ME02581B - Farmaceutski pripravci s otpornošću na topljivi cea - Google Patents
Farmaceutski pripravci s otpornošću na topljivi ceaInfo
- Publication number
- ME02581B ME02581B MEP-2016-218A MEP2016218A ME02581B ME 02581 B ME02581 B ME 02581B ME P2016218 A MEP2016218 A ME P2016218A ME 02581 B ME02581 B ME 02581B
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- Montenegro
- Prior art keywords
- acid sequence
- amino acid
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- pharmaceutical preparation
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- Prior art date
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- 239000008194 pharmaceutical composition Substances 0.000 title 1
- 150000001413 amino acids Chemical group 0.000 claims 34
- 239000000825 pharmaceutical preparation Substances 0.000 claims 29
- 206010028980 Neoplasm Diseases 0.000 claims 16
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- 235000018102 proteins Nutrition 0.000 claims 6
- 102000004169 proteins and genes Human genes 0.000 claims 6
- 108090000623 proteins and genes Proteins 0.000 claims 6
- 108091028043 Nucleic acid sequence Proteins 0.000 claims 5
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- NFGXHKASABOEEW-UHFFFAOYSA-N 1-methylethyl 11-methoxy-3,7,11-trimethyl-2,4-dodecadienoate Chemical group COC(C)(C)CCCC(C)CC=CC(C)=CC(=O)OC(C)C NFGXHKASABOEEW-UHFFFAOYSA-N 0.000 claims 3
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- 229940126619 mouse monoclonal antibody Drugs 0.000 claims 3
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- 208000010507 Adenocarcinoma of Lung Diseases 0.000 claims 2
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- WHUUTDBJXJRKMK-UHFFFAOYSA-N Glutamic acid Natural products OC(=O)C(N)CCC(O)=O WHUUTDBJXJRKMK-UHFFFAOYSA-N 0.000 claims 2
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- 241000282412 Homo Species 0.000 claims 2
- QNAYBMKLOCPYGJ-REOHCLBHSA-N L-alanine Chemical compound C[C@H](N)C(O)=O QNAYBMKLOCPYGJ-REOHCLBHSA-N 0.000 claims 2
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- 235000003704 aspartic acid Nutrition 0.000 claims 2
- OQFSQFPPLPISGP-UHFFFAOYSA-N beta-carboxyaspartic acid Natural products OC(=O)C(N)C(C(O)=O)C(O)=O OQFSQFPPLPISGP-UHFFFAOYSA-N 0.000 claims 2
- 201000008274 breast adenocarcinoma Diseases 0.000 claims 2
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- 239000003814 drug Substances 0.000 claims 2
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- 210000003238 esophagus Anatomy 0.000 claims 2
- 235000013922 glutamic acid Nutrition 0.000 claims 2
- 239000004220 glutamic acid Substances 0.000 claims 2
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- 229940121354 immunomodulator Drugs 0.000 claims 2
- 201000005249 lung adenocarcinoma Diseases 0.000 claims 2
- 229930182817 methionine Natural products 0.000 claims 2
- 210000000496 pancreas Anatomy 0.000 claims 2
- COLNVLDHVKWLRT-UHFFFAOYSA-N phenylalanine Natural products OC(=O)C(N)CC1=CC=CC=C1 COLNVLDHVKWLRT-UHFFFAOYSA-N 0.000 claims 2
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- OUYCCCASQSFEME-UHFFFAOYSA-N tyrosine Natural products OC(=O)C(N)CC1=CC=C(O)C=C1 OUYCCCASQSFEME-UHFFFAOYSA-N 0.000 claims 2
- 238000002965 ELISA Methods 0.000 claims 1
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- ROHFNLRQFUQHCH-YFKPBYRVSA-N L-leucine Chemical compound CC(C)C[C@H](N)C(O)=O ROHFNLRQFUQHCH-YFKPBYRVSA-N 0.000 claims 1
- ROHFNLRQFUQHCH-UHFFFAOYSA-N Leucine Natural products CC(C)CC(N)C(O)=O ROHFNLRQFUQHCH-UHFFFAOYSA-N 0.000 claims 1
- 239000000969 carrier Substances 0.000 claims 1
- 239000013604 expression vector Substances 0.000 claims 1
- 238000009472 formulation Methods 0.000 claims 1
- 230000002068 genetic effect Effects 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 238000000034 method Methods 0.000 claims 1
- 230000000116 mitigating effect Effects 0.000 claims 1
- 239000000203 mixture Substances 0.000 claims 1
- 239000002773 nucleotide Substances 0.000 claims 1
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- 239000003381 stabilizer Substances 0.000 claims 1
- 239000000126 substance Substances 0.000 claims 1
Classifications
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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
-
- 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
- A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
- A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
- A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
- A61P1/18—Drugs for disorders of the alimentary tract or the digestive system for pancreatic disorders, e.g. pancreatic enzymes
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P11/00—Drugs for disorders of the respiratory system
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P15/00—Drugs for genital or sexual disorders; Contraceptives
- A61P15/14—Drugs for genital or sexual disorders; Contraceptives for lactation disorders, e.g. galactorrhoea
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
- A61P35/04—Antineoplastic agents specific for metastasis
-
- 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
- C07K16/30—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
- C07K16/18—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
- C07K16/3007—Carcino-embryonic Antigens
-
- 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
- C07K2317/21—Immunoglobulins specific features characterized by taxonomic origin from primates, e.g. man
-
- 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
- C07K2317/56—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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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K2319/00—Fusion polypeptide
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- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Immunology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Organic Chemistry (AREA)
- Medicinal Chemistry (AREA)
- General Health & Medical Sciences (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Genetics & Genomics (AREA)
- Biochemistry (AREA)
- Molecular Biology (AREA)
- Biophysics (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Engineering & Computer Science (AREA)
- Bioinformatics & Cheminformatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Oncology (AREA)
- Epidemiology (AREA)
- Cell Biology (AREA)
- Mycology (AREA)
- Microbiology (AREA)
- Biomedical Technology (AREA)
- Gynecology & Obstetrics (AREA)
- Pulmonology (AREA)
- Reproductive Health (AREA)
- Pregnancy & Childbirth (AREA)
- Endocrinology (AREA)
- Peptides Or Proteins (AREA)
- Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
- Medicines Containing Material From Animals Or Micro-Organisms (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Micro-Organisms Or Cultivation Processes Thereof (AREA)
- Cephalosporin Compounds (AREA)
- Preparation Of Compounds By Using Micro-Organisms (AREA)
Claims (33)
1. Farmaceutski pripravak namijenjen liječenju epitelnog tumora kod čovjeka, naznačen time što navedeni farmaceutski pripravak sadrži bispecifično jednolančano protutijelo koje ima(a) prvu vežuću domenu koja se specifično veže na ljudski CD3, i(b) drugu vežuću domenu koja se specifično veže na ljudski CEA,gdje navedena druga vežuća domena specifična za ljudski CEA sadrži(i) CDR-H1 koji ima aminokiselinski slijed "SYWMH" (SEQ ID NO. 68), CDR-H2 koji ima aminokiselinski slijed "FIRNKANGGTTEYAASVKG" (SEQ ID NO. 67), CDR-L1 koji ima aminokiselinski slijed "TLRRGINVGAYSIY" (SEQ ID NO. 73), CDR-L2 koji ima aminokiselinski slijed "YKSDSDKQQGS" (SEQ ID NO. 72) i CDR-L3 koji ima aminokiselinski slijed "MIWHSGASAV" (SEQ ID NO. 71);(ii) CDR-H1 koji ima aminokiselinski slijed "SYWMH" (SEQ ID NO. 68), CDR-H2 koji ima aminokiselinski slijed "FILNKANGGTTEYAASVKG" (SEQ ID NO. 145), CDR-L1 koji ima aminokiselinski slijed "TLRRGINVGAYSIY" (SEQ ID NO. 73), CDR-L2 koji ima aminokiselinski slijed "YKSDSDKQQGS" (SEQ ID NO. 72) i CDR-L3 koji ima aminokiselinski slijed "MIWHSGASAV" (SEQ ID NO. 71); ili(iii) CDR-H1 koji ima aminokiselinski slijed "TYAMH" (SEQ ID NO. 70), CDR-H2 koji ima aminokiselinski slijed "LISNDGSNKYYADSVKG" (SEQ ID NO. 69), CDR-L1 koji ima aminokiselinski slijed "TLRRGINVGAYSIY" (SEQ ID NO. 73), CDR-L2 koji ima aminokiselinski slijed "YKSDSDKQQGS" (SEQ ID NO. 72) i CDR-L3 koji ima aminokiselinski slijed "MIWHSGASAV" (SEQ ID NO. 71); igdje navedena druga vežuća domena u najmanju ruku sadrži aminokiselinski slijed "DX1X2X3X4FYFDY" (SEQ ID NO. 65), gdje "X1", "X2", "X3" ili "X4" predstavlja bilo koji aminokiselinski ostatak, aminokiselinski ostatak "D" odgovara Kabatovom položaju 95 u CDR-H3 mišjeg monoklonskog protutijela A5B7, a aminokiselina ostaci "FYFDY" odgovaraju Kabatovim položajima 100, 100a, 100b, 101 odnosno 102 u CDR-H3 mišjeg monoklonskog protutijela A5B7.
2. Farmaceutski pripravak u skladu s patentnim zahtjevom 1, naznačen time što – "X1" predstavlja "R" (Arginin), "F" (Fenilalanin), "M" (Metionin), "E" (Glutaminsku kiselinu) ili "T" (Treonin); – "X2" predstavlja "G" (Glicin), "Y" (Tirozin), "A" (Alanin), "D" (Asparaginsku kiselinu) ili "S" (Serin); – "X3" predstavlja "L" (Leucin), "F" (Fenilalanin), "M" (Metionin), "E" (Glutaminsku kiselinu) ili "T" (Treonin); i – "X4" predstavlja "R" (Arginin), "Y" (Tirozin), "A" (Alanin), "D" (Asparaginsku kiselinu) ili "S" (Serin).
3. Farmaceutski pripravak u skladu s patentnim zahtjevom 1 ili 2, naznačen time što navedena druga vežuća domena specifična za ljudski CEA u najmanju ruku sadrži aminokiselinski slijed "DRGLRFYFDY" (SEQ ID NO. 66) koji odgovara Kabatovim položajima 95-102 u CDR-H3 mišjeg monoklonskog protutijela A5B7.
4. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 3, naznačena time što se navedena prva vežuća domena specifična za CD3 nalazi na C-kraju.
5. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 4, naznačen time što su navedene vežuće domene posložene redoslijedom VHCEA-VLCEA-VHCD3-VLCD3 ili VLCEA-VHCEA-VHCD3-VLCD3.
6. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačen time što je aminokiselinski slijed VH područja u drugoj vežućoj domeni specifičnoj za ljudski CEA SEQ ID NO. 60 ili 146.
7. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 6, naznačen time što je aminokiselinski slijed VH područja u drugoj vežućoj domeni specifičnoj za ljudski CEA SEQ ID NO. 58 ili SEQ ID NO.62.
8. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 7, naznačen time što je aminokiselinski slijed VL područja u drugoj vežućoj domeni specifičnoj za ljudski CEA SEQ ID NO. 64.
9. Farmaceutski pripravak u skladu s bilo koji od patentnih zahtjeva 1 do 8, naznačen time što se V područja u drugoj vežućoj domeni specifičnoj za CEA bira iz skupine koju čine: (a) VH područje se sastoji od aminokiselinskog slijeda prikazanog u SEQ ID NO. 60, a VL područje se sastoji od aminokiselinskog slijeda prikazanog u SEQ ID NO. 64; (b) VH područje se sastoji od aminokiselinskog slijeda prikazanog u SEQ ID NO. 146, a VL područje se sastoji od aminokiselinskog slijeda prikazanog u SEQ ID NO. 64; (c) VH područje se sastoji od aminokiselinskog slijeda prikazanog u SEQ ID NO. 58, a VL područje se sastoji od aminokiselinskog slijeda prikazanog u SEQ ID NO. 64; (d) VH područje se sastoji od aminokiselinskog slijeda prikazanog u SEQ ID NO. 62, a VL područje se sastoji od aminokiselinskog slijeda prikazanog u SEQ ID NO. 64; i (e) VH područje se sastoji od aminokiselinskog slijeda prikazanog u SEQ ID NO. 56, a VL područje se sastoji od aminokiselinskog slijeda prikazanog u SEQ ID NO. 64.
10. Farmaceutski pripravak u skladu s bilo koji od patentnih zahtjeva 1 do 9, naznačen time što navedeno bispecifično jednolančano protutijelo sadrži aminokiselinski slijed kojeg se bira iz skupine koju čine: (a) aminokiselinski slijed kao što je opisan bilo kojim od SEQ ID NO. 6, 8, 16, 18, 24, 26, 32, 34, 40, 42, 126, 130, 134 ili 143; (b) aminokiselinski slijed kojeg kodira nukleinskokiselinski slijed kao što je prikazan u SEQ ID NO. 5, 7, 15, 17, 23, 25, 31, 33, 39, 41, 125, 129, 133 ili 142; i (c) aminokiselinski slijed kojeg kodira nukleinskokiselinski slijed koji je zbog genetskog koda degeneriran s nukleotidnim slijedom iz (b).
11. Farmaceutski pripravak u skladu s bilo koji od patentnih zahtjeva 1 do 10, naznačen time što navedeno bispecifično jednolančano protutijelo sadrži His-biljeg.
12. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 11, naznačena time što je navedeni epitelni tumor gastrointestinalni adenokarcinom, adenokarcinom dojke ili adenokarcinom pluća.
13. Farmaceutski pripravak u skladu s patentnim zahtjevom 12, naznačena time što je navedeni gastrointestinalni adenokarcinom kolorektalni, te adenokarcinom gušterače, jednjaka ili želuca.
14. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 13, naznačen time što je navedeni farmaceutski pripravak namijenjen liječenju uznapredovalih tumora, kasnog stadija tumora, tumorskih pacijenata visoko opterećenih tumorom, metastazirajućih tumora ili tumorskih pacijenata s koncentracijom CEA u serumu višom od 100 ng/ml.
15. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 14, naznačen time što je najmanje jedna od navedene prve ili druge vežuće domene kimerna, ljudskiizirana, nazađena s CDR-om i/ili deimunizirana ili ljudska.
16. Farmaceutski pripravak, naznačen time što sadrži nukleinskokiselinski slijed koji kodira bispecifično jednolančano protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 15.
17. Farmaceutski pripravak, naznačen time što sadrži vektor koji sadrži nukleinskokiselinski slijed u skladu s patentnim zahtjevom 16.
18. Farmaceutski pripravak u skladu s patentnim zahtjevom 17, naznačen time što navedeni vektor dodatno sadrži regulacijski slijed operabilno povezan s navedenim nukleinskokiselinskim slijedom u skladu s patentnim zahtjevom 16.
19. Farmaceutski pripravak u skladu s patentnim zahtjevom 17 ili 18, naznačen time što je navedeni vektor ekspresijski vektor.
20. Farmaceutski pripravak, naznačen time što sadrži domaćin transformiranog ili transficiranog nukleinskom kiselinom u skladu s patentnim zahtjevom 16 ili vektor u skladu s bilo kojim od patentnih zahtjeva 17 do 19.
21. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 20, naznačen time što dodatno sadrži proteinski spoj koji može osigurati aktivacijski signal za imunosne efektorske stanice.
22. Postupak proizvodnje farmaceutskog pripravka u skladu s bilo kojim od patentnih zahtjeva 1 do 21, naznačen time što se navedeni postupak sastoji u uzgoju domaćina u skladu s patentnim zahtjevom 20 u kulturi u uvjetima koji omogućuju eksprimiranje bispecifičnog jednolančanog protutijela u skladu s bilo kojim od patentnih zahtjeva 1 do 15, te u prikupljanju proizvedenog bispecifičnog jednolančanog protutijela iz kulture.
23. Farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 1 do 22, naznačen time što dodatno sadrži pogodne formulacije nosača, stabilizatora i/ili pomoćnih tvari.
24. Upotreba bispecifičnog jednolančanog protutijela u skladu s bilo kojim od patentnih zahtjeva 1 do 15, molekule nukleinske kiseline u skladu s patentnim zahtjevom 16, vektora u skladu s bilo kojim od patentnih zahtjeva 17 do 19, ili domaćina u skladu s patentnim zahtjevom 20, naznačena time što su protutijelo, molekula nukleinske kiseline vektor ili domaćin namijenjeni pripravi farmaceutskog pripravka namijenjenog sprječavanju, liječenju ili ublažavanju epitelnog tumora kod čovjeka.
25. Upotreba u skladu s patentnim zahtjevom 24, naznačena time što je navedeni epitelni tumor gastrointestinalni adenokarcinom, adenokarcinom dojke ili adenokarcinom pluća.
26. Upotreba u skladu s patentnim zahtjevom 25, naznačena time što je navedeni gastrointestinalni adenokarcinom kolorektalni, te adenokarcinom gušterače, jednjaka ili želuca.
27. Upotreba u skladu s bilo kojim od patentnih zahtjeva 24 do 26, naznačena time što je farmaceutski pripravak namijenjen liječenju uznapredovalih tumora, kasnog stadija tumora, tumorskih pacijenata visoko opterećenih tumorom, metastazirajućih tumora ili tumorskih pacijenata s koncentracijom CEA u serumu višom od 100 ng/ml.
28. Upotreba u skladu s bilo kojim od patentnih zahtjeva 1 do 27, naznačena time što je navedeni farmaceutski pripravak pogodan za primjenu u kombinaciji s dodatnim lijekom.
29. Upotreba u skladu s patentnim zahtjevom 28, naznačena time što je navedeni dodatni lijek neproteinski spoj ili proteinski spoj.
30. Upotreba u skladu s patentnim zahtjevom 29, naznačena time što navedeni proteinski spoj može osigurati aktivacijski signal za imunosne efektorske stanice.
31. Upotreba u skladu s patentnim zahtjevom 29 ili 30, naznačena time što se navedeni proteinski spoj ili neproteinski spoj primjenjuje istodobno ili neistodobno s bispecifičnim jednolančanim protutijelom u skladu s bilo kojim od patentnih zahtjeva 1 do 15, molekulom nukleinske kiseline u skladu s patentnim zahtjevom 16, vektorom u skladu s bilo kojim od patentnih zahtjeva 17 do 19, ili domaćinom u skladu s patentnim zahtjevom 20.
32. Komplet, naznačen time što uključuje bispecifično jednolančano protutijelo u skladu s bilo kojim od patentnih zahtjeva 1 do 15, molekulu nukleinske kiseline u skladu s patentnim zahtjevom 16, vektor u skladu s bilo kojim od patentnih zahtjeva 17 do 19, ili domaćina u skladu s patentnim zahtjevom 20.
33. Farmaceutski pripravak u skladu s patentnim zahtjevom 14 ili upotreba u skladu s patentnim zahtjevom 27, naznačeni time što se navedenu koncentraciju CEA u serumu određuje ELISA-om.
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| PCT/EP2006/012425 WO2007071426A1 (en) | 2005-12-21 | 2006-12-21 | Pharmaceutical compositions with resistance to soluble cea |
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- 2006-12-21 BR BRPI0620632-8A patent/BRPI0620632A2/pt active Search and Examination
- 2006-12-21 ES ES06841112.3T patent/ES2595091T3/es active Active
- 2006-12-21 EP EP06841112.3A patent/EP1976880B1/en active Active
- 2006-12-21 WO PCT/EP2006/012425 patent/WO2007071426A1/en not_active Ceased
- 2006-12-21 HR HRP20161216TT patent/HRP20161216T1/hr unknown
- 2006-12-21 EP EP12167996A patent/EP2527370A1/en not_active Withdrawn
- 2006-12-21 KR KR1020087017796A patent/KR101287777B1/ko not_active Expired - Fee Related
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2008
- 2008-06-18 IL IL192277A patent/IL192277A/en not_active IP Right Cessation
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2010
- 2010-11-29 RU RU2010148652/10A patent/RU2573893C2/ru not_active IP Right Cessation
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2012
- 2012-10-03 JP JP2012221161A patent/JP2013056885A/ja not_active Withdrawn
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2013
- 2013-01-14 US US13/740,358 patent/US9695250B2/en active Active
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2016
- 2016-09-19 US US15/269,680 patent/US9982063B2/en active Active
- 2016-09-23 CY CY20161100951T patent/CY1118053T1/el unknown
- 2016-12-21 ME MEP-2016-218A patent/ME02581B/me unknown
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