HRP20170675T1 - Humana anti-il-23 antitijela, sastavi, metode i upotrebe - Google Patents
Humana anti-il-23 antitijela, sastavi, metode i upotrebe Download PDFInfo
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- HRP20170675T1 HRP20170675T1 HRP20170675TT HRP20170675T HRP20170675T1 HR P20170675 T1 HRP20170675 T1 HR P20170675T1 HR P20170675T T HRP20170675T T HR P20170675TT HR P20170675 T HRP20170675 T HR P20170675T HR P20170675 T1 HRP20170675 T1 HR P20170675T1
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- amino acid
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- 238000000034 method Methods 0.000 title claims 5
- 239000000203 mixture Substances 0.000 title claims 3
- 125000003275 alpha amino acid group Chemical group 0.000 claims 56
- 239000003814 drug Substances 0.000 claims 20
- 229940079593 drug Drugs 0.000 claims 20
- 102000011718 Interleukin-23 Subunit p19 Human genes 0.000 claims 11
- 108010076561 Interleukin-23 Subunit p19 Proteins 0.000 claims 11
- 108020004707 nucleic acids Proteins 0.000 claims 7
- 102000039446 nucleic acids Human genes 0.000 claims 7
- 150000007523 nucleic acids Chemical class 0.000 claims 7
- 108091028043 Nucleic acid sequence Proteins 0.000 claims 6
- 239000002773 nucleotide Substances 0.000 claims 6
- 125000003729 nucleotide group Chemical group 0.000 claims 6
- 102000013264 Interleukin-23 Human genes 0.000 claims 4
- 108010065637 Interleukin-23 Proteins 0.000 claims 4
- 210000003403 autonomic nervous system Anatomy 0.000 claims 4
- 210000003169 central nervous system Anatomy 0.000 claims 4
- 241001465754 Metazoa Species 0.000 claims 3
- 230000002526 effect on cardiovascular system Effects 0.000 claims 3
- -1 hormonal drug Substances 0.000 claims 3
- 230000003834 intracellular effect Effects 0.000 claims 3
- 238000007918 intramuscular administration Methods 0.000 claims 3
- 238000007912 intraperitoneal administration Methods 0.000 claims 3
- 238000007919 intrasynovial administration Methods 0.000 claims 3
- 238000001990 intravenous administration Methods 0.000 claims 3
- 238000004519 manufacturing process Methods 0.000 claims 3
- 238000007920 subcutaneous administration Methods 0.000 claims 3
- 108010047041 Complementarity Determining Regions Proteins 0.000 claims 2
- 102000004127 Cytokines Human genes 0.000 claims 2
- 108090000695 Cytokines Proteins 0.000 claims 2
- 230000002924 anti-infective effect Effects 0.000 claims 2
- 150000001875 compounds Chemical class 0.000 claims 2
- 239000000409 cytokine receptor agonist Substances 0.000 claims 2
- 239000000430 cytokine receptor antagonist Substances 0.000 claims 2
- 239000003792 electrolyte Substances 0.000 claims 2
- 239000012530 fluid Substances 0.000 claims 2
- 210000001035 gastrointestinal tract Anatomy 0.000 claims 2
- 230000002489 hematologic effect Effects 0.000 claims 2
- 229940088597 hormone Drugs 0.000 claims 2
- 229940124622 immune-modulator drug Drugs 0.000 claims 2
- 239000002955 immunomodulating agent Substances 0.000 claims 2
- 235000016709 nutrition Nutrition 0.000 claims 2
- 210000000056 organ Anatomy 0.000 claims 2
- 229920001184 polypeptide Polymers 0.000 claims 2
- 102000004196 processed proteins & peptides Human genes 0.000 claims 2
- 108090000765 processed proteins & peptides Proteins 0.000 claims 2
- 210000002345 respiratory system Anatomy 0.000 claims 2
- 230000000699 topical effect Effects 0.000 claims 2
- 230000009261 transgenic effect Effects 0.000 claims 2
- FWMNVWWHGCHHJJ-SKKKGAJSSA-N 4-amino-1-[(2r)-6-amino-2-[[(2r)-2-[[(2r)-2-[[(2r)-2-amino-3-phenylpropanoyl]amino]-3-phenylpropanoyl]amino]-4-methylpentanoyl]amino]hexanoyl]piperidine-4-carboxylic acid Chemical compound C([C@H](C(=O)N[C@H](CC(C)C)C(=O)N[C@H](CCCCN)C(=O)N1CCC(N)(CC1)C(O)=O)NC(=O)[C@H](N)CC=1C=CC=CC=1)C1=CC=CC=C1 FWMNVWWHGCHHJJ-SKKKGAJSSA-N 0.000 claims 1
- 206010071068 Clinically isolated syndrome Diseases 0.000 claims 1
- 101100007328 Cocos nucifera COS-1 gene Proteins 0.000 claims 1
- 208000011231 Crohn disease Diseases 0.000 claims 1
- 206010025323 Lymphomas Diseases 0.000 claims 1
- 208000003435 Optic Neuritis Diseases 0.000 claims 1
- 206010035226 Plasma cell myeloma Diseases 0.000 claims 1
- 201000004681 Psoriasis Diseases 0.000 claims 1
- 201000001263 Psoriatic Arthritis Diseases 0.000 claims 1
- 208000036824 Psoriatic arthropathy Diseases 0.000 claims 1
- 239000005557 antagonist Substances 0.000 claims 1
- 239000002246 antineoplastic agent Substances 0.000 claims 1
- 239000002327 cardiovascular agent Substances 0.000 claims 1
- 229940125692 cardiovascular agent Drugs 0.000 claims 1
- 239000003085 diluting agent Substances 0.000 claims 1
- 239000003937 drug carrier Substances 0.000 claims 1
- 230000000694 effects Effects 0.000 claims 1
- 230000002496 gastric effect Effects 0.000 claims 1
- 238000000338 in vitro Methods 0.000 claims 1
- 238000001727 in vivo Methods 0.000 claims 1
- 201000006417 multiple sclerosis Diseases 0.000 claims 1
- 201000000050 myeloid neoplasm Diseases 0.000 claims 1
- 230000001613 neoplastic effect Effects 0.000 claims 1
- 239000005022 packaging material Substances 0.000 claims 1
- VLYWMPOKSSWJAL-UHFFFAOYSA-N sulfamethoxypyridazine Chemical compound N1=NC(OC)=CC=C1NS(=O)(=O)C1=CC=C(N)C=C1 VLYWMPOKSSWJAL-UHFFFAOYSA-N 0.000 claims 1
- 238000002198 surface plasmon resonance spectroscopy Methods 0.000 claims 1
- 230000037317 transdermal delivery Effects 0.000 claims 1
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- C07K16/244—Interleukins [IL]
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Claims (11)
1. Izolirano IL-23p19 antitijelo, koje je antitijelo koje se veže za p19 podjedinicu IL-23, obuhvaćajući:
(i)
(a) najmanje jednu varijabilnu regiju lakog lanca, spomenuta varijabilna regija lakog lanca obuhvaća:
regija koja utvrđuje komplementarnost lakog lanca 1 (CDRL1) sekvence amino kiseline SEK ID BR: 46;CDRL2 sekvencu amino kiseline SEK ID BR: 52; iCDRL3 sekvencu amino kiseline izabranu iz grupe koja se sastoji od SEK ID BR: 58-61; i
(b) najmanje jednu varijabilnu regiju teškog lanca, spomenuta varijabilna regija teškog lanca obuhvaća:
regija koja utvrđuje komplementarnost teškog lanca 1 (CDRH1) sekvence amino kiseline SEK ID BR: 1;CDRH2 sekvencu amino kiseline izabranu iz grupe koja se sastoji od SEK ID BR: 7 i 8; iCDRH3 sekvencu amino kiseline SEK ID BR: 40;
(ii)
(a) najmanje jednu varijabilnu regiju lakog lanca, spomenuta varijabilna regija lakog lanca obuhvaća:
CDRL1 sekvencu amino kiseline SEK ID BR: 47;CDRL2 sekvencu amino kiseline SEK ID BR: 53; iCDRL3 sekvencu amino kiseline izabranu iz grupe koja se sastoji od SEK ID BR: 62-67; i
(b) najmanje jednu varijabilnu regiju teškog lanca, spomenuta varijabilna regija teškog lanca obuhvaća:
CDRH1 sekvencu amino kiseline SEK ID BR: 2;CDRH2 sekvencu amino kiseline izabranu iz grupe koja se sastoji od SEK ID BR: 9-15; iCDRH3 sekvencu amino kiseline SEK ID BR: 41;
(iii)
(a) najmanje jednu varijabilnu regiju lakog lanca, spomenuta varijabilna regija lakog lanca obuhvaća:
CDRL1 sekvencu amino kiseline SEK ID BR: 49;CDRL2 sekvencu amino kiseline SEK ID BR: 55; iCDRL3 sekvencu amino kiseline SEK ID BR: 70; i
(b) najmanje jednu varijabilnu regiju teškog lanca, spomenuta varijabilna regija teškog lanca obuhvaća:
CDRH1 sekvencu amino kiseline SEK ID BR: 4;CDRH2 sekvencu amino kiseline SEK ID BR: 18; iCDRH3 sekvencu amino kiseline SEK ID BR: 43;
(iv)
(a) najmanje jednu varijabilnu regiju lakog lanca, spomenuta varijabilna regija lakog lanca obuhvaća:
CDRL1 sekvencu amino kiseline SEK ID BR: 50;CDRL2 sekvencu amino kiseline SEK ID BR: 56; iCDRL3 sekvencu amino kiseline izabranu iz grupe koja se sastoji od SEK ID BR: 58-68 i 71-73; i
(b) najmanje jednu varijabilnu regiju teškog lanca, spomenuta varijabilna regija teškog lanca obuhvaća:
CDRH1 sekvencu amino kiseline izabranu iz grupe koja se sastoji od SEK ID BR: 5;CDRH2 sekvencu amino kiseline izabranu iz grupe koja se sastoji od SEK ID BR: 19 i 21-27; iCDRH3 sekvencu amino kiseline SEK ID BR: 44;
(v)
(a) sekvenca amino kiseline varijabilne regije lakog lanca izabrana iz grupe koja se sastoji od SEK ID BR: 82-85; i
(b) sekvenca amino kiseline varijabilne regije teškog lanca izabrana iz grupe koja se sastoji od SEK ID BR: 80 i 81;
(vi)
(a) sekvenca amino kiseline varijabilne regije lakog lanca izabrana iz grupe koja se sastoji od SEK ID BR: 93-98; i(b) sekvenca amino kiseline varijabilne regije teškog lanca izabrana iz grupe koja se sastoji od SEK ID BR: 86-92;
(vii)
(a) sekvenca amino kiseline varijabilne regije lakog lanca SEK ID BR: 102; i(b) sekvenca amino kiseline varijabilne regije teškog lanca SEK ID BR: 101;
(viii)
(a) sekvenca amino kiseline varijabilne regije lakog lanca izabrana iz grupe koja se sastoji od SEK ID BR: 113-116; i(b) sekvenca amino kiseline varijabilne regije teškog lanca izabrana iz grupe koja se sastoji od SEK ID BR: 103-112;
(ix)
(a) sekvenca amino kiseline varijabilne regije lakog lanca koja ima najmanje 95% identičnosti sa bilo kojom od sekvenci amino kiseline izabranih iz grupe koja se sastoji od SEK ID BR: 82-85; i(b) sekvenca amino kiseline varijabilne regije teškog lanca koja ima najmanje 95% identičnosti sa bilo kojom od sekvenci amino kiseline izabranih iz grupe koja se sastoji od SEK ID BR: 80 i 81;
(x)
(a) sekvenca amino kiseline varijabilne regije lakog lanca koja ima najmanje 95% identičnosti sa bilo kojom od sekvenci amino kiseline izabranih iz grupe koja se sastoji od SEK ID BR: 93-98; i(b) sekvenca amino kiseline varijabilne regije teškog lanca koja ima najmanje 95% identičnosti sa bilo kojom od sekvenci amino kiseline izabranih iz grupe koja se sastoji od SEK ID BR: 86-92;
(xi)
(a) sekvenca amino kiseline varijabilne regije lakog lanca koja ima najmanje 95% identičnosti sa sekvencom amino kiseline SEK ID BR: 102; i(b) sekvenca amino kiseline varijabilne regije teškog lanca koja ima najmanje 95% identičnosti sa sekvencom amino kiseline SEK ID BR: 101
(xii)
(a) sekvenca amino kiseline varijabilne regije lakog lanca koja ima najmanje 95% identičnosti sa bilo kojom od sekvenci amino kiseline izabranih iz grupe koja se sastoji od SEK ID BR: 113-116; i(b) sekvenca amino kiseline varijabilne regije teškog lanca koja ima najmanje 95% identičnosti sa bilo kojom od sekvenci amino kiseline izabranih iz grupe koja se sastoji od SEK ID BR: 103-112;
(xiii)
(a) sekvenca amino kiseline varijabilne regije lakog lanca kodirana nukleotidnom sekvencom koja je izabrana iz grupe koja se sastoji od SEK ID BR: 136-138; i(b) sekvenca amino kiseline varijabilne regije teškog lanca kodirana nukleotidnom sekvencom koja je izabrana iz grupe koja se sastoji od SEK ID BR: 133-135;
(xiv)
(a) sekvenca varijabilne regije lakog lanca kodirana nukleotidnom sekvencom koja ima najmanje 95% identičnosti sa bilo kojom od nukleotidnih sekvenci izabranih iz grupe koja se sastoji od SEK ID BR: 136-138; i(b) sekvenca varijabilne regije teškog lanca kodirana nukleotidnom sekvencom koja ima najmanje 95% identičnosti sa bilo kojom od nukleotidnih sekvenci izabranih iz grupe koja se sastoji od SEK ID BR:133-135; ili
(xv)
(a) sekvenca varijabilne regije lakog lanca kodirana nukleotidnom sekvencom koja ima najmanje 95% identičnosti sa bilo kojom od nukleotidnih sekvenci izabranih iz grupe koja se sastoji od SEK ID BR: 142-144; i(b) sekvenca varijabilne regije teškog lanca kodirana nukleotidnom sekvencom koja ima najmanje 95% identičnosti sa bilo kojom od nukleotidnih sekvenci izabranih iz grupe koja se sastoji od SEK ID BR: 139-141.
2. IL-23p19 antitijelo prema patentnom zahtjevu 1, gdje spomenuto antitijelo:
(a) veže IL-23p19 sa najmanje jednim afinitetom izabranim od najmanje 10-9 M, najmanje 10-10 M, najmanje 10-11 M, i najmanje 10-12 M, najmanje 10-13 M, najmanje 10-14 M, i najmanje 10-15 M, kao što je utvrđeno pomoću površinske plazmonske rezonance ili Kinexa metodom; i/ili(b) modulira najmanje jednu aktivnost najmanje jednog IL-23 polipeptida.
3. Izolirana molekula nukleinske kiseline:
(a) kodira najmanje jedno izolirano IL-23p19 antitijelo prema patentnom zahtjevu 1 ili patentnom zahtjevu 2;(b) sadrži najmanje jednu od:
nukleotidnih sekvenci varijabilne regije lakog lanca izabrano iz grupe koja se sastoji od SEK ID BR: 136-138 inukleotidnih sekvenci varijabilne regije teškog lanca izabrano iz grupe koja se sastoji od SEK ID BR: 133-135.
4. Izolirani vektor nukleinske kiseline koji obuhvaća izoliranu molekulu nukleinske kiseline prema patentnom zahtjevu 3.
5. Prokariotska ili eukariotska stanica domaćina obuhvaćajući:
(a) izoliranu molekulu nukleinske kiseline prema patentnom zahtjevu 4; ili(b)
(i) vektor nukleinske kiseline koji kodira varijabilni regija lakog lanca, spomenuta varijabilna regija lakog lanca obuhvaća:
CDRL1 sekvencu amino kiseline SEK ID BR: 50;CDRL2 sekvencu amino kiseline SEK ID BR: 56; iCDRL3 sekvencu amino kiseline SEK ID BR: 73; i
(ii) vektor nukleinske kiseline koji kodira varijabilnu regiju teškog lanca, spomenuta varijabilna regija teškog lanca obuhvaća:
CDRH1 sekvencu amino kiseline SEK ID BR: 5;CDRH2 sekvencu amino kiseline SEK ID BR: 20; iCDRH3 sekvencu amino kiseline SEK ID BR: 44
pri čemu je, opcionalno, spomenuta stanica domaćina najmanje jedna izabrana od COS-1, COS-7, HEK293, BHK21, CHO, BSC-1, HepG2, 653, SP2/0, 293, HeLa, mijeloma, ili stanica limfoma, ili bilo kojeg njihovog derivata, imortalizirane ili transformirane stanice.
6. In vitro metoda za proizvodnju najmanje jednog IL-23p19 antitijela, obuhvaćajući prevođenje molekula nukleinske kiseline prema patentnom zahtjevu 3 pod takvim uvjetima da je IL-23p19 antitijelo eksprimirano u detektabilnim ili nadoknadivim količinama.
7. Sastav koji obuhvaća najmanje jedno izolirano IL-23p19 antitijelo prema patentnom zahtjevu 1 ili patentnom zahtjevu 2 i najmanje jedan farmaceutski prihvatljiv nosač ili razblaživač, opcionalno dodatno obuhvaćajući najmanje jedan spoj ili polipeptid izabran od detektabilne oznake, ili reportera, TNF antagonista, anti infektivnog lijeka, lijeka kardiovaskularnog (CV) sustavaa, lijeka centralnog nervnog sustava (CNS), lijeka autonomnog nervnog sustava (ANS), lijeka respiratornog trakta, lijeka gastrointestinalnog (GI) trakta, hormonalnog lijeka, lijeka za ravnotežu tekućine ili elektrolita, hematološkog lijeka, aneoplastičnog, imunomodulacijskog lijeka, oftalmičkog, ušnog ili nazalnog lijeka, topikalnog lijeka, nutricijskog lijeka, citokina i citokin antagonista.
8. Antitijelo patentnog zahtjeva 1 ili patentnog zahtjeva 2 za upotrebu u in vivo metodi za dijagnostiku ili liječenje stanja povezanog sa IL-23 u stanici, tkivu, organu ili životinji, kao kada je stanje povezano sa IL-23 izabrano iz grupe koju čine: psorijaza, psorijazni artritis, Kronova bolest, multipla skleroza, optički neuritis, i klinički izolirani sindrom, opcionalno:
(a) pri čemu je spomenuto antitijelo pogodno za primjenu u efektivnoj količini od 0,001-50 mg/kilogram na spomenutim stanicama, tkivu, organu ili životinji;(b) pri čemu je spomenuto antitijelo pogodno za primjenu putem najmanje jednog načina izabranog od parenteralnog, subkutanog, intramuskularnog, intravenoznog, intraartikularnog, intrabronhijalnog, intraabdominalnog, intrakapsularnog, intrakartilagenoznog, intrakavitalnog, intracelijalnog, intracerebelarnog, intracerebroventikularnog, intrakoličnog, intracervikalnog, instragastričnog, intrahepatičnog, intramiokardnog, intraostealnog, intrapelvičnog, intrakarličnog, intraperikardialnog, intraperitonealnog, intrapleuralnog, intraprostatičnog, intrapulmonalnog, intrarektalnog, intrarenalnog, intraretinalnog, intraspinalnog, intrasinovijalnog, intratorakalnog, intrauterinog, intravezikalnog, intralezionalnog, vaginalnog, rektalnog, bukalnog, sublingvalnog, intranazalnog, i transdermalnog; ili(c) pri čemu je spomenuto antitijelo pogodno za primjenu, prije, istovremeno, ili posle spomenutog kontakta ili primjene, najmanje jedne kompozicije koja obuhvaća efektivnu količinu najmanje jednog spoja ili polipeptida izabranog od detektabilne oznake ili reportera, anti-infektivnog lijeka, lijeka kardiovaskularnog sustava (CV), lijeka centralnog nervnog sustava (CNS), lijeka autonomnog nervnog sustava (ANS), lijeka respiratornog trakta, lijeka gastrointestinalnog trakta (GI), hormonalnog lijeka, lijeka za ravnotežu tekućine i elektrolita, hematološkog lijeka, antineoplastika, imunomodulacijskog lijeka, oftalmičkog, otičnog, ili nazalnog lijeka, topikalnog lijeka, nutricionog lijeka, citokina, i citokin antagonista.
9. Medicinska naprava, koja sadrži IL-23p19 antitijelo prema patentnom zahtjevu 1 ili patentnom zahtjevu 2, pri čemu je naprava pogodna za kontakt ili primjenu spomenutog IL-23p19 antitijela putem najmanje jednog načina izabranog od parenteralnog, subkutanog, intramuskularnog, intravenoznog, intrartikularnog, intrabronhijalnog, intraabdominalnog, intrakapsularnog, intrakartilagenoznog, intrakavitalnog, intracelijalnog, intracerebelarnog, intracerebroventikularnog, intrakoličnog, intracervikalnog, intragastričnog, intrahepatičnog, intramiokardnog, intraostealnog, intrakarličnog, intraperikardialnog, intraperitonealnog, intrapleuralnog, intraprostatičnog, intrapulmonalnog, intrarektalnog, intrarenalnog, intraretinalnog, intraspinalnog, intrasinovijalnog, intratorakalnog, intrauterinog, intravezikalnog, intralezionalnog, vaginalnog, rektalnog, bukalnog, sublingvalnog, intranazalnog, i transdermalnog.
10. Proizvodni artikl za farmaceutsku ili dijagnostičku upotrebu kod ljudi, koji obuhvaća materijal za pakiranje i spremnik koji obuhvaća otopinu ili liofilizirani oblik IL-23p19 antitijela prema patentnom zahtjevu 1 ili patentnom zahtjevu 2, gdje je opcionalno spomenuti spremnik komponenta parenteralnog, subkutanog, intramuskularnog, intravenoznog, intrartikularnog, intrabronhijalnog, intraabdominalnog, intrakapsularnog, intrakartilagenoznog, intrakavitalnog, intracelijalnog, intracerebelarnog, intracerebroventikularnog, intrakoličnog, intracervikalnog, instragastričnog, intrahepatičnog, intramiokardnog, intraostealnog, intrakarličnog, intraperikardialnog, intraperitonealnog, intrapleuralnog, intraprostatičnog, intrapulmonarnog, intrarektalnog, intrarenalnog, intraretinalnog, intraspinalnog, intrasinovijalnog, intratorakalnog, intrauterinog, intravezikalnog, intralezionalnog, vaginalnog, rektalnog, bukalnog, sublingvalnog, intranazalnog, ili transdermalne isporuke naprave ili sustava.
11. Postupak za proizvodnju izoliranog IL-23p19 antitijela prema patentnom zahtjevu 1 ili patentnom zahtjevu 2, obuhvaćajući pružanje stanice domaćina ili ne-humane transgenične životinjske ili transgenične biljke ili biljne stanice, koja je sposobna za eksprimiranje spomenutog antitijela u nadoknadivim količinama.
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| US75488905P | 2005-12-29 | 2005-12-29 | |
| EP12174197.9A EP2548577B1 (en) | 2005-12-29 | 2006-12-28 | Human anti-il-23 antibodies, compositions, methods and uses |
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| HRP20170675TT HRP20170675T1 (hr) | 2005-12-29 | 2017-05-04 | Humana anti-il-23 antitijela, sastavi, metode i upotrebe |
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