HRP20151227T1 - Sastavi i postupci uporabe za terapeutska protutijela - Google Patents
Sastavi i postupci uporabe za terapeutska protutijela Download PDFInfo
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- HRP20151227T1 HRP20151227T1 HRP20151227TT HRP20151227T HRP20151227T1 HR P20151227 T1 HRP20151227 T1 HR P20151227T1 HR P20151227T T HRP20151227T T HR P20151227TT HR P20151227 T HRP20151227 T HR P20151227T HR P20151227 T1 HRP20151227 T1 HR P20151227T1
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- 238000000034 method Methods 0.000 title claims 4
- 239000000203 mixture Substances 0.000 title 1
- 230000001225 therapeutic effect Effects 0.000 title 1
- 108090000623 proteins and genes Proteins 0.000 claims 30
- 102000004169 proteins and genes Human genes 0.000 claims 29
- 125000003275 alpha amino acid group Chemical group 0.000 claims 16
- 229920001184 polypeptide Polymers 0.000 claims 16
- 102000004196 processed proteins & peptides Human genes 0.000 claims 16
- 108090000765 processed proteins & peptides Proteins 0.000 claims 16
- 210000004027 cell Anatomy 0.000 claims 10
- 239000008194 pharmaceutical composition Substances 0.000 claims 10
- 210000003719 b-lymphocyte Anatomy 0.000 claims 6
- 102000006471 Fucosyltransferases Human genes 0.000 claims 4
- 108010019236 Fucosyltransferases Proteins 0.000 claims 4
- 101000795169 Homo sapiens Tumor necrosis factor receptor superfamily member 13C Proteins 0.000 claims 4
- 102100029690 Tumor necrosis factor receptor superfamily member 13C Human genes 0.000 claims 4
- 150000001413 amino acids Chemical class 0.000 claims 4
- 206010025323 Lymphomas Diseases 0.000 claims 3
- 238000010367 cloning Methods 0.000 claims 3
- 230000000694 effects Effects 0.000 claims 3
- 239000013604 expression vector Substances 0.000 claims 3
- 101150023212 fut8 gene Proteins 0.000 claims 3
- 102000039446 nucleic acids Human genes 0.000 claims 3
- 108020004707 nucleic acids Proteins 0.000 claims 3
- 150000007523 nucleic acids Chemical class 0.000 claims 3
- 208000010839 B-cell chronic lymphocytic leukemia Diseases 0.000 claims 2
- 208000012526 B-cell neoplasm Diseases 0.000 claims 2
- 208000028564 B-cell non-Hodgkin lymphoma Diseases 0.000 claims 2
- 208000031422 Lymphocytic Chronic B-Cell Leukemia Diseases 0.000 claims 2
- 206010035226 Plasma cell myeloma Diseases 0.000 claims 2
- 238000007792 addition Methods 0.000 claims 2
- 230000010056 antibody-dependent cellular cytotoxicity Effects 0.000 claims 2
- 239000013599 cloning vector Substances 0.000 claims 2
- 238000012217 deletion Methods 0.000 claims 2
- 230000037430 deletion Effects 0.000 claims 2
- 238000000338 in vitro Methods 0.000 claims 2
- 238000001727 in vivo Methods 0.000 claims 2
- 210000004962 mammalian cell Anatomy 0.000 claims 2
- 238000006467 substitution reaction Methods 0.000 claims 2
- 208000023275 Autoimmune disease Diseases 0.000 claims 1
- 102000016605 B-Cell Activating Factor Human genes 0.000 claims 1
- 108010028006 B-Cell Activating Factor Proteins 0.000 claims 1
- 208000011691 Burkitt lymphomas Diseases 0.000 claims 1
- 208000025205 Mantle-Cell Lymphoma Diseases 0.000 claims 1
- 208000034578 Multiple myelomas Diseases 0.000 claims 1
- 201000011152 Pemphigus Diseases 0.000 claims 1
- 208000006664 Precursor Cell Lymphoblastic Leukemia-Lymphoma Diseases 0.000 claims 1
- 208000021386 Sjogren Syndrome Diseases 0.000 claims 1
- 208000033559 Waldenström macroglobulinemia Diseases 0.000 claims 1
- 239000004480 active ingredient Substances 0.000 claims 1
- 230000001270 agonistic effect Effects 0.000 claims 1
- 239000000427 antigen Substances 0.000 claims 1
- 102000036639 antigens Human genes 0.000 claims 1
- 108091007433 antigens Proteins 0.000 claims 1
- 238000003556 assay Methods 0.000 claims 1
- 239000012752 auxiliary agent Substances 0.000 claims 1
- 239000000969 carrier Substances 0.000 claims 1
- 210000004978 chinese hamster ovary cell Anatomy 0.000 claims 1
- 208000032852 chronic lymphocytic leukemia Diseases 0.000 claims 1
- 238000012258 culturing Methods 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 239000003814 drug Substances 0.000 claims 1
- 238000001943 fluorescence-activated cell sorting Methods 0.000 claims 1
- 201000003444 follicular lymphoma Diseases 0.000 claims 1
- 125000002446 fucosyl group Chemical group C1([C@@H](O)[C@H](O)[C@H](O)[C@@H](O1)C)* 0.000 claims 1
- 208000032839 leukemia Diseases 0.000 claims 1
- 208000003747 lymphoid leukemia Diseases 0.000 claims 1
- 201000007919 lymphoplasmacytic lymphoma Diseases 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 201000006417 multiple sclerosis Diseases 0.000 claims 1
- 201000000050 myeloid neoplasm Diseases 0.000 claims 1
- 201000001976 pemphigus vulgaris Diseases 0.000 claims 1
- 239000002243 precursor Substances 0.000 claims 1
- 230000035755 proliferation Effects 0.000 claims 1
- 238000003259 recombinant expression Methods 0.000 claims 1
- 206010039073 rheumatoid arthritis Diseases 0.000 claims 1
- 201000000596 systemic lupus erythematosus Diseases 0.000 claims 1
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- C—CHEMISTRY; METALLURGY
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- 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
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- 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
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- 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
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- 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
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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
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/02—Antineoplastic agents specific for leukemia
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- 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
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- 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
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- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
-
- 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
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
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- 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
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- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2317/00—Immunoglobulins specific features
- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
- C07K2317/55—Fab or Fab'
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- 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]
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- 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
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- 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
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- 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
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- Proteomics, Peptides & Aminoacids (AREA)
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- Genetics & Genomics (AREA)
- Biochemistry (AREA)
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- Physical Education & Sports Medicine (AREA)
- Transplantation (AREA)
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- Orthopedic Medicine & Surgery (AREA)
- Neurosurgery (AREA)
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- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Claims (32)
1. Izolirano protutijelo ili funkcionalni protein koji sadrži dio za vezanje antigena od protutijela za ciljani BAFFR polipeptid od SEQ ID NO:87, naznačen/o time, da protutijelo ili funkcionalni protein obuhvaća (i) polipeptid VH koji ima sekvence s najmanje 90 postotaka identiteta sekvence od barem jedne od SEQ ID NO:50 do SEQ ID NO:56 i polipeptid VL koji ima sekvence s najmanje 90 postotaka identiteta od barem jedne od SEQ ID NO:43 do SEQ ID NO:49, i (ii) varijabilno područje jakog lanca CDR3 aminokiselinske sekvence odabrane iz skupine koju čine od SEQ ID NO:16 do SEQ ID NO:21 ili aminokiselinske sekvence koja ima jednu ili dvije aminokiselinske zamjene, jednog ili dva izbacivanja ili dodavanja aminokiselina, u usporedbi sa SEQ ID NO:16 do SEQ ID NO:21 i varijabilno područje slabog lanca CDR3 aminokiselinske sekvence odabrane iz skupine koju čine od SEQ ID NO:37 do SEQ ID NO:42 ili aminokiselinske sekvence koja ima jednu ili dvije aminokiselinske zamjene, jednog ili dva izbacivanja ili dodavanja aminokiselina, u usporedbi sa SEQ ID NO:37 do SEQ ID NO:42, te time da se spomenuto protutijelo ili funkcionalni protein veže na BAFFR polipeptid gdje je KD od 100nM ili manje, kao i da inhibira humanu proliferaciju B-stanica, induciranu s BLyS, gdje je IC50 oko 10nM ili manje, te iscrpljuje B-stanice in vivo ili in vitro.
2. Protutijelo ili funkcionalni protein prema zahtjevu 1, naznačen/o time, da obuhvaća sljedeće:
(a) polipeptidna sekvenca VH od SEQ ID NO:51 i polipeptidna sekvenca VL od SEQ ID NO:44; ili
(b) polipeptidna sekvenca VH od SEQ ID NO:52 i polipeptidna sekvenca VL od SEQ ID NO:45; ili
(c) polipeptidna sekvenca VH od SEQ ID NO:53 i polipeptidna sekvenca VL od SEQ ID NO:46; ili
(d) polipeptidna sekvenca VH od SEQ ID NO:54 i polipeptidna sekvenca VL od SEQ ID NO:47; ili
(e) polipeptidna sekvenca VH od SEQ ID NO:55 i polipeptidna sekvenca VL od SEQ ID NO:48; ili
(f) polipeptidna sekvenca VH od SEQ ID NO:56 i polipeptidna sekvenca VL od SEQ ID NO:49.
3. Izolirano protutijelo ili funkcionalni protein prema zahtjevu 1, naznačen/o time, da obuhvaća sljedeće:
(a) varijabilno područje jakog lanca CDR1 aminokiselinske sekvence odabrane iz skupine koju čine od SEQ ID NO:2 do SEQ ID NO:7; i
(b) varijabilno područje jakog lanca CDR2 aminokiselinske sekvence odabrane iz skupine koju čine od SEQ ID NO:9 do SEQ ID NO:14; i
(c) varijabilno područje jakog lanca CDR3 aminokiselinske sekvence odabrane iz skupine koju čine od SEQ ID NO:16 do SEQ ID NO:21; i
(d) varijabilno područje slabog lanca CDR1 aminokiselinske sekvence odabrane iz skupine koju čine od SEQ ID NO:23 do SEQ ID NO:28; i
(e) varijabilno područje slabog lanca CDR2 aminokiselinske sekvence odabrane iz skupine koju čine od SEQ ID NO:30 do SEQ ID NO:35; i
(f) varijabilno područje slabog lanca CDR3 aminokiselinske sekvence odabrane iz skupine koju čine od SEQ ID NO:37 do SEQ ID NO:42.
4. Protutijelo ili funkcionalni protein prema zahtjevu 3, naznačen/o time, da obuhvaća sljedeće:
(a) CDR1 varijabilno područje jakog lanca od SEQ ID NO:2; CDR2 varijabilno područje jakog lanca od SEQ ID NO:9; CDR3 varijabilno područje jakog lanca od SEQ ID NO:16; CDR1 varijabilno područje slabog lanca od SEQ ID NO:23; CDR2 varijabilno područje slabog lanca od SEQ ID NO:30; i CDR3 varijabilno područje slabog lanca od SEQ ID NO:37; ili
(b) CDR1 varijabilno područje jakog lanca od SEQ ID NO:3; CDR2 varijabilno područje jakog lanca od SEQ ID NO:10; CDR3 varijabilno područje jakog lanca od SEQ ID NO:17; CDR1 varijabilno područje slabog lanca od SEQ ID NO:24; CDR2 varijabilno područje slabog lanca od SEQ ID NO:31; i CDR3 varijabilno područje slabog lanca od SEQ ID NO:38; ili
(c) CDR1 varijabilno područje jakog lanca od SEQ ID NO:4; CDR2 varijabilno područje jakog lanca od SEQ ID NO:11; CDR3 varijabilno područje jakog lanca od SEQ ID NO:18; CDR1 varijabilno područje slabog lanca od SEQ ID NO:25; CDR2 varijabilno područje slabog lanca od SEQ ID NO:32; i CDR3 varijabilno područje slabog lanca od SEQ ID NO:39; ili
(d) CDR1 varijabilno područje jakog lanca od SEQ ID NO:5; CDR2 varijabilno područje jakog lanca od SEQ ID NO:12; CDR3 varijabilno područje jakog lanca od SEQ ID NO:19; CDR1 varijabilno područje slabog lanca od SEQ ID NO:26; CDR2 varijabilno područje slabog lanca od SEQ ID NO:33; i CDR3 varijabilno područje slabog lanca od SEQ ID NO:40; ili
(e) CDR1 varijabilno područje jakog lanca od SEQ ID NO:6; CDR2 varijabilno područje jakog lanca od SEQ ID NO:13; CDR3 varijabilno područje jakog lanca od SEQ ID NO:20; CDR1 varijabilno područje slabog lanca od SEQ ID NO:27; CDR2 varijabilno područje slabog lanca od SEQ ID NO:34; i CDR3 varijabilno područje slabog lanca od SEQ ID NO:41; ili
(f) CDR1 varijabilno područje jakog lanca od SEQ ID NO:7; CDR2 varijabilno područje jakog lanca od SEQ ID NO:14; CDR3 varijabilno područje jakog lanca od SEQ ID NO:21; CDR1 varijabilno područje slabog lanca od SEQ ID NO:28; CDR2 varijabilno područje slabog lanca od SEQ ID NO:35; i CDR3 varijabilno područje slabog lanca od SEQ ID NO:42.
5. Protutijelo ili funkcionalni protein prema bilo kojem od zahtjeva 1 do 4, naznačen/o time, da obuhvaća jaki lanac pune duljine, koji se sastoji od aminokiselinske sekvence koja je najmanje 95% identična aminokiselinskoj sekvenci odabranoj iz skupine koju čine od SEQ ID NO:75 do SEQ ID NO:78 i slabi lanac pune duljine, koji se sastoji od aminokiselinske sekvence koja je najmanje 95% identična aminokiselinskoj sekvenci odabranoj iz skupine koju čine od SEQ ID NO:71 do SEQ ID NO:74.
6. Protutijelo ili funkcionalni protein prema zahtjevu 5, naznačen/o time, da obuhvaća sljedeće:
(a) sekvenca jakog lanca od SEQ ID NO:75 i sekvenca slabog lanca od SEQ ID NO:71; ili
(b) sekvenca jakog lanca od SEQ ID NO:76 i sekvenca slabog lanca od SEQ ID NO:72; ili
(c) sekvenca jakog lanca od SEQ ID NO:77 i sekvenca slabog lanca od SEQ ID NO:73; ili
(d) sekvenca jakog lanca od SEQ ID NO:78 i sekvenca slabog lanca od SEQ ID NO:74.
7. Izolirano protutijelo ili funkcionalni protein prema bilo kojem od prethodnih zahtjeva, naznačen/o time, da navedeno/i protutijelo ili funkcionalni protein iscrpljuje B-stanice in vitro, gdje je EC50 oko 10nM ili manje, 1nM ili manje ili je 100pM ili manje, prema mjerenju u ispitivanju ADCC-iscrpljivanja humanih B-stanica.
8. Protutijelo ili funkcionalni protein prema bilo kojem od prethodnih zahtjeva, naznačen/o time, da je navedeno/i protutijelo ili funkcionalni protein osposobljen za reduciranje postotka B-stanica sve do 90%, in vivo, u usporedbi s netretiranim utjecanjem, prema mjerenju razvrstavanja B-stanica putem fluorescentnog aktiviranja stanica (FACS - Fluorescent Activated Cell Sorting).
9. Protutijelo ili funkcionalni protein prema bilo kojem od prethodnih zahtjeva, naznačen/o time, da navedeno/i protutijelo ili funkcionalni protein nema agonističko djelovanje.
10. Protutijelo prema bilo kojem od prethodnih zahtjeva, naznačen/o time, da je to u potpunosti humano protutijelo ili je to humanizirano protutijelo IgG1.
11. Protutijelo prema bilo kojem od prethodnih zahtjeva, naznačen/o time, da ono obuhvaća Fc-područje aminokiseline koje je mutirano ili kemijski modificirano, pri čemu spomenuto mutirano ili kemijski modificirano Fc-područje aminokiseline, omogućava povećanje ADCC-djelovanja u usporedbi s divljom vrstom Fc-područja.
12. Protutijelo ili funkcionalni protein prema bilo kojem od prethodnih zahtjeva, naznačen/o time, da navedeno/i protutijelo ili protein je hipofukoziliran/o ili nefukoziliran/o te ima smanjene količine fukozilnih ostataka ili ih uopće nema.
13. Protutijelo prema bilo kojem od prethodnih zahtjeva, naznačen/o time, da se proizvodi pomoću rekombinantne ekspresije u staničnoj liniji koja nema fukoziltransferazu, primjerice u staničnoj liniji sisavca s nedovoljnom ekspresijom gena FUT8 koji kodira fukoziltransferazu, čime se povećava ADCC-djelovanje od tako proizvedenih protutijela, u usporedbi s ekspresijom stanične linije kod divlje vrste gena FUT8.
14. Protutijelo ili funkcionalni protein prema bilo kojem od prethodnih zahtjeva, naznačen/o time, da je unakrsno zapriječen/o za vezanje na BAFFR pomoću najmanje jednog protutijela prema zahtjevu 6.
15. Protutijelo ili funkcionalni protein prema bilo kojem od prethodnih zahtjeva, naznačen/o time, da unakrsno sprečava ili je unakrsno zapriječen/o za vezanje na BAFFR pomoću najmanje jednog protutijela prema zahtjevu 6.
16. Farmaceutski sastav, naznačen time, da obuhvaća protutijelo ili funkcionalni protein prema bilo kojem od prethodnih zahtjeva.
17. Farmaceutski sastav prema zahtjevu 16, naznačen time, da postoji u kombinaciji s jednim ili više farmaceutski prihvatljivih pomoćnih sredstava, razrjeđivača ili nosača.
18. Farmaceutski sastav prema zahtjevu 16 ili 17, naznačen time, da dodatno sadrži neke druge djelatne sastojke.
19. Protutijelo, funkcionalni protein ili farmaceutski sastav prema bilo kojem od prethodnih zahtjeva, naznačen/o time, da se upotrebljava kao lijek.
20. Protutijelo, funkcionalni protein ili farmaceutski sastav prema bilo kojem od prethodnih zahtjeva, naznačen/o time, da se upotrebljava u liječenju autoimunih bolesti.
21. Protutijelo, funkcionalni protein ili farmaceutski sastav prema zahtjevu 20, naznačen/o time, da se upotrebljava u liječenju reumatoidnog artritisa, sistemske lupus eritematoze, Sjögrenovog sindroma, bolesti pemphigus vulgaris ili multiple skleroze.
22. Protutijelo, funkcionalni protein ili farmaceutski sastav prema bilo kojem od prethodnih zahtjeva, naznačen/o time, da se upotrebljava u liječenju neoplazme B-stanica.
23. Protutijelo, funkcionalni protein ili farmaceutski sastav za uporabu prema zahtjevu 22, naznačen/o time, da neoplazma B-stanica je limfom, leukemija ili mijelom.
24. Protutijelo, funkcionalni protein ili farmaceutski sastav prema zahtjevu 22 ili zahtjevu 23, naznačen/o time, da se upotrebljava u liječenju non-Hodgkin limfoma B-stanice.
25. Protutijelo, funkcionalni protein ili farmaceutski sastav za uporabu prema zahtjevu 24, naznačen/o time, da non-Hodgkin limfomi B-stanice su sljedeći: mali limfocitni limfom, limfoplazmacitoidni limfom, limfom plaštenih stanica, folikularni limfom, limfom tkiva povezan s limfoidnom mukozom, limfom velikih difuznih stanica i Burkittov limfom; prethodnik B-limfoblastne leukemije; i kronična limfocitna leukemija B-stanica, i višestruki mijelom.
26. Izolirana nukleinska kiselina, naznačena time, da kodira protutijelo ili funkcionalni protein prema bilo kojem od zahtjeva 1 do 25.
27. Vektor kloniranja ili ekspresije, naznačen time, da obuhvaća jednu ili više nukleinskih kiselina prema zahtjevu 26.
28. Vektor kloniranja ili ekspresije prema zahtjevu 27, naznačen time, da obuhvaća barem jednu nukleinsku kiselinu odabranu iz skupine koju čine od SEQ ID NO:79 do SEQ ID NO:86.
29. Stanica domaćina, naznačena time, da obuhvaća jedan ili više vektora kloniranja ili ekspresije prema zahtjevu 27 ili zahtjevu 28.
30. Postupak za proizvodnju protutijela ili funkcionalnog proteina prema bilo kojem od zahtjeva 1 do 25, naznačen time, da obuhvaća kultiviranje stanice domaćina prema zahtjevu 29 i izoliranje navedenog protutijela ili funkcionalnog proteina.
31. Postupak prema zahtjevu 30, naznačen time, da navedena stanica domaćina je stanična linija bez ekspresije fukoziltransferaze.
32. Postupak prema zahtjevu 31, naznačen time, da navedena stanična linija je stanica sisavca nedovoljna za ekspresiju gena koji kodira fukoziltransferazu, poželjno je to CHO stanična linija bez gena FUT8.
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PCT/EP2009/059030 WO2010007082A1 (en) | 2008-07-17 | 2009-07-15 | Compositions and methods of use for therapeutic antibodies |
EP09797499.2A EP2315780B8 (en) | 2008-07-17 | 2009-07-15 | Compositions and methods of use for therapeutic antibodies |
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EP2648750B1 (en) * | 2010-12-10 | 2017-01-25 | Novartis AG | Antibody formulation |
JP2012153788A (ja) * | 2011-01-25 | 2012-08-16 | Nitto Denko Corp | 光学用粘着シート |
US9216219B2 (en) * | 2012-06-12 | 2015-12-22 | Novartis Ag | Anti-BAFFR antibody formulation |
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CN105873949A (zh) | 2014-01-31 | 2016-08-17 | 勃林格殷格翰国际有限公司 | 新的抗baff抗体 |
MA41044A (fr) | 2014-10-08 | 2017-08-15 | Novartis Ag | Compositions et procédés d'utilisation pour une réponse immunitaire accrue et traitement contre le cancer |
CU20170052A7 (es) | 2014-10-14 | 2017-11-07 | Dana Farber Cancer Inst Inc | Moléculas de anticuerpo que se unen a pd-l1 |
WO2017019897A1 (en) | 2015-07-29 | 2017-02-02 | Novartis Ag | Combination therapies comprising antibody molecules to tim-3 |
SI3317301T1 (sl) | 2015-07-29 | 2021-10-29 | Novartis Ag | Kombinirane terapije, ki obsegajo molekule protitelesa na LAG-3 |
JP2019503349A (ja) | 2015-12-17 | 2019-02-07 | ノバルティス アーゲー | Pd−1に対する抗体分子およびその使用 |
RS60477B1 (sr) | 2016-02-10 | 2020-08-31 | Novartis Ag | Upotreba inhibitora aktivnosti ili funkcije pi3k za lečenje primarnog sjögren-ovog sindroma |
US11197928B2 (en) | 2017-01-13 | 2021-12-14 | Board Of Regents, The University Of Texas System | Sustained production of high affinity antigen specific antibody by high dose BAFF receptor-targeting mAb-siRNA conjugate |
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KR20200018498A (ko) * | 2017-06-20 | 2020-02-19 | 테네오바이오, 인코포레이티드 | 항-bcma 중쇄-단독 항체 |
JP7439046B2 (ja) * | 2018-07-20 | 2024-02-27 | テネオツー・インコーポレイテッド | Cd19に結合する重鎖抗体 |
TW202102540A (zh) * | 2019-03-29 | 2021-01-16 | 日商中外製藥股份有限公司 | 包含抗il-6受體抗體之bbb功能低下之抑制劑 |
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