CA3173007A1 - Dosage and administration of anti-c5 antibodies for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (hsct-tma) - Google Patents

Dosage and administration of anti-c5 antibodies for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (hsct-tma) Download PDF

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Publication number
CA3173007A1
CA3173007A1 CA3173007A CA3173007A CA3173007A1 CA 3173007 A1 CA3173007 A1 CA 3173007A1 CA 3173007 A CA3173007 A CA 3173007A CA 3173007 A CA3173007 A CA 3173007A CA 3173007 A1 CA3173007 A1 CA 3173007A1
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Prior art keywords
patient weighing
dose
day
antibody
patient
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Pending
Application number
CA3173007A
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English (en)
French (fr)
Inventor
Stephan ORTIZ
Jonathan MONTELEONE
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Alexion Pharmaceuticals Inc
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Alexion Pharmaceuticals Inc
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Publication date
Application filed by Alexion Pharmaceuticals Inc filed Critical Alexion Pharmaceuticals Inc
Publication of CA3173007A1 publication Critical patent/CA3173007A1/en
Pending legal-status Critical Current

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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
    • 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
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00—Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02—Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • 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
    • A61K2039/54—Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K2039/55—Medicinal preparations containing antigens or antibodies characterised by the host/recipient, e.g. newborn with maternal antibodies
    • 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
    • C07K2317/56—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
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • 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

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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)
  • Organic Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Endocrinology (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Dermatology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Medicinal Preparation (AREA)
CA3173007A 2020-08-13 2021-08-12 Dosage and administration of anti-c5 antibodies for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (hsct-tma) Pending CA3173007A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063065107P 2020-08-13 2020-08-13
US63/065,107 2020-08-13
PCT/US2021/045823 WO2022036151A1 (en) 2020-08-13 2021-08-12 Dosage and administration of anti-c5 antibodies for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (hsct-tma)

Publications (1)

Publication Number Publication Date
CA3173007A1 true CA3173007A1 (en) 2022-02-17

Family

ID=77655658

Family Applications (1)

Application Number Title Priority Date Filing Date
CA3173007A Pending CA3173007A1 (en) 2020-08-13 2021-08-12 Dosage and administration of anti-c5 antibodies for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (hsct-tma)

Country Status (10)

Country Link
US (1) US20240209071A1 (https=)
EP (1) EP4196161A1 (https=)
JP (2) JP7821160B2 (https=)
KR (1) KR20230047179A (https=)
CN (1) CN116249550A (https=)
AU (1) AU2021326526B2 (https=)
CA (1) CA3173007A1 (https=)
IL (1) IL300115A (https=)
MX (1) MX2023001702A (https=)
WO (1) WO2022036151A1 (https=)

Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN120035450A (zh) 2022-09-06 2025-05-23 阿雷克森制药公司 造血干细胞移植物相关血栓性微血管病（hsct-tma）患者的诊断和预后生物标志物谱
TW202426048A (zh) 2022-09-06 2024-07-01 美商阿雷希昂製藥公司 用於治療造血幹細胞移植相關血栓性（ｈｓｃｔ－ｔｍａ）的抗ｃ５抗體的補充劑量和投與

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US8367805B2 (en) 2004-11-12 2013-02-05 Xencor, Inc. Fc variants with altered binding to FcRn
PY09026846A (es) 2008-08-05 2015-09-01 Novartis Ag Composiciones y métodos para anticuerpos que se dirigen a la proteína de complemento c5
JP6654137B2 (ja) * 2013-09-16 2020-02-26 チルドレンズ ホスピタル メディカル センター Ｈｓｃｔ関連血栓性微小血管症の治療のための組成物及び方法
NZ631007A (en) * 2014-03-07 2015-10-30 Alexion Pharma Inc Anti-c5 antibodies having improved pharmacokinetics
CN107207607B (zh) 2014-12-19 2021-05-04 中外制药株式会社 抗-c5抗体及使用方法
JP2019517473A (ja) * 2016-05-27 2019-06-24 アレクシオン ファーマシューティカルズ インコーポレイテッドＡｌｅｘｉｏｎ Ｐｈａｒｍａｃｅｕｔｉｃａｌｓ， Ｉｎｃ． 難治性全身型重症筋無力症の処置のための方法
ES2984352T3 (es) 2016-06-14 2024-10-29 Regeneron Pharma Anticuerpos anti-C5 y usos de los mismos
CA3080187A1 (en) * 2017-10-26 2019-05-02 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh) and atypical hemolytic uremic syndrome (ahus)
JP7577542B2 (ja) 2018-06-04 2024-11-05 アレクシオン ファーマシューティカルズ， インコーポレイテッド 小児患者における非典型溶血性尿毒症症候群（ａＨＵＳ）の治療のための抗Ｃ５抗体の用量および投与
JP2023522208A (ja) * 2020-04-16 2023-05-29 アシスタンス ピュブリック－オピト ド パリ ウイルスによって引き起こされる補体媒介性障害を処置する方法

Also Published As

Publication number Publication date
WO2022036151A1 (en) 2022-02-17
IL300115A (en) 2023-03-01
JP2026026191A (ja) 2026-02-16
JP2023539047A (ja) 2023-09-13
AU2021326526B2 (en) 2025-12-11
KR20230047179A (ko) 2023-04-06
EP4196161A1 (en) 2023-06-21
US20240209071A1 (en) 2024-06-27
AU2021326526A1 (en) 2023-03-02
JP7821160B2 (ja) 2026-02-26
MX2023001702A (es) 2023-03-09
CN116249550A (zh) 2023-06-09

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