HRP20220172T1 - Protutijela protiv cd71 koja se mogu aktivirati, te postupci njihove uporabe - Google Patents

Protutijela protiv cd71 koja se mogu aktivirati, te postupci njihove uporabe Download PDF

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HRP20220172T1
HRP20220172T1 HRP20220172TT HRP20220172T HRP20220172T1 HR P20220172 T1 HRP20220172 T1 HR P20220172T1 HR P20220172T T HRP20220172T T HR P20220172TT HR P20220172 T HRP20220172 T HR P20220172T HR P20220172 T1 HRP20220172 T1 HR P20220172T1
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cancer
amino acid
seq
activatable
group
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HRP20220172TT
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Jason Gary SAGERT
Kimberly Ann TIPTON
Jonathan Alexander Terrett
Shweta SINGH
Annie Yang Weaver
Luc Roland DESNOYERS
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Cytomx Therapeutics, Inc.
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Publication of HRP20220172T1 publication Critical patent/HRP20220172T1/hr

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    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2881—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD71
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Claims (18)

1. Konjugirano protutijelo koje se može aktivirati, koje se, u aktiviranom stanju, veže na CD71, te sadrži: protutijelo, ili njegov fragment koji se veže na antigen, (AB) koji se specifično veže na sisavački CD71, pri čemu se AB specifično veže na ljudski CD71 i CD71 iz majmuna rakojeda, pri čemu AB sadrži VH CDR1 slijed GYTFTSYWMH (SEQ ID NO: 9), VH CDR2 slijed AIYPGNSETG (SEQ ID NO: 10), VH CDR3 slijed ENWDPGFAF (SEQ ID NO: 11), VL CDR1 slijed SASSSVYYMY (SEQ ID NO: 12), VL CDR2 slijed STSNLAS (SEQ ID NO: 14), te VL CDR3 slijed QQRRNYPYT (SEQ ID NO: 15); prikrivajući ostatak (MM) koji inhibira vezanje AB na CD71 kada je protutijelo koje se može aktivirati u nerascijepljenom stanju, te pri čemu je MM polipeptid dug najviše 40 aminokiselina; odcjepljivi ostatak (CM) spregnut s AB, pri čemu je CM polipeptid koji je supstrat za proteazu; prvi spojni peptid (LP1) i drugi spojni peptid (LP2), pri čemu konjugirano protutijelo koje se može aktivirati u nerascijepljenom stanju ima strukturni raspored od N-kraja do C-kraja kao što slijedi: MM-LP1-CM-LP2-AB, te pri čemu je svaki od LP1 i LP2 peptid dug 1 do 20 aminokiselina; i sredstvo konjugirano s AB.
2. Konjugirano protutijelo koje se može aktivirati u skladu s patentnim zahtjevom 1, pri čemu MM: (i) ima konstantu disocijacije za vezanje na AB veću od konstante disocijacije za AB s CD71; i/ili (ii) ne ometa niti konkurira s vezanjem AB na CD71 kada je konjugirano protutijelo koje se može aktivirati u rascijepljenom stanju; i/ili (iii) polipeptidni slijed se razlikuje od slijeda kod ljudskog CD71; i/ili (iv) polipeptidni slijed je najviše 50 % istovjetan bilo kojem prirodnom partneru prilikom vezanja AB.
3. Konjugirano protutijelo koje se može aktivirati u skladu s patentnim zahtjevom 1 ili patentnim zahtjevom 2, pri čemu: (i) AB se bira iz skupine koju čine Fab fragment, F(ab’)2 fragment, scFv, te scAb; i/ili (ii) AB se specifično veže na ljudski CD71; i/ili (iii) AB sadrži varijabilno područje teškog lanca koje sadrži aminokiselinski slijed kojeg se bira iz skupine koju čine SEQ ID NO: 3-5, te varijabilno područje lakog lanca koje sadrži aminokiselinski slijed kojeg se bira iz skupine koju čine SEQ ID NO: 6 i 7; varijabilno područje teškog lanca može sadržavati aminokiselinski slijed SEQ ID NO: 5, a varijabilno područje lakog lanca može sadržavati aminokiselinski slijed SEQ ID NO: 7; i/ili (iv) dva spojna peptida koji ne moraju biti međusobno istovjetni.
4. Konjugirano protutijelo koje se može aktivirati u skladu s bilo kojim od patentnih zahtjeva 1-3, pri čemu AB sadrži: slijed teškog lanca SEQ ID NO: 325 ili 699; i laki lanac koji sadrži aminokiselinski slijed kojeg se bira iz skupine koju čine SEQ ID NO: 327, 329, 331, 333, 335, 337, 650, 652, 654, 656, 658, 660, 670-673, 701-712, 721-788, 809-836, te 841-908.
5. Konjugirano protutijelo koje se može aktivirati u skladu s bilo kojim od patentnih zahtjeva 1-4; pri čemu: (i) sredstvo je toksin ili njegov fragment; ili (ii) sredstvo je inhibitor mikrotubula; ili (iii) sredstvo je sredstvo koje oštećuje nukleinske kiseline; ili (iv) sredstvo se bira iz skupine koju čine dolastatin ili njegov derivat, auristatin ili njegov derivat, majtansinoid ili njegov derivat, duokarmicin ili njegov derivat, kaliheamicin ili njegov derivat, te pirolobenzodiazepin ili njegov derivat; ili (v) sredstvo je auristatin E ili njegov derivat, monometil auristatin E (MMAE), monometil auristatin F (MMAF), monometil auristatin D (MMAD), majtansinoid kojeg se bira iz skupine koju čine DM1 i DM4, majtansinoid DM4, majtansinoid DM1, duokarmicin, pirolobenzodiazepin ili pirolobenzodiazepinski dimer; ili (vi) sredstvo je dokazivi ostatak; pri čemu dokazivi ostatak može biti sredstvo za dijagnosticiranje.
6. Konjugirano protutijelo koje se može aktivirati u skladu s bilo kojim od patentnih zahtjeva 1-5, pri čemu: (i) AB sadrži varijabilno područje teškog lanca koje sadrži aminokiselinski slijed kojeg se bira iz skupine koju čine SEQ ID NO: 3-5, te varijabilno područje lakog lanca koje sadrži aminokiselinski slijed kojeg se bira iz skupine koju čine SEQ ID NO: 6, 7, 809-836, te 841-908; i/ili (ii) protutijelo koje se može aktivirati sadrži kombinaciju aminokiselinskih sljedova, pri čemu se kombinaciju aminokiselinskih sljedova bira iz istog reda u Tablici D, pri čemu za danu kombinaciju: (a) teški lanac AB sadrži aminokiselinske sljedove VH CDR sljedova koji odgovaraju danoj kombinaciji u istom redu iznijetoj u Tablici D, (b) laki lanac AB sadrži aminokiselinske sljedove VL CDR sljedova koji odgovaraju danoj kombinaciji u istom redu iznijetoj u Tablici D, (c) MM sadrži aminokiselinski slijed prikrivajućeg slijeda (MM) koji odgovara danoj kombinaciji u istom redu iznijetoj u Tablici D, i (d) CM sadrži aminokiselinski slijed supstratnog slijeda (CM) koji odgovara danoj kombinaciji u istom redu iznijetoj u Tablici D; i/ili (iii) protutijelo koje se može aktivirati sadrži kombinaciju aminokiselinskih sljedova, pri čemu za danu kombinaciju aminokiselinskih sljedova: (a) teški lanac AB sadrži aminokiselinske sljedove VH slijeda ili VH CDR sljedova koje se bira iz skupine koju čine: VH slijed ili VH CDR sljedovi iznijeti u odgovarajućem stupcu Tablice E, (b) laki lanac AB sadrži aminokiselinske sljedove VL slijeda kojeg se bira iz skupine koju čine SEQ ID NO: 6 i 7 ili VL CDR sljedovi koje se bira iz skupine koju čine SEQ ID NO: 12, 14, te 15, (c) MM sadrži aminokiselinski slijed prikrivajućeg slijeda (MM) kojeg se bira iz skupine koju čine: MM sljedovi iznijeti u odgovarajućem stupcu Tablice E, i (d) CM sadrži aminokiselinski slijed supstratnog slijeda (CM) kojeg se bira iz skupine koju čine: CM sljedovi iznijeti u odgovarajućem stupcu Tablice E; i/ili (iv) protutijelo koje se može aktivirati sadrži: teški lanac koji sadrži aminokiselinski slijed SEQ ID NO: 325 ili 699; i laki lanac koji sadrži aminokiselinski slijed kojeg se bira iz skupine koju čine SEQ ID NO: 327, 329, 331, 333, 335, 337, 650, 652, 654, 656, 658, 660, 670-673, 701-712, 721-788, 809-836, te 841-908.
7. Konjugirano protutijelo koje se može aktivirati u skladu s bilo kojim od patentnih zahtjeva 1-6, pri čemu: AB sadrži teški lanac koji sadrži aminokiselinski slijed SEQ ID NO: 325 ili 699, i laki lanac koji sadrži aminokiselinski slijed kojeg se bira iz skupine koju čine SEQ ID NO: 327, 329, 331, 333, 335, 337, 650, 652, 654, 656, 658, 660, 670-673, 701-712, 721-788, 809-836, te 841-908; i pri čemu se sredstvo bira iz skupine koju čine auristatin E, monometil auristatin F (MMAF), monometil auristatin E (MMAE), monometil auristatin D (MMAD), majtansinoid DM4, majtansinoid DM1, pirolobenzodiazepin, pirolobenzodiazepinski dimer, te duokarmicin.
8. Konjugirano protutijelo koje se može aktivirati u skladu s bilo kojim od patentnih zahtjeva 1-7, pri čemu: (i) MM sadrži aminokiselinski slijed kojeg se bira iz skupine koju čine SEQ ID NO: 16-295, te 297-314; i/ili (ii) MM sadrži aminokiselinski slijed kojeg se bira iz skupine koju čine SEQ ID NO: 16, 17, te 297-314; i/ili (iii) CM sadrži aminokiselinski slijed kojeg se bira iz skupine koju čine SEQ ID NO: 356-423, 680-698, 713, 714, te 789-808; i/ili (iv) CM sadrži aminokiselinski slijed kojeg se bira iz skupine koju čine SEQ ID NO: 406-423, 680-698, 713, 714, te 807-808.
9. Konjugirano protutijelo koje se može aktivirati u skladu s bilo kojim od patentnih zahtjeva 1-8, pri čemu se sredstvo konjugira s AB putem spojnice, te pri čemu spojnica pomoću koje se sredstvo konjugira s AB sadrži ostatak SPDB, ostatak vc ili ostatak PEG2-vc; i/ili pri čemu spojnica i sredstvo konjugirano s AB sadrži ostatak SPDB-DM4, ostatak vc-MMAD, ostatak vc-MMAE, ostatak vc-duokarmicin ili ostatak PEG2-vc-MMAD; i/ili pri čemu je spojnica odcjepljujuća spojnica ili neodcjepljujuća spojnica.
10. Konjugirano protutijelo koje se može aktivirati u skladu s patentnim zahtjevom 1, pri čemu: sredstvo je toksin, a toksin je konjugiran s AB putem spojnice; i pri čemu konjugirano protutijelo koje se može aktivirati sadrži aminokiselinske sljedove, spojnicu, te toksin kojeg se bira iz istog reda u Tablici F, pri čemu za danu kombinaciju: (a) AB sadrži teški lanac koji sadrži aminokiselinski slijed slijeda teškog lanca ili slijed varijabilne domene teškog lanca koji odgovara danoj kombinaciji u istom redu iznijetoj u Tablici F, (b) AB sadrži laki lanac koji sadrži aminokiselinski slijed slijeda lakog lanca ili slijed varijabilne domene lakog lanca koji odgovara danoj kombinaciji u istom redu iznijetoj u Tablici F, i (c) spojnica i toksin sadrže spojnicu i toksin koji odgovaraju danoj kombinaciji u istom redu iznijetoj u Tablici F.
11. Farmaceutski pripravak koji sadrži konjugirano protutijelo koje se može aktivirati u skladu s bilo kojim od patentnih zahtjeva 1-10; i nosač.
12. Farmaceutski pripravak u skladu s patentnim zahtjevom 11 koji sadrži dodatno sredstvo; pri čemu dodatno sredstvo može biti terapijsko sredstvo.
13. Izolirana molekula nukleinske kiseline koja kodira protutijelo koje se može aktivirati za konjugirano protutijelo koje se može aktivirati u skladu s bilo kojim od patentnih zahtjeva 1-10.
14. Vektor koji sadrži izoliranu molekulu nukleinske kiseline u skladu s patentnim zahtjevom 13.
15. Postupak proizvodnje protutijela koje se može aktivirati uzgojem stanice u uvjetima koji dovode do eksprimiranja protutijela koje se može aktivirati, pri čemu stanica sadrži molekulu nukleinske kiseline u skladu s patentnim zahtjevom 13 ili vektor u skladu s patentnim zahtjevom 14.
16. Postupak proizvodnje protutijela koje se može aktivirati, koje se, u aktiviranom stanju, veže na CD71, gdje se postupak sastoji od: (a) uzgoja stanice koja sadrži nukleinskokiselinski konstrukt koji kodira protutijelo koje se može aktivirati u uvjetima koji dovode do eksprimiranja protutijela koje se može aktivirati, pri čemu protutijelo koje se može aktivirati sadrži protutijelo koje se može aktivirati za konjugirano protutijelo koje se može aktivirati u skladu s bilo kojim od patentnih zahtjeva 1-10; i (b) prikupljanja protutijela koje se može aktivirati; izbornom konjugiranju sredstva u skladu s patentnim zahtjevom 5 s prikupljenim protutijelom koje se može aktivirati.
17. Konjugirano protutijelo koje se može aktivirati u skladu s bilo kojim od patentnih zahtjeva 1-10, ili farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 11-12, namijenjeni uporabi kao medikament namijenjen liječenju poremećaja ili bolesti povezane sa stanicama koje eksprimiraju CD71, pri čemu je poremećaj ili bolest rak; pri čemu rak može biti adenokarcinom, rak žučovoda (bilijarni rak), rak mokraćnog mjehura, rak kosti, rak dojke, trostruko negativni rak dojke, rak dojke negativan na Her2, karcinoidni rak, rak vrata maternice, kolangiokarcinom, kolorektalni rak, rak debelog crijeva, rak endometrija, gliom, rak glave i vrata, rak pločastih stanica glave i vrata, leukemija, rak jetre, rak pluća, rak velikih stanica pluća, rak malih stanica pluća, limfom, melanom, orofaringealni rak, rak jajnika, rak gušterače, rak prostate, metastazirajući karcinom prostate otporan na kastraciju, rak bubrega, sarkom, rak kože, rak pločastih stanica, rak želuca, rak testisa, rak štitnjače, urogenitalni rak ili urotelni rak.
18. Konjugirano protutijelo koje se može aktivirati u skladu s bilo kojim od patentnih zahtjeva 1-10, ili farmaceutski pripravak u skladu s bilo kojim od patentnih zahtjeva 11-12, namijenjeni uporabi kao medikament namijenjen liječenju poremećaja ili bolesti kod koje oboljele stanice eksprimiraju CD71, te pri čemu je poremećaj ili bolest rak, pri čemu: (i) rak je adenokarcinom, rak žučovoda (bilijarni rak), rak mokraćnog mjehura, rak kosti, rak dojke, trostruko negativni rak dojke, rak dojke negativan na Her2, karcinoidni rak, rak vrata maternice, kolangiokarcinom, kolorektalni rak, rak debelog crijeva, rak endometrija, gliom, rak glave i vrata, rak pločastih stanica glave i vrata, leukemija, rak jetre, rak pluća, rak velikih stanica pluća, rak malih stanica pluća, limfom, melanom, orofaringealni rak, rak jajnika, rak gušterače, rak prostate, metastazirajući karcinom prostate otporan na kastraciju, rak bubrega, sarkom, rak kože, rak pločastih stanica, rak želuca, rak testisa, rak štitnjače, urogenitalni rak ili urotelni rak; ili (ii) uporaba se sastoji u primjeni dodatnog sredstva; pri čemu dodatno sredstvo može biti terapijsko sredstvo.
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