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DK3101032T3 - Anti-her2-antistof-lægemiddelkonjuagt - Google Patents

Anti-her2-antistof-lægemiddelkonjuagt Download PDF

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Publication number
DK3101032T3
DK3101032T3 DK15743738.5T DK15743738T DK3101032T3 DK 3101032 T3 DK3101032 T3 DK 3101032T3 DK 15743738 T DK15743738 T DK 15743738T DK 3101032 T3 DK3101032 T3 DK 3101032T3
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DK
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Prior art keywords
antibody
ch2ch2
cancer
drug
compound
Prior art date
Application number
DK15743738.5T
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English (en)
Inventor
Hiroyuki Naito
Yusuke Ogitani
Takeshi Masuda
Takashi Nakada
Masao Yoshida
Shinji Ashida
Koji Morita
Hideki Miyazaki
Yuji Kasuya
Ichiro Hayakawa
Yuki Abe
Original Assignee
Daiichi Sankyo Co Ltd
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Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=53756672&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=DK3101032(T3) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Daiichi Sankyo Co Ltd filed Critical Daiichi Sankyo Co Ltd
Application granted granted Critical
Publication of DK3101032T3 publication Critical patent/DK3101032T3/da

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
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    • C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
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    • 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
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    • A61K31/4738—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
    • A61K31/4745—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
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Claims (15)

  1. ANTI-HER2-ANTISTOF-LÆGEMIDDELKONJUAGT E Antistof-lægemiddelkonjugat, hvor en antitumorforbindelse repræsenteret ved følgende formel:
    er konjugeret med et anti-HER2-antistof via en linker med en struktur repræsenteret ved følgende formel: -L1-L2-Lp-NH-(CH2) n1-La-(CH2)n2-C(=O)- via en thioetherbinding, der er dannet ved en disulfidbindingsdel til stede i hængselsdelen af anti-HER2-antistoffet, hvor anti-HER2-antistoffet er forbundet med terminal L1, antitumorforbindelsen er forbundet med carbonylgruppen af -(CH2) n2-C(=O)-delen med nitrogenatomet fra aminogruppen ved position 1 som den forbindende position, hvor n1 repræsenterer et heltal på 0 til 6, n2 repræsenterer et heltal på 0 til 5, L1 repræsenterer -(succinimid-3-yl-N)-(CH2)n3-C(=O)-, hvor n3 repræsenterer et heltal på 2 til 8, L2 repræsenterer -NH-(CH2CH2-O)n4-CH2CH2-C (=O)- eller en enkeltbinding, hvor n4 repræsenterer et heltal på 1 til 6, LP repræsenterer tetrapeptidresten -GGFG-, La repræsenterer -O- eller en enkeltbinding, og -(succinimid-3-yl-N)- har en struktur repræsenteret ved følgende formel:
    der er forbundet med anti-HER2-antistoffet ved position 3 deraf og er forbundet med methylengruppen i linkerstrukturen, der indeholder denne struktur på nitrogenatomet ved position 1.
  2. 2. Antistof-lægemiddelkonjugat ifølge krav 1, hvor lægemiddellinker-strukturdelen med lægemidlet forbundet med -L1-L2-LP-NH-(CH2)n1-La-(CH2)n2-C(=O)- er en lægemiddellinker-struktur valgt fra følgende gruppe: -(succinimid-3-yl-N)-CH2CH2-C(=O)-GGFG-NH-CH2CH2-C(=O)-(NH-DX) -(succinimid-3-yl-N)-CH2CH2-C(=O)-GGFG-NH-CH2CH2CH2-C(=O)-(NH-DX)
    -(succinimid-3-yl-N)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2CH2-C(=O)-(NH-DX) -(succinimid-3-yl-N)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2CH2CH2-C(=O)-(NH-DX) -(succinimid-3-yl-N)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2CH2CH2CH2CH2-C(=O)-(NH- DX) -(succinimid-3-yl-N)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2-O-CH2-C(=O)-(NH-DX) -(succinimid-3-yl-N)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2CH2-O-CH2-C(=O)-(NH-DX) -(succinimid-3-yl-N)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2CH2-O-C(=O)-(NH-DX) -(succinimid-3-yl-N)-CH2CH2-C(=O)-NH-CH2CH2-O-CH2CH2-O-CH2CH2-C(=O)-GGFG-NH- CH2CH2-C(=O)-(NH-DX) -(succinimid-3-yl-N)-CH2CH2-C(=O)-NH-CH2CH2-O-CH2CH2-O-CH2CH2-C(=O)-GGFG-NH- CH2CH2CH2-C(=O)-(NH-DX) -(succinimid-3-yl-N)-CH2CH2-C(=O)-NH-CH2CH2-O-CH2CH2-O-CH2CH2-O-CH2CH2-O- CH2CH2-C(=O)-GGFG-NH-CH2CH2-C(=O)-(NH-DX) -(succinimid-3-yl-N)-CH2CH2-C(=O)-NH-CH2CH2-O-CH2CH2-O-CH2CH2-O-CH2CH2-O- CH2CH2-C(=O)-GGFG-NH-CH2CH2CH2-C(=O)-(NH-DX) hvor -(succinimid-3-yl-N)- har en struktur repræsenteret ved følgende formel:
    der er forbundet med anti-HER2-antistoffet ved position 3 deraf og er forbundet med methylengruppen i linkerstrukturen, der indeholder denne struktur på nitrogenatomet ved position 1, -(NH-DX) repræsenterer en gruppe repræsenteret ved følgende formel:
    hvor nitrogenatomet af aminogruppen ved position 1 er den forbindende position, og -GGFG- repræsenterer tetrapeptidresten -Gly-Gly-Phe-Gly-.
  3. 3. Antistof-lægemiddelkonjugat ifølge krav 2, hvor lægemiddellinker-strukturdelen er en lægemiddellinker-struktur valgt fra følgende gruppe: -(succinimid-3-yl-N)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2-O-CH2-C(=O)-(NH-DX) -(succinimid-3-yl-N)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2CH2-O-CH2-C(=O)-(NH-DX) -(succinimid-3-yl-N)-CH2CH2-C(=O)-NH-CH2CH2-O-CH2CH2-O-CH2CH2-C(=O)-GGFG-NH- CH2CH2CH2-C(=O)-(NH-DX).
  4. 4. Antistof-lægemiddelkonjugat ifølge krav 3, hvor lægemiddellinker-strukturdelen er -(succinimid-3-yl-N)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2-O-CH2-C(=O)-(NH-DX).
  5. 5. Antistof-lægemiddelkonjugat ifølge krav 3, hvor lægemiddellinker-strukturdelen er -(succinimid-3-yl-N)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2CH2-O-CH2-C(=O)-(NH-DX).
  6. 6. Antistof-lægemiddelkonjugat ifølge krav 3, hvor lægemiddellinker-strukturdelen er -(succinimid-3-yl-N)-CH2CH2-C(=O)-NH-CH2CH2-O-CH2CH2-O-CH2CH2-C(=O)-GGFG-NH-CH2CH2CH2-C(=O)-(NH-DX).
  7. 7. Antistof-lægemiddelkonjugat ifølge et hvilket som helst af kravene 1 til 6, hvor anti-HER2-antistoffet omfatter en tungkæde, der består af en aminosyresekvens bestående af aminosyreresterne 1 til 449 of SEQ ID NO: 1 og en letkæde bestående af aminosyresekvensen repræsenteret ved SEQ ID NO: 2.
  8. 8. Antistof-lægemiddelkonjugat ifølge et hvilket som helst af kravene 1 til 6, hvor anti-HER2-antistoffet omfatter en tungkæde, der består af aminosyresekvensen repræsenteret ved SEQ ID NO: 1 og en letkæde bestående af aminosyresekvensen repræsenteret ved SEQ ID NO: 2.
  9. 9. Antistof-lægemiddelkonjugat ifølge et hvilket som helst af kravene 1 til 8, hvor det gennemsnitlige antal enheder af den valgte lægemiddellinker-struktur konjugeret pr. antistofmolekyle er i intervallet fra 2 til 8.
  10. 10. Antistof-lægemiddelkonjugat ifølge et hvilket som helst af kravene 1 til 8, hvor det gennemsnitlige antal enheder af den valgte lægemiddellinker-struktur konjugeret pr. antistofmolekyle er i intervallet fra 3 til 8.
  11. 11. Antistof-lægemiddelkonjugat ifølge et hvilket som helst af kravene 1 til 10, et salt deraf, eller et hydrat deraf, til anvendelse som et lægemiddel.
  12. 12. Antistof-lægemiddelkonjugat ifølge et hvilket som helst af kravene 1 til 10, et salt deraf, eller et hydrat deraf, til anvendelse som et antitumorlægemiddel og/eller anticancerlægemiddel.
  13. 13. Antitumorlægemiddel og/eller anticancerlægemiddel ifølge krav 12, til anvendelse i behandling af lungecancer, urothelial cancer, colorektalcancer, prostatacancer, ovariecancer, pankreascancer, brystcancer, blærecancer, gastrisk cancer, gastrointestinal stromatumor, uterin cervixcancer, esophaguscancer, pladeepitelkarcinom, peritoneal cancer, levercancer, hepatocellulær cancer, coloncancer, rektal cancer, colorektal cancer, endometriecancer, uteruscancer, spytkirtelcancer, nyrecancer, vulvacancer, thyroideacancer, penis cancer, leukæmi, malignt lymfom, plasmacytom, myelom eller sarkom.
  14. 14. Farmaceutisk sammensætning, der indeholder antistof-lægemiddelkonjugatet ifølge et hvilket som helst af kravene 1 til 10, et salt deraf, eller et hydrat deraf som en aktiv bestanddel, og en farmaceutisk acceptabel formuleringsbestanddel.
  15. 15. Farmaceutisk sammensætning ifølge krav 14, til anvendelse i behandling af lungecancer, urothelial cancer, colorektal cancer, prostatacancer, ovariecancer, pankreascancer, brystcancer, blærecancer, gastrisk cancer, gastrointestinal stromatumor, uterin cervixcancer, esophaguscancer, pladeepitelkarcinom, peritoneal cancer, levercancer, hepatocellulær cancer, coloncancer, rektal cancer, colorektal cancer, endometriecancer, uteruscancer, spytkirtelcancer, nyrecancer, vulvacancer, thyroideacancer, peniscancer, leukæmi, malignt lymfom, plasmacytom, myelom eller sarkom.
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