HRP20221135T1 - KOMBINACIJE mRNK KOJE KODIRAJU IMUNOMODULIRAJUĆE POLIPEPTIDE I NJIHOVE UPOTREBE - Google Patents
KOMBINACIJE mRNK KOJE KODIRAJU IMUNOMODULIRAJUĆE POLIPEPTIDE I NJIHOVE UPOTREBE Download PDFInfo
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- HRP20221135T1 HRP20221135T1 HRP20221135TT HRP20221135T HRP20221135T1 HR P20221135 T1 HRP20221135 T1 HR P20221135T1 HR P20221135T T HRP20221135T T HR P20221135TT HR P20221135 T HRP20221135 T HR P20221135T HR P20221135 T1 HRP20221135 T1 HR P20221135T1
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- Croatia
- Prior art keywords
- combination
- mrna
- polypeptide
- seq
- nucleotide sequence
- Prior art date
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- 229920001184 polypeptide Polymers 0.000 title claims 9
- 102000004196 processed proteins & peptides Human genes 0.000 title claims 9
- 108090000765 processed proteins & peptides Proteins 0.000 title claims 9
- 230000002519 immonomodulatory effect Effects 0.000 title 1
- 108020004999 messenger RNA Proteins 0.000 claims 38
- 239000002773 nucleotide Substances 0.000 claims 15
- 125000003729 nucleotide group Chemical group 0.000 claims 15
- 238000000034 method Methods 0.000 claims 14
- 206010028980 Neoplasm Diseases 0.000 claims 8
- 102000004473 OX40 Ligand Human genes 0.000 claims 8
- 108010042215 OX40 Ligand Proteins 0.000 claims 8
- 102000013264 Interleukin-23 Human genes 0.000 claims 7
- 108010065637 Interleukin-23 Proteins 0.000 claims 7
- 210000001744 T-lymphocyte Anatomy 0.000 claims 6
- 150000002632 lipids Chemical class 0.000 claims 5
- 108091033319 polynucleotide Proteins 0.000 claims 5
- 239000002157 polynucleotide Substances 0.000 claims 5
- 102000040430 polynucleotide Human genes 0.000 claims 5
- 125000003275 alpha amino acid group Chemical group 0.000 claims 4
- 108091051828 miR-122 stem-loop Proteins 0.000 claims 4
- 239000002105 nanoparticle Substances 0.000 claims 4
- UVBYMVOUBXYSFV-XUTVFYLZSA-N 1-methylpseudouridine Chemical compound O=C1NC(=O)N(C)C=C1[C@H]1[C@H](O)[C@H](O)[C@@H](CO)O1 UVBYMVOUBXYSFV-XUTVFYLZSA-N 0.000 claims 3
- 229940076838 Immune checkpoint inhibitor Drugs 0.000 claims 3
- 102000014158 Interleukin-12 Subunit p40 Human genes 0.000 claims 3
- 108010011429 Interleukin-12 Subunit p40 Proteins 0.000 claims 3
- 108010076561 Interleukin-23 Subunit p19 Proteins 0.000 claims 3
- -1 amino lipid Chemical class 0.000 claims 3
- 201000011510 cancer Diseases 0.000 claims 3
- 210000004443 dendritic cell Anatomy 0.000 claims 3
- 239000012274 immune-checkpoint protein inhibitor Substances 0.000 claims 3
- 230000006698 induction Effects 0.000 claims 3
- 210000003071 memory t lymphocyte Anatomy 0.000 claims 3
- 108091066112 miR-122-1 stem-loop Proteins 0.000 claims 3
- 108091057488 miR-122-2 stem-loop Proteins 0.000 claims 3
- 108091070501 miRNA Proteins 0.000 claims 3
- 210000000822 natural killer cell Anatomy 0.000 claims 3
- 239000002777 nucleoside Substances 0.000 claims 3
- 150000003833 nucleoside derivatives Chemical class 0.000 claims 3
- 230000001737 promoting effect Effects 0.000 claims 3
- 230000000638 stimulation Effects 0.000 claims 3
- 108020005345 3' Untranslated Regions Proteins 0.000 claims 2
- 230000006052 T cell proliferation Effects 0.000 claims 2
- 230000005867 T cell response Effects 0.000 claims 2
- 230000004913 activation Effects 0.000 claims 2
- 239000000427 antigen Substances 0.000 claims 2
- 102000036639 antigens Human genes 0.000 claims 2
- 108091007433 antigens Proteins 0.000 claims 2
- 239000012636 effector Substances 0.000 claims 2
- 230000000694 effects Effects 0.000 claims 2
- 230000002708 enhancing effect Effects 0.000 claims 2
- 125000003630 glycyl group Chemical group [H]N([H])C([H])([H])C(*)=O 0.000 claims 2
- 230000006872 improvement Effects 0.000 claims 2
- 230000002401 inhibitory effect Effects 0.000 claims 2
- 238000002360 preparation method Methods 0.000 claims 2
- 230000008569 process Effects 0.000 claims 2
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- ZXIATBNUWJBBGT-JXOAFFINSA-N 5-methoxyuridine Chemical compound O=C1NC(=O)C(OC)=CN1[C@H]1[C@H](O)[C@H](O)[C@@H](CO)O1 ZXIATBNUWJBBGT-JXOAFFINSA-N 0.000 claims 1
- LRSASMSXMSNRBT-UHFFFAOYSA-N 5-methylcytosine Chemical compound CC1=CNC(=O)N=C1N LRSASMSXMSNRBT-UHFFFAOYSA-N 0.000 claims 1
- 102100023990 60S ribosomal protein L17 Human genes 0.000 claims 1
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- 101001117317 Homo sapiens Programmed cell death 1 ligand 1 Proteins 0.000 claims 1
- 108091007780 MiR-122 Proteins 0.000 claims 1
- 108700011259 MicroRNAs Proteins 0.000 claims 1
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- 102100024216 Programmed cell death 1 ligand 1 Human genes 0.000 claims 1
- 101710089372 Programmed cell death protein 1 Proteins 0.000 claims 1
- 229930185560 Pseudouridine Natural products 0.000 claims 1
- PTJWIQPHWPFNBW-UHFFFAOYSA-N Pseudouridine C Natural products OC1C(O)C(CO)OC1C1=CNC(=O)NC1=O PTJWIQPHWPFNBW-UHFFFAOYSA-N 0.000 claims 1
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- LNUFLCYMSVYYNW-ZPJMAFJPSA-N [(2r,3r,4s,5r,6r)-2-[(2r,3r,4s,5r,6r)-6-[(2r,3r,4s,5r,6r)-6-[(2r,3r,4s,5r,6r)-6-[[(3s,5s,8r,9s,10s,13r,14s,17r)-10,13-dimethyl-17-[(2r)-6-methylheptan-2-yl]-2,3,4,5,6,7,8,9,11,12,14,15,16,17-tetradecahydro-1h-cyclopenta[a]phenanthren-3-yl]oxy]-4,5-disulfo Chemical compound O([C@@H]1[C@@H](COS(O)(=O)=O)O[C@@H]([C@@H]([C@H]1OS(O)(=O)=O)OS(O)(=O)=O)O[C@@H]1[C@@H](COS(O)(=O)=O)O[C@@H]([C@@H]([C@H]1OS(O)(=O)=O)OS(O)(=O)=O)O[C@@H]1[C@@H](COS(O)(=O)=O)O[C@H]([C@@H]([C@H]1OS(O)(=O)=O)OS(O)(=O)=O)O[C@@H]1C[C@@H]2CC[C@H]3[C@@H]4CC[C@@H]([C@]4(CC[C@@H]3[C@@]2(C)CC1)C)[C@H](C)CCCC(C)C)[C@H]1O[C@H](COS(O)(=O)=O)[C@@H](OS(O)(=O)=O)[C@H](OS(O)(=O)=O)[C@H]1OS(O)(=O)=O LNUFLCYMSVYYNW-ZPJMAFJPSA-N 0.000 claims 1
- 230000014102 antigen processing and presentation of exogenous peptide antigen via MHC class I Effects 0.000 claims 1
- 230000005975 antitumor immune response Effects 0.000 claims 1
- 229960003852 atezolizumab Drugs 0.000 claims 1
- 229950002916 avelumab Drugs 0.000 claims 1
- WGDUUQDYDIIBKT-UHFFFAOYSA-N beta-Pseudouridine Natural products OC1OC(CN2C=CC(=O)NC2=O)C(O)C1O WGDUUQDYDIIBKT-UHFFFAOYSA-N 0.000 claims 1
- 210000004027 cell Anatomy 0.000 claims 1
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- 239000012634 fragment Substances 0.000 claims 1
- 230000006870 function Effects 0.000 claims 1
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- 230000008595 infiltration Effects 0.000 claims 1
- 238000001764 infiltration Methods 0.000 claims 1
- 239000003112 inhibitor Substances 0.000 claims 1
- 230000002601 intratumoral effect Effects 0.000 claims 1
- 229960005386 ipilimumab Drugs 0.000 claims 1
- 238000012423 maintenance Methods 0.000 claims 1
- 238000004519 manufacturing process Methods 0.000 claims 1
- 230000035800 maturation Effects 0.000 claims 1
- 239000002679 microRNA Substances 0.000 claims 1
- 229960003301 nivolumab Drugs 0.000 claims 1
- 229960002621 pembrolizumab Drugs 0.000 claims 1
- 150000003904 phospholipids Chemical class 0.000 claims 1
- PTJWIQPHWPFNBW-GBNDHIKLSA-N pseudouridine Chemical compound O[C@@H]1[C@H](O)[C@@H](CO)O[C@H]1C1=CNC(=O)NC1=O PTJWIQPHWPFNBW-GBNDHIKLSA-N 0.000 claims 1
- 150000003432 sterols Chemical class 0.000 claims 1
- 235000003702 sterols Nutrition 0.000 claims 1
- 229950007217 tremelimumab Drugs 0.000 claims 1
Classifications
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Claims (17)
1. mRNK koja kodira IL-23 polipeptid za upotrebu u postupku liječenja raka, naznačena time što je liječenje u kombinaciji s mRNK koja kodira IL-36-gama polipeptid.
2. mRNK koja kodira IL-36-gama polipeptid za upotrebu u postupku liječenja raka, naznačena time što je liječenje u kombinaciji s mRNK koja kodira IL-23 polipeptid.
3. Kombinacija mRNK, naznačena time što prva mRNK kodira IL-23 polipeptid i druga mRNK kodira IL-36-gama polipeptid.
4. Kombinacija mRNK prema zahtjevu 3, naznačena time što nadalje sadrži mRNK koja kodira polipeptid OX40L.
5. Kombinacija mRNK kako je definirana u zahtjevu 3 ili 4, naznačena time što je za upotrebu u postupku liječenja raka.
6. mRNK za upotrebu prema zahtjevu 1 ili 2 ili kombinacija za upotrebu prema zahtjevu 5, naznačena time što liječenje nadalje obuhvaća davanje mRNK koja kodira polipeptid OX40L.
7. mRNK za upotrebu, kombinacija ili kombinacija za upotrebu prema bilo kojem prethodnom zahtjevu, naznačena time što liječenje i/ili kombinacija dalje sadrži polipeptid inhibitora kontrolne točke ili mRNK koja kodira polipeptid inhibitora kontrolne točke, pri čemu je po izboru polipeptid inhibitora kontrolne točke anti-PD-1 protutijelo, anti-PDL-1 protutijelo, anti-CTLA4, ili fragment koji veže antigen takvog protutijela koje specifično veže PD-1, PD-L1, ili CTLA4, ili njihovu kombinaciju, dalje po izboru pri čemu je polipeptid inhibitora kontrolne točke odabran između anti-PD1 protutijela nivolumaba ili pembrolizumaba, između anti-PD1-L1 protutijela atezolizumaba, avelumaba, durvalumaba ili između anti-CTLA-4 protutijela tremelimumaba ili ipilimumaba, ili njihove kombinacije.
8. mRNK za upotrebu, kombinacija ili kombinacija za upotrebu prema bilo kojem prethodnom zahtjevu, naznačena time što je najmanje jedna od mRNK formulirana da bude inkapsulirana u nanočestici lipida.
9. mRNK za upotrebu, kombinacija ili kombinacija za upotrebu prema zahtjevu 8, naznačena time što lipidna nanočestica sadrži ionizirajući aminolipid, pri čemu izborno lipidna nanočestica ima molarni omjer od 20-60% ionizirajućeg aminolipida; 5-25% fosfolipida: 25-55% sterola; i 0,5-15% PEG-modificiranog lipida; i/ili izborno ionizirajući amino lipid je spoj 18:
[image]
10. mRNK za upotrebu, kombinacija ili kombinacija za upotrebu prema bilo kojem prethodnom zahtjevu, naznačena time što su najmanje dvije mRNK formulirane u odvojenim pripravcima.
11. mRNK za upotrebu, kombinacija ili kombinacija za upotrebu prema bilo kojem prethodnom zahtjevu, naznačena time što su sve mRNK formulirane tako da budu inkapsulirane u istoj lipidnoj nanočestici.
12. mRNK za upotrebu ili kombinacija za upotrebu prema bilo kojem od zahtjeva 1, 2, ili 5-10, naznačena time što postupak obuhvaća odvojenu primjenu jedne ili više mRNK istovremeno ili uzastopno.
13. mRNK za upotrebu, kombinacija ili kombinacija za upotrebu prema bilo kojem prethodnom zahtjevu, naznačena time što
(a) mRNK koja kodira polipeptid IL-23
(i) kodira oba polipeptid IL-12p40 i polipeptid IL-23p19; i/ili
(ii) kodira polipeptid IL-12p40, polipeptid IL-23p19 i poveznicu operativno smještenu između polipeptida IL-12p40 i polipeptida IL-23p19, pri čemu je po izboru poveznica Gly/Ser poveznica, pri čemu po izboru poveznica Gly/Ser sadrži (GnS)m, pri čemu n je 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, ili 20 i m je 1, 2, 3, 4, 5, 6, 7, 8, 9, 10, 15, ili 20, pri čemu dalje po izboru n je 6 i m je 1, ili dalje po izboru poveznica ima aminokiselinsku sekvencu kao što je prikazano u bilo kojoj od SEQ ID NOs: 136-139; ili
(iii) sadrži nukleotidnu sekvencu koja kodira aminokiselinsku sekvencu prikazanu u ili najmanje 70% ili 80% identičnu sa SEQ ID NOs: 1, 3, 4, 5, ili 140, ili
(iv) sadrži nukleotidnu sekvencu prikazanu u ili najmanje 70% ili 80% identičnu sa SEQ ID NO: 141, ili najmanje 70% ili 80% identičnu sa nukleotidnom sekvencom prikazanom u SEQ ID NO: 141, ili
(v) sadrži nukleotidnu sekvencu prikazanu u ili najmanje 70% ili 80% identičnu sa SEQ ID NO: 142, ili najmanje 70% ili 80% identičnu sa nukleotidnom sekvencom prikazanom u SEQ ID NO: 142; i/ili
(b) mRNK koja kodira IL-36-gama polipeptid
(i) sadrži nukleotidnu sekvencu koja kodira aminokiselinsku sekvencu prikazanu u ili najmanje 70% ili 80% identičnu sa SEQ ID NOs: 10, 12 ili 16, ili
(ii) sadrži nukleotidnu sekvencu prikazanu u ili najmanje 70% ili 80% identičnu sa SEQ ID NO: 143, ili najmanje 70% ili 80% identičnu sa nukleotidnom sekvencom prikazanom u SEQ ID NO: 143, ili
(iii) sadrži nukleotidnu sekvencu prikazanu u ili najmanje 70% ili 80% identičnu sa SEQ ID NO: 144, ili najmanje 70% ili 80% identičnu sa nukleotidnom sekvencom prikazanom u SEQ ID NO: 144.
14. mRNK za upotrebu, kombinacija ili kombinacija za upotrebu prema bilo kojem od zahtjeva 4-13, naznačena time što mRNK koja kodira polipeptid OX40L
(i) sadrži nukleotidnu sekvencu koja kodira aminokiselinsku sekvencu prikazanu u ili najmanje 70% ili 80% identičnu sa SEQ ID NOs: 2 i 21, ili
(ii) sadrži nukleotidnu sekvencu prikazanu u ili najmanje 70% ili 80% identičnu sa SEQ ID NO: 145, ili najmanje 70% ili 80% identičnu sa nukleotidnom sekvencom prikazanom u SEQ ID NO: 145, ili
(iii) sadrži nukleotidnu sekvencu prikazanu u ili najmanje 70% ili 80% identičnu sa SEQ ID NO: 146, ili najmanje 70% ili 80% identičnu sa nukleotidnom sekvencom prikazanom u SEQ ID NO: 146.
15. mRNK za upotrebu, kombinacija ili kombinacija za upotrebu prema bilo kojem prethodnom zahtjevu, naznačena time što bilo koja od navedenih mRNK nadalje sadrži jedno ili više mjesta vezanja mikroRNK (miR), pri čemu po izboru
(a) jedno ili više navedenih mjesta vezanja miR nalazi se u 3' UTR; i/ili
(b) jedno ili više navedenih mjesta vezanja miR je mjesto vezanja miR-122, dalje po izboru mjesto vezanja miR-122-3p, mjesto vezanja miR-122-5p ili oboje; i/ili
(c) mRNK sadrži 3' UTR koji sadrži najmanje jedno mjesto vezanja miR-122-5p.
16. mRNK za upotrebu, kombinacija ili kombinacija za upotrebu prema bilo kojem prethodnom zahtjevu, naznačena time što jedna ili više mRNK sadrži najmanje jedan kemijski modificirani nukleozid, po izboru gdje je najmanje jedan kemijski modificirani nukleozid odabran iz skupine koja sadrži pseudouridin, N1-metilpseudouridin, 5-metilcitozin, 5-metoksiuridin i njihovu kombinaciju, nadalje po izboru pri čemu je najmanje jedan kemijski modificirani nukleozid N1-metilpseudouridin, nadalje po izboru pri čemu je mRNK potpuno modificirana N1-metilpseudouridin mRNK.
17. mRNK za upotrebu ili kombinacija za upotrebu prema bilo kojem od zahtjeva 1, 2 ili 5-15, naznačena time što
(a) postupak je postupak smanjenja ili smanjenja veličine tumora ili inhibicije rasta tumora; i/ili
(b) postupak je postupak indukcije T-stanične proliferacije, indukcije T-stanične infiltracije u tumoru, indukcije memorijskog T-staničnog odgovora, povećanja broja NK stanica; i/ili
(c) postupak je postupak
(i) pripremanja dendritičnih stanica;
(ii) poticanja sazrijevanja dendritičnih stanica;
(iii) poticanja proizvodnje staničnih citokina i/ili kemokina koji predstavljaju antigen;
(iv) ekspanzije ili održavanja Th17 stanica;
(v) pojačavanja diferencijacije Th1 i/ili Th9; i
(vi) bilo koja kombinacija (c)(i)-(v);
(d) postupak je postupak aktivacije, stimulacije, promicanja ili poboljšanja proliferacije T stanica, preživljavanja T stanica, regrutiranja T stanica ili njihova kombinacija; i/ili
(e) postupak je postupak aktivacije, stimulacije, poticanja ili poboljšanja proliferacije NK stanica, preživljavanja NK stanica, regrutiranja NK stanica ili njihova kombinacija;
(f) postupak je postupak
(i) promicanja ili pojačavanja ekspanzije i/ili funkcije T stanica;
(ii) promicanja ili pospješivanja razvoja Th1, Th2 i/ili Th9 stanica;
(iii) inhibiranja ili suzbijanja razvoja i/ili aktivnosti Treg;
(iv) promicanja ili poboljšanja razvoja i/ili aktivnosti memorijskih stanica; i
(v) bilo koja kombinacija (f)(i)-(iv);
(g) davanje mRNK ili kombinacije subjektu rezultira (i) povećanjem razine granulocita u jednom ili više uzoraka dobivenih od subjekta u odnosu na graničnu razinu ili u odnosu na razinu nakon primjene jednog polinukleotida koji kodira IL-23, IL-36-gama, ili polipeptid OX40L; (ii) povećanjem razine unakrsne prezentacije dendritičnih stanica u jednom ili više uzoraka dobivenih od subjekta u odnosu na razinu praga ili u odnosu na razinu nakon primjene jednog polinukleotida koji kodira IL-23, IL-36-gama, ili polipeptid OX40L; (iii) povećanjem omjera efektora i supresora T stanica u jednom ili više uzoraka dobivenih od subjekta u odnosu na razinu praga ili u odnosu na omjer nakon primjene jednog polinukleotida koji kodira polipeptid OX40L; (iv) povećanjem razine efektorskih memorijskih T stanica u jednom ili više uzoraka dobivenih od subjekta u odnosu na razinu praga ili u odnosu na razinu nakon primjene jednog polinukleotida koji kodira polipeptid OX40L; (v) povećanjem razine ekspresije PDL1 u jednom ili više uzoraka dobivenih od subjekta u odnosu na razinu praga ili u odnosu na razinu nakon primjene jednog polinukleotida koji kodira IL-23, IL-36-gama ili polipeptid OX40L; ili (vi) njihovom kombinacijom; i/ili
(h) jednim ili više od (i) infiltracijom T stanica u tumoru subjekta, (ii) infiltracijom T stanica u tumoru subjekta; i/ili (iii) odgovor memorijskih T stanica kod subjekta je/ili je usmjeren na antitumorski imunološki odgovor; i/ili (i) postupak obuhvaća intratumorsko davanje jedne ili više navedenih mRNK.
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