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HRP20160190T1 - Protutijela anti-igf - Google Patents

Protutijela anti-igf Download PDF

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HRP20160190T1
HRP20160190T1 HRP20160190T HRP20160190T HRP20160190T1 HR P20160190 T1 HRP20160190 T1 HR P20160190T1 HR P20160190 T HRP20160190 T HR P20160190T HR P20160190 T HRP20160190 T HR P20160190T HR P20160190 T1 HRP20160190 T1 HR P20160190T1
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cancer
igf
antibody molecule
seq
chain
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HRP20160190T
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Paul Adam
Eric Borges
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Boehringer Ingelheim Int
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
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    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/22—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against growth factors ; against growth regulators
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
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    • A61K31/00—Medicinal preparations containing organic active ingredients
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    • A61K31/282—Platinum compounds
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    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
    • A61K31/4353—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/436—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom ortho- or peri-condensed with heterocyclic ring systems the heterocyclic ring system containing a six-membered ring having oxygen as a ring hetero atom, e.g. rapamycin
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    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
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    • A61P35/02—Antineoplastic agents specific for leukemia
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    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
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    • G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • G01N33/57484—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites
    • G01N33/57496—Immunoassay; Biospecific binding assay; Materials therefor for cancer involving compounds serving as markers for tumor, cancer, neoplasia, e.g. cellular determinants, receptors, heat shock/stress proteins, A-protein, oligosaccharides, metabolites involving intracellular compounds
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    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
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    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
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Claims (31)

1. Izolirana molekula ljudskog protutijela, naznačena time, da se a) veže na ljudski IGF-1 i IGF-2 tako, (i) da se sprečava vezanje IGF-1 i IGF-2 na receptor IGF-1 i (ii) da se inhibira signalizacija posredovana s receptorom IGF-1, b) veže na mišji i štakorski IGF-1 i IGF-2, c) ne veže na ljudski inzulin; pri čemu navedena molekula protutijela je takva molekula protutijela koja ima CDR-ove jakog lanca s aminokiselinskim sekvencama SEQ ID NO:21 (CDR1), SEQ ID NO:22 (CDR2) i SEQ ID NO:23 (CDR3) te koja ima CDR-ove slabog lanca s aminokiselinskim sekvencama SEQ ID NO:24 (CDR1), SEQ ID NO:25 (CDR2) i SEQ ID NO:26 (CDR3).
2. Molekula protutijela prema zahtjevu 1, naznačena time, da ima varijabilni jaki lanac koji obuhvaća aminokiselinsku sekvencu SEQ ID NO:28.
3. Molekula protutijela prema zahtjevu 1, naznačena time, da ima varijabilni slabi lanac koji obuhvaća aminokiselinsku sekvencu SEQ ID NO:30.
4. Molekula protutijela prema bilo kojem od zahtjeva 1 do 3, naznačena time, da obuhvaća konstantno područje jakog lanca odabrano iz skupine koju čine sljedeća konstantna područja: IgG1, IgG2, IgG3, IgG4, IgM, IgA i IgE.
5. Molekula protutijela prema zahtjevu 4, naznačena time, da navedeno konstantno područje jakog lanca je IgG1 i obuhvaća aminokiselinsku sekvencu SEQ ID NO:32.
6. Molekula protutijela prema bilo kojem od zahtjeva 1 do 3, naznačena time, da konstantno područje slabog lanca je Igλ.
7. Molekula protutijela prema zahtjevu 6, naznačena time, da navedeno konstantno područje slabog lanca obuhvaća aminokiselinsku sekvencu SEQ ID NO:34.
8. Molekula protutijela prema zahtjevima 2 ili 3, naznačena time, da ima a) jaki lanac koji obuhvaća aminokiselinsku sekvencu SEQ ID NO:39, i b) slabi lanac koji obuhvaća aminokiselinsku sekvencu SEQ ID NO:40.
9. Molekula protutijela prema bilo kojem od zahtjeva 1 do 3, naznačena time, da je to fragment Fab, F(ab')2 ili fragment Fv jednostrukog lanca.
10. Molekula DNK, naznačena time, da kodira varijabilni jaki lanac i varijabilni slabi lanac od molekule protutijela prema bilo kojem od zahtjeva 1 do 9.
11. Molekula DNK prema zahtjevu 10, naznačena time, da ima nukleotidnu sekvencu SEQ ID NO:27 koja kodira varijabilni jaki lanac od protutijela prema zahtjevu 2, te time, da ima nukleotidnu sekvencu SEQ ID NO:29 koja kodira varijabilni slabi lanac od protutijela prema zahtjevu 3.
12. Vektor ekspresije, naznačen time, da sadrži molekulu DNK koja obuhvaća nukleotidnu sekvencu koja kodira varijabilni jaki lanac i varijabilni slabi lanac od molekule protutijela prema bilo kojem od zahtjeva 1 do 9.
13. Vektor ekspresije prema zahtjevu 12, naznačen time, da sadrži molekulu DNK koja obuhvaća nukleotidnu sekvencu od SEQ ID NO:27 i/ili SEQ ID NO:29.
14. Vektor ekspresije prema zahtjevu 12 ili 13, naznačen time, da dodatno sadrži molekulu DNK koja kodira konstantni jaki lanac odnosno konstantni slabi lanac, spojen na molekulu DNK koja kodira varijabilni jaki lanac odnosno varijabilni slabi lanac.
15. Stanica domaćina, naznačena time, da nosi jednoga ili više vektora ekspresije prema zahtjevima 12, 13 ili 14.
16. Stanica domaćina prema zahtjevu 15, naznačena time, da je to stanica sisavca.
17. Postupak proizvodnje protutijela prema bilo kojem od zahtjeva 1 do 9, naznačen time, da obuhvaća transfekciju stanice domaćina sisavca putem jednog ili više vektora prema zahtjevima od 12 do 14, kultivaciju stanice domaćina te oporavljanje i pročišćavanje protutijela.
18. Postupak proizvodnje protutijela prema bilo kojem od zahtjeva 1 do 9, naznačen time, da obuhvaća dobivanje stanice domaćina sisavca, koja sadrži jednoga ili više vektora prema zahtjevima od 12 do 14, te kultivaciju stanice domaćina.
19. Postupak prema zahtjevu 18, naznačen time, da nadalje obuhvaća oporavljanje i pročišćavanje protutijela.
20. Molekula protutijela prema bilo kojem od zahtjeva 1 do 9, naznačena time, da se upotrebljava u medicini.
21. Molekula protutijela prema bilo kojem od zahtjeva 1 do 9, naznačena time, da se upotrebljava u liječenju kanceroznih bolesti odabranih od sljedećih: rakovi hematopoietskog sustava uključujući i leukemije, limfome i mijelome, rakovi gastrointestinalnog trakta uključujući rak ezofagusa, gastrički rak, kolorektalni rak, rak pankreasa, rak jetre, rak žučnog mjehura i rak žučnih vodova, posebno hepatocelularni karcinom; rak bubrega, prostate i mjehura; ginekološki rakovi uključujući rak dojke, rak jajnika, rak cerviksa i endometrijski rak; rakovi kože te glave i vrata uključujući maligne melanome; pedijatrijski rakovi kao što su Wilmsov tumor, neuroblastom i Ewingov sarkom; rakovi mozga kao što je glioblastom; sarkomi kao što su osteosarkom, sarkom mekog tkiva, rabdomiosarkom, hemangiosarkom; rak pluća, posebno rak ne malih stanica pluća; mezoteliom i rak tiroidne žlijezde.
22. Molekula protutijela prema zahtjevu 21, naznačena time, da se lijek upotrebljava u kombinaciji s kemoterapijom na platinskoj bazi, posebno s platinskom duplikatnom terapijom paklitaksel/karboplatin ili gemcitabin/cisplatin, sorafenib ili sa spojem odabranim iz skupine inhibitora za EGFR, VEGF, HER2-neu, AuroraB, Plk1, P13-kinazu ili mTor.
23. Molekula protutijela prema zahtjevu 22, naznačena time, da inhibitor za mTor je rapamicin, temzirolimus, deforolimus ili everolimus.
24. Farmaceutski sastav, naznačen time, da obuhvaća molekulu protutijela prema bilo kojem od zahtjeva 1 do 9 i farmaceutski prikladan nosač.
25. Farmaceutski sastav prema zahtjevu 24, naznačen time, da nadalje obuhvaća jedno ili više dodatnih terapeutskih sredstava odabranih od sljedećih: a) sredstva za oštećivanje DNK, b) terapeutski djelotvorni spojevi koji inhibiraju puteve prijenosa signala ili mitotske kontrolne točke u stanicama raka, c) protudijabetička sredstva.
26. Farmaceutski sastav prema zahtjevu 25, naznačen time, da su navedeni jedan ili više spojeva b) odabrani iz skupine inhibitora za EGFR, VEGF, HER2-neu, AuroraB, Plk1, P13-kinazu ili mTor.
27. Farmaceutski sastav prema bilo kojem od zahtjeva 24 do 26, naznačen time, da se upotrebljava u liječenju kanceroznih bolesti odabranih od sljedećih: rakovi hematopoietskog sustava uključujući i leukemije, limfome i mijelome, rakovi gastrointestinalnog trakta uključujući rak ezofagusa, gastrički rak, kolorektalni rak, rak pankreasa, rak jetre, rak žučnog mjehura i rak žučnih vodova, posebno hepatocelularni karcinom; rak bubrega, prostate i mjehura; ginekološki rakovi uključujući rak dojke, rak jajnika, rak cerviksa i endometrijski rak; rakovi kože te glave i vrata uključujući maligne melanome; pedijatrijski rakovi kao što su Wilmsov tumor, neuroblastom i Ewingov sarkom; rakovi mozga kao što je glioblastom; sarkomi kao što su osteosarkom, sarkom mekog tkiva, rabdomiosarkom, hemangiosarkom; rak pluća, posebno rak ne malih stanica pluća; mezoteliom i rak tiroidne žlijezde.
28. Farmaceutski sastav prema zahtjevu 27, naznačen time, da se nadalje upotrebljava u kombinaciji s kemoterapijom na platinskoj bazi, posebno s platinskom duplikatnom terapijom paklitaksel/karboplatin ili gemcitabin/cisplatin, sorafenib ili sa spojem odabranim iz skupine inhibitora za EGFR, VEGF, HER2-neu, AuroraB, Plk1, P13-kinazu ili mTor.
29. In vitro postupak inhibiranja vezanja IGF-1 i IGF-2 na receptor IGF-1 u stanici sisavca, naznačen time, da obuhvaća davanje molekule protutijela prema bilo kojem od zahtjeva 1 do 9, navedenoj stanici, pri čemu se inhibiraju signalizacija posredovana s receptorom IGF-1 i proliferacija i anti-apoptoza posredovana s IGF-1 i IGF-2.
30. In vitro postupak inhibiranja vezanja IGF-2 na receptor inzulina IR-A u stanici sisavca, naznačen time, da obuhvaća davanje molekule protutijela prema bilo kojem od zahtjeva 1 do 9, navedenoj stanici, pri čemu se inhibira signalizacija posredovana s receptorom inzulina IR-A i gdje se inhibira proliferacija i anti-apoptoza posredovana s IGF-2.
31. In vitro postupak kontrole učinkovitosti liječenja pacijenta od raka s molekulom protutijela koja se veže na IGF-1 i IGF-2, pri čemu navedena molekula protutijela je molekula protutijela prema bilo kojem od zahtjeva 1 do 9, naznačen time, da navedeni postupak obuhvaća sljedeće: a) mjerenje razine ukupnog IGF-1 u biološkom uzorku od navedenog pacijenta, b) mjerenje razine ukupnog IGF-1 u biološkom uzorku od navedenog pacijenta, nakon davanja navedenom pacijentu spomenute molekule protutijela anti-IGF, gdje količina povećanja razine ukupnog IGF-1, u usporedbi s razinom ukupnog IGF-1, mjerenom u koraku a), pokazuje do koje mjere pacijent reagira na liječenje spomenutom molekulom protutijela anti-IGF.
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