HRP20180147T1 - Cea protutijela - Google Patents

Cea protutijela Download PDF

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Publication number
HRP20180147T1
HRP20180147T1 HRP20180147TT HRP20180147T HRP20180147T1 HR P20180147 T1 HRP20180147 T1 HR P20180147T1 HR P20180147T T HRP20180147T T HR P20180147TT HR P20180147 T HRP20180147 T HR P20180147T HR P20180147 T1 HRP20180147 T1 HR P20180147T1
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HR
Croatia
Prior art keywords
antibody
seq
antibody according
increased
cancer
Prior art date
Application number
HRP20180147TT
Other languages
English (en)
Inventor
Thomas U. Hofer
Ralf Hosse
Ekkehard Moessner
Pablo Umana
Original Assignee
Roche Glycart Ag
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Publication date
Application filed by Roche Glycart Ag filed Critical Roche Glycart Ag
Publication of HRP20180147T1 publication Critical patent/HRP20180147T1/hr

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    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/42—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against immunoglobulins
    • 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
    • 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
    • A61K39/39566—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against immunoglobulins, e.g. anti-idiotypic antibodies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06—Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N5/00—Radiation therapy
    • A61N5/10—X-ray therapy; Gamma-ray therapy; Particle-irradiation therapy
    • 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
    • A61P37/00—Drugs for immunological or allergic disorders
    • 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
    • C07K16/3007—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
    • 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
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • 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
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/90—Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

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

Claims (20)

1. Izolirano protutijelo, naznačeno time, da ono veže membranski vezani karcinoembrionski antigen (CEA), pri čemu to protutijelo obuhvaća varijabilnu regiju teškog lanca koja posjeduje: CDR1 teškog lanca od SEQ ID NO:1, CDR2 teškog lanca od SEQ ID NO:13, CDR3 teškog lanca od SEQ ID NO:223, i varijabilnu regiju lakog lanca koja posjeduje: CDR1 lakog lanca od SEQ ID NO:39, CDR2 lakog lanca od SEQ ID NO:49, i CDR3 lakog lanca od SEQ ID NO:56.
2. Protutijelo u skladu s patentnim zahtjevom 1, naznačeno time, da protutijelo obuhvaća okvirne ostatke CH1A1A (SEQ ID NO: 261) ili CH1A1B (SEQ ID NO: 262).
3. Protutijelo u skladu s patentnim zahtjevima 1 ili 2, naznačeno time, da se protutijelo veže za isti epitop kao i mišje monoklonsko protutijelo PR1A3, ili je sposobno da se natječe za vezanje s mišjim monoklonskim protutijelom PR1A3.
4. Protutijelo u skladu s bilo kojim od patentnih zahtjeva 1-3, naznačeno time, da se protutijelo veže za membranski vezanu CEA s Kd od 100 nM, 10 nM, 1 nM ili manje.
5. Protutijelo, naznačeno time, da ono veže membranski vezani humani karcinoembrionski antigen (CEA), pri čemu varijabilna regija teškog lanca sadrži aminokiselinsku sekvencu odabranu iz skupine koju čine SEQ ID NO: 239 i SEQ ID NO: 247, te pritom varijabilna regija lakog lanca sadrži aminokiselinsku sekvencu SEQ ID NO: 209.
6. Protutijelo u skladu s patentnim zahtjevom 5, naznačeno time, da varijabilna regija teškog lanca sadrži aminokiselinsku sekvencu SEQ ID NO: 239 i varijabilna regija lakog lanca sadrži aminokiselinsku sekvencu SEQ ID NO: 209.
7. Protutijelo u skladu s bilo kojim od zahtjeva 1-6, naznačeno time, da protutijelo sadrži Fc regiju koja je bila podvrgnuta glikoinženjeringu.
8. Protutijelo u skladu sa zahtjevom 7, naznačeno time, da su najmanje 20% do 100% N-vezanih oligosaharida u Fc regiji nefukozilirani.
9. Protutijelo u skladu s patentnim zahtjevom 7, naznačeno time, da su najmanje 20% do 100% N-vezanih oligosaharida u Fc regiji prepolovljeni.
10. Protutijelo u skladu sa zahtjevom 7, naznačeno time, da su najmanje 20% do 50% N-vezanih oligosaharida u Fc regiji prepolovljeni, nefukozilirani.
11. Protutijelo u skladu s bilo kojim od zahtjeva 7-10, naznačeno time, da protutijelo ima barem jednu povećanu efektorsku funkciju.
12. Protutijelo u skladu s patentnim zahtjevom 11, naznačeno time, da je barem jedna povećana efektorska funkcija odabrana iz skupine koju čine: povećani afinitet vezivanja Fc receptora, povećana stanična citotoksičnost posredovana protutijelima (ADCC), povećano vezivanje na NK stanice, povećano vezivanje na makrofage, povećano vezivanje na monocite, povećano vezivanje na polimorfonuklearne stanice, izravna signalizacija za induciranje apoptoze, povećano sazrijevanje dendritične stanice i povećano primiranje T stanice.
13. Protutijelo u skladu sa zahtjevom 12, naznačeno time, da protutijelo ima povećanje u ADCC od najmanje 40% do 100% u usporedbi s roditeljskim protutijelom koje nije bilo podvrgnuto glikoinženjeringu.
14. Izolirani polinukleotid, naznačen time, da on kodira protutijelo u skladu s bilo kojim od patentnih zahtjeva 1-13.
15. Vektor, naznačen time, da on obuhvaća polinukleotid prema patentnom zahtjevu 14.
16. Stanica domaćina, naznačena time, da ona obuhvaća vektor prema patentnom zahtjevu 15.
17. Pripravak, naznačen time, da on obuhvaća protutijelo u skladu s bilo kojim od zahtjeva 1-13 i farmaceutski prihvatljiv nosač.
18. Protutijelo prema bilo kojem od zahtjeva 1-13, ili pripravak prema zahtjevu 17, naznačen/o time, da se upotrebljava u liječenju raka koji abnormalno izražava CEA.
19. Protutijelo ili pripravak za uporabu prema zahtjevu 18, naznačen/o time, da je rak odabran iz skupine koja se sastoji od raka debelog crijeva, raka ne-malih stanica pluća (NSCLC), raka želuca, raka gušterače i raka dojke.
20. Protutijelo ili pripravak za uporabu prema zahtjevu 18 ili 19, naznačen/o time, da se protutijelo ili pripravak daje u kombinaciji s kemoterapijom ili terapijom zračenjem.
HRP20180147TT 2011-03-02 2012-02-29 Cea protutijela HRP20180147T1 (hr)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
EP11156665 2011-03-02
PCT/EP2012/053390 WO2012117002A1 (en) 2011-03-02 2012-02-29 Cea antibodies
EP12707732.9A EP2681244B1 (en) 2011-03-02 2012-02-29 Cea antibodies

Publications (1)

Publication Number Publication Date
HRP20180147T1 true HRP20180147T1 (hr) 2018-02-23

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ID=45811481

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Application Number Title Priority Date Filing Date
HRP20180147TT HRP20180147T1 (hr) 2011-03-02 2012-02-29 Cea protutijela

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US (7) US8642742B2 (hr)
EP (2) EP3333193A1 (hr)
JP (1) JP6046642B2 (hr)
KR (1) KR101981342B1 (hr)
CN (1) CN103403029B (hr)
AR (1) AR085591A1 (hr)
AU (1) AU2012222463B9 (hr)
BR (1) BR112013021460B1 (hr)
CA (1) CA2827722C (hr)
CL (1) CL2013002203A1 (hr)
CO (1) CO6781491A2 (hr)
CR (1) CR20130359A (hr)
DK (1) DK2681244T3 (hr)
EA (1) EA029300B1 (hr)
EC (1) ECSP13012859A (hr)
ES (1) ES2657856T3 (hr)
HR (1) HRP20180147T1 (hr)
HU (1) HUE036229T2 (hr)
IL (1) IL227482B (hr)
LT (1) LT2681244T (hr)
MA (1) MA34927B1 (hr)
MX (1) MX347590B (hr)
MY (1) MY164647A (hr)
NO (1) NO2681244T3 (hr)
PE (1) PE20141017A1 (hr)
PH (1) PH12013501508B1 (hr)
PL (1) PL2681244T3 (hr)
PT (1) PT2681244T (hr)
RS (1) RS56793B1 (hr)
SG (1) SG192972A1 (hr)
SI (1) SI2681244T1 (hr)
TW (1) TWI553016B (hr)
UA (1) UA115030C2 (hr)
WO (1) WO2012117002A1 (hr)
ZA (1) ZA201305323B (hr)

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