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 (cg-RX-API-DMAC7.html
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

    • 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
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • A61K39/39591—Stabilisation, fragmentation
    • 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
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/20—Immunoglobulins specific features characterized by taxonomic origin
    • C07K2317/24—Immunoglobulins specific features characterized by taxonomic origin containing regions, domains or residues from different species, e.g. chimeric, humanized or veneered
    • 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
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/526—CH3 domain
    • 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
    • C07K2319/00—Fusion polypeptide
    • C07K2319/90—Fusion polypeptide containing a motif for post-translational modification
    • C07K2319/92—Fusion 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)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Diabetes (AREA)
  • Epidemiology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Microbiology (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 (cg-RX-API-DMAC7.html) 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 (cg-RX-API-DMAC7.html)
EP (2) EP4281472A1 (cg-RX-API-DMAC7.html)
JP (1) JP2024504366A (cg-RX-API-DMAC7.html)
KR (1) KR20230134533A (cg-RX-API-DMAC7.html)
AU (1) AU2022210283A1 (cg-RX-API-DMAC7.html)
CA (1) CA3173016A1 (cg-RX-API-DMAC7.html)
IL (1) IL304593A (cg-RX-API-DMAC7.html)
WO (1) WO2022159373A1 (cg-RX-API-DMAC7.html)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US12240893B2 (en) 2018-10-30 2025-03-04 Alexion Pharmaceuticals, Inc. Subcutaneous dosage and administration of anti-C5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (PNH)
CN116194478A (zh) 2020-06-24 2023-05-30 阿雷克森制药公司 皮下（sc）施用抗c5抗体治疗补体相关病症
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
CA3266977A1 (en) * 2022-09-06 2024-03-14 Alexion Pharmaceuticals, Inc. DIAGNOSTIC AND PROGNOSIS BIOMARKER PROFILES IN PATIENTS WITH HEMATOPOIETIC STEM CELL TRANSPLANT-ASSOCIATED THROMBOTIC MICROANGIOPATHY (HSCT-TMA)

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
JP5878270B2 (ja) 2012-12-19 2016-03-08 プロメラス， エルエルシー 高純度ノルボルネンアルカノールおよびその誘導体の製造方法
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
IL263481B2 (en) 2016-06-14 2024-06-01 Regeneron Pharma Anti-c5 antibodies and uses thereof
ES2965486T3 (es) * 2017-07-27 2024-04-15 Alexion Pharma Inc Formulaciones de anticuerpos anti-C5 de alta concentración
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
US12240893B2 (en) * 2018-10-30 2025-03-04 Alexion Pharmaceuticals, Inc. Subcutaneous dosage and administration of anti-C5 antibodies for treatment of paroxysmal nocturnal hemoglobinuria (PNH)
JP7511566B2 (ja) * 2019-01-25 2024-07-05 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 非典型溶血性尿毒症症候群（ａＨＵＳ）の処置のための抗Ｃ５抗体の投薬量及び投与
MX2021009789A (es) * 2019-02-14 2021-11-17 Alexion Pharma Inc Dosificacion y administracion de anticuerpos anti-c5 para el tratamiento de miastenia gravis generalizada.
JP2023501377A (ja) * 2019-11-08 2023-01-18 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 高濃度抗ｃ５抗体配合物
CN116194478A (zh) * 2020-06-24 2023-05-30 阿雷克森制药公司 皮下（sc）施用抗c5抗体治疗补体相关病症

Also Published As

Publication number Publication date
AU2022210283A9 (en) 2024-10-17
US20240092881A1 (en) 2024-03-21
WO2022159373A1 (en) 2022-07-28
CA3173016A1 (en) 2022-07-28
EP4378479A3 (en) 2024-09-25
EP4281472A1 (en) 2023-11-29
KR20230134533A (ko) 2023-09-21
AU2022210283A1 (en) 2023-08-03
EP4378479A2 (en) 2024-06-05
IL304593A (en) 2023-09-01

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
ES2980453T3 (es) Dosificación y administración de anticuerpos anti-c5 para el tratamiento del síndrome urémico hemolítico atípico (ahus)
US20190023775A1 (en) Dosage and administration of anti-c5 antibodies for treatment
EP4378479A2 (en) Methods of treating complement mediated thrombotic microangiopathy using an anti-c5 antibody
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
WO2025166118A1 (en) Dosage and administration of anti-c5 antibodies for treating iga nephropathy (igan)
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
HK40123339A (en) Antibody molecules to april and uses thereof
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
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

A601 Written request for extension of time

Free format text: JAPANESE INTERMEDIATE CODE: A601

Effective date: 20260501

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20260702