AU2022210283A1 - Methods of treating complement mediated thrombotic microangiopathy using an anti-c5 antibody - Google Patents

Methods of treating complement mediated thrombotic microangiopathy using an anti-c5 antibody Download PDF

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Publication number
AU2022210283A1
AU2022210283A1 AU2022210283A AU2022210283A AU2022210283A1 AU 2022210283 A1 AU2022210283 A1 AU 2022210283A1 AU 2022210283 A AU2022210283 A AU 2022210283A AU 2022210283 A AU2022210283 A AU 2022210283A AU 2022210283 A1 AU2022210283 A1 AU 2022210283A1
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Australia
Prior art keywords
antibody
patient
tma
syndrome
autoimmune
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Pending
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AU2022210283A
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AU2022210283A9 (en
Inventor
Gin-Fu CHEN
Zeeshan KHAWAJA
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Alexion Pharmaceuticals Inc
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Alexion Pharmaceuticals Inc
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Publication of AU2022210283A1 publication Critical patent/AU2022210283A1/en
Publication of AU2022210283A9 publication Critical patent/AU2022210283A9/en
Pending legal-status Critical Current

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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
    • 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
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K39/395Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591Stabilisation, fragmentation
    • 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
    • A61P37/00Drugs for immunological or allergic disorders
    • A61P37/02Immunomodulators
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P7/00Drugs for disorders of the blood or the extracellular fluid
    • A61P7/02Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
    • 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
    • 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
    • C07K2317/52Constant or Fc region; Isotype
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52Constant or Fc region; Isotype
    • C07K2317/526CH3 domain
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/92Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2319/00Fusion polypeptide
    • C07K2319/90Fusion polypeptide containing a motif for post-translational modification
    • C07K2319/92Fusion polypeptide containing a motif for post-translational modification containing an intein ("protein splicing")domain

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Diabetes (AREA)
  • Hematology (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Biochemistry (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Endocrinology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
AU2022210283A 2021-01-22 2022-01-18 Methods of treating complement mediated thrombotic microangiopathy using an anti-c5 antibody Pending AU2022210283A1 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202163140488P 2021-01-22 2021-01-22
US63/140,488 2021-01-22
PCT/US2022/012739 WO2022159373A1 (en) 2021-01-22 2022-01-18 Methods of treating complement mediated thrombotic microangiopathy using an anti-c5 antibody

Publications (2)

Publication Number Publication Date
AU2022210283A1 true AU2022210283A1 (en) 2023-08-03
AU2022210283A9 AU2022210283A9 (en) 2024-10-17

Family

ID=80820704

Family Applications (1)

Application Number Title Priority Date Filing Date
AU2022210283A Pending AU2022210283A1 (en) 2021-01-22 2022-01-18 Methods of treating complement mediated thrombotic microangiopathy using an anti-c5 antibody

Country Status (8)

Country Link
US (1) US20240092881A1 (https=)
EP (2) EP4281472A1 (https=)
JP (1) JP2024504366A (https=)
KR (1) KR20230134533A (https=)
AU (1) AU2022210283A1 (https=)
CA (1) CA3173016A1 (https=)
IL (1) IL304593A (https=)
WO (1) WO2022159373A1 (https=)

Families Citing this family (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3873602B1 (en) 2018-10-30 2023-12-06 Alexion Pharmaceuticals, Inc. Subcutaneous dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh)
EP4583911A1 (en) * 2022-09-06 2025-07-16 Alexion Pharmaceuticals, Inc. Diagnostic and prognostic biomarker profiles in patients with hematopoietic stem cell transplant-associated thrombotic microangiopathy (hsct-tma)
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 (14)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6074642A (en) 1994-05-02 2000-06-13 Alexion Pharmaceuticals, Inc. Use of antibodies specific to human complement component C5 for the treatment of glomerulonephritis
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
WO2014099546A1 (en) 2012-12-19 2014-06-26 Promerus, Llc Process for the preparation of high purity norbornene alkanols and derivatives thereof
NZ631007A (en) 2014-03-07 2015-10-30 Alexion Pharma Inc Anti-c5 antibodies having improved pharmacokinetics
BR112017011235A2 (pt) 2014-12-19 2018-02-06 Chugai Pharmaceutical Co Ltd anticorpos anti-c5 e métodos de uso
CN116769024A (zh) 2016-06-14 2023-09-19 瑞泽恩制药公司 抗c5抗体及其用途
DK3658184T5 (da) * 2017-07-27 2024-08-26 Alexion Pharma Inc Højkoncentrerede anti-c5-antistofformuleringer
EP3802603A1 (en) * 2018-06-04 2021-04-14 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of atypical hemolytic uremic syndrome (ahus) in pediatric patients
EP3873602B1 (en) * 2018-10-30 2023-12-06 Alexion Pharmaceuticals, Inc. Subcutaneous dosage and administration of anti-c5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (pnh)
CN117838856A (zh) * 2019-01-25 2024-04-09 亚力兄制药公司 用于治疗非典型溶血性尿毒综合征(ahus)的抗c5抗体的剂量和施用
EP3924380A1 (en) * 2019-02-14 2021-12-22 Alexion Pharmaceuticals, Inc. Dosage and administration of anti-c5 antibodies for treatment of generalized myasthenia gravis
WO2021091937A1 (en) * 2019-11-08 2021-05-14 Alexion Pharmaceuticals, Inc. High concentration anti-c5 antibody formulations
CA3173011A1 (en) * 2020-06-24 2021-12-30 Alexion Pharmaceuticals, Inc. Subcutaneous (sc) administration of anti-c5 antibodies for treatment of complement-associated conditions

Also Published As

Publication number Publication date
IL304593A (en) 2023-09-01
JP2024504366A (ja) 2024-01-31
EP4378479A2 (en) 2024-06-05
AU2022210283A9 (en) 2024-10-17
US20240092881A1 (en) 2024-03-21
CA3173016A1 (en) 2022-07-28
WO2022159373A1 (en) 2022-07-28
EP4281472A1 (en) 2023-11-29
KR20230134533A (ko) 2023-09-21
EP4378479A3 (en) 2024-09-25

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