JP2024504366A - 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 - Google Patents

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 Download PDF

Info

Publication number
JP2024504366A
JP2024504366A JP2023544294A JP2023544294A JP2024504366A JP 2024504366 A JP2024504366 A JP 2024504366A JP 2023544294 A JP2023544294 A JP 2023544294A JP 2023544294 A JP2023544294 A JP 2023544294A JP 2024504366 A JP2024504366 A JP 2024504366A
Authority
JP
Japan
Prior art keywords
antibody
syndrome
tma
antigen
disease
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
JP2023544294A
Other languages
English (en)
Japanese (ja)
Other versions
JP2024504366A5 (https=
Inventor
ジン-フー チェン,
ジーシャン カワジャ,
Original Assignee
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
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 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 filed Critical 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
Publication of JP2024504366A publication Critical patent/JP2024504366A/ja
Publication of JP2024504366A5 publication Critical patent/JP2024504366A5/ja
Pending legal-status Critical Current

Links

Classifications

    • 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

Landscapes

  • 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)
JP2023544294A 2021-01-22 2022-01-18 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 Pending JP2024504366A (ja)

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
JP2024504366A true JP2024504366A (ja) 2024-01-31
JP2024504366A5 JP2024504366A5 (https=) 2025-01-27

Family

ID=80820704

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2023544294A Pending JP2024504366A (ja) 2021-01-22 2022-01-18 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

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
EP4378479A2 (en) 2024-06-05
AU2022210283A1 (en) 2023-08-03
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

Similar Documents

Publication Publication Date Title
JP7518764B2 (ja) 発作性夜間ヘモグロビン尿症(PNH)および非典型溶血性尿毒症症候群(aHUS)の処置のための抗C5抗体の投薬量および投与
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
US20190023775A1 (en) Dosage and administration of anti-c5 antibodies for treatment
ES2980453T3 (es) Dosificación y administración de anticuerpos anti-c5 para el tratamiento del síndrome urémico hemolítico atípico (ahus)
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
JP2021525718A (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
KR20230047179A (ko) 조혈 줄기세포 이식-연관 혈전성 미세혈관병증(hsct-tma)을 치료하기 위한 항-c5 항체의 복용량 및 투여
HK40110798A (en) Methods of treating complement mediated thrombotic microangiopathy using an anti-c5 antibody
JP7734673B2 (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
WO2025166118A1 (en) Dosage and administration of anti-c5 antibodies for treating iga nephropathy (igan)
JP2025529317A (ja) 造血幹細胞移植関連血栓性微小血管症(hsct-tma)を治療するための抗c5抗体の補足的投薬及び投与
HK40123339A (zh) 针对april的抗体分子及其用途
EA043233B1 (ru) ДОЗИРОВАНИЕ И ВВЕДЕНИЕ АНТИТЕЛ ПРОТИВ C5 ДЛЯ ЛЕЧЕНИЯ ПАЦИЕНТОВ С ПАРОКСИЗМАЛЬНОЙ НОЧНОЙ ГЕМОГЛОБИНУРИЕЙ (PNH) И АТИПИЧНЫМ ГЕМОЛИТИКО-УРЕМИЧЕСКИМ СИНДРОМОМ (aHUS)

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20250117

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20250117

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20260202