HRP20201143T1 - Protutijela anti-cd3 i postupci uporabe - Google Patents
Protutijela anti-cd3 i postupci uporabe Download PDFInfo
- Publication number
- HRP20201143T1 HRP20201143T1 HRP20201143TT HRP20201143T HRP20201143T1 HR P20201143 T1 HRP20201143 T1 HR P20201143T1 HR P20201143T T HRP20201143T T HR P20201143TT HR P20201143 T HRP20201143 T HR P20201143T HR P20201143 T1 HRP20201143 T1 HR P20201143T1
- Authority
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- Croatia
- Prior art keywords
- bispecific antibody
- lymphoma
- cell
- domain
- use according
- Prior art date
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- 238000000034 method Methods 0.000 title claims 4
- 239000005557 antagonist Substances 0.000 claims 11
- 229920001184 polypeptide Polymers 0.000 claims 9
- 102000004196 processed proteins & peptides Human genes 0.000 claims 9
- 108090000765 processed proteins & peptides Proteins 0.000 claims 9
- 208000031671 Large B-Cell Diffuse Lymphoma Diseases 0.000 claims 8
- 210000004027 cell Anatomy 0.000 claims 8
- 206010012818 diffuse large B-cell lymphoma Diseases 0.000 claims 8
- 230000035772 mutation Effects 0.000 claims 8
- 102000017420 CD3 protein, epsilon/gamma/delta subunit Human genes 0.000 claims 6
- 108050005493 CD3 protein, epsilon/gamma/delta subunit Proteins 0.000 claims 6
- 229940049595 antibody-drug conjugate Drugs 0.000 claims 6
- 238000006467 substitution reaction Methods 0.000 claims 6
- 208000003950 B-cell lymphoma Diseases 0.000 claims 5
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- 102100024213 Programmed cell death 1 ligand 2 Human genes 0.000 claims 2
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- 238000007918 intramuscular administration Methods 0.000 claims 1
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- 238000002560 therapeutic procedure Methods 0.000 claims 1
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Classifications
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- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
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- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
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- C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
- C07K16/2809—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against the T-cell receptor (TcR)-CD3 complex
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
- C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
- C07K16/283—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against Fc-receptors, e.g. CD16, CD32, CD64
-
- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
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- C07K16/2863—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against receptors for growth factors, growth regulators
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
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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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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
- C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
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- C07K16/2896—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
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- C—CHEMISTRY; METALLURGY
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- C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
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Claims (33)
1. Bispecifično protutijelo, naznačeno time, da obuhvaća anti-CD3-ogranak koji obuhvaća prvu domenu vezanja, koja sadrži (a) VH domenu koja sadrži aminokiselinsku sekvencu od SEQ ID NO: 184 i (b) VL domenu koja sadrži aminokiselinsku sekvencu od SEQ ID NO: 185, te anti-CD20-ogranak koji obuhvaća drugu domenu vezanja, koja sadrži (a) VH domenu koja sadrži aminokiselinsku sekvencu od SEQ ID NO: 266 i (b) VL domenu koja sadrži aminokiselinsku sekvencu od SEQ ID NO: 267.
2. Bispecifično protutijelo prema patentnom zahtjevu 1, naznačeno time, da (a) anti-CD3-ogranak obuhvaća supstitucijske mutacije T366S, L368A, Y407V i N297G i (b) anti-CD20-ogranak obuhvaća supstitucijske mutacije T366W i N297G.
3. Bispecifično protutijelo prema patentnom zahtjevu 1 ili zahtjevu 2, naznačeno time, da se prva domena vezanja veže na ljudski polipeptid CD3 ili na majmunski polipeptid CD3 cynomolgus (cyno polipeptid CD3).
4. Bispecifično protutijelo prema patentnom zahtjevu 3, naznačeno time, da (a) ljudski polipeptid CD3 je ljudski polipeptid CD3ε ili je ljudski polipeptid CD3γ; ili (b) cyno polipeptid CD3 je cyno polipeptid CD3ε ili cyno polipeptid CD3γ.
5. Bispecifično protutijelo prema bilo kojem od patentnih zahtjeva 1-4, naznačeno time, da bispecifično protutijelo obuhvaća mutaciju mjesta aglikosilacije.
6. Bispecifično protutijelo prema patentnom zahtjevu 5, naznačeno time, da mutacija mjesta aglikosilacije (a) predstavlja supstitucijsku mutaciju i/ili (b) reducira efektorsku funkciju bispecifičnog protutijela.
7. Bispecifično protutijelo prema bilo kojem od patentnih zahtjeva 1-6, naznačeno time, da bispecifično protutijelo obuhvaća supstitucijsku mutaciju u Fc regiji, koja reducira efektorsku funkciju.
8. Bispecifično protutijelo prema patentnom zahtjevu 6, dio (a), ili patentnom zahtjevu 7, naznačeno time, da supstitucijska mutacija je predstavljena na aminokiselinskom ostatku N297, L234, L235 i/ili D265 (EU numeriranje).
9. Bispecifično protutijelo prema patentnom zahtjevu 8, naznačeno time, da je supstitucijska mutacija odabrana iz skupine koju čine N297G, N297A, L234A, L235A i D265A.
10. Bispecifično protutijelo prema bilo kojem od patentnih zahtjeva 1-9, naznačeno time, da bispecifično protutijelo je:
(i) monoklonsko, humanizirano ili kimerno;
(ii) protutijelo pune duljine; i/ili
(iii) IgG protutijelo.
11. Bispecifično protutijelo prema bilo kojem od patentnih zahtjeva 1-10, naznačeno time, da bispecifično protutijelo obuhvaća konstantne domene teškog lanca, pri čemu su konstantne domene teškog lanca odabrane od prve domene CH1(CH11), prve domene CH2(CH21), prve domene CH3(CH31), druge domene CH1(CH12), druge domene CH2(CH22), i druge domene CH3(CH32), te se pritom
najmanje jedna od konstantnih domena teškog lanca uparuje s nekom sljedećom konstantnom domenom teškog lanca, gdje:
(i) svaka od domena CH31 i CH32 sadrži ispupčenje ili šupljinu, s time da se ispupčenje ili šupljina u domeni CH31 može pozicionirati u šupljinu odnosno u ispupčenje od domene CH32; ili
(ii) svaka od domena CH21 i CH22 sadrži ispupčenje ili šupljinu, s time da se ispupčenje ili šupljina u domeni CH21 može pozicionirati u šupljinu odnosno u ispupčenje od domene CH22.
12. Izolirana nukleinska kiselina, naznačena time, da kodira bispecifično protutijelo prema bilo kojem od patentnih zahtjeva 1-11.
13. Vektor, naznačen time, da obuhvaća nukleinsku kiselinu prema patentnom zahtjevu 12.
14. Stanica domaćina, naznačena time, da obuhvaća vektor prema patentnom zahtjevu 13.
15. Postupak proizvodnje bispecifičnog protutijela prema bilo kojem od patentnih zahtjeva 1-11, naznačen time, da postupak obuhvaća kultiviranje stanice domaćina prema patentnom zahtjevu 14 u mediju za uzgoj i ponovno dobivanje bispecifičnog protutijela iz stanice domaćina ili iz medija za uzgoj.
16. Imunokonjugat, naznačen time, da obuhvaća bispecifično protutijelo prema bilo kojem od patentnih zahtjeva 1-11 i citotoksično sredstvo.
17. Pripravak, naznačen time, da obuhvaća bispecifično protutijelo prema bilo kojem od patentnih zahtjeva 1-11 i farmaceutski prihvatljiv nosač, ekscipijent ili razrjeđivač.
18. Pripravak prema patentnom zahtjevu 17, naznačen time, da pripravak nadalje obuhvaća antagonist vezanja PD-1-osi ili dodatno terapeutsko sredstvo.
19. Bispecifično protutijelo prema bilo kojem od patentnih zahtjeva 1-11, naznačeno time, da se upotrebljava u postupku terapije kod:
(i) liječenja ili odgađanja progresije poremećaja stanične proliferacije ili autoimunog poremećaja kod pojedinca kojemu je to potrebno; ili
(ii) poboljšavanja imunološke funkcije kod pojedinca koji ima poremećaj stanične proliferacije ili autoimuni poremećaj.
20. Bispecifično protutijelo za uporabu prema patentnom zahtjevu 19, naznačeno time, da se kod poremećaja stanične proliferacije radi o raku odabranom iz skupine koju čine: rak dojke, kolorektalni rak, rak ne-malih stanica pluća, ne-Hodgkinov limfom (NHL), B-stanični limfom, B-stanična leukemija, multipli mijelom, rak bubrega, rak prostate, rak jetre, rak glave i vrata, melanom, rak jajnika, mezoteliom, glioblastom, difuzni veliki B-stanični limfom (DLBCL) centra klicanja nalik na B-stanični (GCB), aktivirani DLBCL nalik na B-stanični (ABC), folikularni limfom (FL), limfom plaštenih stanica (MCL), akutna mijeloidna leukemija (AML), kronična limfoidna leukemija (CLL), limfom marginalne zone (MZL), leukemija malih limfocita (SLL), limfoplazmatski limfom (LL), Waldenström-makroglobulinemija (WM), limfom centralnog nervnog sustava (CNSL), Burkittov limfom (BL), B-stanična prolimfocitna leukemija, splenički limfom marginalne zone, leukemija vlasastih stanica, splenički limfom/splenička leukemija, neklasificirani splenički difuzni limfom, B-malostanični limfom, varijanta leukemije vlasastih stanica, Waldenström-makroglobulinemija, bolesti teškog lanca, α-bolesti teškog lanca, γ-bolesti teškog lanca, μ-bolesti teškog lanca, mijelom stanica plazme, solitarni koštani plazmocitom, ekstraosealni plazmacitom, ekstranodalni limfom marginalne zone limfnog tkiva vezanog uz sluznicu (MALT-limfom), nodalni limfom marginalne zone, pedijatrijski nodalni limfom marginalne zone, pedijatrijski folikularni limfom, primarni kožni limfom centra folikla, B-velikostanični limfom bogat T-stanicama ili histiocitima, primarni DLBCL od CNS-centralnog nervnog sustava, primarni kožni DLBCL nožnog tipa, EBV-pozitivni DLBCL kod starijih, DLBCL povezan s kroničnom upalom, limfomatoidna granulomatoza, primarni medijastinalni (timički) B-velikostanični limfom, intravaskularni B-velikostanični limfom, ALK-pozitivni B-velikostanični limfom, plazmablastični limfom, B-velikostanični limfom povezan s HHV8-infekcijom i multicentričnom Castelmanovom bolesti, primarni efuzijski limfom: B-stanični limfom, neklasificiran, sa značajkama između difuznog velikog B-staničnog limfoma i Burkittovog limfoma, i B-stanični limfom, neklasificiran, sa značajkama između DLBCL i klasičnog Hodgkinovog limfoma.
21. Bispecifično protutijelo za uporabu prema patentnom zahtjevu 19, naznačeno time, da se autoimuni poremećaj odabire iz skupine koju čine: reumatoidni artritis, mladenački reumatoidni artritis, sustavni eritematozni lupus (SLE), Wegenerova bolest, upalna bolest crijeva, idiopatska trombocitopenijska purpura (ITP), trombocitna trombocitopenijska purpura (TTP), autoimuna trombocitopenija, multipla skleroza, psorijaza, IgA nefropatija, IgM polineuropatija, mijastenija gravis, vaskulitis, dijabetes melitus, Reynaudov sindrom, Sjögrenov sindrom, glomerulonefritis, optički neuromijelitis (NMO) i IgG neuropatija.
22. Bispecifično protutijelo za uporabu prema bilo kojem od patentnih zahtjeva 19-21, naznačeno time, da se bispecifično protutijelo veže na (a) molekulu CD3 koja se nalazi na imunoefektorskoj stanici i (b) molekulu CD20 koja se nalazi na ciljnoj stanici koja je različita od imunoefektorske stanice.
23. Bispecifično protutijelo za uporabu prema patentnom zahtjevu 22, naznačeno time, da bispecifično protutijelo aktivira imunoefektorsku stanicu što slijedi nakon vezanja na (a) i (b).
24. Bispecifično protutijelo za uporabu prema bilo kojem od patentnih zahtjeva 19-23, naznačeno time, da je bispecifično protutijelo formulirano za primjenu kod pojedinca kako slijedi:
(i) u dozi od 0,01 mg/kg do 10 mg/kg, od 0,1 mg/kg do 10 mg/kg, ili od 1 mg/kg; ili
(ii) u kombinaciji s primjenom antagonista vezanja PD-1-osi i/ili s dodatnim terapeutskim sredstvom.
25. Bispecifično protutijelo za uporabu prema patentnom zahtjevu 24, dio (ii), naznačeno time, da se antagonist vezanja PD-1-osi odabire iz skupine koju čine: antagonist vezanja PD-1, antagonist vezanja PD-L1, i antagonist vezanja PD-L2.
26. Bispecifično protutijelo za uporabu prema patentnom zahtjevu 24, dio (ii), naznačeno time, da antagonist vezanja PD-1-osi je:
(i) antagonist vezanja PD-1 odabran iz skupine koja se sastoji od sljedećih: MDX-1106 (nivolumab), MK-3475 (lambrolizumab) i AMP-224;
(ii) antagonist vezanja PD-L1 odabran iz skupine koja se sastoji od sljedećih: YW243.55.S70, MPDL3280A, MDX-1105, i MEDI4736; ili
(iii) antagonist vezanja PD-L2, gdje antagonist vezanja PD-L2 je protutijelo ili imunoadhezin.
27. Bispecifično protutijelo za uporabu prema bilo kojem od patentnih zahtjeva 19-26, naznačeno time, da je bispecifično protutijelo formulirano za primjenu u kombinaciji s davanjem rituksimaba, obinutuzumaba, ili konjugata protutijelo-lijek (ADC-antibody-drug conjugate).
28. Bispecifično protutijelo za uporabu prema patentnom zahtjevu 27, naznačeno time, da je bispecifično protutijelo formulirano za primjenu u kombinaciji s jednim ADC.
29. Bispecifično protutijelo za uporabu prema patentnom zahtjevu 28, naznačeno time, da ADC je konjugat anti-CD79b-ADC.
30. Bispecifično protutijelo za uporabu prema patentnom zahtjevu 29, naznačeno time, da anti-CD79b-ADC je polatuzumab-vedotin.
31. Bispecifično protutijelo za uporabu prema bilo kojem od patentnih zahtjeva 19-30, naznačeno time, da je bispecifično protutijelo formulirano za primjenu kod pojedinca davanjem supkutano, intravenozno, intramuskularno, topikalno, oralno, transdermalno, intraperitonealno, intraorbitalno, putem implantacije, putem inhalacije, intratekalno, intraventrikularno ili intranazalno.
32. Bispecifično protutijelo za uporabu prema bilo kojem od patentnih zahtjeva 19-31, naznačeno time, da je pojedinac čovjek.
33. Komplet, naznačen time, da obuhvaća:
(a) pripravak prema patentnom zahtjevu 17 ili 18; i
(b) pakirni umetak koji sadrži upute za primjenu pripravka kod pojedinca u svrhu liječenja ili odgađanja progresije poremećaja stanične proliferacije ili autoimunog poremećaja.
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US10851178B2 (en) | 2011-10-10 | 2020-12-01 | Xencor, Inc. | Heterodimeric human IgG1 polypeptides with isoelectric point modifications |
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JOP20200236A1 (ar) | 2012-09-21 | 2017-06-16 | Regeneron Pharma | الأجسام المضادة لمضاد cd3 وجزيئات ربط الأنتيجين ثنائية التحديد التي تربط cd3 وcd20 واستخداماتها |
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US10968276B2 (en) | 2013-03-12 | 2021-04-06 | Xencor, Inc. | Optimized anti-CD3 variable regions |
AU2014205086B2 (en) | 2013-01-14 | 2019-04-18 | Xencor, Inc. | Novel heterodimeric proteins |
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2019
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2020
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2022
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