HRP20220131T1 - Nova terapija s t-staničnim receptorima i imunološka terapija koja koristi iste - Google Patents

Nova terapija s t-staničnim receptorima i imunološka terapija koja koristi iste Download PDF

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HRP20220131T1
HRP20220131T1 HRP20220131TT HRP20220131T HRP20220131T1 HR P20220131 T1 HRP20220131 T1 HR P20220131T1 HR P20220131T T HRP20220131T T HR P20220131TT HR P20220131 T HRP20220131 T HR P20220131T HR P20220131 T1 HRP20220131 T1 HR P20220131T1
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Croatia
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antigen recognition
construct
seq
amino acid
cancer
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HRP20220131TT
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Leonie ALTEN
Sebastian Bunk
Dominik Maurer
Claudia Wagner
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Immatics Biotechnologies Gmbh
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Priority claimed from DE102016123847.3A external-priority patent/DE102016123847B3/de
Application filed by Immatics Biotechnologies Gmbh filed Critical Immatics Biotechnologies Gmbh
Publication of HRP20220131T1 publication Critical patent/HRP20220131T1/hr
Publication of HRP20220131T8 publication Critical patent/HRP20220131T8/hr

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Claims (19)

1. Konstrukt za prepoznavanje antigena koji se specifično i / ili selektivno veže na antigeni peptid MAGEA1 od SEQ ID BR: 133 kada je navedeni antigen predstavljen putem HLA, pri čemu navedeni konstrukt za prepoznavanje antigena sadrži komplementarne određujuće regije (CDR) CDR1, CDR2 i CDR3 sekvence koje imaju aminokiselinsku sekvencu SEQ ID BR: 49, SEQ ID BR: 50 i SEQ ID BR: 51, odnosno CDR1, CDR2 i CDR3 sekvence koje imaju aminokiselinsku sekvencu SEQ ID BR: 55, SEQ ID BR: 56 i SEQ ID BR: 57, odnosno; pri čemu navedeni konstrukt za prepoznavanje antigena sadrži odgovarajuće CDR aminokiselinske sekvence s ne više od jedne modificirane aminokiseline, pri čemu je spomenuta modificirana aminokiselina po mogućnosti prva ili posljednja aminokiselina dotičnog CDR-a i modifikacija je konzervativna supstitucija, i pri čemu je spomenuti antigen konstrukt koji prepoznaje ne veže selektivno nijedan od peptida SEQ ID BR: 143 do 152.
2. Konstrukt za prepoznavanje antigena koji se specifično i / ili selektivno veže na antigeni peptid MAGEA1 od SEQ ID BR: 133 kada je navedeni antigen predstavljen putem HLA, pri čemu je navedeni konstrukt za prepoznavanje antigena T-stanični receptor (TCR) ili njegov fragment i sadrži komplementarne određujuće regije (CDR) CDR1, CDR2 i CDR3 sekvence koje imaju aminokiselinsku sekvencu SEQ ID BR: 49 i SEQ ID BR: 51, odnosno CDR1 i CDR3 sekvence koje imaju aminokiselinsku sekvencu SEQ ID BR: 55 i SEQ ID BR: 57, odnosno; pri čemu navedeni konstrukt za prepoznavanje antigena sadrži odgovarajuće CDR aminokiselinske sekvence s ne više od jedne modificirane aminokiseline, pri čemu je spomenuta modificirana aminokiselina po mogućnosti prva ili posljednja aminokiselina dotičnog CDR-a i modifikacija je konzervativna supstitucija, i pri čemu je spomenuti antigen konstrukt koji prepoznaje ne veže selektivno nijedan od peptida SEQ ID BR: 143 do 152.
3. Konstrukt za prepoznavanje antigena prema zahtjevu 2, pri čemu navedeni konstrukt za prepoznavanje antigena nadalje sadrži CDR2 koje imaju aminokiselinsku sekvencu SEQ ID BR: 50 i CDR2 koje imaju aminokiselinsku sekvencu SEQ ID BR: 56.
4. Konstrukt za prepoznavanje antigena u skladu s bilo kojim od patentnih zahtjeva 1 do 3, pri čemu je konstrukt za prepoznavanje antigena antitijelo, ili njegov derivat ili fragment, ili αβ T-stanični receptor (TCR), ili njegov derivat ili fragment; ili γδ TCR ili njegov derivat ili fragment.
5. Konstrukt za prepoznavanje antigena prema zahtjevu 4, pri čemu je navedeno antitijelo bispecifično antitijelo.
6. Konstrukt za prepoznavanje antigena u skladu s patentnim zahtjevom 2 ili 4, pri čemu je navedeni TCR s jednim lancem (scTCR) i/ili topivi TCR.
7. Konstrukt za prepoznavanje antigena prema bilo kojem od zahtjeva 1 do 6, koji sadrži TCR varijabilnu regiju lanca koja ima najmanje 90%, poželjno 95%, identičnost sekvence sa sekvencijom aminokiselina odabranom između SEQ ID BR. 52 i 58.
8. Konstrukt za prepoznavanje antigena u skladu s bilo kojim od patentnih zahtjeva 1 do 7, pri čemu je konstrukt za prepoznavanje antigena TCR ili njegov fragment, koji sadrži najmanje jednu sekvencu TCR α i jednu TCR β lančanu sekvencu, pri čemu navedena sekvenca lanca TCR α sadrži varijabilnu regiju sekvenca koja ima aminokiselinsku sekvencu SEQ ID br. 52, i gdje navedena sekvenca TCR β lanca sadrži sekvencu varijabilne regije koja ima sekvencu aminokiselina SEQ ID br. 58.
9. Nukleinska kiselina koja kodira konstrukt za prepoznavanje antigena prema bilo kojem od zahtjeva 1 do 8.
10. Vektor koji sadrži nukleinsku kiselinu prema zahtjevu 9.
11. Stanica domaćin koja sadrži konstrukt za prepoznavanje antigena prema bilo kojem od zahtjeva 1 do 8, ili nukleinsku kiselinu prema zahtjevu 9, ili vektor prema zahtjevu 10, prema potrebi, stanica domaćin je limfocit, po mogućnosti T limfocit ili T limfocit rodonačelnik, po mogućnosti CD4 ili CD8 pozitivne T-stanice.
12. Farmaceutski pripravak, koji sadrži konstrukt za prepoznavanje antigena prema bilo kojem zahtjevu od 1 do 8, ili nukleinsku kiselinu prema zahtjevu 9, ili vektor prema zahtjevu 10, ili stanicu domaćina prema zahtjevu 11, i farmaceutski prihvatljiv nosač, stabilizator i / ili pomoćne tvari.
13. Konstrukt za prepoznavanje antigena prema bilo kojem od zahtjeva 1 do 8, ili nukleinska kiselina prema zahtjevu 9, ili vektor prema zahtjevu 10, ili stanica domaćin prema zahtjevu 11, ili farmaceutski pripravak prema zahtjevu 12, za uporaba u medicini, po potrebi za upotrebu u dijagnozi, prevenciji i / ili liječenju proliferativne bolesti.
14. Konstrukt koji prepoznaje antigen, nukleinska kiselina, vektor ili stanica domaćin, ili farmaceutski pripravak, za upotrebu u skladu s patentnim zahtjevom 13, pri čemu je proliferativna bolest rak, kao što je rak pluća nemalih stanica, rak pluća malih stanica, rak bubrežnih stanica, rak mozga, rak želuca, kolorektalni rak, hepatocelularni rak, rak glave i vrata, rak gušterače, rak prostate, leukemija, rak dojke, karcinom Merkelovih stanica, melanom, rak jajnika, rak mokraćnog mjehura, rak maternice, žučnog mjehura i rak žučnih kanala, rak jednjaka ili njihova kombinacija.
15. Konstrukt za prepoznavanje antigena, nukleinska kiselina, vektor ili stanica domaćin ili farmaceutski pripravak za upotrebu prema zahtjevu 13 ili 14, naznačen time, da konstrukt za prepoznavanje antigena prema bilo kojem od zahtjeva 1 do 8, ili nukleinska kiselina prema zahtjevu 9, ili vektor prema zahtjevu 10, ili stanica domaćin prema zahtjevu 11, ili farmaceutski pripravak prema zahtjevu 12 je imunoterapeutski spoj.
16. Konstrukt koji prepoznaje antigen, nukleinska kiselina, vektor ili stanica domaćin, ili farmaceutski pripravak, za upotrebu u skladu s bilo kojim od patentnih zahtjeva 13 do 15, pri čemu navedena upotreba uključuje prijenos adaptivnih imunoloških stanica na pacijenta kojem je potrebno liječenje , kao što je heterologni ili autologni prijenos T stanica.
17. Postupak proizvodnje konstrukta za prepoznavanje antigena MAGEA1 koji eksprimira staničnu liniju, pri čemu sadrži a) pružanje prikladne stanice domaćina, b) osiguravanje genetskog konstrukta koji sadrži kodirajuću sekvencu koja kodira konstrukt za prepoznavanje antigena prema bilo kojem od zahtjeva 1 do 8, c) uvođenje navedenog genetskog konstrukta u spomenutu prikladnu stanicu domaćina, d) izražavanje navedenog genetskog konstrukta spomenutom prikladnom stanicom domaćina.
18. Postupak prema zahtjevu 17, koji nadalje obuhvaća izolaciju i pročišćavanje konstrukta za prepoznavanje antigena iz prikladne stanice domaćina i, po potrebi, rekonstituciju konstrukta za prepoznavanje antigena u T-stanici.
19. In vitro metoda otkrivanja raka u biološkom uzorku koja uključuje: e) dovođenje u kontakt biološkog uzorka s konstruktom koji prepoznaje antigen prema bilo kojem od zahtjeva 1 do 8, i f) otkrivanje vezanja konstrukta koji prepoznaje antigen na biološki uzorak.
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