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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JPWO2020132600A5 (https=
JP2022514381A5 (https=
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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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    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K16/00Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies
    • C07K16/18Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/24Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against cytokines, lymphokines or interferons
    • C07K16/244Interleukins [IL]
    • C07K16/248IL-6
    • 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
    • A61K31/41Heterocyclic 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
    • A61K31/41961,2,4-Triazoles
    • 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
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • 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
    • A61K31/495Heterocyclic 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
    • A61K31/505Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim
    • A61K31/519Pyrimidines; Hydrogenated pyrimidines, e.g. trimethoprim ortho- or peri-condensed with heterocyclic rings
    • A61K31/52Purines, e.g. adenine
    • A61K31/522Purines, e.g. adenine having oxo groups directly attached to the heterocyclic ring, e.g. hypoxanthine, guanine, acyclovir
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00Medicinal preparations containing organic active ingredients
    • A61K31/63Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide
    • A61K31/635Compounds containing para-N-benzenesulfonyl-N-groups, e.g. sulfanilamide, p-nitrobenzenesulfonyl hydrazide having a heterocyclic ring, e.g. sulfadiazine
    • 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
    • A61K39/39516Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum from serum, plasma
    • 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
    • A61K39/39533Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/3955Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against proteinaceous materials, e.g. enzymes, hormones, lymphokines
    • 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
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • A61P37/06Immunosuppressants, e.g. drugs for graft rejection
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/545Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M1/00Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
    • A61M1/34Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
    • A61M1/3496Plasmapheresis; Leucopheresis; Lymphopheresis
    • 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
    • C07K2317/56Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565Complementarity 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)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (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 (3)

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JP2022514381A true JP2022514381A (ja) 2022-02-10
JPWO2020132600A5 JPWO2020132600A5 (https=) 2022-12-19
JP2022514381A5 JP2022514381A5 (https=) 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 (https=)
EP (1) EP3897718A4 (https=)
JP (1) JP2022514381A (https=)
KR (1) KR20210106521A (https=)
CN (1) CN113194996B (https=)
AU (1) AU2019404553A1 (https=)
BR (1) BR112021010615A2 (https=)
CA (1) CA3121934A1 (https=)
WO (1) WO2020132600A1 (https=)

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
US20220288202A1 (en) * 2019-09-04 2022-09-15 Cedars-Sinai Medical Center Use of Calcineurin Inhibitor Free CTLA4-IG + Anti-IL6/IL6R For Long Term Immunosuppression in Solid Organ Transplant Recipients
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)

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US4946778A (en) 1987-09-21 1990-08-07 Genex Corporation Single polypeptide chain binding molecules
CA1292686C (en) 1986-10-27 1991-12-03 Ze'ev Shaked Pharmaceutical compositions of recombinant interleukin-2 and formulation process
CA1294215C (en) 1986-10-27 1992-01-14 Ze'ev Shaked Pharmaceutical compositions of recombinant beta-interferon and formulation processes
US5530101A (en) 1988-12-28 1996-06-25 Protein Design Labs, Inc. Humanized immunoglobulins
HUE032563T2 (en) * 2007-05-21 2017-09-28 Alderbio Holdings Llc Antibodies to IL-6 and their use
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
EP2834368A2 (en) * 2012-04-04 2015-02-11 Assistance Publique - Hopitaux De Paris Endothelial cells activation biomarkers characterizing antibody mediated rejection and uses thereof
JP6636803B2 (ja) * 2013-02-05 2020-01-29 エンクマフ エスアーエールエル Bcmaに対する抗体の選択のための方法
NZ719724A (en) * 2013-11-22 2022-08-26 Takeda Pharmaceuticals Co Methods of treating antibody-mediated rejection in organ transplant patients with c1-esterase inhibitor
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
CN111867627A (zh) * 2018-01-04 2020-10-30 维塔里斯股份有限公司 抗IL-6抗体例如克拉扎珠单抗(Clazakizumab)用于使实体器官移植接受者脱敏和/或用于预防、稳定或减轻抗体介导的排斥(ABMR)的用途
JP2022512937A (ja) * 2018-11-08 2022-02-07 セダーズ-シナイ メディカル センター Hla感作患者を脱感作し患者における腎移植を改善するためのクラザキズマブの使用

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

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