HRP20210372T1 - Anti-lag3 antitijela i antigen-vezujući fragmenti - Google Patents

Anti-lag3 antitijela i antigen-vezujući fragmenti Download PDF

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HRP20210372T1
HRP20210372T1 HRP20210372TT HRP20210372T HRP20210372T1 HR P20210372 T1 HRP20210372 T1 HR P20210372T1 HR P20210372T T HRP20210372T T HR P20210372TT HR P20210372 T HRP20210372 T HR P20210372T HR P20210372 T1 HRP20210372 T1 HR P20210372T1
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Croatia
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antibody
antigen
heavy chain
binding fragment
light chain
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HRP20210372TT
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English (en)
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Linda Liang
Laurence FAYADAT-DILMAN
Rene De Waal Malefyt
Gopalan Raghunathan
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Merck Sharp & Dohme Corp.
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Application filed by Merck Sharp & Dohme Corp. filed Critical Merck Sharp & Dohme Corp.
Publication of HRP20210372T1 publication Critical patent/HRP20210372T1/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
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • 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
    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P31/00—Antiinfectives, i.e. antibiotics, antiseptics, chemotherapeutics
    • 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
    • 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
    • A61P37/02—Immunomodulators
    • 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
    • A61P37/02—Immunomodulators
    • A61P37/04—Immunostimulants
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00—Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • 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
    • C07K16/2803—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2818—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
    • 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
    • C07K16/2896—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • 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
    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507—Comprising a combination of two or more separate 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
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/32—Immunoglobulins specific features characterized by aspects of specificity or valency specific for a neo-epitope on a complex, e.g. antibody-antigen or ligand-receptor
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/33—Crossreactivity, e.g. for species or epitope, or lack of said crossreactivity
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • 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
    • 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
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • 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
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2333/00—Assays involving biological materials from specific organisms or of a specific nature
    • G01N2333/435—Assays involving biological materials from specific organisms or of a specific nature from animals; from humans
    • G01N2333/705—Assays involving receptors, cell surface antigens or cell surface determinants
    • G01N2333/70596—Molecules with a "CD"-designation not provided for elsewhere in G01N2333/705
    • Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
    • Y02A—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE
    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
    • Y02A50/30—Against vector-borne diseases, e.g. mosquito-borne, fly-borne, tick-borne or waterborne diseases whose impact is exacerbated by climate change

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  • Health & Medical Sciences (AREA)
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  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)

Claims (21)

1. Antitijelo ili njegov antigen-vezujući fragment koje se specifično veže za ljudski LAG3 i sadrži varijabilnu domenu lakog lanca koji sadrži aminokiselinsku sekvencu prikazanu u aminokiselinama 21-131 prema SEQ ID NO: 126 i varijabilnu domenu teškog lanca koji sadrži aminokiselinsku sekvencu prikazanu u aminokiselinama 1-119 prema SEQ ID NO: 116.
2. Antitijelo ili njegov antigen-vezujući fragment prema patentnom zahtjevu 1 koje sadrži imunoglobulin lakog lanca koji sadrži aminokiselinsku sekvencu prikazanu u aminokiselinama 21-238 prema SEQ ID NO: 126 i imunoglobulin teškog lanca koji sadrži aminokiselinsku sekvencu prikazanu u SEQ ID NO: 116.
3. Antitijelo prema patentnom zahtjevu 1 koje se sastoji od dva imunoglobulina lakog lanca i dva imunoglobulina teškog lanca, pri čemu se svaki imunoglobulin lakog lanca sastoji od aminokiselinske sekvence prikazane u aminokiselinama 21-238 prema SEQ ID NO: 126 i svaki imunoglobulin teškog lanca se sastoji od aminokiselinske sekvence varijabilne domene teškog lanca prikazane u aminokiselinama 1-119 prema SEQ ID NO: 116 i konstantne regije ljudskog IgG4.
4. Antitijelo prema patentnom zahtjevu 3, naznačeno time što konstantna regija ljudskog IgG4 sadrži S228P mutaciju prema EU sistemu.
5. Antitijelo prema patentnom zahtjevu 1 koje se sastoji od dva imunoglobulina lakog lanca i dva imunoglobulina teškog lanca, pri čemu svaki imunoglobulin lakog lanca sadrži aminokiselinsku sekvencu prikazanu u aminokiselinama 21-238 prema SEQ ID NO: 126 i svaki imunoglobulin teškog lanca sadrži aminokiselinsku sekvencu prikazanu u SEQ ID NO: 116.
6. Antitijelo prema patentnom zahtjevu 1 koje se sastoji od dva imunoglobulina lakog lanca i dva imunoglobulina teškog lanca, pri čemu se svaki imunoglobulin lakog lanca sastoji od aminokiselinske sekvence prikazane u aminokiselinama 21-238 prema SEQ ID NO: 126 i svaki imunoglobulin teškog lanca se sastoji od aminokiselinske sekvence prikazane u SEQ ID NO: 116.
7. Antitijelo prema patentnom zahtjevu 1, koje se sastoji od dva imunoglobulina lakog lanca i dva imunoglobulina teškog lanca, pri čemu se svaki imunoglobulin lakog lanca sastoji od aminokiselinske sekvence prikazane u aminokiselinama 21-238 prema SEQ ID NO: 126 i svaki imunoglobulin teškog lanca sadrži aminokiselinsku sekvencu prikazanu aminokiselinama 1-119 prema SEQ ID NO: 116.
8. Antitijelo ili antigen-vezujući fragment prema bilo kojem od patentnih zahtjeva 1-7 koje je eksprimirano iz stanice jajnika kineskog hrčka.
9. Antitijelo ili antigen-vezujući fragment prema bilo kojem od patentnih zahtjeva 1-7 koje je glikozilirano sa jednim ili više CHO N-vezanih glikana koji su G0-F, G1 -F, G2-F, G0, G1, G2 ili Man5.
10. Pripravak koji sadrži antitijelo ili antigen-vezujući fragment prema bilo kojem od patentnih zahtjeva 1 do 9 i farmaceutski prihvatljiv nosač ili razblaživač.
11. Pripravak prema patentnom zahtjevu 10 koji dodatno sadrži anti-PD-1 antitijelo.
12. Pripravak prema patentnom zahtjevu 11, naznačen time što, anti-PD-1 antitijelo je pembrolizumab.
13. Uređaj za ubrizgavanje koji sadrži antitijelo ili antigen-vezujući fragment prema bilo kojem od patentnih zahtjeva 1-9 ili pripravak prema bilo kojem od patentnih zahtjeva 10-12.
14. Polinukleotid koji kodira: varijabilnu domenu lakog lanca i varijabilnu domenu teškog lanca ili imunoglobulin lakog lanca i imunoglobulin teškog lanca antitijela ili antigen-vezujućih fragmenata prema bilo kojem od patentnih zahtjeva 1-9.
15. Vektor koji sadrži polinukleotid prema patentnom zahtjevu 14.
16. Stanica domaćina koja sadrži antitijelo ili antigen-vezujući fragment prema bilo kojem od patentnih zahtjeva 1-9, polinukleotid prema patentnom zahtjevu 14 ili vektor prema patentnom zahtjevu 15.
17. Postupak za proizvodnju antitijela ili njegovog antigen-vezujućeg fragmenta prema bilo kojem od patentnih zahtjeva 1-9 koji sadrži: a. kultiviranje stanice domaćina koja sadrži polinukleotid koji kodira imunoglobulin lakog lanca i imunoglobulin teškog lanca antitijela, ili varijabilnu domenu lakog lanca i varijabilnu domenu teškog lanca antigen-vezujućeg fragmenta u mediju kulture pod uvjetima povoljnim za ekspresiju polinukleotida; i b. izborno, izoliranje antitijela ili antigen-vezujućeg fragmenta iz stanice domaćina i/ili mediju kulture.
18. Postupak prema patentnom zahtjevu 17 naznačen time što stanica domaćina je stanica jajnika kineskog hrčka.
19. Antitijelo ili njegov antigen-vezujući fragment koje se specifično veže za ljudski LAG3 koje je proizvod postupka prema patentnom zahtjevu 17 ili 18.
20. Antitijelo ili antigen-vezujući fragment prema bilo kojem od patentnih zahtjeva 1-9 ili pripravak prema bilo kojem od patentnih zahtjeva 10-12, za uporabu u liječenju ljudskog tijela terapijom.
21. Antitijelo ili antigen-vezujući fragment prema bilo kojem od patentnih zahtjeva 1-9 ili pripravak prema bilo kojem od patentnih zahtjeva 10-12, za uporabu u liječenju raka.
HRP20210372TT 2014-08-19 2021-03-03 Anti-lag3 antitijela i antigen-vezujući fragmenti HRP20210372T1 (hr)

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US201462039081P 2014-08-19 2014-08-19
US201562171319P 2015-06-05 2015-06-05
EP15753877.8A EP3182999B1 (en) 2014-08-19 2015-08-17 Anti-lag3 antibodies and antigen-binding fragments
PCT/US2015/045481 WO2016028672A1 (en) 2014-08-19 2015-08-17 Anti-lag3 antibodies and antigen-binding fragments

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HRP20210372T1 true HRP20210372T1 (hr) 2021-07-09

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US (6) US20170290914A1 (hr)
EP (2) EP3182999B1 (hr)
JP (3) JP2017532059A (hr)
KR (2) KR102037197B1 (hr)
CN (1) CN107001470B (hr)
AP (1) AP2017009763A0 (hr)
AU (3) AU2015305770C1 (hr)
BR (1) BR112017003194B8 (hr)
CA (2) CA3082655A1 (hr)
CL (1) CL2017000311A1 (hr)
CO (1) CO2017001558A2 (hr)
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DK (1) DK3182999T3 (hr)
DO (1) DOP2017000047A (hr)
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HR (1) HRP20210372T1 (hr)
HU (1) HUE053641T2 (hr)
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