ME02842B - Potpuno ljudska antitijela specifična za cadm1 - Google Patents

Potpuno ljudska antitijela specifična za cadm1

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Publication number
ME02842B
ME02842B MEP-2017-194A MEP19417A ME02842B ME 02842 B ME02842 B ME 02842B ME P19417 A MEP19417 A ME P19417A ME 02842 B ME02842 B ME 02842B
Authority
ME
Montenegro
Prior art keywords
antibody
variable region
chain variable
seq
cadm1
Prior art date
Application number
MEP-2017-194A
Other languages
German (de)
English (en)
French (fr)
Inventor
Jonathan Alexander Terrett
Heidi Leblanc
Haichun Huang
Erika Meaddough
Chin Pan
Bingliang Chen
Chetana Rao-Naik
Original Assignee
Squibb & Sons Llc
Oxford Biotherapeutics Ltd
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Filing date
Publication date
Application filed by Squibb & Sons Llc, Oxford Biotherapeutics Ltd filed Critical Squibb & Sons Llc
Publication of ME02842B publication Critical patent/ME02842B/me

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • A61K33/24—Heavy metals; Compounds thereof
    • A61K33/243—Platinum; Compounds thereof
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3007—Carcino-embryonic Antigens
    • 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • A61P35/02—Antineoplastic agents specific for leukemia
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3023—Lung
    • 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
    • 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
    • C07K2317/40—Immunoglobulins specific features characterized by post-translational modification
    • C07K2317/41—Glycosylation, sialylation, or fucosylation
    • 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
    • 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
    • C07K2317/732—Antibody-dependent cellular cytotoxicity [ADCC]
    • 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
    • C07K2317/77—Internalization into the cell

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Immunology (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Oncology (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Cell Biology (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Biomedical Technology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Inorganic Chemistry (AREA)
  • Hematology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Claims (14)

1. Izolovana monoklonalna antitijela, ili njegov deo koji vezuje antigen, ili fragment antitela koji vezuje epitop na ljudski CADM1 i obuhvata promenljivi region teškog lanca koji obuhvata sekvencu amino kiseline iznetu u SEK ID BR: 19, 20, ili 21 promenljivi region lakog lanca koji obuhvata sekvencu amino kiseline iznetu u SEK ID BR: 22, 23, ili 24.
2. Izolovana monoklonalna antitelo, ili njego deo koji vezuje antigen, ili fragment antitela koji vezuje epitop na ljudski CADM1 i koji obuhvata:(a) promenljivi region teškog lanca CDR1 koji obuhvata SEK ID BR: 1, promenljivi region teškog lanca CDR2 koji obuhvata SEK ID BR: 4, promenljivi region teškog lanca CDR3 koji obuhvata SEK ID BR: 7, promenljivi region lakog lanca CDR1 koji obuhvata SEK ID BR: 10, promenljivi region lakog lanca CDR2 koji obuhvata SEK ID BR: 13, i promenljivi region lakog lanca CDR3 koji obuhvata SEK ID BR: 16;ili(b) promenljivi region teškog lanca CDR1 koji obuhvata SEK ID BR: 2, promenljivi region teškog lanca CDR2 koji obuhvata SEK ID BR: 5, promenljivi region teškog lanca CDR3 koji obuhvata SEK ID BR: 8, promenljivi region lakog lanca CDR1 koji obuhvata SEK ID BR: 11, promenljivi region lakog lanca CDR2 koji obuhvata SEK ID BR: 14, i promenljivi region lakog lanca CDR3 koji obuhvata SEK ID BR: 17;ili(e) promenljivi region teškog lanca CDR1 koji obuhvata SEK ID BR: 3,promenljivi region teškog lanca CDR2 koji obuhvata SEK ID BR: 6, promenljivi region teškog lanca CDR3 koji obuhvata SEK ID BR: 9, promenljivi region lakog lanca CDR1 koji obuhvata SEK ID BR: 12, promenljivi region lakog lanca CDR2 koji obuhvata SEK ID BR: 15, i promenljivi region lakog lanca CDR3 kojiobuhvata SEK IDBR: 18.
3. Antitelo iz patentnog zahteva 1 ili patentnog zahteva 2:(A) pri čemu pomenuto antitelo jeste antitelo pune dužine lgG1, lgG2, lgG3, ili lgG4 izotipa;(B) pri čemu se pomenuto antitelo bira iz grupe koja obuhvata celo antitelo, fragment antitela, humanizovano antitelo, ljudsko antitelo, antitelo jednog lanca, projektovano antitelo koje kao rezultat daje povećano vezivanje na Fc receptore i/ili povećanu učinkovitost za ADCC, i bispecifično antitelo; (C) pri čemu ovo antitelo koje se konjuguje na terapijski agens, poželjno gde je terapijski agens je citotoksin ili radioaktivni izotop; ili(D) pri čemu se pomenuto antitelo vezuje na ljudski CADM1 sa EC50 u opsegu od < 50 nM, preporučljivo pri ćemu se pomenuto antitelo vezuje na ljudski CADM1 sa ECso u opsegu < 10 nM, i još preporućljivije pri ćemu se pomenuto antitelo vezuje na ljudski CADM1 sa ECso u opsegu< 1 nM.
4. Supstanca koja obuhvata izolovana antitelo, deo koji vezuje antigen ili fragment antitela koji vezuje epitop na ljudski CADM1 iz patentnog zahteva 1 ili patentnog zahteva 2 i farmaceutski prihvatljivog nosača.
5. Izolovani moleku! nukleinske kiseline koji kodira teški ili laki lanac antitela ili deo koji vezuje antigen ili fragment antitela koji vezuje epitop na ljudski CADM1 iz patentnog zahteva 1 ili patentnog zahteva 2; ili vektor ekspresije koji obuhvata pomenuti moleku! nukleinske kiseline; ili ćeliju domaćina koja obuhvata pomenuti vektor ekspresije.
6. Postupak za pripremu anti-CADM1 antitela, pomenuti postupak obuhvata korake:dobijanja ćelije domaćina koja obuhvata jedan ili više molekula nukleinske kiseline koji kodira antitelo iz patentnog zahteva 1 ili patentnog zahteva 2, rast ili uzgoj ćelije domaćina u kulturi ćelije domaćina; obezbeđivanje uslova kulture ćeije domaćina pri čemu se ispoljava jedan ili više molekula nukleinske kiseline; i oporavlja antitelo iz ćelije domaćina ili iz kulture ćelije domaćina.
7 Izolovana monoklonalna antitelo, ili njegov deo koji vezuje antigen, ili fragment antitela kako je definisano u patentnom zahtevu 1 ili patentnom zahtevu 2 za upotrebu u postupku za lečenje ili sprečavanje bolesti povezane sa ciljnim ćelijama koje ispoljavaju CADM1, preporučljivo pri čemu je pomenuta bolest kancer kod čoveka, i još preporućljivije pri čemu se pomenuti kancer kod čoveka bira iz grupe koja obuhvata: sitnoćelijski kancer pluća, leukemija T ćelije kod odraslih, nesitnoćelijski kancer pluća (uključujući skvamozne karcinome i adenokarcinome), melanom, kancer dojke, kolorektalni kancer, kancer jajnika, kancer prostate, neuroendokrine kancere ukljućujući kancere pluća, nadbubrežne žlezde, hipofize, Gl trakta, bubrega, jetre (ukljućujući hepatoćelijske karcinome), pankreas (uključujući insulinome i glukagonome), glioblastome, i kardinoidne tumore uključujući tumore pankreasa, pluća, Gl trakta, jetre i bubrega.
8. Izolovana monoklonalna antitelo ili njegov deo koji vezuje antigen, ili fragment antitela prema patentnom zahtevu 1 ili patentnom zahtevu 2 koji vezuje epitop na ljudski CADM1 i obuhvata promenljivi region teškog lanca i promenljivi region lakog lanca izabrane iz grupe koja obuhvata:amino kiselinu promenljivog regiona teškog lanca iznetu u SEK ID BR: 19 i sekvencu amino kiseline promenljivog regiona teškog lanca iznetu u SEK ID BR: 22;sekvencu amino kiseline promenljivog regiona teškog lanca iznetu u SEK ID BR: 20 i sekvencu amino kiseline promenljivog regiona lakog lanca iznetu u SEK ID BR: 23; isekvencu amino kiseline promenljivog regiona teškog lanca iznetu u SEK ID BR: 21 i sekvencu amino kiseline promenljivog regiona lakog lanca iznetu u SEK ID BR: 24.
9. Izolovane antitelo iz patentnog zahteva 8:pri čemu se pomenuto antitelo bira iz grupe koja obuhvata: celo antitelo, fragment antitela, humanizovano antitelo, ljudsko antitelo, antitelo jednog lanca, projektovano antitelo koje kao rezultat daje povećano vezivanje na Fc receptore i/ili povećanu učinkovitost za ADCC, i bispecifično antitelo;
10. Supstanca koja obuhvata izolovane antitelo ili njegov deo koji vezuje antigen iz patentnog zahteva 8 i farmaceutski prihvatljiv nosač.
11 . Izolovani molekul nukleinske kiseline koji kodira teški ili laki lanac izolovanog antitela ili njegov deo koji vezuje antigen iz patentnog zahteva 8; ili vektor ekspresije koji obuhvata pomenuti molekul nukleinske kiseline; ili ćeliju domaćina koja obuhvata pomenuti vektor ekspresije.
12. Hibridom koji ispoljava antitelo ili deo koji vezuje antigen ili fragment antitela koji vezuje epitop na ljudski CADM1 iz bilo kog od patentnih zahteva 1, 2 ili 8.
13. Postupak za pravljenje antitela iz bilo kog od patentnih zahteva 1, 2 ili 8 koji obuhvata korake:imunizovanja transgenske životinje koje obuhvata ljudske gene imunoglobulina sa CADM1 peptidom;oporavljanja B ćelje iz pomenute transgenske životinje;pravljenje hibridoma iz pomenutih B ćelija;selekcija hibridoma koji ispoljavaju antitela koja vezuju CADM1; ioporavljanja pomenutih antitela koja vezuju CADM1 iz pomenutih izabranih hibridoma.
14. Postupak za pravljenje anti-CADM1 antitela, pomenuti postupak obuhvata korake:imunizovanja transgenske životinje koja obuhvata ljudske gene imunoglobulina sa CADM1 peptidom;oporavljanja mRNK iz B ćelije pomenute transgenske životinje;pretvaranje pomenute mRNK u cDNK;ispoljavanje pomenute cONK u fagima tako da se anti-CADM1 antitela kodirana pomenutom cDNKpredstavljaju na površini pomenutih faga;biranje faga koji predstavljaju anti-CADM1 antitela;oporavljanja molekula nukleinske kiseline iz pomenutih izabranih faga koji kodiraju pomenute anti CADM1 imunoglobulina;ispoljavanje pomenutih oporavljenih molekula nukleinske kiseline u ćeliji domaćinu; ioporavljanje antitela kako je definisano u bilo kom od patentnih zahteva 1, 2 ili 8 iz pomenute ćelije domaćina koji vežu CADM1.
5. lmunokonjugat koji obuhvata (i) izolovane antitelo kako se tvrdi u patentnom zahtevu 8 ili patentnom zahtevu 9 i (ii) terapijski agens.
MEP-2017-194A 2009-03-05 2010-03-05 Potpuno ljudska antitijela specifična za cadm1 ME02842B (me)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US20947109P 2009-03-05 2009-03-05
US20939009P 2009-03-05 2009-03-05
EP10708470.9A EP2403878B1 (en) 2009-03-05 2010-03-05 Fully human antibodies specific to cadm1
PCT/US2010/026315 WO2010102175A1 (en) 2009-03-05 2010-03-05 Fully human antibodies specific to cadm1

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ME02842B true ME02842B (me) 2018-01-20

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US (2) US8420084B2 (me)
EP (1) EP2403878B1 (me)
JP (1) JP5816558B2 (me)
KR (1) KR101769160B1 (me)
CN (1) CN102341412B (me)
AU (1) AU2010221186B2 (me)
BR (1) BRPI1009232B1 (me)
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EA (1) EA028336B1 (me)
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HR (1) HRP20171274T1 (me)
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ME (1) ME02842B (me)
MX (1) MX2011009220A (me)
NZ (1) NZ594682A (me)
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UA (1) UA102891C2 (me)
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