DK2440228T3 - Glucoseregulerende polypeptider og fremgangsmåder til fremstilling og anvendelse deraf - Google Patents

Glucoseregulerende polypeptider og fremgangsmåder til fremstilling og anvendelse deraf Download PDF

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DK2440228T3
DK2440228T3 DK10786730.1T DK10786730T DK2440228T3 DK 2440228 T3 DK2440228 T3 DK 2440228T3 DK 10786730 T DK10786730 T DK 10786730T DK 2440228 T3 DK2440228 T3 DK 2440228T3
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xten
sequence
fusion protein
gpxten
seq
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Jeffrey L Cleland
Volker Schellenberger
Joshua Silverman
Willem P Stemmer
Benjamin Spink
Chia-Wei Wang
Nathan Geething
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Amunix Operating Inc
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Claims (15)

1. Isoleret nukleinsyre omfattende en polynukleotidsekvens, der koder for et fusionsprotein omfattende et glucoseregulerende peptid (GP), hvor polynukleotidsekvensen (i) omfatter en sekvens, der hybridiserer under stringente betingelser med AE864 i tabel 9 (SEQ ID NO: 243) eller Ex4-AE864 i tabel 36 (SEQ ID NO: 897), eller komplementet deraf, og har mindst 70 % sekvensidentitet eller 80 % eller 90 % eller 95 % eller 97 % eller 98 % eller 99 % til 100 % sekvensidentitet med AE864 i tabel 9 (SEQ ID NO: 243) eller Ex4-AE864 i tabel 36 (SEQ ID NO: 897) eller komplementet deraf, og (ii) koder for et fusionsprotein omfattende (a) exendin-4 og har en amino-syresekvens, der udviser mindst 95 % sekvensidentitet med Ex4-AE864 i tabel 36 (SEQ ID NO: 896), eller (b) GLP-1 og har en aminosyresekvens, der udviser mindst 95 % sekvensidentitet med GLP1-AE864 i tabel 36 (SEQ ID NO: 986), og som bevarer mindst en del af den biologiske aktivitet af det native GP.
2. Isoleret nukleinsyre ifølge krav 1, hvor det glucoseregulerende peptid (GP) er mindst ca. 90 % eller ca. 95 % identisk med en aminosyresekvens udvalgt blandt exendin-4 i tabel 1 (SEQ ID NO: 4) eller hGLP-1 i tabel 1 (SEQ ID NO: 6) eller humant GLP-1 i tabel 1 (SEQ ID NO: 8).
3. Isoleret nukleinsyre ifølge krav 1 eller krav 2, hvor fusionsproteinet, når det indgives til et individ med behov herfor, opnår en terapeutisk virkning, der er sammenlignelig med det tilsvarende GP, der ikke har XTEN'et, under anvendelse af en i øvrigt ækvivalent molær mængde, selv om fusionsproteinet indgives mindre hyppigt til et individ sammenlignet med det tilsvarende GP, der ikke har XTEN.
4. Isoleret nukleinsyre ifølge et hvilket som helst af kravene 1-3, hvor fusionsproteinet omfatter en polypeptidsekvens af GLP1-AE864 i tabel 36 (SEQ ID NO: 986).
5. Isoleret nukleinsyre ifølge krav 4, hvor fusionsproteinet omfatter polypep-tidsekvensen af Ex4-AE864 i tabel 36 (SEQ ID NO: 896).
6. Isoleret nukleinsyre ifølge krav 1, hvor polynukleotidsekvensen omfatter Ex4-AE864 i tabel 36 (SEQ ID NO: 897).
7. Ekspressionsvektor, der omfatter polynukleotidsekvensen ifølge et hvilket som helst af kravene 1-6.
8. Fusionsprotein omfattende et GP, der er mindst 90 % eller ca. 95 % identisk med en aminosyresekvens udvalgt blandt exendin-4 i tabel 1 (SEQ ID NO: 4) eller hGLP-1 i tabel 1 (SEQ ID NO: 6) eller humant GLP-1 i tabel 1 (SEQ ID NO: 8), hvor GP'et er forbundet med et forlænget rekombinant polypeptid (XTEN) af mindst ca. 200 aminosyrerester til anvendelse i en fremgangsmåde til behandling af en glucoseregulerende peptid-relateret tilstand hos et individ, hvilken fremgangsmåde omfatter (i) eksprimering af fusionsproteinet fra et polynukleotid omfattende en sekvens, der hybridiserer under stringente betingelser med AE864 i tabel 9 (SEQ ID NO: 243), eller komplementet deraf, og har mindst 70 % sekvensidentitet eller 80 % eller 90 % eller 95 % eller 97 % eller 98 % eller 99 % til 100 % sekvensidentitet med AE864 i tabel 9 (SEQ ID NO: 243). (ii) indgivelse til individet af en terapeutisk virksom mængde af fusionsproteinet, hvor XTEN'et er kendetegnet ved, at: (a) XTEN-sekvensen omfatter mindst ca. 200 sammenhængende aminosyrer, der udviser mindst 90 % eller ca. 95 % sekvensidentitet med aminosyresekvens AE864 i tabel 5 (SEQ ID NO: 199); (b) XTEN-sekvensen ikke har en forudsagt T-celle-epitop, når den analyseres ved hjælp af TEPITOPE-algoritmen, hvor TEPITOPE-algoritme-forudsigelsen af epitoper inden for XTEN-sekvensen er baseret på en score på -9 eller højere; (c) det har en delsekvens-score på mindre end 10; og (d) summen af glycin (G)-, alanin (A)-, serin (S)-, threonin (T)-, glutamat (E)-og prolin (P)-rester udgør mere end ca. 90 % af de samlede aminosyrerester af XTEN'et.
9. Anvendelse af et fusionsprotein omfattende et GP, der er mindst 90 % eller ca. 95 % identisk med en aminosyresekvens udvalgt blandt exendin-4 i tabel 1 (SEQ ID NO: 4) eller hGLP-1 i tabel 1 (SEQ ID NO: 6) eller humant GLP-1 i tabel 1 (SEQ ID NO: 8), hvor GP'et er forbundet med et forlænget rekombinant polypeptid (XTEN) af mindst ca. 200 aminosyrerester til fremstilling af et medikament til behandling af en glucoseregulerende peptidrelateret tilstand hos et individ, hvilken anvendelse omfatter (i) eksprimering af fusionsproteinet fra et polynukleotid omfattende en sekvens, der hybridiserer under stringente betingelser med AE864 i tabel 9 (SEQ ID NO: 243), eller komplementet deraf, og har mindst 70 % sekvensidentitet eller 80 % eller 90 % eller 95 % eller 97 % eller 98 % eller 99 % til 100 % sekvensidentitet med AE864 i tabel 9 (SEQ ID NO: 243). (ii) indgivelse til individet af en terapeutisk virksom mængde af fusionsproteinet, hvor XTEN'et er kendetegnet ved, at: (a) XTEN-sekvensen omfatter mindst ca. 200 sammenhængende aminosyrer, der udviser mindst 90 % eller ca. 95 % sekvensidentitet med aminosyrese-kvens AE864 i tabel 5 (SEQ ID NO: 199); (b) XTEN-sekvensen ikke har en forudsagt T-celle-epitop, når den analyseres ved hjælp af TEPITOPE-algoritmen, hvor TEPITOPE-algoritme-forudsigelsen af epitoper inden for XTEN-sekvensen er baseret på en score på -9 eller højere; (c) det har en delsekvens-score på mindre end 10; og (d) summen af glycin (G)-, alanin (A)-, serin (S)-, threonin (T)-, glutamat (E)-og prolin (P)-rester udgør mere end ca. 90 % af de samlede aminosyrerester af XTEN'et.
10. Fusionsprotein til anvendelse, eller anvendelse, ifølge krav 8 eller krav 9, hvor GP'et er exendin-4 i tabel 1 (SEQ ID NO: 4).
11. Fusionsprotein til anvendelse, eller anvendelse, ifølge krav 9 eller 10, hvor: i) indgivelsen resulterer i en længere terminal halveringstid, når det indgives til et individ, sammenlignet med det tilsvarende glucoseregulerende peptid, der ikke har XTEN'et, når det indgives til et individ i en sammenlignelig molær dosis; og/eller ii) fusionsproteinet opnår en sammenlignelig terapeutisk virkning som et tilsvarende GP, der ikke har XTEN'et, under anvendelse af en i øvrigt ækvivalent molær mængde, selv om fusionsproteinet indgives mindre hyppigt til et individ sammenlignet med det tilsvarende GP, der ikke har XTEN'et.
12. Fusionsprotein til anvendelse, eller anvendelse, ifølge et hvilket som helst af kravene 8-11, hvor: i) fusionsproteinet kodes af en nukleinsyre omfattende en polynukleotidsekvens, der hybridiserer under stringente betingelser med AE864 i tabel 9 (SEQ ID NO: 243) eller komplementet deraf, og som har mindst 70 % sekvensidentitet eller 80 % eller 90 % eller 95 % eller 97 % eller 98 % eller 99 % til 100 % sekvensidentitet med polynukleotidsekvensen Ex4-AE864 i tabel 36 (SEQ ID NO: 897); og/eller ii) den terapeutisk virksomme mængde resulterer i mindst en tredoblig af den tid, der tilbringes inden for et fastslået terapeutisk vindue for fusionsproteinet sammenlignet med det tilsvarende GP, der ikke har XTEN'et, når det indgivne fusionsprotein og det tilsvarende GP, der ikke har XTEN'et, er af en sammenlignelig dosis; og/eller iii) den glucoseregulerende peptid-relaterede tilstand er udvalgt blandt ung-domsdiabetes, type l-diabetes, type Il-diabetes, adipositas, akut hypoglykæmi, akut hyperglykæmi, natlig hypoglykæmi, kronisk hyperglykæmi, glucagono-mer, sekretoriske forstyrrelser i luftvejene, arthritis, osteoporose, sygdom i centralnervesystemet, restenose, neurodegenerativ sygdom, nyresvigt, kongestiv hjerteinsufficiens, nefrotisk syndrom, cirrose, lungeødem, hypertension, slagtilfælde, irritabel tyktarm, myokardieinfarkt, akut koronart syndrom, postkirurgiske katabolske forandringer, hibernerende myokardium, diabetisk kardi-omyopati, utilstrækkelig urinudskillelse af natrium, unormalt høj kaliumkoncentration i urinen, polycystisk ovariesyndrom, respiratorisk distress, nefropati, systolisk dysfunktion af venstre ventrikel, diarré, postoperativt dumping-syndrom, kritisk sygdom-polyneuropati (CIPN), dyslipidæmi, organvævsskade forårsaget af reperfusion af blodgennemstrømning efter iskæmi, og koronar hjertesygdom-risikofaktor (CHDRF)-syndrom.
13. Fremgangsmåde til fremstilling af et fusionsprotein, der kodes af nukleinsyren ifølge et hvilket som helst af kravene 1-6, omfattende: (a) tilvejebringelse af en værtscelle, der omfatter nukleinsyren ifølge krav 1 eller 2; (b) dyrkning af værtscellen under betingelser, der tillader ekspression af fusionsproteinet; og (c) udvinding af fusionsproteinet.
14. Fremgangsmåde ifølge krav 13, hvor i) værtscellen er en prokaryotisk eller en eukaryotisk celle; og ii) det isolerede fusionsprotein udvindes fra værtscellecytoplasma i en i det væsentlige opløselig form.
15. Isoleret værtscelle omfattende nukleinsyren ifølge et hvilket som helst af kravene 1-6, eller vektoren ifølge krav 7, hvor værtscellen er en prokaryotisk eller eukaryotisk værtscelle, hvor den prokaryotiske værtscelle eventuelt er E. coli.
DK10786730.1T 2009-06-08 2010-06-08 Glucoseregulerende polypeptider og fremgangsmåder til fremstilling og anvendelse deraf DK2440228T3 (da)

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Application Number Priority Date Filing Date Title
US26819309P 2009-06-08 2009-06-08
US23683609P 2009-08-25 2009-08-25
US28095509P 2009-11-10 2009-11-10
PCT/US2010/023106 WO2010091122A1 (en) 2009-02-03 2010-02-03 Extended recombinant polypeptides and compositions comprising same
US12/699,761 US8673860B2 (en) 2009-02-03 2010-02-03 Extended recombinant polypeptides and compositions comprising same
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AU2010258898B8 (en) 2015-02-05
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US8957021B2 (en) 2015-02-17
US10000543B2 (en) 2018-06-19
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US20100323956A1 (en) 2010-12-23
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US20170158748A1 (en) 2017-06-08
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US20150274800A1 (en) 2015-10-01
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US9540430B2 (en) 2017-01-10
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EP2440228A4 (en) 2013-06-26
PT2440228T (pt) 2018-12-24

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