HRP20170757T1 - Terapeutski pripravci nukleaze i postupci - Google Patents
Terapeutski pripravci nukleaze i postupci Download PDFInfo
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- HRP20170757T1 HRP20170757T1 HRP20170757TT HRP20170757T HRP20170757T1 HR P20170757 T1 HRP20170757 T1 HR P20170757T1 HR P20170757T T HRP20170757T T HR P20170757TT HR P20170757 T HRP20170757 T HR P20170757T HR P20170757 T1 HRP20170757 T1 HR P20170757T1
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- amino acid
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- 238000000034 method Methods 0.000 title claims 3
- 101710163270 Nuclease Proteins 0.000 title 1
- 239000000203 mixture Substances 0.000 title 1
- 230000001225 therapeutic effect Effects 0.000 title 1
- 108090000765 processed proteins & peptides Proteins 0.000 claims 23
- 229920001184 polypeptide Polymers 0.000 claims 22
- 102000004196 processed proteins & peptides Human genes 0.000 claims 22
- 102000006382 Ribonucleases Human genes 0.000 claims 10
- 108010083644 Ribonucleases Proteins 0.000 claims 10
- 125000003275 alpha amino acid group Chemical group 0.000 claims 9
- 238000006467 substitution reaction Methods 0.000 claims 7
- 201000000596 systemic lupus erythematosus Diseases 0.000 claims 6
- 230000035772 mutation Effects 0.000 claims 4
- 238000002360 preparation method Methods 0.000 claims 4
- 210000004027 cell Anatomy 0.000 claims 3
- 235000018417 cysteine Nutrition 0.000 claims 3
- 150000001945 cysteines Chemical class 0.000 claims 3
- 150000007523 nucleic acids Chemical class 0.000 claims 3
- 235000001014 amino acid Nutrition 0.000 claims 2
- 230000008878 coupling Effects 0.000 claims 2
- 238000010168 coupling process Methods 0.000 claims 2
- 238000005859 coupling reaction Methods 0.000 claims 2
- 239000013604 expression vector Substances 0.000 claims 2
- NOESYZHRGYRDHS-UHFFFAOYSA-N insulin Chemical compound N1C(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(NC(=O)CN)C(C)CC)CSSCC(C(NC(CO)C(=O)NC(CC(C)C)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CCC(N)=O)C(=O)NC(CC(C)C)C(=O)NC(CCC(O)=O)C(=O)NC(CC(N)=O)C(=O)NC(CC=2C=CC(O)=CC=2)C(=O)NC(CSSCC(NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2C=CC(O)=CC=2)NC(=O)C(CC(C)C)NC(=O)C(C)NC(=O)C(CCC(O)=O)NC(=O)C(C(C)C)NC(=O)C(CC(C)C)NC(=O)C(CC=2NC=NC=2)NC(=O)C(CO)NC(=O)CNC2=O)C(=O)NCC(=O)NC(CCC(O)=O)C(=O)NC(CCCNC(N)=N)C(=O)NCC(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC=CC=3)C(=O)NC(CC=3C=CC(O)=CC=3)C(=O)NC(C(C)O)C(=O)N3C(CCC3)C(=O)NC(CCCCN)C(=O)NC(C)C(O)=O)C(=O)NC(CC(N)=O)C(O)=O)=O)NC(=O)C(C(C)CC)NC(=O)C(CO)NC(=O)C(C(C)O)NC(=O)C1CSSCC2NC(=O)C(CC(C)C)NC(=O)C(NC(=O)C(CCC(N)=O)NC(=O)C(CC(N)=O)NC(=O)C(NC(=O)C(N)CC=1C=CC=CC=1)C(C)C)CC1=CN=CN1 NOESYZHRGYRDHS-UHFFFAOYSA-N 0.000 claims 2
- 108020004707 nucleic acids Proteins 0.000 claims 2
- 102000039446 nucleic acids Human genes 0.000 claims 2
- 238000003259 recombinant expression Methods 0.000 claims 2
- 206010039073 rheumatoid arthritis Diseases 0.000 claims 2
- 208000026872 Addison Disease Diseases 0.000 claims 1
- 208000004300 Atrophic Gastritis Diseases 0.000 claims 1
- 208000032116 Autoimmune Experimental Encephalomyelitis Diseases 0.000 claims 1
- 206010071155 Autoimmune arthritis Diseases 0.000 claims 1
- 208000023275 Autoimmune disease Diseases 0.000 claims 1
- 208000008439 Biliary Liver Cirrhosis Diseases 0.000 claims 1
- 208000033222 Biliary cirrhosis primary Diseases 0.000 claims 1
- 206010009900 Colitis ulcerative Diseases 0.000 claims 1
- 102000000989 Complement System Proteins Human genes 0.000 claims 1
- 108010069112 Complement System Proteins Proteins 0.000 claims 1
- 206010063075 Cryptogenic cirrhosis Diseases 0.000 claims 1
- 208000036495 Gastritis atrophic Diseases 0.000 claims 1
- 208000024869 Goodpasture syndrome Diseases 0.000 claims 1
- 206010072579 Granulomatosis with polyangiitis Diseases 0.000 claims 1
- 208000030836 Hashimoto thyroiditis Diseases 0.000 claims 1
- 208000035186 Hemolytic Autoimmune Anemia Diseases 0.000 claims 1
- 206010020850 Hyperthyroidism Diseases 0.000 claims 1
- 102000004877 Insulin Human genes 0.000 claims 1
- 108090001061 Insulin Proteins 0.000 claims 1
- 208000007466 Male Infertility Diseases 0.000 claims 1
- 206010028665 Myxoedema Diseases 0.000 claims 1
- 108091028043 Nucleic acid sequence Proteins 0.000 claims 1
- 108020002230 Pancreatic Ribonuclease Proteins 0.000 claims 1
- 102000005891 Pancreatic ribonuclease Human genes 0.000 claims 1
- 206010034277 Pemphigoid Diseases 0.000 claims 1
- 201000011152 Pemphigus Diseases 0.000 claims 1
- 208000031845 Pernicious anaemia Diseases 0.000 claims 1
- 206010057249 Phagocytosis Diseases 0.000 claims 1
- 208000002500 Primary Ovarian Insufficiency Diseases 0.000 claims 1
- 208000012654 Primary biliary cholangitis Diseases 0.000 claims 1
- 108010076504 Protein Sorting Signals Proteins 0.000 claims 1
- 206010039710 Scleroderma Diseases 0.000 claims 1
- 208000021386 Sjogren Syndrome Diseases 0.000 claims 1
- 206010042742 Sympathetic ophthalmia Diseases 0.000 claims 1
- 206010067584 Type 1 diabetes mellitus Diseases 0.000 claims 1
- 201000006704 Ulcerative Colitis Diseases 0.000 claims 1
- 206010046851 Uveitis Diseases 0.000 claims 1
- 230000002159 abnormal effect Effects 0.000 claims 1
- 150000001413 amino acids Chemical class 0.000 claims 1
- 230000010056 antibody-dependent cellular cytotoxicity Effects 0.000 claims 1
- 230000001363 autoimmune Effects 0.000 claims 1
- 201000000448 autoimmune hemolytic anemia Diseases 0.000 claims 1
- 239000012752 auxiliary agent Substances 0.000 claims 1
- 210000004899 c-terminal region Anatomy 0.000 claims 1
- 208000016644 chronic atrophic gastritis Diseases 0.000 claims 1
- 230000001684 chronic effect Effects 0.000 claims 1
- 208000025302 chronic primary adrenal insufficiency Diseases 0.000 claims 1
- 230000004540 complement-dependent cytotoxicity Effects 0.000 claims 1
- 208000018631 connective tissue disease Diseases 0.000 claims 1
- 201000001981 dermatomyositis Diseases 0.000 claims 1
- 206010012601 diabetes mellitus Diseases 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 239000012636 effector Substances 0.000 claims 1
- 208000012997 experimental autoimmune encephalomyelitis Diseases 0.000 claims 1
- 208000003816 familial cirrhosis Diseases 0.000 claims 1
- ZZUFCTLCJUWOSV-UHFFFAOYSA-N furosemide Chemical compound C1=C(Cl)C(S(=O)(=O)N)=CC(C(O)=O)=C1NCC1=CC=CO1 ZZUFCTLCJUWOSV-UHFFFAOYSA-N 0.000 claims 1
- 208000006454 hepatitis Diseases 0.000 claims 1
- 231100000283 hepatitis Toxicity 0.000 claims 1
- 239000000710 homodimer Substances 0.000 claims 1
- 230000028993 immune response Effects 0.000 claims 1
- 229940125396 insulin Drugs 0.000 claims 1
- 201000002364 leukopenia Diseases 0.000 claims 1
- 231100001022 leukopenia Toxicity 0.000 claims 1
- 201000006417 multiple sclerosis Diseases 0.000 claims 1
- 206010028417 myasthenia gravis Diseases 0.000 claims 1
- 208000003786 myxedema Diseases 0.000 claims 1
- 230000014207 opsonization Effects 0.000 claims 1
- 201000001976 pemphigus vulgaris Diseases 0.000 claims 1
- 230000008782 phagocytosis Effects 0.000 claims 1
- 208000005987 polymyositis Diseases 0.000 claims 1
- 206010036601 premature menopause Diseases 0.000 claims 1
- 230000002265 prevention Effects 0.000 claims 1
- 206010043778 thyroiditis Diseases 0.000 claims 1
- 208000005057 thyrotoxicosis Diseases 0.000 claims 1
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- 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
- C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
- C12N9/14—Hydrolases (3)
- C12N9/16—Hydrolases (3) acting on ester bonds (3.1)
- C12N9/22—Ribonucleases RNAses, DNAses
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- A61K38/43—Enzymes; Proenzymes; Derivatives thereof
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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
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- C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
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- C12N11/00—Carrier-bound or immobilised enzymes; Carrier-bound or immobilised microbial cells; Preparation thereof
- C12N11/02—Enzymes or microbial cells immobilised on or in an organic carrier
- C12N11/06—Enzymes or microbial cells immobilised on or in an organic carrier attached to the carrier via a bridging agent
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- C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
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- C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
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- C12Y—ENZYMES
- C12Y301/00—Hydrolases acting on ester bonds (3.1)
- C12Y301/27—Endoribonucleases producing 3'-phosphomonoesters (3.1.27)
- C12Y301/27005—Pancreatic ribonuclease (3.1.27.5)
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02P—CLIMATE CHANGE MITIGATION TECHNOLOGIES IN THE PRODUCTION OR PROCESSING OF GOODS
- Y02P20/00—Technologies relating to chemical industry
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- Y02P20/582—Recycling of unreacted starting or intermediate materials
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Claims (15)
1. Polipeptid koji sadrži RNazu i varijantu Fc domene, naznačen time daje RNaza operativno vezana, proizvoljno sa spojnicom, na varijantu Fc domene, pri čemu je varijanta Fc domene varijanta ljudske IgGl Fc domene koja sadrži amino kiselinsku supstituciju koja smanjuje vezivanje, u usporedbi s divljim tipom, na Fcy receptor ili komplementarni protein ili oboje, pri čemu polipeptid ima smanjenu efektorsku funkciju proizvoljno odabranu iz skupine koju čine opsonizacija, fagocitoza, citotoksičnost ovisna o komplementu, te stanična citotoksičnost ovisna o antitijelima.
2. Polipeptid prema zahtjevu 1 naznačen time da:
(a) RNaza je ljudska RNaza, kao stoje ljudska RNaza 1 gušterače; i/ili
(b) Fc domena sadrži zglobnu dome, CH2 domenu i CH3 domenu; i/ili
(c) vodeća sekvenca, kao stoje ljudski VK3LP peptid, je vezana naN-terminalni kraj RNaze.
3. Polipeptid prema zahtjevu 1 ili zahtjevu 2, naznačen time da:
(a) Fc domena sadrži modificiranu zglobnu domenu koja sadrži barem jednu supstituciju, proizvoljno pri čemu modificirana zglobna domena sadrži mutaciju u jednom ili više od tri zglobna cisteina, kao stoje SCC ili SSS; i/ili
(b) pri čemu Fc domena sadrži modificiranu CH2 domenu koja sadrži barem jednu supstituciju, proizvoljno pri čemu je supstitucija odabrana iz skupine koju čine P238S, P331S, N297S ili njihova kombinacija.
4. Polipeptid prema zahtjevu 1 ili zahtjevu 2. naznačen time da
(a) RNaza sadrži sekvencu amino kiseline koja je barem 90% identična sa sekvencom amino kiseline iznesenom u SEQ ID NO: 149 proizvoljno bez
njene vodeće sekvence, ili sadrži 100 ili više susjednih aminokiselina iz SEQ IDNo. 149; i/ili
(b) Fc domena sadrži sekvencu amino kiseline koja je barem 90%, 91%, 92%, 93%, 94%, 95%, 96%, 97% ili 98% identična sa sekvencom amino kiseline iznesenom u SEQ 1D NO: 145, proizvoljno sadrži modificiranu zglobnu domenu koja sadrži barem jednu supstituciju, proizvoljno pri čemu modificirana zglobna domena sadrži mutaciju u jednom ili više od tri zglobna cisteina, kao što je SCC ili SSS; i/ili proizvoljno sadrži jednu ili više Fc mutacija koje su odabrane od P238S, P331S, K322S, i N279S.
5. Polipeptid prema zahtjevu 1, naznačen time da:
polipeptid sadrži sekvencu amino kiseline koja je barem 90%, 91%, 92%, 93%, 94%,
95%, 96%, 97% ili 98% identična sa sekvencom amino kiseline iznesenom u SEQ 1D
NO: 163, proizvoljno bez njene vodeće sekvence; ili
polipeptid sadrži sekvencu amino kiseline koja je barem 90%, 91%, 92%, 93%, 94%,
95%. 96%, 97% ili 98% identična sa sekvencom amino kiseline iznesenom u SEQ 1D
NO: 161, proizvoljno bez njene vodeće sekvence;
proizvoljno pri čemu Fc domena sadrži modificiranu zglobnu domenu koja sadrži
barem jednu supstituciju, proizvoljno pri čemu modificirana zglobna domena sadrži
mutaciju u jednom ili više od tri zglobna cisteina, kao što je SCC ili SSS; i/ili
modificirana CH2 domena sadrži barem jednu supstituciju koja je odabrana iz skupine
koju čine P238S, P331S, N297S ili njihova kombinacija.
6. Polipeptid prema bilo kojem od prethodnih zahtjeva, naznačen time da:
RNaza je operativno vezana na Fc domenu preko domene spojnice, proizvoljno pri
čemu domena spojnice je polipeptidna spojnica, kao stoje gly-ser spojnica; i/ili
pri čemu je RNaza operativno vezana na N-terminalni završetak Fc domene,
proizvoljno sa spojnicom; i/ili
pri čemu je RNaza operativno vezana na C-terminalni završetak Fc domene,
proizvoljno sa spojnicom; i/ili
pri čemu polipeptid sadrži ljudsku VK3LP peptidnu vodeću sekvencu vezanu naN-
terminalni završetak RNaze.
7. Pripravak naznačen time da sadrži polipeptid prema bilo kojem od prethodnih zahtjeva i farmaceutski prihvatljiv nosač.
8. Molekula nukleinske kiseline naznačena time da kodira polipeptid prema bilo kojem od zahtjeva 1 do 6.
9. Rekombinantni ekspresijski vektor naznačen time da sadrži molekulu nukleinske kiseline prema zahtjevu 8.
10. Stanica domaćin naznačena time da je transformirana s rekombinantnim ekspresijskim vektorom prema zahtjevu 9.
11. Postupak za dobivanje polipeptida iz bilo kojeg od zahtjeva 1 do 6, naznačen time da sadrži: osiguravanje stanice domaćina koja sadrži sekvencu nukleinske kiseline koja kodira polipeptid; te održavanje stanice domaćina pod uvjetima u kojima se eksprimira polipeptid.
12. Polipeptid iz bilo kojeg od zahtjeva 1 do 6 naznačen time daje za uporabu u postupku liječenja ili prevencije stanja povezanih s abnormalnim imunološkim odgovorom; proizvoljno pri čemu stanje je autoimuna bolest, proizvoljno sistemski eritemski lupus (SLE). ili je proizvoljno odabrana iz skupine koju čine inzulinski dijabetes melitus, multipla skleroza, eksperimentalni autoimuni encefalomijelitis, reumatoidni artritis, eksperimentalni autoimuni artritis, miastenija gravis, tiroiditis, eksperimentalni oblik uveoretinitisa, Hashimotov tiroiditis, primarni miksedem, tireotoksikoza, perniciozna anemija, autoimuni atrofični gastritis, Addisonova bolest, prerana menopauza, muška neplodnost, juvenilni dijabetes, Goodpastureov sindrom, pemfigus vulgaris, pemfigoid, simpatička oftalmija, fakogeni uveitis, autoimuna hemolitička anemija, idiopatska leukopenija, primarna bilijarna ciroza, aktivni kronični hepatitis Hbs-ve, kriptogena ciroza, ulcerativni kolitis, Sjogrenov sindrom, sklerodermija, Wegenerova granulomatoza, polimiozitis, dermatomiozitis, diskoidni LE, sistemski eritemski lupus (SLE) i bolest vezivnog tkiva.
13. Dimerni polipeptid naznačen time da sadrži polipeptid prema bilo kojem od zahtjeva 1-6, proizvoljno homodimer.
14. Pripravak naznačen time da sadrži dimerni polipeptid prema zahtjevu 13 i farmaceutski prihvatljivo pomoćno sredstvo.
15. Polipeptid prema bilo kojem od zahtjeva 1 do 6, pripravak prema zahtjevu 7, dimerni polipeptid prema zahtjevu 13 ili pripravak prema zahtjevu 14, naznačen time da je za upotrebu u postupku za liječenje sistemskog eritemskog lupusa (SLE).
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