HRP20211848T1 - Anti-her2 antitijelo-lijek konjugat - Google Patents

Anti-her2 antitijelo-lijek konjugat Download PDF

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Publication number
HRP20211848T1
HRP20211848T1 HRP20211848TT HRP20211848T HRP20211848T1 HR P20211848 T1 HRP20211848 T1 HR P20211848T1 HR P20211848T T HRP20211848T T HR P20211848TT HR P20211848 T HRP20211848 T HR P20211848T HR P20211848 T1 HRP20211848 T1 HR P20211848T1
Authority
HR
Croatia
Prior art keywords
ch2ch2
ggfg
maleimid
antibody
her2 antibody
Prior art date
Application number
HRP20211848TT
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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 Company, Limited
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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=HRP20211848(T1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Daiichi Sankyo Company, Limited filed Critical Daiichi Sankyo Company, Limited
Publication of HRP20211848T1 publication Critical patent/HRP20211848T1/hr

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    • A61K47/6889—Conjugates wherein the antibody being the modifying agent and wherein the linker, binder or spacer confers particular properties to the conjugates, e.g. peptidic enzyme-labile linkers or acid-labile linkers, providing for an acid-labile immuno conjugate wherein the drug may be released from its antibody conjugated part in an acidic, e.g. tumoural or environment
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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
    • A61K31/47—Quinolines; Isoquinolines
    • 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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    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3046—Stomach, Intestines
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3069—Reproductive system, e.g. ovaria, uterus, testes, prostate
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • 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
    • C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation

Claims (14)

1. Postupak za proizvodnju antitijelo-lijek konjugata koji obuhvaća reagiranje spoja predstavljenog sljedećom formulom: (maleimid-N-il)-(CH2)n3-C(=O)-L2-LP-NH-(CH2)n1-La-(CH2)n2-C(=O)-(NH-DX) sa anti-HER2 antitijelom ili njegovim reaktivnim derivatom i konjugiranje lijek-veznik segmenta za antitijelo postupkom za formiranje tioetarske veze na mjestu disulfidne veze prisutne u zglobnom dijelu antitijela, pri čemu n1 predstavlja cijeli broj od 0 do 6, n2 predstavlja cijeli broj od 0 do 5, n3 predstavlja cijeli broj od 2 do 8, L2 predstavlja -NH-(CH2CH2-O)n4-CH2CH2-C(=O)- ili jednostruku vezu, pri čemu n4 predstavlja cijeli broj od 1 do 6, LP predstavlja tetrapeptidni ostatak -GGFG- gdje G predstavlja glicin i F predstavlja fenilalanin, La predstavlja -O- ili jednostruku vezu, i (maleimid-N-il)- je grupa predstavljena sljedećom formulom: [image] pri čemu atom dušika je vezujući položaj, i -(NH-DX) je grupa predstavljena sljedećom formulom: [image] pri čemu atom dušika amino grupe na položaju 1 je vezujući položaj.
2. Postupak prema patentnom zahtjevu 1, pri čemu spoj je jedan odabran iz sljedeće grupe: (maleimid-N-il)-CH2CH2-C(=O)-GGFG-NH-CH2CH2-C =O)-(NH-DX), (maleimid-N-il)-CH2CH2-C(=O)-GGFG-NH-CH2CH2CH2-C(=O)-(NH-DX), (maleimid-N-il)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2CH2-C(=O)-(NH-DX), maleimid-N-il)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2CH2CH2-C(=O)-(NH-DX), (maleimid-N-il)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2CH2CH2CH2CH2-C(=O)-(NH-DX), (maleimid-N-il)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2-O-CH2-C(=O)-(NH-DX), (maleimid-N-il)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2CH2-O-CH2-C(=O)-(NH-DX), (maleimid-N-il)-CH2CH2-C(=O)-NH-CH2CH2-O-CH2CH2-O-CH2CH2-C(=O)-GGFG-NH-CH2CH2-C(=O)-(NH-DX), (maleimid-N-il)-CH2CH2-C(=O)-NH-CH2CH2-O-CH2CH2-O-CH2CH2-C(=O)-GGFG-NH-CH2CH2CH2-C(=O)-(NH-DX), (maleimid-N-il)-CH2CH2-C(=O)-NH-CH2CH2-O-CH2CH2-O-CH2CH2-O-CH2CH2-O-CH2CH2-C(=O)-GGFG-NH-CH2CH2-C(=O)-(NH-DX), i (maleimid-N-il)-CH2CH2-C(=O)-NH-CH2CH2-O-CH2CH2-O-CH2CH2-O-CH2CH2-O-CH2CH2-C(=O)-GGFG-NH-CH2CH2CH2-C(=O)-(NH-DX).
3. Postupak prema patentnom zahtjevu 2, pri čemu spoj je jedno odabran iz sljedeće grupe: (maleimid-N-il)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2-O-CH2-C(=O)-(NH-DX), (maleimid-N-il)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2CH2-O-CH2-C(=O)-(NH-DX), i (maleimid-N-il)-CH2CH2-C(=O)-NH-CH2CH2-O-CH2CH2-O-CH2CH2-C(=O)-GGFG-NH-CH2CH2CH2-C(=O)-(NH-DX).
4. Postupak prema patentnom zahtjevu 3, pri čemu spoj je: (maleimid-N-il)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2-O-CH2-C(=O)-(NH-DX).
5. Postupak prema patentnom zahtjevu 3, pri čemu spoj je: (maleimid-N-il)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2CH2-O-CH2-C(=O)-(NH-DX).
6. Postupak prema patentnom zahtjevu 3, pri čemu spoj je: (maleimid-N-il)-CH2CH2-C(=O)-NH-CH2CH2-O-CH2CH2-O-CH2CH2-C(=O)-GGFG-NH-CH2CH2CH2-C(=O)-(NH-DX).
7. Postupak prema patentnom zahtjevu 1, pri čemu antitijelo-lijek konjugat ima lijek-veznik strukturu predstavljenu sljedećom formulom: - (Sukcinimid-3-il-N)-(CH2)n3-C(=O)-L2-LP-NH-(CH2)n1-La-(CH2)n2-C(=O)-(NH-DX), koja je konjugirana za anti-HER2 antitijelo putem tioetarske veze formirane na mjestu disulfidne veze prisutne u zglobnom dijelu anti-HER2 antitijela.
8. Postupak prema patentnom zahtjevu 4, pri čemu antitijelo-lijek konjugat ima lijek-veznik strukturu predstavljenu sljedećom formulom: - (Sukcinimid-3-il-N)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2-O-CH2-C(=O)-(NH-DX), koja je konjugirana za anti-HER2 antitijelo putem tioetarske veze formirane na mjestu disulfidne veze prisutne u zglobnom dijelu anti-HER2 antitijela.
9. Postupak prema patentnom zahtjevu 5, pri čemu antitijelo-lijek konjugat ima lijek-veznik strukturu predstavljenu sljedećom formulom: - (Sukcinimid-3-il-N)-CH2CH2CH2CH2CH2-C(=O)-GGFG-NH-CH2CH2-O-CH2-C(=O)-(NH-DX), koja je konjugirana za anti-HER2 antitijelo putem tioetarske veze formirane na mjestu disulfidne veze prisutne u zglobnom dijelu anti-HER2 antitijela.
10. Postupak prema patentnom zahtjevu 6, pri čemu antitijelo-lijek konjugat ima lijek-veznik strukturu predstavljenu sljedećom formulom: - (Sukcinimid-3-il-N)-CH2CH2-C(=O)-NH-CH2CH2-O-CH2CH2-O-CH2CH2-C(=O)-GGFG-NH-CH2CH2CH2-C(=O)-(NH-DX), koja je konjugirana za anti-HER2 antitijelo putem tioetarske veze formirane na mjestu disulfidne veze prisutne u zglobnom dijelu anti-HER2 antitijela.
11. Postupak u skladu sa bilo kojim od patentnih zahtjeva 1 do 10, pri čemu anti-HER2 antitijelo sadrži težak lanac koji se sastoji od aminokiselinske sekvence koja se sastoji od aminokiselinskih ostataka 1 do 449 sa SEK ID BR: 1 i lak lanac koji se sastoji od aminokiselinske sekvence predstavljene sa SEK ID BR: 2.
12. Postupak u skladu sa bilo kojim od patentnih zahtjeva 1 do 10, pri čemu anti-HER2 antitijelo sadrži težak lanac koji se sastoji od aminokiselinske sekvence predstavljene sa SEK ID BR: 1 i laki lanac koji se sastoji od aminokiselinske sekvence predstavljene sa SEK ID BR: 2.
13. Postupak u skladu sa bilo kojim od patentnih zahtjeva 1 do 12, pri čemu je prosječan broj jedinica odabrane lijek-veznik strukture konjugirane po antitijelu u opsegu od 2 do 8.
14. Postupak u skladu sa bilo kojim od patentnih zahtjeva 1 do 12, pri čemu je prosječan broj jedinica odabrane lijek-veznik strukture konjugirane po antitijelu u opsegu od 3 do 8.
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