AU2021326526B2 - 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)

Info

Publication number
AU2021326526B2
AU2021326526B2 AU2021326526A AU2021326526A AU2021326526B2 AU 2021326526 B2 AU2021326526 B2 AU 2021326526B2 AU 2021326526 A AU2021326526 A AU 2021326526A AU 2021326526 A AU2021326526 A AU 2021326526A AU 2021326526 B2 AU2021326526 B2 AU 2021326526B2
Authority
AU
Australia
Prior art keywords
patient weighing
dose
day
patient
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.)
Active
Application number
AU2021326526A
Other languages
English (en)
Other versions
AU2021326526A1 (en
Inventor
Jonathan MONTELEONE
Stephan ORTIZ
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 AU2021326526A1 publication Critical patent/AU2021326526A1/en
Application granted granted Critical
Publication of AU2021326526B2 publication Critical patent/AU2021326526B2/en
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

Classifications

    • 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

Landscapes

  • 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)
AU2021326526A 2020-08-13 2021-08-12 Dosage and administration of anti-C5 antibodies for treating hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA) Active AU2021326526B2 (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)

Related Child Applications (1)

Application Number Title Priority Date Filing Date
AU2026201836 Division 2021-08-12

Publications (2)

Publication Number Publication Date
AU2021326526A1 AU2021326526A1 (en) 2023-03-02
AU2021326526B2 true AU2021326526B2 (en) 2025-12-11

Family

ID=77655658

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2021326526A Active AU2021326526B2 (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

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019084438A1 (en) * 2017-10-26 2019-05-02 Alexion Pharmaceuticals, Inc. ASSAY AND ADMINISTRATION OF ANTI-C5 ANTIBODIES FOR THE TREATMENT OF NOCTURNAL PAROXYSTIC HEMOGLOBINURIA (PNH) AND ATYPICAL HEMOLYTIC AND UREMIC SYNDROME (AHUS)
WO2019236345A1 (en) * 2018-06-04 2019-12-12 Alexion Pharmaceuticals, Inc. DOSAGE AND ADMINISTRATION OF ANTI-C5 ANTIBODIES FOR TREATMENT OF ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) IN PEDIATRIC PATIENTS

Family Cites Families (8)

* 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
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

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019084438A1 (en) * 2017-10-26 2019-05-02 Alexion Pharmaceuticals, Inc. ASSAY AND ADMINISTRATION OF ANTI-C5 ANTIBODIES FOR THE TREATMENT OF NOCTURNAL PAROXYSTIC HEMOGLOBINURIA (PNH) AND ATYPICAL HEMOLYTIC AND UREMIC SYNDROME (AHUS)
WO2019236345A1 (en) * 2018-06-04 2019-12-12 Alexion Pharmaceuticals, Inc. DOSAGE AND ADMINISTRATION OF ANTI-C5 ANTIBODIES FOR TREATMENT OF ATYPICAL HEMOLYTIC UREMIC SYNDROME (aHUS) IN PEDIATRIC PATIENTS

Non-Patent Citations (7)

* Cited by examiner, † Cited by third party
Title
Jodele, S. et al., 'Complement blockade for TA-TMA: lessons learned from a large pediatric cohort treated with eculizumab', Blood, (2020-03-26), vol. 135, no. 13, pages 1049 - 1057, doi: 10.1182/BLOOD.2019004218. *
Kulasekararaj, A. et al., 'Ravulizumab (ALXN1210) vs eculizumab in C5-inhibitor-experienced adult patients with PNH: the 302 study', Blood, (2019-02-07), vol. 133, no. 6, pages 540 - 549, doi: 10.1182/blood-2018-09-876805. *
Lee, J. et al., 'Ravulizumab (ALXN1210) vs eculizumab in adult patients with PNH naive to complement inhibitors: the 301 study', Blood, (2019-02-07), vol. 133, no. 6, pages 530 - 539, doi: 10.1182/blood-2018-09-876136. *
Patriquin, C. and Kuo, K., 'Eculizumab and Beyond: The Past, Present, and Future of Complement Therapeutics', Transfusion Medicine Reviews, (2019-10-01), vol. 33, no. 4, pages 256 - 265, doi: 10.1016/J.TMRV.2019.09.004. *
Roth, A. et al., 'Ravulizumab (ALXN1210) in patients with paroxysmal nocturnal hemoglobinuria: results of 2 phase 1b/2 studies', Blood Advances, (2018-09-11), vol. 2, no. 17, pages 2176 - 2185, doi: 10.1182/ bloodadvances.2018020644. *
Sahelijo, L. et al., Blood, (2015-12-03), vol. 126, no. 23, pages 4777, doi: 10.1182/BLOOD.V126.23.4777.4777. *
Sheridan, D. et al., 'Design and preclinical characterization of ALXN1210: A novel anti-C5 antibody with extended duration of action', PLOS ONE, vol. 13, no. 4, (2018-04-12), pages e0195909, doi: 10.1371/journal.pone.0195909. *

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
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
CA3173007A1 (en) 2022-02-17

Similar Documents

Publication Publication Date Title
US12460012B2 (en) Dosage and administration of anti-C5 antibodies for treatment of atypical hemolytic uremic syndrome (aHUS) in pediatric patients
US12404320B2 (en) Dosage and administration of anti-C5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (PNH) in pediatric patients
US12240893B2 (en) Subcutaneous dosage and administration of anti-C5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (PNH)
AU2024266818A1 (en) Dosage and administration of anti-C5 antibodies for treatment of atypical hemolytic uremic syndrome (aHUS)
US20230235035A1 (en) Dosage and administration of anti-c5 antibodies for treating paroxysmal nocturnal hemoglobinuria (pnh) in pediatric patients
JP2026026191A (ja) 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
US20230303670A1 (en) Subcutaneous (sc) administration of anti-c5 antibodies for treatment of complement-associated conditions
US20230348579A1 (en) Dosage and administration of anti-c5 antibodies for treating c5-mediated glomerular nephritis (gn), including lupus nephritis (ln) and/or iga nephropathy (igan)
WO2022265915A1 (en) Dosage and administration of anti-c5 antibodies for treating dermatomyositis (dm)
US20240279320A1 (en) Dosage and administration of anti-c5 antibodies for treating dermatomyositis (dm)
TW202545563A (zh) 用於治療iga腎病(igan)之抗c5抗體的劑量與投予
CA3269097A1 (en) Dosage and administration of anti-c5 antibodies for preventing or minimizing cardiac surgery associated acute kidney injury (csa-aki) and/or subsequent major adverse kidney events (make) in patients with chronic kidney disease
HK40097452A (en) Subcutaneous dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh)
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)

Legal Events

Date Code Title Description
FGA Letters patent sealed or granted (standard patent)