stanicu prema bilo kojem od patentnih zahtjeva 1 do 12, naznačen time, da sadrži korake a) kultivacije stanice domaćina prema patentnom zahtjevu 15 u uvjetima prikladnima za ekspresiju bispecifične molekule vezane na antigen koji aktivira T stanicu i b) ponovnog dobivanja bispecifične molekule vezane na antigen koji aktivira T stanicu. 
17. Farmaceutski pripravak, naznačen time, da se sastoji od bispecifične molekule vezane na antigen koji aktivira T stanicu prema bilo kojem od patentnih zahtjeva 1 do 12 i farmaceutski prihvatljivog nosača. 
18. Bispecifična molekula vezana na antigen koji aktivira T stanicu prema bilo kojem od patentnih zahtjeva 1 do 12 ili farmaceutski pripravak prema patentnom zahtjevu 17, naznačeni time, da se primjenjuju kao medikament. 
19. Bispecifična molekula vezana na antigen koji aktivira T stanicu prema bilo kojem od patentnih zahtjeva 1 do 12 ili farmaceutski pripravak prema patentnom zahtjevu 17, naznačeni time, da su za primjenu u liječenju raka.
HRP20201156TT 2014-11-20 2020-07-23 Zajednički laki lanci i postupci primjene HRP20201156T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP14194097 2014-11-20
EP15797972.5A EP3221357B1 (en) 2014-11-20 2015-11-17 Common light chains and methods of use
PCT/EP2015/076745 WO2016079081A1 (en) 2014-11-20 2015-11-17 Common light chains and methods of use

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HRP20201156T1 true HRP20201156T1 (hr) 2020-11-13

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US (3) US20170253670A1 (hr)
EP (2) EP3747905A1 (hr)
JP (2) JP7164949B2 (hr)
KR (1) KR20170087486A (hr)
CN (1) CN107207609B (hr)
BR (1) BR112017010513A2 (hr)
CA (1) CA2968162A1 (hr)
DK (1) DK3221357T3 (hr)
ES (1) ES2808853T3 (hr)
HK (1) HK1244011A1 (hr)
HR (1) HRP20201156T1 (hr)
HU (1) HUE049650T2 (hr)
LT (1) LT3221357T (hr)
MX (1) MX381724B (hr)
PL (1) PL3221357T3 (hr)
PT (1) PT3221357T (hr)
RS (1) RS60615B1 (hr)
RU (1) RU2747011C2 (hr)
SI (1) SI3221357T1 (hr)
WO (1) WO2016079081A1 (hr)

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