DK3030264T3 - Bispecifikke monovalente fc-diabodies, som kan binde cd32b og cd79b, og anvendelser heraf - Google Patents
Bispecifikke monovalente fc-diabodies, som kan binde cd32b og cd79b, og anvendelser heraf Download PDFInfo
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- DK3030264T3 DK3030264T3 DK14834798.2T DK14834798T DK3030264T3 DK 3030264 T3 DK3030264 T3 DK 3030264T3 DK 14834798 T DK14834798 T DK 14834798T DK 3030264 T3 DK3030264 T3 DK 3030264T3
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- Prior art keywords
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- seq
- polypeptide chain
- diabody
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Classifications
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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
- 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
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- 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
- A61P37/00—Drugs for immunological or allergic disorders
-
- 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
- A61P37/02—Immunomodulators
-
- 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
- A61P37/02—Immunomodulators
- A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
-
- 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
- C07K16/283—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 Fc-receptors, e.g. CD16, CD32, CD64
-
- 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
- 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
- C07K2317/30—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
- C07K2317/52—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
-
- 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
- C07K2317/70—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
- C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
- C07K2317/74—Inducing cell proliferation
-
- 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
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
- C07K2319/70—Fusion polypeptide containing domain for protein-protein interaction
- C07K2319/73—Fusion polypeptide containing domain for protein-protein interaction containing coiled-coiled motif (leucine zippers)
Claims (13)
1. Bispecifik monovalent Fc-diabody, hvori den bispecifikke monovalente Fc-diabody specifikt kan binde til en epitop af CD32B og til en epitop af CD79b og har et IgG Fc-domæne, hvori den bispecifikke monovalente Fc-diabody omfatter en første polypeptidkæde, en anden polypeptidkæde og en tredje polypeptidkæde, hvori den første og den anden polypeptidkæde er kovalent bundet til hinanden, og den første og den tredje polypeptidkæde er kovalent bundet til hinanden, og hvori: A. den første polypeptidkæde i den N-terminale til C-terminale retning omfatter: i. et domæne 1, der omfatter: (1) et subdomæne (1A), der omfatter et cysteinholdigt peptid (SEQ ID NO:1); og (2) et subdomæne (IB), der omfatter en polypeptidportion af et IgG Fc-domæne, som har CH2- og CH3-domæner i et IgG-immunoglobulin-Fc-område; ii. et domæne 2, der omfatter: (1) et subdomæne (2A), der omfatter et VL-domæne i et monoklonalt antistof, som kan binde til CD32B (VLcd32b) (SEQ ID NO:11); og (2) et subdomæne (2B), der omfatter et VH-domæne i et monoklonalt antistof, som kan binde til CD79b (VHCd791d) (SEQ ID NO:14), hvori subdomænerne (2A) og (2B) er adskilt fra hinanden af en peptidlinker (Linker 2) (SEQ ID N0:4); iii. et domæne 3, hvori domænet 3 er et E-coil-domæne (SEQ ID NO:7) eller et K-coil-domæne (SEQ ID NO:8), hvori domænet 3 er adskilt fra domænet 2 af en peptidlinker (SEQ ID N0:5); og iv. et C-terminalt spacerpeptid (SEQ ID NO:6); B. den anden polypeptidkæde i den N-terminale til C-terminale retning omfatter: i. et domæne 1, der omfatter: (1) et subdomæne (1A), der omfatter et VL-domæne i et monoklonalt antistof, som kan binde til CD7 9b (VLcd791d) (SEQ ID NO:13); og (2) et subdomæne (IB), der omfatter et VH-domæne i et monoklonalt antistof, som kan binde til CD32B (VHcd32b) (SEQ ID NO:12); hvori subdomænerne (1A) og (IB) er adskilt fra hinanden af en peptidlinker (Linker 2) (SEQ ID N0:4); ii. et domæne 2, hvori domænet 2 er et K-coil-domæne (SEQ ID NO:8) eller et E-coil-domæne (SEQ ID NO:7), hvori domænet 2 er adskilt fra domænet 1 af en peptidlinker (SEQ ID NO:5); og hvori domænet 3 i den første polypeptidkæde og domænet 2 i den anden polypeptidkæde ikke begge er E-coil-domæner eller begge K-coil-domæner; og C. den tredje polypeptidkæde i den N-terminale til C-terminale retning omfatter et domæne 1, der omfatter: (1) et subdomæne (1A), der omfatter et cysteinholdigt peptid (SEQ ID NO:1); og (2) et subdomæne (IB), der omfatter en polypeptidportion af et IgG Fc-domæne, som har CH2- og CH3-domæner i et IgG-immunoglobulin-Fc-område; og hvori: (a) polypeptidportionerne af IgG Fc-domænerne i den første og tredje polypeptidkæde danner IgG Fc-domænet; (b) VL-domænet i den første polypeptidkæde og VH-domænet i den anden polypeptidkæde danner et antigenbindende domæne, som specifikt kan binde til en epitop af CD32B; og (c) VH-domænet i den første polypeptidkæde og VL-domænet i den anden polypeptidkæde danner et antigenbindende domæne, som specifikt kan binde til en epitop af CD79b.
2. Bispecifik monovalent Fc-diabody ifølge krav 1, hvori subdomænet (IB) i den første polypeptidkæde omfatter en sekvens, der er forskellig fra sekvensen i subdomænet (IB) i den tredje polypeptidkæde.
3. Bispecifik monovalent Fc-diabody ifølge krav 1, hvori subdomænet (IB) i den første polypeptidkæde har aminosyresekvensen ifølge SEQ ID NO:9, og subdomænet (IB) i den tredje polypeptidkæde har aminosyresekvensen ifølge SEQ ID NO:10.
4. Bispecifik monovalent Fc-diabody ifølge krav 1, hvori subdomænet (IB) i den første polypeptidkæde har aminosyresekvensen ifølge SEQ ID NO:10, og subdomænet (IB) i den tredje polypeptidkæde har aminosyresekvensen ifølge SEQ ID NO: 9.
5. Bispecifik monovalent Fc-diabody ifølge et af kravene 1-2, hvori domænet 1 i den første polypeptidkæde og/eller domænet 1 i den tredje polypeptidkæde omfatter en variant CH2-CH3-sekvens, som har ændret binding til en Fcy-receptor.
6. Bispecifik monovalent Fc-diabody ifølge et af kravene 1-5, hvori domænet 3 i den første polypeptidkæde omfatter en E-coil (SEQ ID NO: 7) , og domænet 2 i den anden polypeptidkæde omfatter en K-coil (SEQ ID NO:8).
7. Bispecifik monovalent Fc-diabody ifølge et af kravene 1-5, hvori domænet 3 i den første polypeptidkæde omfatter en K-coil (SEQ ID NO:8), og domænet 2 i den anden polypeptidkæde omfatter en E- coil (SEQ ID NO:7).
8. Bispecifik monovalent Fc-diabody, hvori det bispecifikke monovalente Fc-diabody specifikt kan binde til en epitop af CD32B og til en epitop af CD79b og har et IgG Fc-domæne, hvori den bispecifikke monovalente Fc-diabody omfatter: (1) en første polypeptidkæde, som har aminosyresekvensen ifølge SEQ ID NO:15 (2) en anden polypeptidkæde, som har aminosyresekvensen ifølge SEQ ID NO:16, og (3) en tredje polypeptidkæde, som har aminosyresekvensen i følge SEQ ID NO: 17, hvori aminosyreresterne 1-10 i den tredje polypeptidkæde er peptid 1 (SEQ ID NO:l), og aminosyreresterne 11-227 i den tredje polypeptidkæde er CH2- og CH3-domænerne i et IgG-antistofs Fc-område (SEQ ID NO:10) hvori den første og den anden polypeptidkæde er kovalent bundet til hinanden ved hjælp af en første disulfidbinding, og den første og den tredje polypeptidkæde er kovalent bundet til hinanden ved hjælp af en anden disulfidbinding.
9. Farmaceutisk sammensætning, der omfatter den bispecifikke monovalente Fc-diabody ifølge et af kravene 1-8 og en fysiologisk acceptabel bærer.
10. Bispecifik monovalent-Fc diabody ifølge et hvilket som helst af kravene 1-8 eller i den farmaceutiske sammensætning ifølge krav 9 til anvendelse ved behandling af en inflammatorisk sygdom eller tilstand.
11. Bispecifik monovalent Fc-diabody eller farmaceutisk sammensætning til anvendelse ifølge krav 10, hvori den inflammatoriske sygdom eller tilstand er en autoimmun sygdom.
12. Bispecifik monovalent Fc-diabody eller farmaceutisk sammensætning til anvendelse ifølge krav 11, hvori den autoimmune sygdom er systemisk lupus erythematosus (SLE).
13. Bispecifik monovalent Fc-diabody eller farmaceutisk sammensætning til anvendelse ifølge krav 10, hvori den inflammatoriske sygdom eller tilstand er graft versus hostsygdom (GvHD).
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201361864217P | 2013-08-09 | 2013-08-09 | |
US201361866416P | 2013-08-15 | 2013-08-15 | |
US201361869519P | 2013-08-23 | 2013-08-23 | |
US201361907525P | 2013-11-22 | 2013-11-22 | |
PCT/US2014/049848 WO2015021089A1 (en) | 2013-08-09 | 2014-08-06 | Bi-specific monovalent fc diabodies that are capable of binding cd32b and cd79b and uses thereof |
Publications (1)
Publication Number | Publication Date |
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DK3030264T3 true DK3030264T3 (da) | 2019-04-23 |
Family
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Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
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DK14834798.2T DK3030264T3 (da) | 2013-08-09 | 2014-08-06 | Bispecifikke monovalente fc-diabodies, som kan binde cd32b og cd79b, og anvendelser heraf |
Country Status (25)
Country | Link |
---|---|
US (1) | US10344092B2 (da) |
EP (1) | EP3030264B1 (da) |
JP (1) | JP6395834B2 (da) |
KR (1) | KR102294018B1 (da) |
CN (2) | CN105611943B (da) |
AU (1) | AU2014306105B2 (da) |
CA (1) | CA2920021C (da) |
CL (1) | CL2016000293A1 (da) |
DK (1) | DK3030264T3 (da) |
DO (1) | DOP2016000044A (da) |
EA (1) | EA033658B1 (da) |
ES (1) | ES2720730T3 (da) |
GE (1) | GEP201706794B (da) |
HU (1) | HUE043229T2 (da) |
IL (1) | IL244009B (da) |
MX (1) | MX2016001741A (da) |
PE (1) | PE20160508A1 (da) |
PH (1) | PH12016500242A1 (da) |
PL (1) | PL3030264T4 (da) |
PT (1) | PT3030264T (da) |
SG (1) | SG11201600855VA (da) |
TN (1) | TN2016000042A1 (da) |
TW (1) | TW201536805A (da) |
UA (1) | UA116479C2 (da) |
WO (1) | WO2015021089A1 (da) |
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GB201412659D0 (en) | 2014-07-16 | 2014-08-27 | Ucb Biopharma Sprl | Molecules |
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