HRP20192080T1 - Terapeutske fuzije nukleaza-albumine i postupci - Google Patents

Terapeutske fuzije nukleaza-albumine i postupci Download PDF

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HRP20192080T1
HRP20192080T1 HRP20192080TT HRP20192080T HRP20192080T1 HR P20192080 T1 HRP20192080 T1 HR P20192080T1 HR P20192080T T HRP20192080T T HR P20192080TT HR P20192080 T HRP20192080 T HR P20192080T HR P20192080 T1 HRP20192080 T1 HR P20192080T1
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Croatia
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albumin
variant
fragment
domain
polypeptide according
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HRP20192080TT
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English (en)
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James Arthur Posada
Chris GABEL
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Resolve Therapeutics, Llc
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Publication of HRP20192080T1 publication Critical patent/HRP20192080T1/hr

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    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12NMICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N9/00Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14Hydrolases (3)
    • C12N9/16Hydrolases (3) acting on ester bonds (3.1)
    • C12N9/22Ribonucleases RNAses, DNAses
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K14/00Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/76Albumins
    • C07K14/765Serum albumin, e.g. HSA
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y301/00Hydrolases acting on ester bonds (3.1)
    • C12Y301/21Endodeoxyribonucleases producing 5'-phosphomonoesters (3.1.21)
    • C12Y301/21001Deoxyribonuclease I (3.1.21.1)
    • CCHEMISTRY; METALLURGY
    • C12BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12YENZYMES
    • C12Y301/00Hydrolases acting on ester bonds (3.1)
    • C12Y301/27Endoribonucleases producing 3'-phosphomonoesters (3.1.27)
    • C12Y301/27005Pancreatic ribonuclease (3.1.27.5)
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00Medicinal preparations containing peptides
    • A61K38/16Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/43Enzymes; Proenzymes; Derivatives thereof
    • A61K38/46Hydrolases (3)
    • A61K38/465Hydrolases (3) acting on ester bonds (3.1), e.g. lipases, ribonucleases
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/31Fusion polypeptide fusions, other than Fc, for prolonged plasma life, e.g. albumin

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  • Chemical & Material Sciences (AREA)
  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Biochemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • General Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Medicinal Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Biotechnology (AREA)
  • Microbiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Toxicology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Peptides Or Proteins (AREA)
  • Enzymes And Modification Thereof (AREA)

Claims (18)

1. Polipeptid koji sadrži prvu nukleaznu domenu, drugu nukleaznu domenu, i albumin, ili varijantu albumina koja ima više od 80% identičnosti s aminokiselinskom sekvencom ljudskog serumskog albumina prikazanom u SEQ ID NO: 1, ili ulomak albumina koji sadrži najmanje domenu III albumina ili domenu III albumina i dodatnu domenu odabranu iz skupine koja se sastoji od domene I, domene II i domene III, pri čemu je prva i/ili druga nukleazna domena operativno povezana s albuminom, ili njegovom varijantom ili ulomkom, proizvoljno preko poveznice, pri čemu je prva nukleazna domena RNaza i druga nukleazna domena je ljudska DNaza1 koja sadrži supstitucije aminokiselina E13R, N74K, A114F, i T205K, numeriranje aminokiselina se odnosi na SEQ ID NO: 66.
2. Polipeptid prema patentnom zahtjevu 1, naznačen time što je druga nukleazna domena operativno povezana na N-terminalni kraj albumina, ili njegovu varijantu, i prva nukleazna domena je operativno povezana na C-terminalni kraj albumina, ili njegovu varijantu, poželjno pri čemu su druga i prva nukleazna domena operativno povezane na odgovarajuće N- i C- terminalne krajeve, albumina, ili njegovu varijantu, preko poveznice.
3. Polipeptid prema patentnom zahtjevu 1, naznačen time što je prva nukleazna domena operativno povezana na N-terminalni kraj albumina, ili njegovu varijantu ili ulomak, i druga nukleazna domena je operativno povezana na C-terminalni kraj albumina, ili njegovu varijantu ili ulomak, poželjno pri čemu su prva i druga nukleazna domena operativno povezane na odgovarajuće N- i C-terminalne krajeve, albumina, ili njegovu varijantu ili ulomak, preko poveznice.
4. Polipeptid prema patentnom zahtjevu 1, naznačen time što je prva nukleazna domena operativno povezana na drugu nukleaznu domenu preko poveznice, i druga nukleazna domena je operativno povezana na albumin, ili njegovu varijantu ili ulomak, poželjno pri čemu je druga nukleazna domena operativno povezana na N-terminalni kraj albumina, ili njegovu varijantu ili ulomak ili poželjno pri čemu je druga nukleazna domena operativno povezana na C-terminalni kraj albumina, ili njegovu varijantu ili ulomak.
5. Polipeptid prema bilo kojem od patentnih zahtjeva 1-4, naznačen time što je RNaza humana RNaza divljeg tipa, kao što je humana RNaza1 gušterače kao što je navedeno u SEQ ID NO: 75, ili mutirajuća RNaza, kao što je aglikozilirana ili podglikozilirana RNaza1, kao što je humana RNaza1 N34S/N76S/N88S prikazana kao SEQ ID NO: 84.
6. Polipeptid prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time što razgrađuje cirkulirajuću RNA i/ili DNA i RNA i/ili DNA u imunološkim kompleksima, ili inhibira proizvodnju interferona, ili oboje.
7. Polipeptid prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time što domena poveznice je polipeptidna poveznica, kao što je poveznica gly-ser, ili pri čemu domena poveznice je NLG poveznica.
8. Polipeptid prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time što albumin, ili njegova varijantu ili ulomak, povećava poluživot u serumu.
9. Polipeptid prema bilo kojem od prethodnih patentnih zahtjeva, naznačen time što je albumin, ili njegova varijanta ili ulomak, izveden iz ljudskog serumskog albumina, serumskog albumina primata, serumskog albumina glodavca, goveđeg serumskog albumina, konjskog serumskog albumina, kozjeg serumskog albumina, ovčjeg serumskog albumina, psećeg serumskog albumina, serumskog albumina zamorca, pilećeg serumskog albumina, ili svinjskog serumskog albumina, poželjno pri čemu je albumin, ili njegova varijanta ili ulomak, izveden iz ljudskog serumskog albumina, poželjno pri čemu je albumin više od 85% identičan odgovarajućoj aminokiselinskoj sekvenci prikazanoj u SEQ ID NO: 1, poželjno pri čemu je albumin, ili njegova varijanta ili ulomak, više od 90% identičan odgovarajućoj aminokiselinskoj sekvenci prikazanoj u SEQ ID NO: 1, poželjno pri čemu je albumin, ili njegova varijanta ili ulomak, više od 95% identičan odgovarajućoj aminokiselinskoj sekvenci prikazanoj u SEQ ID NO: 1.
10. Polipeptid prema patentnom zahtjevu 9, naznačen time što se varijanta ili ulomak ljudskog serumskog albumina veže na FcRn s većim afinitetom od onog za odgovarajući divlji tip ljudskog serumskog albumina ili njegovog ulomka.
11. Polipeptid prema patentnom zahtjevu 1 naznačen time što sadrži aminokiselinsku sekvencu navedenu u SEQ ID NO: 112-114 ili 120-122, ili hibridnu molekulu nukleaza-albumin koja sadrži aminokiselinsku sekvencu najmanje 90% identičnu aminokiselinskoj sekvenci navedenoj u SEQ ID NO: 112-114 ili 120-122.
12. Pripravak naznačen time što sadrži polipeptid prema bilo kojem od prethodnih zahtjeva i nosač.
13. Molekula nukleinske kiseline naznačena time što kodira po polipeptid prema bilo kojem od zahtjeva 1 do 10.
14. Rekombinantni ekspresijski vektor naznačen time što sadrži molekulu nukleinske kiseline u skladu sa zahtjevom 13.
15. Stanica domaćina naznačena time što je transformirana s rekombinantnim ekspresijskim vektorom prema zahtjevu 14.
16. Postupak za proizvodnju polipeptida prema bilo kojem od patentnih zahtjeva 1-11, naznačen time što obuhvaća: osiguravanje stanice domaćina koja sadrži sekvencu nukleinske kiseline koja kodira polipeptid; i održavanje stanice domaćina u uvjetima u kojima se eksprimira hibridna molekula nukleaze-albumina.
17. Polipeptid prema bilo kojem od patentnih zahtjeva 1-11 ili pripravak prema zahtjevu 12 naznačen time što je za uporabu u liječenju ili prevenciji sistemskog eritemskog lupusa (SLE).
18. Polipeptid prema bilo kojem od patentnih zahtjeva 1-11 ili pripravak prema zahtjevu 12 naznačen time što je za uporabu u liječenju ili prevenciji Sjogrenovog sindroma.
HRP20192080TT 2013-10-31 2019-11-19 Terapeutske fuzije nukleaza-albumine i postupci HRP20192080T1 (hr)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201361898384P 2013-10-31 2013-10-31
US201361898393P 2013-10-31 2013-10-31
US201361898370P 2013-10-31 2013-10-31
EP14802986.1A EP3063275B1 (en) 2013-10-31 2014-10-31 Therapeutic nuclease-albumin fusions and methods
PCT/US2014/063572 WO2015066550A1 (en) 2013-10-31 2014-10-31 Therapeutic nuclease-albumin fusions and methods

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HRP20192080T1 true HRP20192080T1 (hr) 2020-02-07

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US (2) US10988745B2 (hr)
EP (1) EP3063275B1 (hr)
DK (1) DK3063275T3 (hr)
ES (1) ES2759252T3 (hr)
HR (1) HRP20192080T1 (hr)
PL (1) PL3063275T3 (hr)
SI (1) SI3063275T1 (hr)
WO (2) WO2015066550A1 (hr)

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US10988745B2 (en) 2021-04-27
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