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HRP20171749T1 - Protutijela specifična za claudin 6 (cldn6) - Google Patents

Protutijela specifična za claudin 6 (cldn6) Download PDF

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Publication number
HRP20171749T1
HRP20171749T1 HRP20171749TT HRP20171749T HRP20171749T1 HR P20171749 T1 HRP20171749 T1 HR P20171749T1 HR P20171749T T HRP20171749T T HR P20171749TT HR P20171749 T HRP20171749 T HR P20171749T HR P20171749 T1 HRP20171749 T1 HR P20171749T1
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Croatia
Prior art keywords
seq
identified
amino acid
acid sequence
antibody
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HRP20171749TT
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English (en)
Inventor
Ugur Sahin
Özlem TÜRECI
Michael Koslowski
Korden Walter
Stefan WÖLL
Maria Kreuzberg
Bernd Hubner
Michael Erdeljan
Original Assignee
Ganymed Pharmaceuticals Gmbh
Johannes Gutenberg-Universität Mainz
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Publication date
Priority claimed from EP09014136A external-priority patent/EP2322555A1/en
Application filed by Ganymed Pharmaceuticals Gmbh, Johannes Gutenberg-Universität Mainz filed Critical Ganymed Pharmaceuticals Gmbh
Publication of HRP20171749T1 publication Critical patent/HRP20171749T1/hr

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Claims (16)

1. Protutijelo sposobno vezati CLDN6, poželjno CLDN povezano s površinom stanice koju izražava CLDN6, te je sposoban razlikovati CLDN6 na površini stanice koja izražava CLDN6 i CLDN6 mutanta na površini stanice koja izražava navedeni CLDN6 mutant, naznačeno time da CLDN6 mutant obuhvaća mutaciju alalnina na položaju 35, 37 ili 39 aminokiselinske sekvence SEQ ID NO: 2 ili SEQ ID NO: 8, i gdje protutijelo sadrži teški lanac protutijela koji sadrži CDR3 sekvencu teškog lanca protutijela odabranu iz skupine koja se sastoji od ARDYGYVLDY identificiranog unutar SEQ ID NO: 34, ARDYGFVLDY identificiranog unutar SEQ ID NO: 36, ARDFGYVLDY identificirane unutar SEQ ID NO: 38 i ARDYGYVFDY identificirane unutar SEQ ID NO: 40.
2. Protutijelo sukladno patentnom zahtjevu 1, što nije bitno da se veže za CLDN9 povezanu s površinom stanice koja izražava CLDN9.
3. Protutijelo sukladno patentnom zahtjevu 1 ili 2, što nije bitno da se veže za CLDN4 povezanu s površinom stanice koja izražava CLDN4 i/ili nije bitno da se veže za CLDN3 povezanu s površinom stanice koja izražava CLDN3.
4. Protutijelo sukladno bilo kojem od patentnih zahtjeva 1-3, naznačeno time stoje specifično za CLDN6.
5. Protutijelo sukladno bilo kojem od patentnih zahtjeva 1 -4, naznačeno time što je sposobno vezati se za epitop smješten unutar izvanstaničnog dijela CLDN6, pri čemu se spomenuti izvanstanični dio CLDN6 preferirano sadrži sekvencu aminokiselina SEQ ID NO: 6 ili SEQ ID NO: 7.
6. Protutijelo sukladno bilo kojem od patentnih zahtjeva 1-5, naznačeno time da CLDN6 ima aminokiselinsku sekvencu SEQ ID NO: 2 ili aminokiselinsku sekvencu SEQ ID NO: 8.
7. Protmijelo sukladno bilo kojem od patentnih zahtjeva 1-6, koje ima jednu ili više od slijedećih aktivnosti: (i) ubijanje stanica koja eksprimira CLDN6, (ii) inhibiciju proliferacije stanica koja eksprimira CLDN6, (iii) inhibiranje stvaranja kolonija stanica koje eksprimiraju CLDN6, (iv) posredovanje u remisiji utvrđenih tumora, (v) sprječavanje stvaranja i ponovnog stvaranja tumora, i (vi) inhibicija metastaza stanica koje eksprimiraju CLDN6. i/ili koje pokazuje jednu ili više imunološkog efektora protiv stanice koja nosi CLDN6 u svojoj prirodnoj konformaciji, pri čemu je jedna ili više funkcija imunog efektora preferirano odabrana iz skupine koja se sastoji od komplemenata citotoksičnosti (CDC), stanično posredovane citotoksičnosti ovisne o antitijelu (ADCC), indukcije apoptoze, i inhibicije proliferacije, poželjno efektorske funkcije ADCC i/ili CDC.
8. Protutijelo sukladno bilo kojem od patentnih zahtjeva 1-7, koje je monoklonsko, kimerno, humano ili humanizirano protutijelo, ili fragment protutijela.
9. Protutijelo odabrano iz skupine koja se sastoji od (i) protutijela proizvedenog ili koje se može dobiti od klona deponiranog pod pristupnim br. DSM ACC3067 (GT512muMAB 59A), DSM ACC3068 (GT512muMAB 60A), DSM ACC3069 (GT512muMAB 61D), DSM ACC3070 (GT512muMAB 64A), DSM ACC3071 (GT512muMAB 65A), DSM ACC3072 (GT512muMAB 66B), DSM ACC3073 (GT512muMAB 67A), DSM ACC3089 (GT512muMAB 55A), ili DSM ACC3G90 (GT512muMAB 89A), (ii) protutijela koje je kimerizirano ili humanizirano oblik protutijela pod (i), i (iii) protutijela koje sadrži antigen vezujući dio ili antigen vezujuće mjesto protutijela pod (i) naznačeno time što sadrži set HCDRs i LCDRs odabran iz skupine koja se sastoji od (a) HCDR1 aminokiselinske sekvence GYSFTGYT identificirane unutar SEQIDNO: 34, HCDR2 aminokiselinske sekvence INPYNGGT identificirane unutar SEQID NO: 34, HCDR3 aminokiselinske sekvence ARDYGYVLDY identificirane unutar SEQ ID NO: 34, LCDR1 aminokiselinske sekvence SSVSY identificirane unutar SEQ ID NO: 35, LCDR2 aminokiselinske sekvence STS identificirane unutar SEQ ID NO: 35, i LCDR3 aminokiselinske sekvence QQRSIYPPWT identificirane unutar SEQ ID NO: 35; (b) HCDR1 aminokiselinske sekvence GYSFTGYT identificirane unutar SEQ ID NO: 36, HCDR2 aminokiselinske sekvence INPYNGGT identificirane unutar SEQ ID NO: 36, HCDR3 aminokiselinske sekvence ARDYGFVLDY identificirane unutar SEQ ID NO: 36, LCDR1 aminokiselinske sekvence SSVSY identificirane unutar SEQ ID NO: 37, LCDR2 aminokiselinske sekvence STS identificirane unutar SEQ ID NO: 37, i LCDR3 aminokiselinske sekvence QQRSNYPPWT identificirane unutar SEQ ID NO: 37; (c) HCDR1 aminokiselinske sekvence GYSFTGYT identificirane unutar SEQ ID NO: 38, HCDR2 aminokiselinske sekvence INPYNGGI identificirane unutar SEQ ID NO: 38, HCDR3 aminokiselinske sekvence ARDFGYVLDY identificirane unutar SEQ ID NO: 38, LCDRI aminokiselinske sekvence SSVSY identifikovane unutar SEQ ID NO: 39, LCDR2 aminokiselinske sekvence STS identificirane unutar SEQ ID NO: 39, i LCDR3 aminokiselinske sekvence QQRSTYPPWT identificirane unutar SEQ ID NO: 39; i (d) HCDR1 aminokiselinske sekvence GYSFTGYT identificirane unutar SEQ ID NO: 40, HCDR2 aminokiselinske sekvence INPYNGGS identificirane unutar SEQ ID NO: 40, HCDR3 aminokiselinske sekvence ARDYGYVFDY identificirane unutar SEQ IDNO: 40, LCDRI aminokiselinske sekvence SSVNY identificirane unutar SEQ ID NO: 41, LCDR2 aminokiselinske sekvence STS identificirane unutar SEQ ID NO: 41, i LCDR3 aminokiselinske sekvence QQRNNYPPWT identificirane unutar SEQ IDNO: 41.
10. Hibridoma sposoban za proizvodnju protutijela sukladno bilo kojem patentnih zahtjeva 1-9.
11. Hibridoma deponiran pod pristupnim br. DSM ACC3067 (GT512muMAB 59A), DSM ACC3068 (GT512muMAB 60A), DSM ACC3069 (GT512muMAB 61D), DSM ACC3070 (GT512muMAB 64A), DSM ACC3071 (GT512muMAB 65A), DSM ACC3072 (GT512muMAB 66B), DSM ACC3073 (GT512muMAB 67A), DSM ACC3089 (GT512muMAB 55A), ili DSM ACC3090 (GT512rnuMAB 89A).
12. Konjugat koji sadrži protutijelo sukladno bilo kojem od patentnih zahtjeva 1-9 povezano s terapijskim sredstvom, naznačeno time što je terapijsko sredstvo poželjno toksin, radioizotop, lijek ili citotoksični agens.
13. Farmaceutska kompozicija koja sadrži protutijelo sukladno bilo kojem od patentnih zahtjeva 1-9 i/ili konjugat sukladno patentnom zahtjevu 12, i farmaceutski prihvatljivi nosač.
14. ProrutijeJo sukladno bilo kojem od patentnih zahtjeva ]-9 i/iJi konjugat sukladno patentnom zahtjevu 12 za upotrebu u postupku inhibiranja rasta, ubijanja ili inhibiranja metastatskog širenja stanice koja izražava CLDN6 i koja je naznačena time daje CLDN6 asociran s njenom staničnom površinom, koji sadrži dovođenje u kontakt stanice s protutijelom i/ili konjugatom.
15. Protutijelo sukladno bilo kojem od patentnih zahtjeva 1-9, konjugat sukladno patentnom zahtjevu 12 ili farmaceutski pripravak sukladno patentnom zahtjevu 13 za upotrebu u postupku liječenja ili prevencije bolesti ili poremećaja koji uključuje stanicu i koja je karakterizirana udruživanjem CLDN6 sa svojom površinom stanice.u subjektu.
16. Protutijelo, konjugat ili farmaceutski sastav za upotrebu sukladno patentnom zahtjevu 15, naznačeno time da je bolest ili poremećaj povezana s tumorom kao što je karcinom, pri čemu je karcinom poželjno odabran iz skupine koju čine karcinom jajnika, naročito adenokarcinoma jajnika i teratokarcinoma jajnika, karcinom pluća, uključujući i mali (SCLC) i karcinom pluća ne-malih stanica (NSCLC), posebno karcinom pluća skvamoznih stanica i adenokarcinom, karcinom želuca, karcinom dojke, karcinom jetre, karcinom pankreasa, karcinom kože, naročito karcinom bazalnih satanica i karcinom skvamoznih stanica, malignog melanoma, karcinom glave i vrata, posebno malignog pleomorfhi adenom, sarkom, posebno sinovijalnog sarkoma i karcinosarkoma, karcinom žučnog kanala, karcinom mokraćnog mjehura, posebno karcinoma prelaznih stanica i papilarnog karcinoma, karcinom bubrega, posebno karcinom bubrežnih stanica uključujući karcinom jasnih stanica i papilamog carcinoma bubrežnih stanica, karcinom debelog crijeva, karcinom tankog crijeva, uključujući karcinom ileuma, posebno adenokarcinom tankog crijeva i adenokarcinom ileuma, testikularnog embrionalnog karcinoma, placentalnog koriokarcinoma, karcinom cerviksa, rak testisa, posebno testikularnog seminoma, testikularnog teratoma i embrijskog raka testisa, karcinom maternice, tumor zametnutih stanica kao što je teratokarcinom ili embrijski karcinom, posebno tumor zametnutih stanica testisa, i njihovi metastatski oblici.
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