HRP20240267T1 - Modificirani relaksin polipeptidi i njihove uporabe - Google Patents

Modificirani relaksin polipeptidi i njihove uporabe Download PDF

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HRP20240267T1
HRP20240267T1 HRP20240267TT HRP20240267T HRP20240267T1 HR P20240267 T1 HRP20240267 T1 HR P20240267T1 HR P20240267T T HRP20240267T T HR P20240267TT HR P20240267 T HRP20240267 T HR P20240267T HR P20240267 T1 HRP20240267 T1 HR P20240267T1
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Croatia
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amino acid
relaxin polypeptide
encoded amino
naturally encoded
kda
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HRP20240267TT
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Vadim KARYNOV
Nick Knudsen
Amha Hewet
Kristine De Dios
Jason Pinkstaff
Lorraine Sullivan
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Ambrx, Inc.
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Application filed by Ambrx, Inc. filed Critical Ambrx, Inc.
Publication of HRP20240267T1 publication Critical patent/HRP20240267T1/hr

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    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/575—Hormones
    • C07K14/64—Relaxins
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    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/56—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule
    • A61K47/59—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes
    • A61K47/60—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an organic macromolecular compound, e.g. an oligomeric, polymeric or dendrimeric molecule obtained otherwise than by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyureas or polyurethanes the organic macromolecular compound being a polyoxyalkylene oligomer, polymer or dendrimer, e.g. PEG, PPG, PEO or polyglycerol
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    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/22—Hormones
    • A61K38/2221—Relaxins
    • A—HUMAN NECESSITIES
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Claims (13)

1. Modificirani relaksin polipeptid, naznačen time, da sadrži neprirodno kodiranu aminokiselinu, pri čemu: (a) relaksin polipeptid sadrži polipeptidni A lanac relaksina od SEQ ID NO: 4, koji je supstituiran s neprirodno kodiranom aminokiselinoma na ostatku 1 od A lanca, i polipeptidni B lanac relaksina od SEQ ID NO: 6, i opcionalno sadrži najviše jednu supstituciju s aminokiselinom koja se pojavljuje prirodno; i (b) neprirodno kodirana aminokiselina je analog ili derivat fenilalanina koji je opcionalno povezan na poveznik, polimer, polimer topiv u vodi, ili biološki aktivnu molekulu, gdje se neprirodno kodirana aminokiselina bira od parasupstituiranog, ortosupstituiranog, ili metasupstituiranog fenilalanina koji sadrži karbonilnu skupinu, aminooksi skupinu, hidrazidnu skupinu, hidrazinsku skupinu, semikarbazidnu skupinu, azidnu skupinu, ili alkinsku skupinu, ili je para-acetil-L-fenilalanin ili para-azido-L-fenilalanin, a poželjno jest para-acetil-L-fenilalanin.
2. Modificirani relaksin polipeptid prema patentnom zahtjevu 1, naznačen time, da je spomenuta neprirodno kodirana aminokiselina povezana na navedeni poveznik, polimer, polimer topiv u vodi, ili biološki aktivnu molekulu.
3. Modificirani relaksin polipeptid prema patentnom zahtjevu 1 ili zahtjevu 2, naznačen time, da je spomenuta neprirodno kodirana aminokiselina povezana preko oksim-poveznika na navedeni poveznik, polimer, polimer topiv u vodi, ili biološki aktivnu molekulu.
4. Modificirani relaksin polipeptid prema bilo kojem od patentnih zahtjeva 1-3, naznačen time, da je neprirodno kodirana aminokiselina povezana na polimer topiv u vodi.
5. Modificirani relaksin polipeptid prema bilo kojem od patentnih zahtjeva 1-3, naznačen time, da je neprirodno kodirana aminokiselina povezana na polimer koji sadrži poli(etilen glikol), opcionalno, koji ima prosječnu molekulsku masu od između oko 0,1 KDa i oko 100 kDa, između oko 0,1 kDa i oko 50 kDa, između oko 1 kDa i oko 40 kDa, između oko 5 kDa i oko 40 kDa, ili oko 20 kDa.
6. Modificirani relaksin polipeptid prema bilo kojem od patentnih zahtjeva 1-5, naznačen time, da je navedeni modificirani relaksin polipeptid rekombinantan, proizvodi se u eukariotskoj stanici domaćina, proizvodi se u ne-eukariotskoj stanici domaćina, ili se proizvodi putem in vitro translacije.
7. Modificirani relaksin polipeptid prema bilo kojem od patentnih zahtjeva 1-6, naznačen time, da je za uporabu kao lijek.
8. Modificirani relaksin polipeptid prema bilo kojem od patentnih zahtjeva 1-6, naznačen time, da je za uporabu u liječenju pojedinca koji boluje od ateroskleroze; dijabetesa tipa 1; dijabetesa tipa 2; bolesti koronarnih arterija; skleroderme; moždanog udara; dijastoličke disfunkcije; porodične hiperkolesterolemije; izolirane sistoličke hipertenzije; primarne hipertenzije; sekundarne hipertenzije; hipertrofije lijevog ventrikula; ukočenosti arterija povezane s dugotrajnim pušenjem duhana; ukočenosti arterija povezane s pretilošću; ukočenosti arterija povezane sa životnom dobi; sustavnog eritematoznog lupusa; preeklampsije; hiperkolesterolemije; ili je za uporabu u povećavanju arterijske postojanosti u perimenopauzi, menopauzi, i postmenopauzi kod žena s rizikom za prethodno navedene poremećaje; ili je za modulaciju vazokonstrikcije, NO proizvodnje, ili agregacije trombocita; ili je za uporabu u liječenju angiotenzin-II (AngII)-posredovane vazokonstrikcije ili endotelin-1 (ET-1)-posredovane vazokonstrikcije; ili je za uporabu u liječenju zatajenja srca, kongestivnog zatajenja srca, gubitka ili oštećenja miokardijskog tkiva, povećanja tlaka kod punjenja ventrikula, stresa zida ventrikula, ili oslabljenja integracije arterijske i venske vazodilatacije.
9. Uporaba modificiranog relaksin polipeptida prema bilo kojem od patentnih zahtjeva 1-6, naznačena time, da je za proizvodnju lijeka za liječenje pojedinca koji boluje od ateroskleroze; dijabetesa tipa 1; dijabetesa tipa 2; bolesti koronarnih arterija; skleroderme; moždanog udara; dijastoličke disfunkcije; porodične hiperkolesterolemije; izolirane sistoličke hipertenzije; primarne hipertenzije; sekundarne hipertenzije; hipertrofije lijevog ventrikula; ukočenosti arterija povezane s dugotrajnim pušenjem duhana; ukočenosti arterija povezane s pretilošću; ukočenosti arterija povezane sa životnom dobi; sustavnog eritematoznog lupusa; preeklampsije; hiperkolesterolemije; ili za uporabu u povećavanju arterijske postojanosti u perimenopauzi, menopauzi, i postmenopauzi kod žena s rizikom za prethodno navedene poremećaje; ili za modulaciju vazokonstrikcije, NO proizvodnje, ili agregacije trombocita; ili za uporabu u liječenju angiotenzin-II (AngII)-posredovane vazokonstrikcije ili endotelin-1 (ET-1)-posredovane vazokonstrikcije; ili za uporabu u liječenju zatajenja srca, kongestivnog zatajenja srca, gubitka ili oštećenja miokardijskog tkiva, povećanja tlaka kod punjenja ventrikula, stresa zida ventrikula, ili oslabljenja integracije arterijske i venske vazodilatacije.
10. Modificirani relaksin polipeptid prema bilo kojem od patentnih zahtjeva 1-6, naznačen time, da je za uporabu u liječenju zatajenja srca.
11. Uporaba modificiranog relaksin polipeptida prema bilo kojem od patentnih zahtjeva 1-6, naznačena time, da je za proizvodnju lijeka za uporabu u liječenju zatajenja srca.
12. Stanica domaćina, naznačena time, da sadrži nukleinsku kiselinu koja kodira polipeptid A lanca relaksina od SEQ ID NO: 4 supstituiranog s neprirodno kodiranom aminokiselinom na ostatku 1 od A lanca, i polipeptid B lanca relaksina od SEQ ID NO: 6, i opcionalno sadrži najviše jednu supstituciju s aminokiselinom koja se pojavljuje prirodno, pri čemu neprirodno kodirana aminokiselina jest para-acetil-fenilalanin, stanica domaćina sadrži ortogonalnu tRNA sintetazu i/ili ortogonalnu tRNA koja, kada se spomenuta nukleinska kiselina translatira, rezultira u inkorporiranju spomenute neprirodno kodirane aminokiseline u spomenutom polipeptidu A lanca relaksina, i polinukleotid sadrži najmanje jedan selektorski kodon odabran iz skupine koju čine amber kodon, oker kodon, opal kodon, unikatni kodon, rijedak kodon, i četverobazni kodon, pri čemu navedeni selektorski kodon kodira spomenutu neprirodno kodiranu aminokiselinu.
13. Postupak proizvodnje modificiranog relaksin polipeptida prema bilo kojem od patentnih zahtjeva 1-6, naznačen time, da obuhvaća: uzgoj stanica što uključuje (1) polinukleotid ili polinukleotide koji kodiraju navedeni polipeptid A lanca relaksina i navedeni polipeptid B lanca relaksina, koji sadrže selektorski kodon koji kodira spomenutu neprirodno kodiranu aminokiselinu, (2) ortogonalnu RNA sintetazu i (3) ortogonalnu tRNA pod uvjetima koji dopuštaju ekspresiju relaksin polipeptida koji sadrži spomenutu neprirodno kodiranu aminokiselinu; te pročišćavanje relaksin polipeptida koji sadrži spomenutu neprirodno kodiranu aminokiselinu.
HRP20240267TT 2010-08-17 2011-08-17 Modificirani relaksin polipeptidi i njihove uporabe HRP20240267T1 (hr)

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US37458210P 2010-08-17 2010-08-17
EP19170008.7A EP3572091B1 (en) 2010-08-17 2011-08-17 Modified relaxin polypeptides and their uses

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