ES2684950T3 - Usos de inmunoconjugados dirigidos a CD138 - Google Patents

Usos de inmunoconjugados dirigidos a CD138 Download PDF

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Publication number
ES2684950T3
ES2684950T3 ES12798723.8T ES12798723T ES2684950T3 ES 2684950 T3 ES2684950 T3 ES 2684950T3 ES 12798723 T ES12798723 T ES 12798723T ES 2684950 T3 ES2684950 T3 ES 2684950T3
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Spain
Prior art keywords
dose
carcinoma
immunoconjugate
seq
amino acid
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Active
Application number
ES12798723.8T
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English (en)
Inventor
Gregor Schulz
Frank Osterroth
Thomas Haeder
Christoph Bruecher
Gabriele Niemann
Andre Engling
Christoph Uherek
Benjamin Daelken
Andrea Wartenberg-Demand
Chantal Zuber
Marcus Gutscher
Katrin Bernoester
Martin Koenig
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Biotest AG
Immunogen Inc
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Biotest AG
Immunogen Inc
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Application granted granted Critical
Publication of ES2684950T3 publication Critical patent/ES2684950T3/es
Active legal-status Critical Current
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    • 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
    • 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
    • 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
    • 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
    • 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
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6807—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug or compound being a sugar, nucleoside, nucleotide, nucleic acid, e.g. RNA antisense
    • A61K47/6809—Antibiotics, e.g. antitumor antibiotics anthracyclins, adriamycin, doxorubicin or daunomycin
    • 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
    • A61K47/6851—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 determinant of a tumour cell
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Immunology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Cell Biology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biomedical Technology (AREA)
  • Oncology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

Un inmunoconjugado para su uso en el tratamiento de una enfermedad asociada a células diana que expresan CD138 en un sujeto humano, donde el inmunoconjugado comprende al menos un anticuerpo dirigido a diana de ingeniería que marca como diana células que expresan CD138 y al menos una molécula efectora, donde dicho anticuerpo dirigido a diana de ingeniería se fija funcionalmente a dicha molécula efectora para formar dicho inmunoconjugado, donde preferentemente al menos parte del anticuerpo dirigido a diana de ingeniería confiere propiedades de isotipo IgG4, donde la molécula efectora es al menos un maitansinoide, donde el anticuerpo dirigido a diana de ingeniería comprende: (i) una región variable de cadena pesada CDR1 que comprende los restos de aminoácidos 31 a 35 de SEQ ID NO: 1, una región variable de cadena pesada CDR2 que comprende los restos de aminoácidos 51 a 68 de SEQ ID NO: 1 y una región variable de cadena pesada CDR3 que comprende los restos de aminoácidos 99 a 111 de SEQ ID NO: 1; y (ii) una región variable de cadena ligera CDR1 que comprende los restos de aminoácidos 24 a 34 de SEQ ID NO: 2, una región variable de cadena ligera CDR2 que comprende los restos de aminoácidos 50 a 56 de SEQ ID NO: 2 y una región variable de cadena ligera CDR3 que comprende los restos de aminoácidos 89 a 97 de SEQ ID NO: 2; donde el inmunoconjugado ha de administrarse en un régimen de múltiples dosis, donde la dosis de agregado a administrarse dentro de un ciclo de tratamiento activo es una dosis tolerable máxima agregada (AMTD) o una fracción de AMTD y donde dicha AMTD y/o dicha fracción excede la dosis que resulta en toxicidad limitante de dosis (DLT) cuando el inmunoconjugado se administra como una dosis única, incluyendo como parte de un régimen de dosis única múltiple dentro de dicho ciclo de tratamiento activo y/o excede la dosis tolerable máxima (MTD) cuando el inmunoconjugado se administra como una sola dosis, incluyendo como parte de un régimen de dosis única múltiple dentro de dicho ciclo de tratamiento activo, donde la dosis tolerable máxima agregada es al menos 240 mg/m2, preferentemente 300 mg/m2, preferentemente 360 mg/m2, preferentemente 420 mg/m2, donde la dosis que resulta en dicha toxicidad limitante de dosis es 200 mg/m2 y/o la dosis tolerable máxima al menos 160 mg/m2 o al menos 180 mg/m2, donde el inmunoconjugado ha de administrarse en un ciclo de tratamiento activo de 21 días, al menos tres veces dentro de dichos 21 días, donde el ciclo de tratamiento activo incluye la administración del inmunoconjugado realizándose al menos una vez a la semana, donde la enfermedad asociada a las células diana que expresan CD138 es mieloma múltiple, carcinoma de células renales, cáncer de endometrio, cáncer cervical, adenocarcinoma de próstata, carcinoma pancreático, cáncer gástrico, cáncer de vejiga, carcinoma mamario, hepato-carcinoma, carcinoma colorrectal, carcinoma de colon, carcinoma de células escamosas, cáncer de pulmón, linfoma no Hodgkiniano, carcinoma de timo, carcinoma de útero, carcinoma urinario o carcinoma de ovario.
ES12798723.8T 2011-12-08 2012-12-07 Usos de inmunoconjugados dirigidos a CD138 Active ES2684950T3 (es)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201161568640P 2011-12-08 2011-12-08
US201161568640P 2011-12-08
US201261722367P 2012-11-05 2012-11-05
US201261722367P 2012-11-05
PCT/EP2012/074867 WO2013083817A1 (en) 2011-12-08 2012-12-07 Uses of immunoconjugates targeting cd138

Publications (1)

Publication Number Publication Date
ES2684950T3 true ES2684950T3 (es) 2018-10-05

Family

ID=47326154

Family Applications (1)

Application Number Title Priority Date Filing Date
ES12798723.8T Active ES2684950T3 (es) 2011-12-08 2012-12-07 Usos de inmunoconjugados dirigidos a CD138

Country Status (15)

Country Link
US (2) US10117932B2 (es)
EP (1) EP2788030B1 (es)
JP (1) JP6218746B2 (es)
KR (1) KR20140100571A (es)
CN (1) CN104302324A (es)
AU (1) AU2012372140B9 (es)
BR (1) BR112014013694A2 (es)
CA (1) CA2858133A1 (es)
ES (1) ES2684950T3 (es)
HK (1) HK1203053A1 (es)
IL (1) IL232991A0 (es)
MX (1) MX358680B (es)
RU (1) RU2632108C2 (es)
SG (1) SG11201402887SA (es)
WO (1) WO2013083817A1 (es)

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TWI541022B (zh) * 2013-12-18 2016-07-11 應克隆公司 針對纖維母細胞生長因子受體－３（ｆｇｆｒ３）之化合物及治療方法
US11041021B2 (en) 2014-05-23 2021-06-22 University Of Florida Research Foundation, Incorporated Car based immunotherapy
US10647778B2 (en) * 2015-02-09 2020-05-12 University Of Florida Research Foundation, Incorporated Bi-specific chimeric antigen receptor and uses thereof
EP3259352A4 (en) 2015-02-19 2018-12-05 University of Florida Research Foundation, Inc. Chimeric antigen receptors and uses thereof
TW201711702A (zh) * 2015-06-04 2017-04-01 應克隆公司 使用針對纖維母細胞生長因子受體３（ｆｇｆｒ３）之化合物的療法
WO2017190096A1 (en) 2016-04-29 2017-11-02 University Of Florida Research Foundation Incorporated Chimeric antigen receptors and uses thereof
WO2019035938A1 (en) 2017-08-16 2019-02-21 Elstar Therapeutics, Inc. MULTISPECIFIC MOLECULES BINDING TO BCMA AND USES THEREOF
WO2019070726A1 (en) 2017-10-02 2019-04-11 Visterra, Inc. CD73 BINDING ANTIBODY MOLECULES AND USES THEREOF
AR116563A1 (es) * 2018-10-02 2021-05-19 Mitsubishi Tanabe Pharma Corp Agentes de unión biespecíficos dirigidos a sindecano-1 y receptor de factor de crecimiento de fibroblastos
WO2024181570A1 (ja) * 2023-03-02 2024-09-06 大鵬薬品工業株式会社 抗ｃｄ１３８抗体を含む抗体薬物複合体

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EP2788030B1 (en) 2018-06-20
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US20190117770A1 (en) 2019-04-25
HK1203053A1 (en) 2015-10-16
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IL232991A0 (en) 2014-07-31
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CN104302324A (zh) 2015-01-21
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AU2012372140B2 (en) 2015-09-17

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