HRP20171315T1 - Optimizacija humanih antitijela koja vezuju limfocitni aktivacijski gen-3 (lag-3), i njihove primjene - Google Patents

Optimizacija humanih antitijela koja vezuju limfocitni aktivacijski gen-3 (lag-3), i njihove primjene Download PDF

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HRP20171315T1
HRP20171315T1 HRP20171315TT HRP20171315T HRP20171315T1 HR P20171315 T1 HRP20171315 T1 HR P20171315T1 HR P20171315T T HRP20171315T T HR P20171315TT HR P20171315 T HRP20171315 T HR P20171315T HR P20171315 T1 HRP20171315 T1 HR P20171315T1
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antibody
antigen
binding portion
immunoconjugate
bispecific molecule
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Nils Lonberg
Mohan Srinivasan
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Bristol-Myers Squibb Company
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Publication of HRP20171315T1 publication Critical patent/HRP20171315T1/hr

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    • A—HUMAN NECESSITIES
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    • 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
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
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    • A61K45/00—Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
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    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6849—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a receptor, a cell surface antigen or a cell surface determinant
    • 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
    • A61P31/12—Antivirals
    • 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
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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • 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
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    • C07—ORGANIC CHEMISTRY
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    • 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
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    • C07—ORGANIC CHEMISTRY
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    • 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
    • C07K16/2827—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 B7 molecules, e.g. CD80, CD86
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • A61K2039/505—Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507—Comprising a combination of two or more separate 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
    • 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
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    • C07—ORGANIC CHEMISTRY
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    • 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
    • C07K16/3061—Blood cells
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    • C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
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    • 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
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    • C07K2317/75—Agonist effect on antigen
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    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
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    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

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Claims (35)

1. Izolirano monoklonsko antitijelo, ili njegov antigen-vezujući dio, koji vezuje humani LAG-3, gdje CDR1, CDR2, i CDR3 regije teškog lanca sadrže aminokiselinske sekvence sa identifikacijskim brojevima sekvenci - SEQ ID NOs: 15, 16, i 17, redom, i gdje CDR1, CDR2, i CDR3 regije lakog lanca sadrže aminokiselinske sekvence sa SEQ ID NOs: 18, 19, i 20, redom.
2. Antitijelo, ili njegov antigen-vezujući dio, patentnog zahtjeva 1, gdje varijabilna regija teškog lanca sadrži aminokiselinsku sekvencu sa SEQ ID NO: 12, i varijabilnu regiju lakog lanca sadrži aminokiselinsku sekvencu sa SEQ ID NO: 14.
3. Antitijelo, ili njegov antigen-vezujući dio, bilo kojeg od prethodnih patentnih zahtjeva, koji pokazuje jednu ili kombinaciju sljedećih svojstava: (a) vezivanje za majmunski LAG-3; (b) nedostatak vezivanja za mišji LAG-3; (c) vezivanje za LAG-3 molekule glavnog kompleksa histokompatibilnosti (MHC) klase II; (d) inhibira vezivanje LAG-3 za molekule glavnog kompleksa histokompatibilnosti (MHC) klase II; ili (e) stimulira imunološki odgovor.
4. Antitijelo, ili njegov antigen-vezujući dio, bilo kojeg od prethodnih patentnih zahtjeva, koji stimulira proizvodnju interleukina-2 (IL-2) u odgovoru antigen-specifične T stanice i/ili stimulira anti-tumorski imunološki odgovor.
5. Antitijelo, ili njegov antigen-vezujući dio, bilo kojeg od prethodnih patentnih zahtjeva, koji se vezuje za humani LAG-3 sa KD od 0.27 x 10-9 M ili manje kao što je određeno površinskom plazmonskom rezonancom.
6. Antitijelo, ili njegov antigen-vezujući dio, bilo kojeg od prethodnih patentnih zahtjeva, koje je humano antitijelo.
7. Antitijelo, ili njegov antigen-vezujući dio, bilo kojeg od prethodnih patentnih zahtjeva, koje je IgG1, IgG2 ili IgG4 izotip.
8. Antitijelo, ili njegov antigen-vezujući dio, bilo kojeg od prethodnih patentnih zahtjeva, koje je IgG4 izotip.
9. Antitijelo, ili njegov antigen-vezujući dio, bilo kojeg od prethodnih patentnih zahtjeva, koje je fragment antitijela ili antitijelo sa jednim lancem.
10. Antitijelo bilo kojeg od patentnih zahtjeva 1-8, koje je antitijelo u punoj dužini.
11. Antitijelo bilo kojeg od patentnih zahtjeva 1-8 ili 10, gdje antitijelo je izolirano IgG4 humano monoklonsko antitijelo u punoj dužini koje se vezuje za humani LAG-3 sa KD od 0.27 x 10-9 M ili manje kao što je određeno površinskom plazmonskom rezonancom.
12. Bispecifična molekula koja sadrži antitijelo, ili njegov antigen-vezujući dio, bilo kojeg od prethodnih patentnih zahtjeva, i drugo antitijelo ili njegov antigen-vezujući dio.
13. Imunokonjugat koji sadrži antitijelo, ili njegov antigen-vezujući dio, bilo kojeg od patentnih zahtjeva 1-11, vezan za terapijski agens.
14. Imunokonjugat patentnog zahtjeva 13, gdje terapijski agens je citotoksin ili radioaktivni izotop.
15. Kompozicija koji sadrži antitijelo, ili njegov antigen-vezujući dio, bilo kojeg od patentnih zahtjeva 1-11, bispecifična molekula patentnog zahtjeva 12, ili imunokonjugat patentnog zahtjeva 13 ili 14, i farmaceutski prihvatljiv nosač.
16. Kompozicija patentnog zahtjeva 15, koja dalje sadrži antikancerogeni agens.
17. Kompozicija patentnog zahtjeva 16, gdje antikancerogeni agens je antitijelo ili kemoterapijski agens.
18. Kompozicija patentnog zahtjeva 17, gdje antitijelo je antitijelo u punoj dužini.
19. Kompozicija patentnog zahtjeva 17 ili 18, gdje antitijelo je IgG4 izotip.
20. Izolirana nukleinska kiselina koja kodira varijabilnu regiju teškog i lakog lanca antitijela, ili njegov antigen-vezujući dio, patentnog zahtjeva 1 ili 2.
21. Ekspresivni vektor koji sadrži nukleinsku kiselinu patentnog zahtjeva 20.
22. Stanica domaćina koja sadrži ekspresivni vektor patentnog zahtjeva 21.
23. Metoda za pripremanje anti-LAG-3 antitijela koja sadrži eksprimiranje antitijela u stanici domaćina patentnog zahtjeva 22 i izoliranje antitijela iz stanice domaćina.
24. Antitijelo, ili njegov antigen-vezujući dio, bilo kojeg od patentnih zahtjeva 1-11, ili bispecifična molekula patentnog zahtjeva 12, ili imunokonjugat patentnog zahtjeva 13 ili 14 za primjenu u metodi stimulacije imunološkog odgovora kod subjekta.
25. Antitijelo, antigen-vezujući dio, bispecifična molekula, ili imunokonjugat za primjenu u skladu sa patentnim zahtjevom 24, gdje subjekt je subjekt koji ima tumor i imunološki odgovor na tumor je stimuliran.
26. Antitijelo, antigen-vezujući dio, bispecifična molekula, ili imunokonjugat za primjenu u skladu sa patentnim zahtjevom 24, gdje subjekt je subjekt koji ima virus i imunološki odgovor na virus je stimuliran.
27. Antitijelo, antigen-vezujući dio, bispecifična molekula, ili imunokonjugat za primjenu u skladu sa patentnim zahtjevom 24, gdje imunološki odgovor je odgovor antigen-specifične T stanice, tako da je odgovor antigen-specifične T stanice stimuliran.
28. Antitijelo, antigen-vezujući dio, bispecifična molekula, ili imunokonjugat za primjenu u skladu sa patentnim zahtjevom 27, gdje je proizvodnja interleukina-2 pomoću antigen-specifične T stanice stimulirana.
29. Antitijelo, antigen-vezujući dio, bispecifična molekula, ili imunokonjugat za primjenu u skladu sa bilo kojim od patentnih zahtjeva 24-26, koji dalje sadrži administraciju najmanje jednog dodatnog imunostimulirajućeg antitijela.
30. Antitijelo, antigen-vezujući dio, bispecifična molekula, ili imunokonjugat za primjenu u skladu sa patentnim zahtjevom 29, gdje najmanje jedno imunostimulirajuće dodatno antitijelo je anti-PD-1 antitijelo.
31. Antitijelo, antigen-vezujući dio, bispecifična molekula, ili imunokonjugat za primjenu u skladu sa patentnim zahtjevom 29, gdje najmanje jedno dodatno imunostimulirajuće antitijelo je anti-PD-L1 antitijelo.
32. Antitijelo, antigen-vezujući dio, bispecifična molekula, ili imunokonjugat za primjenu u skladu sa patentnim zahtjevom 29, gdje najmanje jedno dodatno imunostimulirajuće antitijelo je anti-CTLA-4 antitijelo.
33. Antitijelo, ili njegov antigen-vezujući dio, bilo kojeg od patentnih zahtjeva 1-11, bispecifična molekula patentnog zahtjeva 12, ili imunokonjugat patentnog zahtjeva 13 ili 14 za primjenu u metodi za inhibiranje rasta tumorskih stanica kod subjekta.
34. Antitijelo, ili njegov antigen-vezujući dio, bilo kojeg od patentnih zahtjeva 1-11, bispecifična molekula patentnog zahtjeva 12, ili imunokonjugat patentnog zahtjeva 13 ili 14 za primjenu u metodi za liječenje virusne infekcije kod subjekta.
35. Primjena antitijela, ili njegov antigen-vezujući dio, bilo kojeg od patentnih zahtjeva 1-11, bispecifična molekula patentnog zahtjeva 12, ili imunokonjugat patentnog zahtjeva 13 ili 14, u proizvodnji lijeka za stimuliranje imunološkog odgovora, opcionalno odgovor antigen specifične T stanice, ili inhibiranje rasta tumorskih stanica, ili liječenje virusne infekcije kod subjekta.
HRP20171315TT 2012-07-02 2017-08-31 Optimizacija humanih antitijela koja vezuju limfocitni aktivacijski gen-3 (lag-3), i njihove primjene HRP20171315T1 (hr)

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US201261667058P 2012-07-02 2012-07-02
PCT/US2013/048999 WO2014008218A1 (en) 2012-07-02 2013-07-02 Optimization of antibodies that bind lymphocyte activation gene-3 (lag-3), and uses thereof
EP13737946.7A EP2867258B1 (en) 2012-07-02 2013-07-02 Optimization of human antibodies that bind lymphocyte activation gene-3 (lag-3), and uses thereof

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HRP20201852TT HRP20201852T8 (hr) 2012-07-02 2020-11-20 Optimizacija antitijela koja vezuju limfocitni aktivacijski gen-3 (lag-3), i njihove primjene

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US (6) US9505839B2 (hr)
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JP (5) JP6320376B2 (hr)
KR (5) KR102126596B1 (hr)
CN (2) CN108101991B (hr)
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AU (4) AU2013286914B2 (hr)
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