HRP20150933T1 - Pripravci antagonista pd-1 i postupci uporabe - Google Patents
Pripravci antagonista pd-1 i postupci uporabe Download PDFInfo
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- HRP20150933T1 HRP20150933T1 HRP20150933TT HRP20150933T HRP20150933T1 HR P20150933 T1 HRP20150933 T1 HR P20150933T1 HR P20150933T T HRP20150933T T HR P20150933TT HR P20150933 T HRP20150933 T HR P20150933T HR P20150933 T1 HRP20150933 T1 HR P20150933T1
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- 238000000034 method Methods 0.000 title claims 10
- 239000000203 mixture Substances 0.000 title claims 4
- 239000005557 antagonist Substances 0.000 title claims 2
- 108700030875 Programmed Cell Death 1 Ligand 2 Proteins 0.000 claims 25
- 108020001507 fusion proteins Proteins 0.000 claims 25
- 102000037865 fusion proteins Human genes 0.000 claims 25
- 108090000765 processed proteins & peptides Proteins 0.000 claims 24
- 101100407308 Mus musculus Pdcd1lg2 gene Proteins 0.000 claims 21
- 102100024213 Programmed cell death 1 ligand 2 Human genes 0.000 claims 21
- CMSMOCZEIVJLDB-UHFFFAOYSA-N Cyclophosphamide Chemical compound ClCCN(CCCl)P1(=O)NCCCO1 CMSMOCZEIVJLDB-UHFFFAOYSA-N 0.000 claims 14
- 125000003275 alpha amino acid group Chemical group 0.000 claims 12
- 239000003795 chemical substances by application Substances 0.000 claims 12
- 230000002708 enhancing effect Effects 0.000 claims 11
- 229960004397 cyclophosphamide Drugs 0.000 claims 10
- 230000005867 T cell response Effects 0.000 claims 9
- 150000001413 amino acids Chemical class 0.000 claims 7
- 239000012634 fragment Substances 0.000 claims 7
- 238000000338 in vitro Methods 0.000 claims 7
- AOJJSUZBOXZQNB-TZSSRYMLSA-N Doxorubicin Chemical compound O([C@H]1C[C@@](O)(CC=2C(O)=C3C(=O)C=4C=CC=C(C=4C(=O)C3=C(O)C=21)OC)C(=O)CO)[C@H]1C[C@H](N)[C@H](O)[C@H](C)O1 AOJJSUZBOXZQNB-TZSSRYMLSA-N 0.000 claims 6
- 102000004196 processed proteins & peptides Human genes 0.000 claims 6
- 206010028980 Neoplasm Diseases 0.000 claims 5
- 201000011510 cancer Diseases 0.000 claims 5
- 108060003951 Immunoglobulin Proteins 0.000 claims 4
- 230000000259 anti-tumor effect Effects 0.000 claims 4
- 102000018358 immunoglobulin Human genes 0.000 claims 4
- 241000282412 Homo Species 0.000 claims 3
- 239000005517 L01XE01 - Imatinib Substances 0.000 claims 3
- 239000002147 L01XE04 - Sunitinib Substances 0.000 claims 3
- -1 anthracyclines Chemical compound 0.000 claims 3
- 229940045799 anthracyclines and related substance Drugs 0.000 claims 3
- 229960004679 doxorubicin Drugs 0.000 claims 3
- 239000003623 enhancer Substances 0.000 claims 3
- 229960002411 imatinib Drugs 0.000 claims 3
- KTUFNOKKBVMGRW-UHFFFAOYSA-N imatinib Chemical compound C1CN(C)CCN1CC1=CC=C(C(=O)NC=2C=C(NC=3N=C(C=CN=3)C=3C=NC=CC=3)C(C)=CC=2)C=C1 KTUFNOKKBVMGRW-UHFFFAOYSA-N 0.000 claims 3
- 229960001756 oxaliplatin Drugs 0.000 claims 3
- DWAFYCQODLXJNR-BNTLRKBRSA-L oxaliplatin Chemical compound O1C(=O)C(=O)O[Pt]11N[C@@H]2CCCC[C@H]2N1 DWAFYCQODLXJNR-BNTLRKBRSA-L 0.000 claims 3
- 229920001184 polypeptide Polymers 0.000 claims 3
- WINHZLLDWRZWRT-ATVHPVEESA-N sunitinib Chemical compound CCN(CC)CCNC(=O)C1=C(C)NC(\C=C/2C3=CC(F)=CC=C3NC\2=O)=C1C WINHZLLDWRZWRT-ATVHPVEESA-N 0.000 claims 3
- 229960001796 sunitinib Drugs 0.000 claims 3
- 101001117312 Homo sapiens Programmed cell death 1 ligand 2 Proteins 0.000 claims 2
- 208000002495 Uterine Neoplasms Diseases 0.000 claims 2
- 208000015181 infectious disease Diseases 0.000 claims 2
- 206010046766 uterine cancer Diseases 0.000 claims 2
- VEEGZPWAAPPXRB-BJMVGYQFSA-N (3e)-3-(1h-imidazol-5-ylmethylidene)-1h-indol-2-one Chemical compound O=C1NC2=CC=CC=C2\C1=C/C1=CN=CN1 VEEGZPWAAPPXRB-BJMVGYQFSA-N 0.000 claims 1
- 229940122815 Aromatase inhibitor Drugs 0.000 claims 1
- 206010005003 Bladder cancer Diseases 0.000 claims 1
- 208000003174 Brain Neoplasms Diseases 0.000 claims 1
- 206010006187 Breast cancer Diseases 0.000 claims 1
- 208000026310 Breast neoplasm Diseases 0.000 claims 1
- 206010009944 Colon cancer Diseases 0.000 claims 1
- 208000035473 Communicable disease Diseases 0.000 claims 1
- 208000000461 Esophageal Neoplasms Diseases 0.000 claims 1
- 208000008839 Kidney Neoplasms Diseases 0.000 claims 1
- 206010058467 Lung neoplasm malignant Diseases 0.000 claims 1
- 208000001894 Nasopharyngeal Neoplasms Diseases 0.000 claims 1
- 206010061306 Nasopharyngeal cancer Diseases 0.000 claims 1
- 206010030155 Oesophageal carcinoma Diseases 0.000 claims 1
- 206010033128 Ovarian cancer Diseases 0.000 claims 1
- 206010061535 Ovarian neoplasm Diseases 0.000 claims 1
- 206010061902 Pancreatic neoplasm Diseases 0.000 claims 1
- 206010060862 Prostate cancer Diseases 0.000 claims 1
- 208000000236 Prostatic Neoplasms Diseases 0.000 claims 1
- 206010038389 Renal cancer Diseases 0.000 claims 1
- 208000000453 Skin Neoplasms Diseases 0.000 claims 1
- 208000005718 Stomach Neoplasms Diseases 0.000 claims 1
- 210000001744 T-lymphocyte Anatomy 0.000 claims 1
- 208000024313 Testicular Neoplasms Diseases 0.000 claims 1
- 206010057644 Testis cancer Diseases 0.000 claims 1
- 208000007097 Urinary Bladder Neoplasms Diseases 0.000 claims 1
- 239000004037 angiogenesis inhibitor Substances 0.000 claims 1
- 229940121369 angiogenesis inhibitor Drugs 0.000 claims 1
- 239000003886 aromatase inhibitor Substances 0.000 claims 1
- 230000001413 cellular effect Effects 0.000 claims 1
- 208000029742 colonic neoplasm Diseases 0.000 claims 1
- 239000000539 dimer Substances 0.000 claims 1
- 201000004101 esophageal cancer Diseases 0.000 claims 1
- 206010017758 gastric cancer Diseases 0.000 claims 1
- 201000005787 hematologic cancer Diseases 0.000 claims 1
- 239000000833 heterodimer Substances 0.000 claims 1
- 239000000710 homodimer Substances 0.000 claims 1
- 239000003112 inhibitor Substances 0.000 claims 1
- 201000010982 kidney cancer Diseases 0.000 claims 1
- 230000021633 leukocyte mediated immunity Effects 0.000 claims 1
- 201000007270 liver cancer Diseases 0.000 claims 1
- 208000014018 liver neoplasm Diseases 0.000 claims 1
- 201000005202 lung cancer Diseases 0.000 claims 1
- 208000020816 lung neoplasm Diseases 0.000 claims 1
- 208000015486 malignant pancreatic neoplasm Diseases 0.000 claims 1
- 230000011278 mitosis Effects 0.000 claims 1
- 239000000178 monomer Substances 0.000 claims 1
- 201000002528 pancreatic cancer Diseases 0.000 claims 1
- 208000008443 pancreatic carcinoma Diseases 0.000 claims 1
- 201000000849 skin cancer Diseases 0.000 claims 1
- 201000011549 stomach cancer Diseases 0.000 claims 1
- 238000006467 substitution reaction Methods 0.000 claims 1
- 201000003120 testicular cancer Diseases 0.000 claims 1
- 201000005112 urinary bladder cancer Diseases 0.000 claims 1
Classifications
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- A—HUMAN NECESSITIES
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/177—Receptors; Cell surface antigens; Cell surface determinants
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/66—Phosphorus compounds
- A61K31/675—Phosphorus compounds having nitrogen as a ring hetero atom, e.g. pyridoxal phosphate
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- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
- A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
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- A—HUMAN NECESSITIES
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
- C07K—PEPTIDES
- C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
- C07K14/70503—Immunoglobulin superfamily
- C07K14/70532—B7 molecules, e.g. CD80, CD86
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- C—CHEMISTRY; METALLURGY
- C07—ORGANIC CHEMISTRY
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- C07K2319/00—Fusion polypeptide
- C07K2319/33—Fusion polypeptide fusions for targeting to specific cell types, e.g. tissue specific targeting, targeting of a bacterial subspecies
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- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
- Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
- Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
- Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change
Claims (30)
1. Pripravak koji sadrži:
fuzijski protein koji sadrži prve i druge dijelove peptida pri čemu navedeni dio prvog peptida sadrži sekvencu aminokiseline odabranu od: divljeg tipa B7-DC, sekvence aminokiseline koja ima najmanje 98% identičnosti sa aminokiselinama 20-221 ili 20-121 iz SEQ ID NO: 1 i koji konkurira in vitro s divljim tipom B7-DC oko vezivanja na PD-1, fragmenta B7-DC koji konkurira in vitro s divljim tipom B7-DC oko vezivanja na PD-1, te izvan staničnu domenu od B7-DC i navedeni dio drugog peptida sadrži dio imunoglobulina (Ig);
za uporabu u postupku povećavanja odgovora T stanica kod čovjeka;
pri čemu je čovjek onaj kojemu se prethodno daje pripravak koji sadrži sredstvo za pojačavanje odabrano iz skupa koji sadrži: ciklofosfamid, analog ciklofosfamida, sunitinib, anti-TGFβ, imatinib, antracikline, oksaliplatin i doksorubicin, te pri čemu doziranje sredstva za pojačavanje ne djeluje izravno na antitumorsku aktivnost;
te pri čemu je odgovor T stanica koji se postiže nakon davanja fuzijskog proteina veći od odgovora T stanica koji se postiže davanjem bilo samog fuzijskog proteina ili samog sredstva za pojačavanje.
2. Pripravak koji sadrži
sredstvo za pojačavanje koje je odabrano iz skupa koji sadrži: ciklofosfamid, analog ciklofosfamida, sunitinib, anti-TGFβ, imatinib, antracikline, oksaliplatin i doksorubicin,
za uporabu u postupku povećanja odgovora T stanica kod čovjeka;
pri čemu doziranje sredstva za pojačavanje ne djeluje izravno na antitumorsku aktivnost;
pri čemu čovjek je onaj kojemu se naknadno treba dati pripravak koji sadrži koji sadrži fuzijski protein koji sadrži dijelove prvog i drugog peptida pri čemu navedeni dio prvog peptida sadrži sekvencu aminokiseline odabranu od: divljeg tipa B7-DC, sekvence aminokiseline koja ima najmanje 98% identičnosti sa aminokiselinama 20-221 ili 20-121 iz SEQ ID NO: 1 i koji konkurira in vitro s divljim tipom B7-DC oko vezivanja na PD-1, fragment B7-DC koji konkurira in vitro s divljim tipom B7-DC oko vezivanja na PD-1, te izvan staničnu domenu od B7-DC i navedeni dio drugog peptida sadrži dio imunoglobulina (Ig),;
te pri čemu je odgovor T stanica koji se postiže nakon davanja fuzijskog proteina veći od odgovora T stanica koji se postiže davanjem bilo samog fuzijskog proteina ili samog sredstva za pojačavanje.
3. Pripravak za uporabu prema zahtjevu 1 ili 2 naznačen time da navedeni dio prvog peptida sadrži divlji tip polipeptida B7-DC.
4. Pripravak za uporabu prema zahtjevu 3 naznačen time da navedeni B7-DC je ljudski B7-DC.
5. Pripravak za uporabu prema zahtjevu 1 ili 2 naznačen time da navedeni dio prvog peptida sadrži fragment B7-DC koji ne sadrži bilo koji dio transmembranskog dijela navedenog polipeptida B7-DC.
6. Pripravak za uporabu prema zahtjevu 5 naznačen time da navedeni dio prvog peptida sadrži topivi dio navedenog polipeptida B7-DC i navedeni dio drugog peptida sadrži Fc regiju protutijela, ali ne sadrži bilo koju varijabilnu regiju navedenog protutijela.
7. Pripravak za uporabu prema zahtjevu 5 ili 6 naznačen time da navedeni dio prvog peptida sadrži sekvencu aminokiseline od SEQ ID NO: 3 i navedeni dio drugog polipeptida sadrži Fc regiju protutijela, ali ne sadrži bilo koju varijabilnu regiju navedenog protutijela.
8. Pripravak za uporabu prema zahtjevu 1 ili 2 naznačen time da navedeni dio prvog peptida sadrži sekvencu aminokiseline koja ima najmanje 98% identičnosti s aminokiselinama 20-221 ili 20-121 iz SEQ ID NO: 1.
9. Pripravak za uporabu prema zahtjevu 8 naznačen time da navedeni dio prvog peptida sadrži sekvencu aminokiseline od aminokiselina 20-221 ili 20-121 iz SEQ ID NO: 1.
10. Pripravak za uporabu prema zahtjevu 1 ili 2 naznačen time da navedeni fuzijski protein sadrži sekvencu aminokiseline koja ima najmanje 95% identičnosti sa sekvencom iz SEQ ID NO: 9, 10, 12 ili 13.
11. Pripravak za uporabu prema zahtjevu 10 naznačen time da navedeni fuzijski protein sadrži sekvencu aminokiseline iz SEQ ID NO: 9, 10, 12, ili 13.
12. Pripravak za uporabu prema bilo kojem prethodnom zahtjevu naznačen time da navedeni fuzijski protein je monomer.
13. Pripravak za uporabu prema bilo koje od zahtjeva 1 do 11 naznačen time da navedeni fuzijski protein tvori dimer.
14. Pripravak za uporabu prema zahtjevu 13 naznačen time da navedeni fuzijski protein tvori homodimer.
15. Pripravak za uporabu prema zahtjevu 13 naznačen time da navedeni fuzijski protein tvori heterodimer.
16. Pripravak za uporabu prema bilo kojem prethodnom zahtjevu naznačen time da navedeno sredstvo za pojačavanje je ciklofosfamid ili analog ciklofosfamida.
17. Pripravak za uporabu prema bilo kojem prethodnom zahtjevu naznačen time da je za uporabu u postupku prema bilo kojem prethodnom zahtjevu pri čemu se navedeno sredstvo za pojačavanje daje najmanje X sati prije davanja navedenog fuzijskog proteina, pri čemu je X odabran od 1, 2, 3, 5, 10, 15, 20, 24 i 30.
18. Pripravak za uporabu prema bilo kojem prethodnom zahtjevu naznačen time da navedeni fuzijski protein sadrži fragment divljeg tipa B7-DC koji konkurira in vitro s divljim tipom B7-DC oko vezivanja na PD-1.
19. Pripravak za uporabu prema zahtjevu 18 naznačen time da navedeni fragment divljeg tipa B7-DC ne sadrži bilo koji dio transmembranskog dijela takvog polipeptida.
20. Pripravak za uporabu prema zahtjevu 18 naznačen time da navedeni B7-DC polipeptid je ljudski polipeptid B7-DC.
21. Pripravak za uporabu prema zahtjevu 1 ili 2 naznačen time da navedeni dio prvog peptida sadrži izvan staničnu domenu B7-DC ili polipeptid koji se od njega razlikuje samo za konzervativne aminokiselinske supstitucije.
22. Pripravak za uporabu prema bilo kojem prethodnom zahtjevu naznačen time da se navedeni fuzijski protein koristi u količini koja je dovoljna za liječenje raka ili infekcije pomoću povećanog imunološkog odgovora posredovanog T stanicama.
23. Pripravak za uporabu prema zahtjevu 1 ili 2 naznačen time da navedeni postupak obuhvaća liječenje raka.
24. Pripravak za uporabu prema zahtjevu 1 ili 2 naznačen time da navedeni postupak obuhvaća liječenje zarazne bolesti.
25. Pripravak za uporabu prema zahtjevu 23 naznačen time da navedeni rak je rak mokraćnog mjehura, rak mozga, rak dojke, rak maternice, rak debelog crijeva, rak jednjaka, rak bubrega, rak jetre, rak pluća, nazofaringealni karcinom, rak gušterače, rak prostate, rak kože, rak želuca, rak maternice, rak jajnika, rak testisa, ili hematološki karcinom.
26. Pripravak za uporabu prema zahtjevu 23 naznačen time da je za uporabu u navedenom postupku pri čemu navedeni postupak dodatno obuhvaća davanje najmanje jednog dodatnog sredstva koje je koje je odabrano iz skupine koja sadrži anti-PD-1 protutijelo, anti-CTLA4 protutijelo, inhibitor mitoze, inhibitor aromataze, antagonist A2AR, te inhibitor angiogeneze s navedenim fuzijskim proteinom.
27. Komplet dijelova koji sadrži:
fuzijski protein koji sadrži dijelove prvog i drugog peptida pri čemu navedeni dio prvog peptida sadrži aminokiseline 20-221 iz SEQ ID NO: 1, te navedeni dio drugog peptida obuhvaća dio imunoglobulina (Ig);
i ciklofosfamid;
naznačen time da je za uporabu u postupku liječenja raka;
pri čemu se navedeni ciklofosfamid se daje prije navedenog fuzijskog proteina i navedeni fuzijski protein se daje bez ciklofosfamida nakon davanja ciklofosfamida;
pri čemu doziranje ciklofosfamida ne djeluje izravno na antitumorsku aktivnost.
28. Pripravak za uporabu prema zahtjevu 27 naznačen time da navedeni dio drugog peptida sadrži aminokiseline 245-476 iz ljudskog IgGI.
29. Pripravak za uporabu prema zahtjevu 27 naznačen time da je za uporabu u postupku prema zahtjevu 27 pri čemu se navedeni ciklofosfamid daje navedenom pacijentu najmanje 24 sata prije davanja fuzijskog proteina.
30. Komplet (kit) dijelova koji sadrži:
fuzijski protein koji sadrži dijelove prvog i drugog peptida pri čemu navedeni dio prvog peptida sadrži sekvencu aminokiseline odabranu od: divljeg tipa B7-DC, sekvence aminokiseline koja ima najmanje 98% identičnosti s aminokiselinama 20-221 ili 20-121 iz SEQ ID NO: 1 i koja se natječe in vitro s divljim tipom B7-DC oko vezivanja na PD-1, fragment B7-DC koji se natječe in vitro s divljim tipom B7-DC oko vezivanja na PD-1, te izvan stanične domene B7-DC i navedeni dio drugog peptida obuhvaća dio imunoglobulina (Ig);
i sredstvo za pojačavanje koje je odabrano iz skupine koja sadrži: ciklofosfamid, analog ciklofosfamida, sunitinib, anti-TGFβ, imatinib, antracikline, oksaliplatin i doksorubicin;
naznačen time da je za uporabu u postupku povećanja odgovora T stanica kod čovjeka;
pri čemu se navedeno sredstvo za pojačavanje daje prije navedenog fuzijskog proteina i navedeni fuzijski protein se daje bez navedenog sredstva za pojačavanje nakon davanja navedenog sredstva za pojačavanje;
pri čemu doziranje sredstva za pojačavanje ne djeluje izravno na antitumorsku aktivnost;
i pri čemu je odgovor T stanica koji se postiže nakon davanja fuzijskog proteina veći od odgovora T stanica koji se postiže davanjem bilo fuzijskog proteina samog ili samog sredstva za pojačavanje.
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