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AR086412A1 - Uso del anticuerpo anti-cd19 inmunoconjugado con maitansinoide para el tratamiento del sintoma tumores de celulas b - Google Patents

Uso del anticuerpo anti-cd19 inmunoconjugado con maitansinoide para el tratamiento del sintoma tumores de celulas b

Info

Publication number
AR086412A1
AR086412A1 ARP120101724A ARP120101724A AR086412A1 AR 086412 A1 AR086412 A1 AR 086412A1 AR P120101724 A ARP120101724 A AR P120101724A AR P120101724 A ARP120101724 A AR P120101724A AR 086412 A1 AR086412 A1 AR 086412A1
Authority
AR
Argentina
Prior art keywords
maitansinoid
immunoconjugate
approximately
patient
symptom
Prior art date
Application number
ARP120101724A
Other languages
English (en)
Inventor
Rodica Morariu
Original Assignee
Sanofi Sa
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Family has litigation
First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=46085972&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=AR086412(A1) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
Application filed by Sanofi Sa filed Critical Sanofi Sa
Publication of AR086412A1 publication Critical patent/AR086412A1/es

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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/537Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines spiro-condensed or forming part of bridged ring systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/33Heterocyclic compounds
    • A61K31/395Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/535Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines
    • A61K31/5365Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with at least one nitrogen and one oxygen as the ring hetero atoms, e.g. 1,2-oxazines ortho- or peri-condensed with heterocyclic ring systems
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K45/00Medicinal preparations containing active ingredients not provided for in groups A61K31/00 - A61K41/00
    • A61K45/06Mixtures of active ingredients without chemical characterisation, e.g. antiphlogistics and cardiaca
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/68Medicinal 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
    • A61K47/6801Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/68033Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a maytansine
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/50Medicinal 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
    • A61K47/51Medicinal 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
    • A61K47/68Medicinal 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
    • A61K47/6835Medicinal 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
    • A61K47/6849Medicinal 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • A61P35/02Antineoplastic agents specific for leukemia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P43/00Drugs for specific purposes, not provided for in groups A61P1/00-A61P41/00
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803Immunoglobulins [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
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/30Immunoglobulins [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
    • C07K16/3061Blood cells
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/20Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51Complete heavy chain or Fd fragment, i.e. VH + CH1
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/515Complete light chain, i.e. VL + CL
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/77Internalization into the cell
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Cell Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Hematology (AREA)
  • Dermatology (AREA)
  • Microbiology (AREA)
  • Oncology (AREA)
  • Mycology (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)
  • Nitrogen And Oxygen Or Sulfur-Condensed Heterocyclic Ring Systems (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicinal Preparation (AREA)

Abstract

Reivindicación 1: Un método para tratar el síntoma tumores de células B CD19+ en un paciente que lo requiere, en donde dicho método comprende administrar a dicho paciente cantidades terapéuticamente efectivas del inmunoconjugado de maitansinoide anti-CD19.Reivindicación 2: Un método según la reivindicación 1, en el que el inmunoconjugado se administra con un régimen de dosificación que reduce la toxicidad resultante del tratamiento. Reivindicación 3: Un método según una cualquiera de las reivindicaciones 1 y 2, en el que la toxicidad es toxicidad ocular que da como resultado acontecimientos adversos relacionados con el ojo. Reivindicación 6: Un método para tratar el síntoma tumores de células B CD19+ en un paciente que lo necesita, en donde dicho método comprende las etapas de administrar al paciente una dosis inicial de aproximadamente 55 mg/m2 del inmunoconjugado de maitansinoide anti-CD19; y administrar al paciente una pluralidad de dosis subsiguientes de aproximadamente 55 mg/m2 del inmunoconjugado de maitansinoide anti-CD19, en donde las dosis subsiguientes están separadas entre sí en el tiempo por intervalos de aproximadamente una semana. Reivindicación 12: Un método según una cualquiera de las reivindicaciones 1 a 11, en donde dicho síntoma tumores de células B CD19+ es un síntoma leucemia o un síntoma linfoma. Reivindicación 20: Un método según la reivindicación 13, en el que dicho síntoma linfoma no-Hodgkin es una enfermedad resistente a rituximab. Reivindicación 30: Un método según una cualquiera de las reivindicaciones 1 a 29, en el que el inmunoconjugado de maitansinoide anti-CD19 tiene la fórmula (1). Reivindicación 38: Inmunoconjugado de maitansinoide anti-CD19 para tratar un paciente humano diagnosticado de un síntoma tumor maligno de células CD19+, por medio de un método que comprende las etapas de administrar al paciente una dosis inicial de aproximadamente 55 mg/m2 del inmunoconjugado de maitansinoide anti-CD19; y administrar al paciente una pluralidad de dosis subsiguientes de aproximadamente 55 mg/m2 del inmunoconjugado de maitansinoide anti-CD19, en donde las dosis subsiguientes están separadas entre sí en el tiempo por intervalos de aproximadamente una semana. Reivindicación 40: Un artículo manufacturado que comprende: a) un material de envasado; b) un inmunoconjugado de maitansinoide anti-CD19; y c) una etiqueta o prospecto de envase, contenido dentro de dicho material de envasado, que indica que el citado inmunoconjugado de maitansinoide anti-CD19 se administra al paciente a una dosis inicial de aproximadamente 55 mg/m2, y en una pluralidad de dosis subsiguientes, separadas entre sí en el tiempo por intervalos de aproximadamente una semana, en una cantidad que es de aproximadamente 55 mg/m2.
ARP120101724A 2011-05-17 2012-05-16 Uso del anticuerpo anti-cd19 inmunoconjugado con maitansinoide para el tratamiento del sintoma tumores de celulas b AR086412A1 (es)

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP11290232A EP2524929A1 (en) 2011-05-17 2011-05-17 Use of anti-CD19 maytansinoid immunoconjugate antibody for the treatment of CD19+ B-cell malignancies syptoms

Publications (1)

Publication Number Publication Date
AR086412A1 true AR086412A1 (es) 2013-12-11

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ID=46085972

Family Applications (1)

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ARP120101724A AR086412A1 (es) 2011-05-17 2012-05-16 Uso del anticuerpo anti-cd19 inmunoconjugado con maitansinoide para el tratamiento del sintoma tumores de celulas b

Country Status (30)

Country Link
US (2) US9555126B2 (es)
EP (2) EP2524929A1 (es)
JP (4) JP6050328B2 (es)
KR (1) KR20140043388A (es)
CN (2) CN103547596A (es)
AR (1) AR086412A1 (es)
AU (3) AU2012258254B2 (es)
BR (1) BR112013029330A8 (es)
CA (1) CA2835738A1 (es)
CL (1) CL2013003272A1 (es)
CO (1) CO6821893A2 (es)
CR (1) CR20130593A (es)
DO (1) DOP2013000260A (es)
EA (1) EA028574B1 (es)
EC (1) ECSP13013084A (es)
GT (1) GT201300276A (es)
IL (3) IL229380B (es)
MA (1) MA35180B1 (es)
MX (1) MX347019B (es)
MY (1) MY163736A (es)
NI (1) NI201300119A (es)
PE (1) PE20141018A1 (es)
PH (2) PH12013502305A1 (es)
SG (2) SG194894A1 (es)
TN (1) TN2013000468A1 (es)
TW (3) TW201834687A (es)
UA (1) UA114401C2 (es)
UY (1) UY34077A (es)
WO (1) WO2012156455A1 (es)
ZA (1) ZA201309400B (es)

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Publication number Publication date
AU2012258254B2 (en) 2016-04-21
EA028574B1 (ru) 2017-12-29
CL2013003272A1 (es) 2014-08-01
PH12017501368A1 (en) 2018-01-29
IL257475A (en) 2018-06-28
IL229380A0 (en) 2014-01-30
TW201834687A (zh) 2018-10-01
US20170196988A1 (en) 2017-07-13
PE20141018A1 (es) 2014-08-27
SG10201609729VA (en) 2016-12-29
DOP2013000260A (es) 2014-01-31
JP2018021020A (ja) 2018-02-08
TW201249460A (en) 2012-12-16
EA201391714A1 (ru) 2014-03-31
NZ618012A (en) 2016-03-31
AU2016206317A1 (en) 2016-08-11
MX347019B (es) 2017-04-07
PH12013502305A1 (en) 2019-07-03
GT201300276A (es) 2015-03-23
ECSP13013084A (es) 2014-01-31
UA114401C2 (uk) 2017-06-12
EP2524929A1 (en) 2012-11-21
ZA201309400B (en) 2015-04-29
US20140072587A1 (en) 2014-03-13
JP2019142961A (ja) 2019-08-29
AU2012258254A1 (en) 2013-05-02
KR20140043388A (ko) 2014-04-09
UY34077A (es) 2013-01-03
MX2013013455A (es) 2014-02-17
CO6821893A2 (es) 2013-12-31
US9555126B2 (en) 2017-01-31
TN2013000468A1 (en) 2015-03-30
CN103547596A (zh) 2014-01-29
EP2710034A1 (en) 2014-03-26
CA2835738A1 (en) 2012-11-22
BR112013029330A2 (pt) 2016-11-29
NI201300119A (es) 2014-02-28
SG194894A1 (en) 2013-12-30
BR112013029330A8 (pt) 2018-01-30
MY163736A (en) 2017-10-31
CR20130593A (es) 2014-01-09
IL263728A (en) 2019-01-31
TWI601537B (zh) 2017-10-11
MA35180B1 (fr) 2014-06-02
TW201726167A (zh) 2017-08-01
IL229380B (en) 2018-02-28
JP6181273B2 (ja) 2017-08-16
JP6050328B2 (ja) 2016-12-21
JP2014515036A (ja) 2014-06-26
WO2012156455A1 (en) 2012-11-22
AU2018201504A1 (en) 2018-03-22
JP2017081926A (ja) 2017-05-18
CN107007840A (zh) 2017-08-04

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