AR126739A1 - Anticuerpo dirigido contra cldn18.2, anticuerpo biespecífico y el uso de estos - Google Patents

Anticuerpo dirigido contra cldn18.2, anticuerpo biespecífico y el uso de estos

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Publication number
AR126739A1
AR126739A1 ARP220102131A ARP220102131A AR126739A1 AR 126739 A1 AR126739 A1 AR 126739A1 AR P220102131 A ARP220102131 A AR P220102131A AR P220102131 A ARP220102131 A AR P220102131A AR 126739 A1 AR126739 A1 AR 126739A1
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Argentina
Prior art keywords
cell
antibody
bispecific antibody
agent
antibody according
Prior art date
Application number
ARP220102131A
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English (en)
Inventor
Ming Jheng
- Wang Yongqiang Jin
Yun Zhang
Chuchu Zhao
Yunxing Yang
Fei Chen
Beibei Qin
Yuetao Wu
Yi Ding
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Harbour Biomed Shangai Co Ltd
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Publication date
Application filed by Harbour Biomed Shangai Co Ltd filed Critical Harbour Biomed Shangai Co Ltd
Publication of AR126739A1 publication Critical patent/AR126739A1/es

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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
    • 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
    • A61K39/3955—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • 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
    • A61P35/00—Antineoplastic agents
    • 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
    • C07K16/2809—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 the T-cell receptor (TcR)-CD3 complex
    • 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
    • A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
    • 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
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • 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
    • C07K2317/35—Valency
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51—Complete heavy chain or Fd fragment, i.e. VH + CH1
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515—Complete light chain, i.e. VL + CL
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/522—CH1 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/524—CH2 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/526—CH3 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/53—Hinge
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55—Fab or Fab'
    • 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
    • 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
    • C07K2317/50—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
    • C07K2317/567—Framework region [FR]
    • 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
    • C07K2317/569—Single domain, e.g. dAb, sdAb, VHH, VNAR or nanobody®
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622—Single chain antibody (scFv)
    • 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
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    • 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
    • C07K2317/734—Complement-dependent cytotoxicity [CDC]
    • 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

Abstract

La presente invención divulga anticuerpos dirigidos contra CLDN18.2, anticuerpos biespecíficos y el uso de estos. El anticuerpo dirigido contra CLDN18.2 es un anticuerpo de cadena pesada monodominio que tiene una alta afinidad por las células tumorales que expresan CLDN18.2 de forma endógena y puede inducir una actividad endocítica alta. El anticuerpo biespecífico puede actuar sobre CLDN18.2 y CD3, y retiene el efecto de unión de un Fc a un FcRn; en cambio, se prefiere un Fc mutado para reducir la unión a un FcgR y de este modo la activación de linfocitos T inespecíficos provocada por el entrelazamiento de un FcgR. Se optimiza la actividad del extremo CD3 de tal manera que se puede reducir la liberación de citocinas comunes en el CRS, tales como IL6 y TNFa. Reivindicación 1: Un anticuerpo dirigido contra CLDN18.2 que comprende una región variable de cadena pesada que comprende HCDR1, HCDR2 y HCDR3, en donde la HCDR1 comprende una secuencia de aminoácidos como se expone en una cualquiera de las SEQ ID Nº 16 - 18, la HCDR2 comprende una secuencia de aminoácidos como se expone en una cualquiera de las SEQ ID Nº 42 - 46 y las SEQ ID Nº 48 - 54, y la HCDR3 comprende una secuencia de aminoácidos como se expone en una cualquiera de las SEQ ID Nº 77 - 82. Reivindicación 13: Un ácido nucleico aislado que codifica el anticuerpo de acuerdo con una cualquiera de las reivindicaciones 1 - 7 o el anticuerpo biespecífico de acuerdo con una cualquiera de las reivindicaciones 8 - 12. Reivindicación 14: Un vector de expresión recombinante que comprende el ácido nucleico aislado de acuerdo con la reivindicación 13, en donde preferentemente, el vector de expresión recombinante es un plásmido, un cósmido, un fago o un vector vírico, en donde el vector vírico es preferentemente un vector retrovírico, un vector lentivírico, un vector adenovírico o un vector vírico adenoasociado. Reivindicación 15: Un transformante que comprende el vector de expresión recombinante de acuerdo con la reivindicación 14 en una célula hospedadora, en donde preferentemente, la célula hospedadora es una célula BL21, TG1 de E. coli o una célula CHO-K1. Reivindicación 16: Un receptor antigénico quimérico que comprende el anticuerpo de acuerdo con una cualquiera de las reivindicaciones 1 - 7 o el anticuerpo biespecífico de acuerdo con una cualquiera de las reivindicaciones 8 - 12. Reivindicación 17: Una célula modificada genéticamente que comprende el anticuerpo de acuerdo con una cualquiera de las reivindicaciones 1 - 7 o el anticuerpo biespecífico de acuerdo con una cualquiera de las reivindicaciones 8 - 12, en donde preferentemente, la célula modificada genéticamente es una célula eucariota, preferentemente una célula humana aislada, y más preferentemente una célula inmunitaria tal como un linfocito T o un linfocito NK. Reivindicación 18: Un método para preparar un anticuerpo biespecífico que comprende cultivar el transformante de acuerdo con la reivindicación 15 y obtener el anticuerpo o el anticuerpo biespecífico a partir del cultivo. Reivindicación 19: Un conjugado de anticuerpo-fármaco que comprende un agente citotóxico y el anticuerpo de acuerdo con una cualquiera de las reivindicaciones 1 - 7 o el anticuerpo biespecífico de acuerdo con una cualquiera de las reivindicaciones 8 - 12, en donde preferentemente, el agente citotóxico es MMAF o MMAE. Reivindicación 20: Una composición farmacéutica que comprende el anticuerpo de acuerdo con una cualquiera de las reivindicaciones 1 - 7 o el anticuerpo biespecífico de acuerdo con una cualquiera de las reivindicaciones 8 - 12 y un portador farmacéuticamente aceptable; en donde preferentemente, la composición farmacéutica comprende además uno o más del grupo que consiste en un agente hormonal, un agente dirigido a una molécula de bajo peso molecular, un inhibidor del proteasoma, un agente para la obtención de imágenes, un agente de diagnóstico, un agente quimioterápico, un fármaco oncolítico, un agente citotóxico, una citocina, un activador de una molécula coestimuladora, un inhibidor de una molécula inhibidora y una vacuna.
ARP220102131A 2021-08-09 2022-08-08 Anticuerpo dirigido contra cldn18.2, anticuerpo biespecífico y el uso de estos AR126739A1 (es)

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CN202110909032 2021-08-09

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US (1) US20230134183A1 (es)
KR (1) KR20240044467A (es)
AR (1) AR126739A1 (es)
AU (1) AU2022326063A1 (es)
CA (1) CA3228137A1 (es)
IL (1) IL310578A (es)
TW (1) TW202334215A (es)
WO (1) WO2023016348A1 (es)

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US20230134183A1 (en) 2023-05-04
TW202334215A (zh) 2023-09-01
WO2023016348A1 (en) 2023-02-16
CA3228137A1 (en) 2023-02-16
IL310578A (en) 2024-03-01
KR20240044467A (ko) 2024-04-04
AU2022326063A1 (en) 2024-03-14

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