HRP20230941T1 - Anti-tigit antitijela i postupci njihove primjene - Google Patents

Anti-tigit antitijela i postupci njihove primjene Download PDF

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HRP20230941T1
HRP20230941T1 HRP20230941TT HRP20230941T HRP20230941T1 HR P20230941 T1 HRP20230941 T1 HR P20230941T1 HR P20230941T T HRP20230941T T HR P20230941TT HR P20230941 T HRP20230941 T HR P20230941T HR P20230941 T1 HRP20230941 T1 HR P20230941T1
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antibody
heavy chain
optionally
amino acid
acid sequence
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HRP20230941TT
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Dhan Sidhartha CHAND
Nicholas Stuart Wilson
Dennis John Underwood
Benjamin Maxime MORIN
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Agenus Inc.
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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
    • C07K16/2818—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
    • A—HUMAN NECESSITIES
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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
    • C07K16/2875—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 NGF/TNF superfamily, e.g. CD70, CD95L, CD153, CD154
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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
    • C07K16/2878—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 NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • C—CHEMISTRY; METALLURGY
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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
    • 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
    • G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
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    • G01N33/5044—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics involving specific cell types
    • G01N33/5047—Cells of the immune system
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    • A—HUMAN NECESSITIES
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
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    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
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    • C07K2317/71—Decreased effector function due to an Fc-modification
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    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
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    • C07K2317/734—Complement-dependent cytotoxicity [CDC]
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    • Y02—TECHNOLOGIES OR APPLICATIONS FOR MITIGATION OR ADAPTATION AGAINST CLIMATE CHANGE
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    • Y02A50/00—TECHNOLOGIES FOR ADAPTATION TO CLIMATE CHANGE in human health protection, e.g. against extreme weather
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Claims (12)

1. Izolirano antitijelo koje se specifično vezuje za humani TIGIT, antitijelo koje sadrži varijabilnu regiju teškog lanca (VH) koji sadrži aminokiselinsku sekvencu danu u SEK ID BR: 9, i varijabilnu regiju lakog lanca (VL) koji sadrži aminokiselinsku sekvencu danu u SEK ID BR: 10.
2. Izolirano antitijelo prema patentnom zahtjevu 1, pri čemu antitijelo sadrži konstantnu regiju teškog lanca odabranu od grupe koja se sastoji od humanog IgG1, IgG2, IgG3, IgG4, IgA1, i IgA2.
3. Izolirano antitijelo prema patentnom zahtjevu 1 ili 2, pri čemu antitijelo sadrži: (a) IgG1 konstantna regija teškog lanca, po izboru gdje (i) IgG1 konstantna regija teškog lanca sadrži aminokiselinsku sekvencu iz SEK ID BR: 19; (ii) aminokiselinska sekvenca konstantne regije teškog lanca IgG1 sadrži N297A mutaciju numeriranu prema EU sistemu numeracije; (iii) konstantna regija teškog lanca IgG1 sadrži aminokiselinsku sekvencu iz SEK ID BR: 20; (iv) aminokiselinska sekvenca konstantne regije teškog lanca IgG1 sadrži L234F, L235F i N297A mutacije, numerirane prema EU sistemu numeracije; (v) konstantna regija teškog lanca IgG1 sadrži aminokiselinsku sekvencu iz SEK ID BR: 21; (vi) aminokiselinska sekvenca konstantne regije teškog lanca IgG1 sadrži S239D i I332E mutacije, numerirane prema EU sistemu numeracije; (vii) konstantna regija teškog lanca IgG1 sadrži aminokiselinsku sekvencu iz SEK ID BR: 22; (viii) aminokiselinska sekvenca konstantne regije teškog lanca IgG1 sadrži S239D, A330L i I332E mutacije, numerirane prema EU sistemu numeracije; (ix) konstantna regija teškog lanca IgG1 sadrži aminokiselinsku sekvencu iz SEK ID BR: 23; (x) aminokiselinska sekvenca konstantne regije teškog lanca IgG1 sadrži L235V, F243L, R292P, Y300L i P396L mutacije, numerirane prema EU sistemu numeracije; (xi) konstantna regija teškog lanca IgG1 sadrži aminokiselinsku sekvencu iz SEK ID BR: 24; (xii) aminokiselinska sekvenca konstantne regije teškog lanca IgG1 sadrži S267E i L328F mutacije, numerirane prema EU sistemu numeracije; (xiii) konstantna regija teškog lanca IgG1 sadrži aminokiselinsku sekvencu iz SEK ID BR: 25; ili (xiv) konstantna regija teškog lanca IgG1 je afukoziliran; ili (b) konstantna regija teškog lanca IgG4 , po izboru gdje (i) aminokiselinska sekvenca konstantne regije teškog lanca IgG4 sadrži S228P mutaciju, numeriranu prema EU sistemu numeracije; i/ili (ii) konstantna regija teškog lanca IgG4 sadrži aminokiselinsku sekvencu iz SEK ID BR: 26.
4. Izolirano antitijelo prema bilo kojem od patentnih zahtjeva 1-3, pri čemu antitijelo sadrži konstantnu regiju lakog lanca koji sadrži aminokiselinsku sekvencu iz SEK ID BR: 28.
5. Izolirano antitijelo prema bilo kojem od patentnih zahtjeva 1-4, pri čemu antitijelo sadrži teški lanac koji sadrži aminokiselinsku sekvencu odabranu iz grupe koja se sastoji od SEK ID Brojevima: 11-18 i/ili laki lanac koji sadrži aminokiselinsku sekvencu iz SEK ID BR: 27.
6. Izolirano antitijelo prema bilo kojem od patentnih zahtjeva 1-5, pri čemu: (a) antitijelo je humano antitijelo; (b) antitijelo je bispecifično antitijelo; (c) antitijelo je konjugirano sa citotoksičnim agensom, citostatičkim agensom, toksinom, radionuklidom ili oznakom koja se može detektirati; i/ili (d) antitijelo je unakrsno povezano sa drugim antitijelom ili njegovim fragmentom.
7. Izolirani polinukleotid koji kodira VH i VL, ili teški lanac i laki lanac, antitijela prema bilo kojem od patentnih zahtjeva 1-6.
8. Vektor koji sadrži polinukleotid prema patentnom zahtjevu 7.
9. Rekombinantna stanica domaćina koja sadrži: (a) polinukleotid prema patentnom zahtjevu 7; (b) vektor prema patentnom zahtjevu 8; ili (c) prvi polinukleotid koji kodira VH, ili teški lanac, antitijela prema bilo kojem od patentnih zahtjeva 1-6, i drugi polinukleotid koji kodira VL, ili laki lanac, antitijela prema bilo kojem od patentnih zahtjeva 1-6.
10. Farmaceutska kompozicija koja sadrži antitijelo prema bilo kojem od patentnih zahtjeva 1-6, polinukleotid prema patentnom zahtjevu 7, vektor prema patentnom zahtjevu 8, ili stanicu domaćina prema patentnom zahtjevu 9 i farmaceutski prihvatljiv nosač ili ekscipiens.
11. Postupak za proizvodnju antitijela koje se specifično vezuje za humani TIGIT, postupak koji obuhvaća kultivaciju stanica domaćina prema patentnom zahtjevu 9 tako da se polinukleotid eksprimira i antitijelo se proizvodi.
12. Antitijelo prema bilo kojem od patentnih zahtjeva 1-6, polinukleotid prema patentnom zahtjevu 7, vektor prema patentnom zahtjevu 8, stanica domaćina prema patentnom zahtjevu 9 ili farmaceutska kompozicija prema patentnom zahtjevu 10 za primjenu u liječenju raka ili infektivne bolesti, po izboru gdje (a) antitijelo se (i) administrira intravenozno, po izboru pri 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 10 mg/kg, 15 mg/kg, 20 mg/kg ili više, po izboru u intervalu od jednom u tri tjedna; (ii) administrira subkutano; (iii) administrira intratumoralno, po izboru pri 0.03 mg/kg, 0.1 mg/kg, 0.3 mg/kg, 1 mg/kg, 3 mg/kg, 6 mg/kg, 10 mg/kg, 15 mg/kg, 20 mg/kg, ili više, po izboru u intervalu od jednom u tri tjedna; ili (iv) isporučuje u limfni čvor koji drenira tumor; i/ili (b) dodatni terapijski agens se administrira, po izboru pri čemu se dodatni terapijski agens administrira sistemski, po izboru pri čemu (i) antitijelo se administrira za primjenu u liječenju solidnog tumora i dodatni terapijski agens sadrži anti-PD-1 antitijelo, po izboru pri čemu je anti-PD-1 antitijelo pembrolizumab ili nivolumab; (ii) antitijelo se administrira za primjenu u liječenju karcinoma pločastih stanica glave i vrata i dodatni terapijski agens je anti-EGFR antitijelo, po izboru pri čemu anti-EGFR antitijelo je cetuksimab, po izboru gdje se kemoterapijski agens administrira, po izboru gdje se kemoterapijski agens administrira sistemski, i po izboru gdje je kemoterapijski agens gemcitabin; (iii) antitijelo se administrira za primjenu u liječenju HER2+ raka dojke i dodatni terapijski agens je anti-HER2 antitijelo, po izboru gdje je anti-HER2 antitijelo trastuzumab, po izboru gdje se administrira kemoterapijski agens, po izboru gdje se kemoterapijski agens administrira sistematski, po izboru gdje je kemoterapijski agens gemcitabin; (iv) dodatni terapijski agens je kemoterapeutik ili agens koji cilja kontrolnu točku, pri čemu je agens za ciljanje kontrolne točke odabran iz grupe koja se sastoji od antagonističkog anti-PD-1 antitijela, antagoniststičkog anti-PD-L1 antitijela, antagonističkog anti-PD-L2 antitijela, antagonističkog anti-CTLA-4 antitijela, antagonističkog anti-TIM-3 antitijela, antagonističkog anti-LAG-3 antitijela, antagonističkog VISTA antitijela, antagonističkog CD96 antitijela, antagonističkog anti-CEACAM1 antitijela, agonističkog anti-CD137 antitijela, agonističkog anti-GITR antitijela, i agonističkog anti-OX40 antitijela; (v) dodatni terapijski agens je inhibitor indolamin-2,3-dioksigenaze (IDO), po izboru pri čemu je inhibitor odabran iz grupe koja se sastoji od epakadostata, F001287, indoksimoda i NLG919; ili (vi) dodatni terapijski agens je cjepivo, po izboru pri čemu cjepivo sadrži peptidni kompleks proteina toplinskog šoka (HSPPC) koji sadrži protein toplinskog šoka u kompleksu sa antigenim peptidom, po izboru pri čemu (1) protein toplinskog šoka je hsc70 i u kompleksu je sa antigenim peptidom koji je u vezi sa tumorom; ili (2) protein toplinskog šoka je gp96 protein i u kompleksu je sa antigenim peptidom koji je u vezi sa tumorom, pri čemu je HSPPC izveden iz tumora.
HRP20230941TT 2017-05-01 2018-05-01 Anti-tigit antitijela i postupci njihove primjene HRP20230941T1 (hr)

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US201762492829P 2017-05-01 2017-05-01
US201762500345P 2017-05-02 2017-05-02
PCT/US2018/030453 WO2018204363A1 (en) 2017-05-01 2018-05-01 Anti-tigit antibodies and methods of use thereof
EP18724768.9A EP3618863B1 (en) 2017-05-01 2018-05-01 Anti-tigit antibodies and methods of use thereof

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