HRP20231156T1 - Kombinacija anti-pd-1 antitijela i bispecifičnih anti-cd20/anti-cd3 antitijela za liječenje raka - Google Patents
Kombinacija anti-pd-1 antitijela i bispecifičnih anti-cd20/anti-cd3 antitijela za liječenje raka Download PDFInfo
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- 239000000427 antigen Substances 0.000 claims 33
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- C07K16/2887—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
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Claims (14)
1. Antitijelo ili njegov fragment koji se veže za antigen koji specifično veže programiranu staničnu smrt 1 (PD-1) za upotrebu u postupku liječenja B-staničnog ne-Hodgkinovog limfoma u kombinaciji s bispecifičnim antitijelom koje sadrži prvi krak koji se veže za antigen i koji specifično veže CD20 i drugi krak koji se veže za antigen koji specifično veže CD3, pri čemu navedeni postupak obuhvaća davanje subjektu kome je to potrebno terapeutski efikasne količine svakog antitijela ili fragmenta, pri čemu:
anti-PD-1 antitijelo ili njegov fragment koji se veže za antigen sadrži tri regije koje određuju komplementarnost teškog lanca (CDR) (HCDR1, HCDR2 i HCDR3) i tri CDR lakog lanca (LCDR1, LCDR2 i LCDR3), pri čemu HCDR1 sadrži aminokiselinsku sekvencu SEQ ID NO: 3; HCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 4; HCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 5; LCDR1 sadrži aminokiselinsku sekvencu SEQ ID NO: 6; LCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 7; i LCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 8;
prvi krak bispecifičnog antitijela koji se veže za antigen obuhvaća tri regije koje određuju komplementarnost teškog lanca (CDR) (A-HCDR1, A-HCDR2 i A-HCDR3) i tri CDR laka lanca (LCDR1, LCDR2 i LCDR3), pri čemu A-HCDR1 sadrži aminokiselinsku sekvencu SEQ ID NO: 14; A-HCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO:15; A-HCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 16; LCDR1 sadrži aminokiselinsku sekvencu SEQ ID NO: 17; LCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 18; i LCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 19;
drugi krak bispecifičnog antitijela koji se veže za antigen sadrži tri CDR teška lanca (B-HCDR1, B-HCDR2 i B-HCDR3) i tri CDR laka lanca (LCDR1, LCDR2 i LCDR3), pri čemu B-HCDR1 sadrži aminokiselinsku sekvencu od SEQ ID NO: 20; B-HCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 21; B-HCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 22; LCDR1 sadrži aminokiselinsku sekvencu SEQ ID NO: 17; LCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 18; i LCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 19; i
svaka doza anti-PD-1 antitijela sadrži 0.1 do 20 mg/kg tjelesne težine subjekta.
2. Bispecifično antitijelo koje sadrži prvi krak koji se veže za antigen koji specifično veže CD20 i drugi krak koji se veže za antigen koji specifično veže CD3 za upotrebu u postupku liječenja B-staničnog ne-Hodkinovog limfoma u kombinaciji s antitijelom ili njegovim fragmentom koji veže antigen koji specifično veže programiranu staničnu smrt 1 (PD-1), spomenuti postupak obuhvaća davanje subjektu kome je to potrebno terapeutski efikasne količine svakog antitijela ili fragmenta, pri čemu:
anti-PD-1 antitijelo ili njegov fragment koji se veže za antigen sadrži tri regije koje određuju komplementarnost teškog lanca (CDR) (HCDR1, HCDR2 i HCDR3) i tri CDR lakog lanca (LCDR1, LCDR2 i LCDR3), pri čemu HCDR1 sadrži aminokiselinsku sekvencu SEQ ID NO: 3; HCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 4; HCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 5; LCDR1 sadrži aminokiselinsku sekvencu SEQ ID NO: 6; LCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 7; i LCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 8;
prvi krak bispecifičnog antitijela koji se veže za antigen obuhvaća tri regije koje određuju komplementarnost teškog lanca (CDR) (A-HCDR1, A-HCDR2 i A-HCDR3) i tri CDR laka lanca (LCDR1, LCDR2 i LCDR3), pri čemu A-HCDR1 sadrži aminokiselinsku sekvencu SEQ ID NO: 14; A-HCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO:15; A-HCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 16; LCDR1 sadrži aminokiselinsku sekvencu SEQ ID NO: 17; LCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 18; i LCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 19;
drugi krak bispecifičnog antitijela koje se veže za antigen sadrži tri CDR teška lanca (B-HCDR1, B-HCDR2 i B-HCDR3) i tri CDR laka lanca (LCDR1, LCDR2 i LCDR3), pri čemu B-HCDR1 sadrži aminokiselinsku sekvencu od SEQ ID NO: 20; B-HCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 21; B-HCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 22; LCDR1 sadrži aminokiselinsku sekvencu SEQ ID NO: 17; LCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 18; i LCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 19; i
svaka doza anti-PD-1 antitijela sadrži 0-1 do 20 mg/kg tjelesne težine subjekta.
3. Farmaceutski sastav za upotrebu u postupku liječenja B-staničnog ne-Hodgkinovog limfoma, pri čemu spomenuta kompozicija sadrži antitijelo ili njegov fragment koji se veže za antigen koji specifično veže programiranu staničnu smrt 1 (PD-1) i bispecifično antitijelo koje sadrži prvi antigen koji se veže krak koji specifično veže CD20 i drugi krak koji se veže za antigen koji specifično veže CD3, pri čemu:
anti-PD-1 antitijelo ili njegov fragment koji se veže za antigen sadrži tri regije koje određuju komplementarnost teškog lanca (CDR) (HCDR1, HCDR2 i HCDR3) i tri CDR lakog lanca (LCDR1, LCDR2 i LCDR3), pri čemu HCDR1 sadrži aminokiselinsku sekvencu SEQ ID NO: 3; HCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 4; HCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 5; LCDR1 sadrži aminokiselinsku sekvencu SEQ ID NO: 6; LCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 7; i LCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 8;
prvi krak bispecifičnog antitijela koji se veže za antigen sadrži tri CDR teška lanca (A-HCDR1, A-HCDR2 i A-HCDR3) i tri CDR laka lanca (LCDR1, LCDR2 i LCDR3), pri čemu A-HCDR1 sadrži aminokiselinsku sekvencu od SEQ ID NO: 14; A-HCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 15; A-HCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 16; LCDR1 sadrži aminokiselinsku sekvencu SEQ ID NO: 17; LCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 18; i LCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 19;
drugi krak bispecifičnog antitijela koji se veže za antigen sadrži tri CDR teška lanca (B-HCDR1, B¬HCDR2 i B-HCDR3) i tri CDR laka lanca (LCDR1, LCDR2 i LCDR3), pri čemu B-HCDR1 sadrži aminokiselinsku sekvencu od SEQ ID NO: 20; B-HCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 21; B-HCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 22; LCDR1 sadrži aminokiselinsku sekvencu SEQ ID NO: 17; LCDR2 sadrži aminokiselinsku sekvencu SEQ ID NO: 18; i LCDR3 sadrži aminokiselinsku sekvencu SEQ ID NO: 19; i
kompozicija sadrži 0.05 do 600 mg anti-PD-1 antitijela.
4. Antitijelo ili antigen-vezujući fragment, koje specifično veže PD-1 za upotrebu prema zahtjevu 1 ili bispecifično antitijelo za upotrebu prema zahtjevu 2, pri čemu:
(a) svaka doza anti-PD-1 antitijela sadrži 0.3, 1, 3, ili 10 mg/kg telesne težine subjekta; ili
(b) svaka doza anti-PD-1 antitijela sadrži 0.05 do 600 mg.
5. Antitijelo, antigen-vezujući fragment ili bispecifično antitijelo za upotrebu prema bilo kojem od zahtjeva 1, 2 ili 4, pri čemu:
(a) svaka doza bispecifičnog antitijela sadrži 0,1 do 10 mg/kg tjelesne težine subjekta; ili
(b) svaka doza bispecifičnog antitijela sadrži 10 do 8000 mikrograma, opcionalno pri čemu svaka doza anti-PD-1 antitijela sadrži 1, 3 ili 10 mg/kg i svaka doza bispecifičnog antitijela sadrži 30, 100, 300, 1000 ili 2000 mikrograma.
6. Antitijelo, antigen-vezujući fragment ili bispecifično antitijelo za upotrebu prema bilo kojem od zahtjeva 1, 2, 4 ili 5, pri čemu:
(a) svaka doza anti-PD-1 antitijela se primjenjuje 0,5 -12 tjedana neposredno nakon prethodne doze;
(b) svaka doza bispecifičnog antitijela se primjenjuje 0,5 -12 tjedana neposredno nakon prethodne doze, opcionalno pri čemu se svaka doza anti-PD-1 antitijela primjenjuje jednom u dva tjedna ili jednom u tri tjedna, a svaka doza antitijela na PD-1 bispecifično antitijelo se primjenjuje jednom tjedno; i/ili
(c) svaka doza bispecifičnog antitijela se dijeli na 2-5 frakcija u periodu doziranja.
7. Antitijelo, antigen-vezujući fragment ili bispecifično antitijelo za upotrebu prema bilo kojem od zahtjeva 1, 2, 4, 5 ili 6, pri čemu je anti-PD-1 antitijelo davano prije, istovremeno s ili nakon bispecifičnog antitijela, opcionalno gdje je anti-PD-1 antitijelo davano prije bispecifičnog antitijela, kao što je gdje anti-PD-1 antitijelo je davano 1 tjedan prije bispecifičnog antitijela.
8. Antitijelo, antigen-vezujući fragment ili bispecifično antitijelo ili farmaceutski sastav za upotrebu prema bilo kojem od zahtjeva 1-7, pri čemu su antitijela davana intravenski, potkožno, ili intraperitonealno.
9. Antitijelo, antigen-vezujući fragment, bispecifično antitijelo ili farmaceutska kompozicija za upotrebu prema bilo kojem od zahtjeva 1-8, pri čemu:
(a) subjekt je rezistentan ili neadekvatno reagira na, ili je relapsirao nakon prethodne terapije;
(b) tretman proizvodi terapeutski efekt izabran iz grupe koja se sastoji od usporavanja rasta tumora, smanjenja broja tumorskih stanica, regresije tumora, povećanja preživljavanja, djelomičnog odgovora i potpunog odgovora, opcionalno pri čemu je rast tumora odgođen za najmanje 10 dana u usporedbi sa neliječenim subjektom; i/ili
(c) rast tumora je inhibiran za najmanje 10% u usporedbi s neliječenim subjektom, ili je rast tumora inhibiran za najmanje 10% u usporedbi sa subjektom koji je primijenjen s bilo kojim antitijelom kao monoterapija.
10. Antitijelo, antigen-vezujući fragment ili bispecifično antitijelo za upotrebu prema bilo kojem od zahtjeva 1, 2, 4, 5 ili 6, pri čemu se anti-PD-1 antitijelo daje prije bispecifičnog antitijela i tumorski rast je inhibiran za najmanje 20% u usporedbi sa subjektom kome je davano bispecifično anti-CD20/anti-CD3 antitijelo prije anti-PD-1 antitijela.
11. Antitijelo, antigen-vezujući fragment, bispecifično antitijelo ili farmaceutski sastav za upotrebu prema bilo kojem od zahtjeva 1-10, dalje koji obuhvaća davanje subjektu trećeg terapeutskog agensa ili terapije, pri čemu je treći terapeutski agens ili terapija odabran iz grupe koja se sastoji iz zračenja, kirurgije, kemoterapeutskog sredstva, cjepiva protiv raka, PD-L1 inhibitora, LAG-3 inhibitora, CTLA-4 inhibitora, TIM3 inhibitora, BTLA inhibitora, TIGIT inhibitora, CD47 inhibitora, inhibitora indoleamin- 2,3-dioksigenaze (IDO), antagonista vaskularnog endotelnog faktora rasta (VEGF), inhibitora angiopoetina-2 (Ang2), inhibitora transformirajućeg faktora rasta beta (TGFb), inhibitora receptora epidermalnog faktora rasta (EGFR), antitijela na tumor-specifični antigen, cjepivo Bacillus Calmette-Guerin, faktora stimulacije kolonije granulocita-makrofaga, citotoksina, inhibitora receptora interleukina 6 (IL-6R), inhibitora receptora interleukina 4 (IL-4R), IL- 10 inhibitora, IL-2, IL-7, IL-21, IL-15, konjugata antitijelo-lek, antiinflamatornog lijeka i dijetetskog suplementa.
12. Antitijelo, antigen-vezujući fragment, bispecifično antitijelo ili farmaceutski sastav za upotrebu prema bilo kojem od zahtjeva 1-11, pri čemu anti-PD-1 antitijelo ili njegov fragment za vezanje antigena sadrži:
(a) varijabilnu regiju teškog lanca (HCVR) koji sadrži aminokiselinsku sekvencu SEQ ID NO: 1 i varijabilnu regiju lakog lanca (LCVR) koji sadrži aminokiselinsku sekvencu SEQ ID NO: 2; ili
(b) težak lanac koji sadrži aminokiselinsku sekvencu SEQ ID NO: 9 i laki lanac koji sadrži aminokiselinsku sekvencu SEQ ID NO: 10.
13. Antitijelo, antigen-vezujući fragment, bispecifično antitijelo, ili farmaceutski sastav za upotrebu prema bilo kojem od zahtjeva 1-12, pri čemu:
drugi krak za vezivanje antigena bispecifičnog antitijela sadrži A-HCVR koji sadrži aminokiselinsku sekvencu SEQ ID NO: 11 i LCVR koji sadrži aminokiselinsku sekvencu SEQ ID NO: 12.
14. Antitijelo, antigen-vezujući fragment, bispecifično antitijelo ili farmaceutski sastav za upotrebu prema bilo kojem od zahtjeva 1-13, pri čemu drugi krak za vezanje antigena bispecifičnog antitijela sadrži B-HCVR koji sadrži aminokiselinsku sekvencu SEQ ID NO: 13 i LCVR koji sadrži aminokiselinsku sekvencu SEQ ID NO: 12.
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| EP16826557.7A EP3394103B1 (en) | 2015-12-22 | 2016-12-21 | Combination of anti-pd-1 antibodies and bispecific anti-cd20/anti-cd3 antibodies to treat cancer |
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