JP2022514381A - 臓器移植の慢性抗体介在性拒絶反応の処置でのクラザキズマブ - Google Patents

臓器移植の慢性抗体介在性拒絶反応の処置でのクラザキズマブ Download PDF

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JP2022514381A
JP2022514381A JP2021535670A JP2021535670A JP2022514381A JP 2022514381 A JP2022514381 A JP 2022514381A JP 2021535670 A JP2021535670 A JP 2021535670A JP 2021535670 A JP2021535670 A JP 2021535670A JP 2022514381 A JP2022514381 A JP 2022514381A
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months
polypeptide
seq
clazakizumab
abmr
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JP2022514381A5 (enExample
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スタンレー・シー・ジョーダン
アシュリー・エー・ヴォー
ノリコ・アマーマン
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セダーズ－シナイ メディカル センター
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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244—Interleukins [IL]
    • C07K16/248—IL-6
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/41—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having five-membered rings with two or more ring hetero atoms, at least one of which being nitrogen, e.g. tetrazole
    • A61K31/4196—1,2,4-Triazoles
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/33—Heterocyclic compounds
    • A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
    • A61K31/495—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with two or more nitrogen atoms as the only ring heteroatoms, e.g. piperazine or tetrazines
    • A61K31/505—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519—Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52—Purines, e.g. adenine
    • A61K31/522—Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/63—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
    • A61K31/635—Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
    • 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
    • A61K39/39516—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum from serum, plasma
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00—Drugs for disorders of the urinary system
    • A61P13/12—Drugs for disorders of the urinary system of the kidneys
    • 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
    • A61P37/02—Immunomodulators
    • A61P37/06—Immunosuppressants, e.g. drugs for graft rejection
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
    • A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34—Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/3496—Plasmapheresis; Leucopheresis; Lymphopheresis
    • 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
    • C07K2317/50—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]

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Transplantation (AREA)
  • Endocrinology (AREA)
  • Urology & Nephrology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
JP2021535670A 2018-12-20 2019-12-20 臓器移植の慢性抗体介在性拒絶反応の処置でのクラザキズマブ Pending JP2022514381A (ja)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US201862783136P 2018-12-20 2018-12-20
US62/783,136 2018-12-20
US201962855993P 2019-06-01 2019-06-01
US62/855,993 2019-06-01
PCT/US2019/068103 WO2020132600A1 (en) 2018-12-20 2019-12-20 Clazakizumab in the treatment of chronic antibody-mediated rejection of organ transplant

Publications (2)

Publication Number Publication Date
JP2022514381A true JP2022514381A (ja) 2022-02-10
JP2022514381A5 JP2022514381A5 (enExample) 2022-12-19

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JP2021535670A Pending JP2022514381A (ja) 2018-12-20 2019-12-20 臓器移植の慢性抗体介在性拒絶反応の処置でのクラザキズマブ

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US (2) US20220073605A1 (enExample)
EP (1) EP3897718A4 (enExample)
JP (1) JP2022514381A (enExample)
KR (1) KR20210106521A (enExample)
CN (1) CN113194996B (enExample)
AU (1) AU2019404553A1 (enExample)
BR (1) BR112021010615A2 (enExample)
CA (1) CA3121934A1 (enExample)
WO (1) WO2020132600A1 (enExample)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8062864B2 (en) 2007-05-21 2011-11-22 Alderbio Holdings Llc Nucleic acids encoding antibodies to IL-6, and recombinant production of anti-IL-6 antibodies
CN114423782A (zh) * 2019-09-04 2022-04-29 西达赛奈医疗中心 不含钙调磷酸酶抑制剂的ctla4-ig+抗il6/il6r用于对实体器官移植受体进行长期免疫抑制的用途
WO2025122579A1 (en) * 2023-12-04 2025-06-12 Cedars-Sinai Medical Center Cadherin 6 expression status in determination of renal fibrosis and related uses thereof

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4946778A (en) 1987-09-21 1990-08-07 Genex Corporation Single polypeptide chain binding molecules
CA1294215C (en) 1986-10-27 1992-01-14 Ze'ev Shaked Pharmaceutical compositions of recombinant beta-interferon and formulation processes
CA1292686C (en) 1986-10-27 1991-12-03 Ze'ev Shaked Pharmaceutical compositions of recombinant interleukin-2 and formulation process
US5530101A (en) 1988-12-28 1996-06-25 Protein Design Labs, Inc. Humanized immunoglobulins
CN101754772B (zh) * 2007-05-21 2015-08-19 奥尔德生物控股有限责任公司 针对il-6的抗体及其用途
US8062864B2 (en) 2007-05-21 2011-11-22 Alderbio Holdings Llc Nucleic acids encoding antibodies to IL-6, and recombinant production of anti-IL-6 antibodies
WO2013150375A2 (en) * 2012-04-04 2013-10-10 Assistance Publique Hôpitaux De Paris Endothelial cells activation biomarkers characterizing antibody mediated rejection and uses thereof
US9963513B2 (en) * 2013-02-05 2018-05-08 Engmab Sàrl Method for the selection of antibodies against BCMA
ES2708655T3 (es) * 2013-11-22 2019-04-10 Shire Viropharma Inc Métodos para tratar el rechazo mediado por anticuerpos en pacientes con trasplante de órganos con el inhibidor de la c1-esterasa
US11065319B2 (en) * 2014-02-04 2021-07-20 3Dt Holdings, Llc Methods for diagnosing and reducing incidences of cardiac allograft rejection
US20170022280A1 (en) * 2015-07-24 2017-01-26 Cedars-Sinai Medical Center Method for treating antibody-mediated rejection post-transplantation
AU2019205488A1 (en) * 2018-01-04 2020-07-23 Cedars-Sinai Medical Center Use of anti-iL-6 antibody, e.g., Clazakizumab for desensitization of solid organ transplant recipients and/or for preventing, stabilizing or reducing antibody mediated rejection (ABMR)
BR112021007633A2 (pt) * 2018-11-08 2021-10-13 Cedars-Sinai Medical Center Uso de clazakizumabe para dessensibilizar e melhorar o transplante renal em pacientes sensibilizados por hla

Non-Patent Citations (2)

* Cited by examiner, † Cited by third party
Title
CHOI, J. ET AL., AM J TRANSPLANT, vol. 17, JPN6023039805, 2017, pages 2381 - 2389, ISSN: 0005338522 *
NCT03380377, CLAZAKIZUMAB FOR CHRONIC AND ACTIVE ANTIBODY MEDIATED REJECTION POST-KIDNEY TRANSPLANT,, JPN6023039804, 26 February 2018 (2018-02-26), ISSN: 0005338521 *

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Publication number Publication date
US20220073605A1 (en) 2022-03-10
KR20210106521A (ko) 2021-08-30
EP3897718A4 (en) 2022-09-14
WO2020132600A1 (en) 2020-06-25
CN113194996B (zh) 2024-06-28
AU2019404553A1 (en) 2021-06-24
CN113194996A (zh) 2021-07-30
BR112021010615A2 (pt) 2021-11-03
CA3121934A1 (en) 2020-06-25
US20250263480A1 (en) 2025-08-21
EP3897718A1 (en) 2021-10-27

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