HRP20191083T1 - Molekule antitijela za tim-3 i njihove upotrebe - Google Patents

Molekule antitijela za tim-3 i njihove upotrebe Download PDF

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HRP20191083T1
HRP20191083T1 HRP20191083TT HRP20191083T HRP20191083T1 HR P20191083 T1 HRP20191083 T1 HR P20191083T1 HR P20191083T T HRP20191083T T HR P20191083TT HR P20191083 T HRP20191083 T HR P20191083T HR P20191083 T1 HRP20191083 T1 HR P20191083T1
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Croatia
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seq
amino acid
acid sequence
antibody molecule
heavy chain
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HRP20191083TT
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Catherine Anne SABATOS-PEYTON
Barbara Brannetti
Alan S. Harris
Thomas Huber
Thomas Pietzonka
Jennifer Marie Mataraza
Walter A. Blattler
Daniel J. Hicklin
Maximiliano Vasquez
Rosemarie H. Dekruyff
Dale T. Umetsu
Gordon James Freeman
Tiancen HU
John A. Taraszka
Fangmin Xu
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Novartis Ag
Children's Medical Center Corporation
Dana-Farber Cancer Institute, Inc.
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Application filed by Novartis Ag, Children's Medical Center Corporation, Dana-Farber Cancer Institute, Inc. filed Critical Novartis Ag
Publication of HRP20191083T1 publication Critical patent/HRP20191083T1/hr

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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
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Claims (24)

1. Molekula antitijela sposobna vezati se na imunoglobulin domenu humane T-stanice i mucin domenu 3 (TIM-3), koja sadrži: (a) varijabilnu regiju teškog lanca (VH) koja sadrži VHCDR1 sekvencu amino kiselina odabranu od SEQ ID NO:9; VHCDR2 sekvencu amino kiselina SEQ ID NO: 10; i VHCDR3 sekvencu amino kiselina SEQ ID NO:5; i varijabilnu regiju lakog lanca (VL) koja sadrži VLCDR1 sekvencu amino kiselina SEQ ID NO: 12, VLCDR2 sekvencu amino kiselina SEQ ID NO: 13, i VLCDR3 sekvencu amino kiselina SEQ ID NO: 14; (b) VH koja sadrži VHCDR1 sekvencu amino kiselina odabranu od SEQ ID NO: 3; VHCDR2 sekvencu amino kiselina SEQ ID NO: 4; i VHCDR3 sekvencu amino kiselina SEQ ID NO: 5; i VL koja sadrži VLCDR1 sekvencu amino kiselina SEQ ID NO: 6, VLCDR2 sekvencu amino kiselina SEQ ID NO: 7, i VLCDR3 sekvencu amino kiselina SEQ ID NO: 8; (c) VH koja sadrži VHCDR1 sekvencu amino kiselina odabranu od SEQ ID NO: 9; VHCDR2 sekvencu amino kiselina SEQ ID NO: 25; i VHCDR3 sekvencu amino kiselina SEQ ID NO: 5; i VL koja sadrži VLCDR1 sekvencu amino kiselina SEQ ID NO: 12, VLCDR2 sekvencu amino kiselina SEQ ID NO: 13, i VLCDR3 sekvencu amino kiselina SEQ ID NO: 14; (d) VH koja sadrži VHCDR1 sekvencu amino kiselina odabranu od SEQ ID NO: 3; VHCDR2 sekvencu amino kiselina SEQ ID NO: 24; i VHCDR3 sekvencu amino kiselina SEQ ID NO: 5; i VL koja sadrži VLCDR1 sekvencu amino kiselina SEQ ID NO: 6, VLCDR2 sekvencu amino kiselina SEQ ID NO: 7, i VLCDR3 sekvencu amino kiselina SEQ ID NO: 8; (e) VH koja sadrži VHCDR1 sekvencu amino kiselina odabranu od SEQ ID NO: 9; VHCDR2 sekvencu amino kiselina SEQ ID NO: 31; i VHCDR3 sekvencu amino kiselina SEQ ID NO: 5; i VL koja sadrži VLCDR1 sekvencu amino kiselina SEQ ID NO: 12, VLCDR2 sekvencu amino kiselina SEQ ID NO: 13, i VLCDR3 sekvencu amino kiselina SEQ ID NO: 14; ili (f) VH koja sadrži VHCDR1 sekvencu amino kiselina odabranu od SEQ ID NO: 3; VHCDR2 sekvencu amino kiselina SEQ ID NO: 30; i VHCDR3 sekvencu amino kiselina SEQ ID NO: 5; i VL koja sadrži VLCDR1 sekvencu amino kiselina SEQ ID NO: 6, VLCDR2 sekvencu amino kiselina SEQ ID NO: 7, i VLCDR3 sekvencu amino kiselina SEQ ID NO: 8.
2. Molekula antitijela prema zahtjevu 1, pri čemu je spomenuta molekula antitijela humanizirana molekula antitijela i/ili monospecifična molekula antitijela ili bispecifična molekula antitijela.
3. Molekula antitijela prema zahtjevu 1 ili zahtjevu 2, pri čemu je spomenuta molekula antitijela bispecifična molekula antitijela koja ima prvu specifičnost vezanja za TIM-3 i drugu specifičnost vezanja za PD-1, LAG-3, CEACAM-1, CEACAM-5, PD-L1 ili PD-L2; i/ili gdje spomenuta molekula antitijela sadrži antigen vezujući fragment antitijela, antigen vezujuću polovicu antitijela ili antigen vezujući fragment polovice antitijela.
4. Molekula antitijela prema bilo kojem od zahtjeva 1-3, koja je Fab, F(ab')2, Fv ili jednolančani Fv fragment (scFv); ili koja sadrži konstantnu regiju teškog lanca odabranu od IgG1, IgG2, IgG3 i IgG4, ili konstantnu regiju teškog lanca odabranu od IgG1, IgG2, IgG3 i IgG4 i konstantnu regiju lakog lanca odabranu od konstantnih regija lakog lanca kappa ili lambda.
5. Molekula antitijela prema bilo kojem od zahtjeva 1-4, koja sadrži: VH koja sadrži sekvencu amino kiselina odabranu od SEQ ID NO: 1, 16, 26, 32, 36, 44, 48, 52, 60, 68, 72, 76, 80, 84, 92 ili 100, ili koja sadrži sekvencu amino kiselina barem 85 % identičnu s bilo kojom od SEQ ID NOs: 1, 16, 26, 32, 36, 44, 48, 52, 60, 68, 72, 76, 80, 84, 92 ili 100; i/ili VL koja sadrži sekvencu amino kiselina odabranu od SEQ ID NO: 2, 20, 40, 56, 64, 88, 96 ili 104, ili koja sadrži sekvencu amino kiselina barem 85 % identičnu s bilo kojom od SEQ ID NOs: 2, 20, 40, 56, 64, 88, 96 ili 104.
6. Molekula antitijela prema bilo kojem od zahtjeva 1-5, koja sadrži: VH koja sadrži sekvencu amino kiselina odabranu od SEQ ID NO: 1, 16, 26, 32, 36, 44, 48, 52, 60, 68, 72, 76, 80, 84, 92 ili 100; i/ili VL koja sadrži sekvencu amino kiselina odabranu od SEQ ID NO: 2, 20, 40, 56, 64, 88, 96 ili 104.
7. Molekula antitijela prema bilo kojem od zahtjeva 1-6, koja sadrži: teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 18, 121, 28, 34, 38, 116, 46, 50, 54, 62, 70, 74, 78, 82, 86, 94 ili 102; i/ili laki lanac koji sadrži sekvencu amino kiselina odabranu od SEQ ID NO: 22, 42, 58, 66, 90, 98 ili 106.
8. Molekula antitijela prema bilo kojem od zahtjeva 1-6, koja sadrži: (a) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 1 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 2; (b) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 16 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 20; (c) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 26 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 20; (d) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 32 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 20; (e) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 36 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 40; (f) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 44 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 40; (g) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 48 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 40; (h) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 36 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 20; (i) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 16 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 40; (j) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 52 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 56; (k) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 60 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 56; (l) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 52 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 64; (m) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 60 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 64; (n) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 68 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 64; (o) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 72 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 64; (p) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 76 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 56; (q) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 80 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 56; (r) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 68 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 56; (s) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 72 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 56; (t) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 76 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 64; (u) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 80 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 64; (v) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 84 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 88; (w) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 92 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 96; ili (x) VH koja sadrži sekvencu amino kiselina SEQ ID NO: 100 i VL koja sadrži sekvencu amino kiselina SEQ ID NO: 104.
9. Molekula antitijela prema bilo kojem od zahtjeva 1-5, koja sadrži: (a) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 18 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 22; (b) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 28 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 22; (c) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 34 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 22; (d) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 38 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 42; (e) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 46 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 42; (f) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 50 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 42; (g) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 116 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 22; (h) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 121 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 42; (i) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 54 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 58; (j) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 62 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 58; (k) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 54 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 66; (l) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 62 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 66; (m) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 70 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 66; (n) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 74 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 66; (o) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 78 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 58; (p) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 82 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 58; (q) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 70 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 58; (r) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 74 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 58; (s) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 78 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 66; (t) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 82 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 66; (u) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 86 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 90; (v) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 94 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 98; ili (w) teški lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 102 i laki lanac koji sadrži sekvencu amino kiselina SEQ ID NO: 106.
10. Molekula antitijela prema bilo kojem od zahtjeva 1 do 9, koja sadrži: (a) humanu IgG4 konstantnu regiju teškog lanca s mutacijom na poziciji 228 prema EU numeraciji ili poziciji 108 SEQ ID NO:108 ili 110 i kappa konstantnu regiju lakog lanca; (b) humanu IgG4 konstantnu regiju teškog lanca sa Serin na Prolin mutacijom na poziciji 228 prema EU numeraciji ili poziciji 108 SEQ ID NO:108 ili 110 i kappa konstantnu regiju lakog lanca; (c) humanu IgG1 konstantnu regiju teškog lanca s Asparagin na Alanin mutacijom na poziciji 297 prema EU numeraciji ili poziciji 180 SEQ ID NO:112 i kappa konstantnu regiju lakog lanca; (d) humanu IgG1 konstantnu regiju teškog lanca s Aspartat na Alanin mutacijom na poziciji 265 prema EU numeraciji ili poziciji 148 SEQ ID NO:113 i Prolin na Alanin mutaciju na poziciji 329 prema EU numeraciji ili poziciji 212 SEQ ID NO: 113, i kappa konstantnu regiju lakog lanca; ili (e) humanu IgG1 konstantnu regiju teškog lanca s Leucin na Alanin mutacijom na poziciji 234 prema EU numeraciji ili poziciji 117 SEQ ID NO:114 i Leucin na Alanin mutaciju na poziciji 235 prema EU numeraciji ili poziciji 118 SEQ ID NO: 114, i kappa konstantnu regiju lakog lanca.
11. Molekula antitijela prema bilo kojem od zahtjeva 1-10, koja ima jedno, dva, tri ili sva od sljedećih svojstava: (a) sposobna je vezati se na humani TIM-3 uz disocijacijsku konstantu (KD) od manje od oko 0,5 nM; (b) sposobna je reducirati: (i) vezanje TIM-3 na fosfatidilserin (PtdSer), HMGB1, CEACAM-1, Semaforin 4-A ili njihovu kombinaciju, ili stanicu koja izražava PtdSer, HMGB1, CEACAM-1, Semaforin 4-A ili njihovu kombinaciju; ili (ii) penetraciju membrane TIM-3 posredovanu PtdSer-om; (c) sposobna je poboljšati antigen-specifični odziv T stanice; ilI (d) veže IgV domenu ili TIM-3.
12. Farmaceutski sastav koji sadrži molekulu antitijela prema bilo kojem od zahtjeva 1-11 i farmaceutski prihvatljivi nosač, ekscipijens ili stabilizator.
13. Izolirana nukleinska kiselina koja šifrira VH i VL molekule antitijela prema bilo kojem od zahtjeva 1-11.
14. Nukleinska kiselina koja šifrira CDRove teškog lanca 1-3 i CDR-ove lakog lanca 1-3 molekule antitijela prema bilo kojem od zahtjeva 1-11.
15. Nukleinska kiselina prema zahtjevu 14, koja sadrži: sekvencu nukleotida koja šifrira VH, pri čemu spomenuta sekvenca nukleotida sadrži SEQ ID NO: 11, 17, 29, 33, 37, 45, 49, 53, 61, 69, 73, 77, 81, 85, 93, 101, 115 ili 120, ili je barem 85 % identična s bilo kojom od SEQ ID NO: 11, 17, 29, 33, 37, 45, 49, 53, 61, 69, 73, 77, 81, 85, 93, 101, 115 ili 120; i: sekvencu nukleotida koja šifrira VL, pri čemu spomenuta sekvenca nukleotida sadrži SEQ ID NO: 15, 21, 41, 57, 65, 89, 97, 105, 118, 123, 125 ili 127, ili je barem 85 % identična s bilo kojom od SEQ ID NO: 15, 21, 41, 57, 65, 89, 97, 105, 118, 123, 125 ili 127.
16. Nukleinska kiselina prema zahtjevu 14 ili zahtjevu 15, koja sadrži sekvencu nukleotida koja šifrira teški lanac, pri čemu spomenuta sekvenca nukleotida sadrži bilo koju od SEQ ID NO: 19, 29, 35, 39, 47, 51, 55, 63, 71, 75, 79, 83, 87, 95, 103, 117 ili 122, ili je barem 85 % identična sa bilo kojom od SEQ ID NO: 19, 29, 35, 39, 47, 51, 55, 63, 71, 75, 79, 83, 87, 95, 103, 117 ili 122; i sekvencu nukleotida koja šifrira laki lanac, pri čemu spomenuta sekvenca nukleotida sadrži bilo koju od SEQ ID NO: 23, 43, 59, 67, 91, 99, 107, 119, 124, 126, 128, ili je barem 85 % identična sa bilo kojom od SEQ ID NO: 23, 43, 59, 67, 91, 99, 107, 119, 124, 126, 128.
17. Ekspresijski vektor koji sadrži nukleinsku kiselinu prema bilo kojem od zahtjeva 13-16.
18. Stanica domaćina koja sadrži nukleinsku kiselinu prema bilo kojem od zahtjeva 13-16.
19. Postupak proizvodnje molekule antitijela ili fragmenta iste, koji sadrži kultiviranje stanice domaćina prema zahtjevu 18 pri uvjetima prikladnim za ekspresiju gena.
20. Postupak detektiranja TIM-3 u biološkom uzorku, koji sadrži (i) kontaktiranje uzorka ili subjekta s molekulom antitijela prema bilo kojem od zahtjeva 1-11 pri uvjetima koji dozvoljavaju da se dogodi interakcija molekule antitijela i polipeptida, te (ii) detektiranje formiranja kompleksa između molekule antitijela i uzorka ili subjekta.
21. Postupak detektiranja TIM-3 u biološkom uzorku prema zahtjevu 20, pri čemu korak (i) dodatno sadrži kontaktiranje referentnog uzorka ili subjekta s molekulom antitijela prema bilo kojem od zahtjeva 1-11 pri uvjetima koji dozvoljavaju da se dogodi interakcija molekule antitijela i polipeptida, te korak (ii) dodatno sadrži detektiranje formiranja kompleksa između molekule antitijela i referentnog uzorka ili subjekta.
22. Molekula antitijela prema bilo kojem od zahtjeva 1-11, ili farmaceutski sastav prema zahtjevu 12, za uporabu u postupku stimuliranja imunog odziva ili liječenju raka ili zarazne bolesti u subjektu.
23. Molekula antitijela, ili farmaceutski sastav, za uporabu prema zahtjevu 22, pri čemu subjekt ima, ili mu je identificirano da ima, jedno ili više od: (a) rak koji izražava TIM-3; (b) rak koji je pozitivan na jedno, dvoje ili sve od PD-L1, CD8 ili IFN-γ; (c) rak koji je trostruko pozitivan na PD-L1, CD8 i IFN- γ; ili (d) rak koji je pozitivan na Tumor Infiltrirajući Limfocit (TIL).
24. Molekula antitijela, ili farmaceutski sastav, za uporabu prema zahtjevu 22 ili 23, pri čemu: molekula antitijela je primijenjena u dozi od oko 1 do 30 mg/kg ili 1 do 5 mg/kg; molekula antitijela je primijenjena jednom tjedno do jednom svaka 2, 3, ili 4 tjedna; ili molekula antitijela je primijenjena u dozi od oko 10 do 20 mg/kg svaki drugi tjedan.
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