CN115996748A - 用APRIL结合抗体治疗IgA肾病的方法 - Google Patents

用APRIL结合抗体治疗IgA肾病的方法 Download PDF

Info

Publication number
CN115996748A
CN115996748A CN202180046732.2A CN202180046732A CN115996748A CN 115996748 A CN115996748 A CN 115996748A CN 202180046732 A CN202180046732 A CN 202180046732A CN 115996748 A CN115996748 A CN 115996748A
Authority
CN
China
Prior art keywords
antibody
formulation
april
administration
concentration
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
CN202180046732.2A
Other languages
English (en)
Chinese (zh)
Inventor
T·范德拉尔
S·霍纳曼
J·杜洛斯
E·德科克
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.)
Aduro Biotech Holdings Europe BV
Chinook Medical
Original Assignee
Aduro Biotech Holdings Europe BV
Chinook Medical
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 Aduro Biotech Holdings Europe BV, Chinook Medical filed Critical Aduro Biotech Holdings Europe BV
Publication of CN115996748A publication Critical patent/CN115996748A/zh
Pending legal-status Critical Current

Links

Images

Classifications

    • 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
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/16Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
    • A61K47/18Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
    • A61K47/183Amino acids, e.g. glycine, EDTA or aspartame
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/22Heterocyclic compounds, e.g. ascorbic acid, tocopherol or pyrrolidones
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K47/00Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
    • A61K47/06Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
    • A61K47/26Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/0012Galenical forms characterised by the site of application
    • A61K9/0019Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P13/00Drugs for disorders of the urinary system
    • A61P13/12Drugs for disorders of the urinary system of the kidneys
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61PSPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00Antineoplastic agents
    • 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
    • C07K16/28Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2875Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the NGF/TNF superfamily, e.g. CD70, CD95L, CD153, CD154
    • 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
    • A61K2039/54Medicinal preparations containing antigens or antibodies characterised by the route of administration
    • 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
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00Medicinal preparations containing antigens or antibodies
    • A61K2039/55Medicinal preparations containing antigens or antibodies characterised by the host/recipient, e.g. newborn with maternal antibodies
    • 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
    • C07K2317/90Immunoglobulins specific features characterized by (pharmaco)kinetic aspects or by stability of the immunoglobulin
    • C07K2317/94Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Organic Chemistry (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Dermatology (AREA)
  • Urology & Nephrology (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
CN202180046732.2A 2020-05-29 2021-05-28 用APRIL结合抗体治疗IgA肾病的方法 Pending CN115996748A (zh)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202062704831P 2020-05-29 2020-05-29
US62/704,831 2020-05-29
PCT/US2021/035011 WO2021243298A1 (en) 2020-05-29 2021-05-28 Methods of treating iga nephropathy with an april binding antibody

Publications (1)

Publication Number Publication Date
CN115996748A true CN115996748A (zh) 2023-04-21

Family

ID=78722933

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202180046732.2A Pending CN115996748A (zh) 2020-05-29 2021-05-28 用APRIL结合抗体治疗IgA肾病的方法

Country Status (11)

Country Link
US (1) US20210379183A1 (https=)
EP (1) EP4157339A4 (https=)
JP (1) JP7843248B2 (https=)
KR (1) KR20230017223A (https=)
CN (1) CN115996748A (https=)
AU (1) AU2021279035A1 (https=)
BR (1) BR112022024262A2 (https=)
CA (1) CA3179812A1 (https=)
IL (1) IL298370A (https=)
MX (1) MX2022014995A (https=)
WO (1) WO2021243298A1 (https=)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2026067804A1 (zh) * 2024-09-30 2026-04-02 信立泰(成都)生物技术有限公司 一种抗april抗体或其抗原结合片段及用途

Families Citing this family (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
NL2011406C2 (en) 2013-09-06 2015-03-10 Bionovion Holding B V Method for obtaining april-binding peptides, process for producing the peptides, april-binding peptides obtainable with said method/process and use of the april-binding peptides.
NL2014108B1 (en) 2015-01-09 2016-09-30 Aduro Biotech Holdings Europe B V Altered april binding antibodies.
US20240092921A1 (en) 2022-04-25 2024-03-21 Visterra, Inc. Antibody molecules to april and uses thereof
AU2023366516A1 (en) 2022-10-28 2025-05-15 Aduro Biotech Holdings, Europe B.V. Treatment of iga nephropathy using an endothelin receptor antagonist and an april binding antibody
JP2025536433A (ja) * 2022-11-07 2025-11-05 サンレノ セラピューティクス (シャンハイ) リミテッド IgA腎症を治療するためのエンドセリン受容体アンタゴニストとグルココルチコイドとの組み合わせ
WO2026050274A2 (en) * 2024-08-27 2026-03-05 Paragon Therapeutics, Inc. April binding proteins, compositions, and methods of use thereof

Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20080260737A1 (en) * 2007-03-27 2008-10-23 Ponce Rafael A COMBINATION OF BLyS AND/OR APRIL INHIBITION AND IMMUNNOSUPPRESSANTS FOR TREATMENT OF AUTOIMMUNE DISEASE
US20090148462A1 (en) * 2005-10-13 2009-06-11 Human Genome Sciences, Inc. Methods and compositions for use in treatment of patients with autoantibody positive disease
CN102258464A (zh) * 2003-04-04 2011-11-30 健泰科生物技术公司 高浓度抗体和蛋白制剂
CN102271707A (zh) * 2008-10-29 2011-12-07 惠氏有限责任公司 单域抗原结合性分子的制剂
CN102946861A (zh) * 2010-03-01 2013-02-27 普罗杰尼克制药股份有限公司 浓缩蛋白制剂及其用途
US8613919B1 (en) * 2012-08-31 2013-12-24 Bayer Healthcare, Llc High concentration antibody and protein formulations
CN107207602A (zh) * 2015-01-09 2017-09-26 艾杜罗生物科技欧洲控股有限责任公司 改良的april结合抗体
CN110869002A (zh) * 2017-05-02 2020-03-06 默沙东公司 程序性死亡受体1(pd-1)抗体的稳定制剂及其使用方法

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
UA74798C2 (uk) * 1999-10-06 2006-02-15 Байоджен Айдек Ма Інк. Спосіб лікування раку у ссавця за допомогою поліпептиду, що протидіє взаємодії april з його рецепторами
WO2007142667A2 (en) * 2005-10-13 2007-12-13 Human Genome Sciences, Inc. Treatment of patients with autoantibody positive disease
CA2754127C (en) * 2009-03-02 2017-04-18 Stichting Top Institute Pharma Antibodies against a proliferating inducing ligand (april)
JP2018534295A (ja) * 2015-10-28 2018-11-22 アドゥロ バイオテック,インク. 「インターフェロン遺伝子刺激因子」依存性シグナル伝達を活性化するための組成物および方法
JOP20170017B1 (ar) * 2016-01-25 2021-08-17 Amgen Res Munich Gmbh تركيب صيدلي يتضمن تركيبات جسم مضاد ثنائي الاختصاص
WO2018201064A1 (en) * 2017-04-28 2018-11-01 Amgen Inc. N-acetylated and non-acetylated dipeptides containing arginine to reduce the viscosity of viscous compositions of therapeutic polypeptides
CA3079946A1 (en) * 2017-10-30 2019-05-09 Sanofi Biotechnology Methods for treating or preventing asthma by administering an il-4r antagonist
CN110464842B (zh) * 2018-05-11 2022-10-14 信达生物制药(苏州)有限公司 包含抗pcsk9抗体的制剂及其用途

Patent Citations (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN102258464A (zh) * 2003-04-04 2011-11-30 健泰科生物技术公司 高浓度抗体和蛋白制剂
US20090148462A1 (en) * 2005-10-13 2009-06-11 Human Genome Sciences, Inc. Methods and compositions for use in treatment of patients with autoantibody positive disease
US20080260737A1 (en) * 2007-03-27 2008-10-23 Ponce Rafael A COMBINATION OF BLyS AND/OR APRIL INHIBITION AND IMMUNNOSUPPRESSANTS FOR TREATMENT OF AUTOIMMUNE DISEASE
CN102271707A (zh) * 2008-10-29 2011-12-07 惠氏有限责任公司 单域抗原结合性分子的制剂
CN102946861A (zh) * 2010-03-01 2013-02-27 普罗杰尼克制药股份有限公司 浓缩蛋白制剂及其用途
US8613919B1 (en) * 2012-08-31 2013-12-24 Bayer Healthcare, Llc High concentration antibody and protein formulations
CN107207602A (zh) * 2015-01-09 2017-09-26 艾杜罗生物科技欧洲控股有限责任公司 改良的april结合抗体
CN110869002A (zh) * 2017-05-02 2020-03-06 默沙东公司 程序性死亡受体1(pd-1)抗体的稳定制剂及其使用方法

Non-Patent Citations (7)

* Cited by examiner, † Cited by third party
Title
"Determining Molecular Weight (Mw) and Second Virial Coefficient (B 22 ) of monoclonal antibodies using ARGEN", FLUENCE ANALYTICS, 18 January 2018 (2018-01-18) *
BORWANKAR AU: "Viscosity Reduction of a Concentrated Monoclonal Antibody with Arginine·HCl and Arginine·Glutamate", INDUSTRIAL & ENGINEERING CHEMISTRY RESEARCH, vol. 55, 24 August 2016 (2016-08-24) *
MATHEW J. ROBINSON等: "Selective Stabilization and Destabilization of Protein Domains in Tissue-Type Plasminogen Activator Using Formulation Excipients", MOLECULAR PHARMACEUTICS, vol. 16, no. 2, 19 December 2018 (2018-12-19) *
PETER STÄRTZEL等: "Freeze-Drying of L -Arginine/Sucrose-Based Protein Formulations, Part 2: Optimization of Formulation Design and Freeze-Drying Process Conditions for an L -Arginine Chloride-Based Protein Formulation System", vol. 104, no. 12, 30 September 2015 (2015-09-30) *
THAKKAR SV等: "Excipients Differentially Influence the Conformational Stability and Pretransition Dynamics of Two IgG1 Monoclonal Antibodies", JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 101, no. 9, 20 April 2014 (2014-04-20) *
THAKKAR SV等: "Excipients Differentially Infuence the Conformational Stability and Pretransition Dynamics of Two IgG1 Monoclonal Antibodies", JOURNAL OF PHARMACEUTICAL SCIENCES, vol. 101, no. 9, 20 April 2014 (2014-04-20), pages 3069 *
靳倩等: "注射用制剂关键理化属性的研究进展", 中国新药杂志, vol. 28, no. 9, 15 May 2019 (2019-05-15) *

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2026067804A1 (zh) * 2024-09-30 2026-04-02 信立泰(成都)生物技术有限公司 一种抗april抗体或其抗原结合片段及用途

Also Published As

Publication number Publication date
WO2021243298A1 (en) 2021-12-02
MX2022014995A (es) 2023-02-09
EP4157339A4 (en) 2024-08-07
AU2021279035A1 (en) 2023-02-02
BR112022024262A2 (pt) 2023-02-23
CA3179812A1 (en) 2021-12-02
IL298370A (en) 2023-01-01
EP4157339A1 (en) 2023-04-05
JP7843248B2 (ja) 2026-04-09
KR20230017223A (ko) 2023-02-03
JP2023527563A (ja) 2023-06-29
US20210379183A1 (en) 2021-12-09

Similar Documents

Publication Publication Date Title
US20250074985A1 (en) Stable formulations of anti-ctla4 antibodies alone and in combination with programmed death receptor 1 (pd-1) antibodies and methods of use thereof
CN115996748A (zh) 用APRIL结合抗体治疗IgA肾病的方法
CN107257692B (zh) Il-17抗体的药物产品和稳定液体组合物
US20240287198A1 (en) Anti-cd40 antibodies for use in prevention of graft rejection
CN118924895A (zh) 用于癌症治疗的结合her2、nkg2d和cd16的多特异性结合蛋白的药物制剂和剂量方案
EP3608336B1 (en) Pan elr+ cxc chemokine antibodies
RU2714919C2 (ru) Антитела, нейтрализующие gm-csf, для применения в лечении ревматоидного артрита или в качестве анальгетиков
CN106794255A (zh) 使用针对cd28的域抗体治疗系统性红斑狼疮的方法
US20240279323A1 (en) Methods for the treatment of scleroderma and related conditions
TW202200203A (zh) 包含抗IL-23p19抗體的製劑、其製備方法和用途
CN119451990A (zh) 与抗pd-1抗体组合的抗ilt4抗体或其抗原结合片段的稳定制剂及其使用方法
TW202206102A (zh) Pd-l1/lag-3雙特異性抗體製劑及其製備方法和用途
WO2022111612A1 (zh) 包含抗tigit/pd-1双特异性抗体的制剂及其制备方法和用途
RU2845158C1 (ru) Способы лечения атопического дерматита путем введения антагониста il-4r
US20260083857A1 (en) Anti-pd-1 antibody-attenuated il-2 immunoconjugate formulations
CN120225565A (zh) 抗ilt4抗体或其抗原结合片段的药物制剂及其使用方法

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination