JP2024538091A - 第ｖｉｉｉ因子キメラタンパク質の製剤およびその使用 - Google Patents

第ｖｉｉｉ因子キメラタンパク質の製剤およびその使用 Download PDF

Info

Publication number
JP2024538091A
JP2024538091A JP2024522237A JP2024522237A JP2024538091A JP 2024538091 A JP2024538091 A JP 2024538091A JP 2024522237 A JP2024522237 A JP 2024522237A JP 2024522237 A JP2024522237 A JP 2024522237A JP 2024538091 A JP2024538091 A JP 2024538091A
Authority
JP
Japan
Prior art keywords
pharmaceutical composition
sucrose
arginine
poloxamer
histidine
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
JP2024522237A
Other languages
English (en)
Japanese (ja)
Other versions
JP2024538091A5 (enExample
Inventor
タイラー・カーレッジ
ランドル・モールディン
ティモシー・アール・マッコイ
ルブナ・ムザーラック・タジ
Original Assignee
バイオベラティブ セラピューティクス 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 バイオベラティブ セラピューティクス インコーポレイテッド filed Critical バイオベラティブ セラピューティクス インコーポレイテッド
Publication of JP2024538091A publication Critical patent/JP2024538091A/ja
Publication of JP2024538091A5 publication Critical patent/JP2024538091A5/ja
Pending legal-status Critical Current

Links

Images

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • A61K38/36—Blood coagulation or fibrinolysis factors
    • A61K38/37—Factors VIII
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/02—Inorganic compounds
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10—Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183—Amino acids, e.g. glycine, EDTA or aspartame
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22—Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • 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
    • A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Hematology (AREA)
  • Immunology (AREA)
  • Biochemistry (AREA)
  • Dermatology (AREA)
  • Molecular Biology (AREA)
  • Zoology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Inorganic Chemistry (AREA)
  • Diabetes (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Organic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Peptides Or Proteins (AREA)
JP2024522237A 2021-10-15 2022-10-14 第ｖｉｉｉ因子キメラタンパク質の製剤およびその使用 Pending JP2024538091A (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202163256432P 2021-10-15 2021-10-15
US63/256,432 2021-10-15
PCT/US2022/078097 WO2023064886A1 (en) 2021-10-15 2022-10-14 Formulations of factor viii chimeric proteins and uses thereof

Publications (2)

Publication Number Publication Date
JP2024538091A true JP2024538091A (ja) 2024-10-18
JP2024538091A5 JP2024538091A5 (enExample) 2025-10-21

Family

ID=84362012

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2024522237A Pending JP2024538091A (ja) 2021-10-15 2022-10-14 第ｖｉｉｉ因子キメラタンパク質の製剤およびその使用

Country Status (13)

Country Link
US (1) US20240358800A1 (enExample)
EP (2) EP4415693B1 (enExample)
JP (1) JP2024538091A (enExample)
KR (1) KR20240082408A (enExample)
CN (1) CN118103034A (enExample)
AU (1) AU2022366974A1 (enExample)
CA (1) CA3229979A1 (enExample)
CO (1) CO2024004211A2 (enExample)
ES (1) ES3068733T3 (enExample)
IL (1) IL311969A (enExample)
MX (1) MX2024004494A (enExample)
TW (1) TW202334244A (enExample)
WO (1) WO2023064886A1 (enExample)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EA201691111A1 (ru) 2014-01-10 2017-01-30 Байоджен Ма Инк. Химерные белки фактора viii и их применение

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ATE198277T1 (de) * 1992-10-02 2001-01-15 Genetics Inst Zusammensetzung, welche den koagulationsfaktor viii beinhaltet; verfahren zu deren herstellung und die benutzung eines oberflächenaktiven stoffes als stabilisator
KR102914074B1 (ko) 2018-05-18 2026-01-16 바이오버라티브 테라퓨틱스 인크. A형 혈우병의 치료 방법

Also Published As

Publication number Publication date
ES3068733T3 (en) 2026-06-02
EP4740963A2 (en) 2026-05-13
EP4415693A1 (en) 2024-08-21
WO2023064886A1 (en) 2023-04-20
EP4740963A3 (en) 2026-07-22
CA3229979A1 (en) 2023-04-20
EP4415693B1 (en) 2026-02-18
TW202334244A (zh) 2023-09-01
KR20240082408A (ko) 2024-06-10
CN118103034A (zh) 2024-05-28
MX2024004494A (es) 2024-07-15
EP4415693C0 (en) 2026-02-18
CO2024004211A2 (es) 2024-04-18
AU2022366974A1 (en) 2024-05-30
US20240358800A1 (en) 2024-10-31
IL311969A (en) 2024-06-01

Similar Documents

Publication Publication Date Title
JP7861172B2 (ja) Ｘｔｅｎを有するトロンビン切断可能リンカー及びその使用
ES2969528T3 (es) Mutantes de FGF21 y usos de los mismos
KR102659212B1 (ko) 인자 ix 융합 단백질 및 이의 제조 방법 및 사용 방법
ES2758827T3 (es) Formulaciones para enzimas lisosómicas
EP3793588B1 (en) Methods of treating hemophilia a
CN103917554B (zh) 用于改善重构后纯化的因子viii的稳定性的方法
US20180134761A1 (en) Compositions and Methods of Use for Treating Metabolic Disorders
TWI835773B (zh) 組合物及使用方法
CN101379189A (zh) 具有延长的半衰期的经修饰的凝血因子VIIa
JP2016506911A (ja) 疾患の治療または予防に用いるためのファクター１およびファクター２タンパク質、およびその阻害剤
CN105163751A (zh) 复合物
JP2024522855A (ja) 第ｖｉｉｉ因子キメラタンパク質の製剤およびその使用
EP4415693B1 (en) Formulations of factor viii chimeric proteins and uses thereof
CN118076373A (zh) 用于联合疗法的包括生长分化因子-15变体和胰高血糖素样肽-1受体激动剂的组合物
WO2024077335A1 (en) Factor ix variant polypeptides for administration to soft tissue
EP4362971A1 (en) Factor ix subcutaneous administration with enhanced safety
KR102058864B1 (ko) 인자 vii의 융합 단백질을 포함하는 안정성이 개선된 약학적 조성물
WO2024141054A1 (zh) 包含融合蛋白的药物组合物及其用途
EA051115B1 (ru) Составы на основе химерных белков, содержащих фактор viii, и варианты их применения
EP3448414B1 (en) Nope for treatment of pathological muscle loss and weakness
CN115485290A (zh) 作为血管生成素模拟物和Tie2激动剂治疗血管疾病的C4结合蛋白C端区段和血管生成素-1纤维蛋白原样域之间的嵌合融合体
BR112015031194B1 (pt) Molécula quimérica, composição farmacêutica, e uso dos anteriores

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20251010

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20251010