AU2023338677A1 - Supplemental dosage and administration of anti-c5 antibodies for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (hsct-tma) - Google Patents

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

Info

Publication number
AU2023338677A1
AU2023338677A1 AU2023338677A AU2023338677A AU2023338677A1 AU 2023338677 A1 AU2023338677 A1 AU 2023338677A1 AU 2023338677 A AU2023338677 A AU 2023338677A AU 2023338677 A AU2023338677 A AU 2023338677A AU 2023338677 A1 AU2023338677 A1 AU 2023338677A1
Authority
AU
Australia
Prior art keywords
dose
patient weighing
patient
day
antibody
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.)
Pending
Application number
AU2023338677A
Other languages
English (en)
Inventor
Jonathan MONTELEONE
Stephan ORTIZ
Xiaofeng Wang Rears
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Alexion Pharmaceuticals Inc
Original Assignee
Alexion Pharmaceuticals Inc
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
Application filed by Alexion Pharmaceuticals Inc filed Critical Alexion Pharmaceuticals Inc
Publication of AU2023338677A1 publication Critical patent/AU2023338677A1/en
Pending legal-status Critical Current

Links

Classifications

    • 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
    • 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
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P37/00—Drugs for immunological or allergic disorders
    • A61P37/02—Immunomodulators
    • 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
    • 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
    • C07K2317/70—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

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Immunology (AREA)
  • Veterinary Medicine (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Endocrinology (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Epidemiology (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)
AU2023338677A 2022-09-06 2023-09-01 Supplemental dosage and administration of anti-c5 antibodies for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (hsct-tma) Pending AU2023338677A1 (en)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202263404061P 2022-09-06 2022-09-06
US63/404,061 2022-09-06
US202363440984P 2023-01-25 2023-01-25
US63/440,984 2023-01-25
PCT/US2023/031836 WO2024054408A1 (en) 2022-09-06 2023-09-01 Supplemental dosage and administration of anti-c5 antibodies for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (hsct-tma)

Publications (1)

Publication Number Publication Date
AU2023338677A1 true AU2023338677A1 (en) 2025-03-27

Family

ID=88192212

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2023338677A Pending AU2023338677A1 (en) 2022-09-06 2023-09-01 Supplemental dosage and administration of anti-c5 antibodies for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (hsct-tma)

Country Status (9)

Country Link
EP (1) EP4583910A1 (enExample)
JP (1) JP2025529317A (enExample)
KR (1) KR20250060282A (enExample)
CN (1) CN120076827A (enExample)
AU (1) AU2023338677A1 (enExample)
CA (1) CA3266974A1 (enExample)
IL (1) IL319413A (enExample)
TW (1) TW202426048A (enExample)
WO (1) WO2024054408A1 (enExample)

Family Cites Families (11)

* 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
ES2796078T3 (es) * 2013-09-16 2020-11-25 Childrens Hospital Med Ct Composiciones y métodos para el tratamiento de la microangiopatía trombótica asociada al hsct
NZ711451A (en) 2014-03-07 2016-05-27 Alexion Pharma Inc Anti-c5 antibodies having improved pharmacokinetics
EA201791366A1 (ru) 2014-12-19 2018-02-28 Чугаи Сейяку Кабусики Кайся Антитела к c5 и способы их применения
WO2016200627A1 (en) * 2015-06-09 2016-12-15 Children's Hospital Medical Center Dosing algorithm for complement inhibitor
TW201718014A (zh) * 2015-10-12 2017-06-01 諾華公司 C5抑制劑於移植相關微血管病之用途
IL263481B2 (en) 2016-06-14 2024-06-01 Regeneron Pharma Anti-c5 antibodies and uses thereof
JP2023503776A (ja) * 2019-09-27 2023-02-01 ヴォリューション イミュノ ファーマシューティカルズ エスエイ 造血幹細胞移植後の血栓性微小血管症(hsct-tma)の治療方法
JP7821160B2 (ja) 2020-08-13 2026-02-26 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 造血幹細胞移植関連血栓性微小血管症(hsct-tma)を処置するための抗c5抗体の用量及び投与
CA3173016A1 (en) * 2021-01-22 2022-07-28 Gin-Fu CHEN Methods of treating complement mediated thrombotic microangiopathy using an anti-c5 antibody

Also Published As

Publication number Publication date
JP2025529317A (ja) 2025-09-04
TW202426048A (zh) 2024-07-01
CA3266974A1 (en) 2024-03-14
WO2024054408A1 (en) 2024-03-14
IL319413A (en) 2025-05-01
EP4583910A1 (en) 2025-07-16
CN120076827A (zh) 2025-05-30
KR20250060282A (ko) 2025-05-07

Similar Documents

Publication Publication Date Title
JP7577542B2 (ja) 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
JP7520725B2 (ja) 小児患者における発作性夜間ヘモグロビン尿症(pnh)の治療のための抗c5抗体の用量および投与
US12240893B2 (en) Subcutaneous dosage and administration of anti-C5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (PNH)
JP2026048838A (ja) 高濃度抗c5抗体配合物
KR20210119420A (ko) 비정형 용혈성 요독증후군(ahus)의 치료를 위한 항-c5 항체의 복용량 및 투여
JP2023533030A (ja) 小児患者において発作性夜間血色素尿症(pnh)を治療するための抗c5抗体の投薬量及び投与
JP2024504366A (ja) 抗c5抗体を使用して補体媒介血栓性微小血管障害症を治療する方法
JP2024503724A (ja) 免疫調節抗体およびその使用
WO2025166118A1 (en) Dosage and administration of anti-c5 antibodies for treating iga nephropathy (igan)
AU2021326526A1 (en) Dosage and administration of anti-C5 antibodies for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA)
US20230172930A1 (en) Use of complement factor d inhibitors alone or in combination with anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria
EP4583910A1 (en) Supplemental dosage and administration of anti-c5 antibodies for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (hsct-tma)
CN118103064A (zh) 用补体旁路途径抑制剂治疗镰状细胞病或β地中海贫血的方法
JP2023507852A (ja) 抗c5抗体を使用して妊娠関連非典型溶血性尿毒症症候群を治療する方法
HK40055105B (en) Subcutaneous dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh)
HK40055105A (en) Subcutaneous dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh)