DK4080209T3 - Method of determining toxicity of an immunomodulatory drug for use in humans - Google Patents

Method of determining toxicity of an immunomodulatory drug for use in humans Download PDF

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Publication number
DK4080209T3
DK4080209T3 DK22173216.7T DK22173216T DK4080209T3 DK 4080209 T3 DK4080209 T3 DK 4080209T3 DK 22173216 T DK22173216 T DK 22173216T DK 4080209 T3 DK4080209 T3 DK 4080209T3
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DK
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Prior art keywords
humans
immunomodulatory drug
determining toxicity
toxicity
determining
Prior art date
Application number
DK22173216.7T
Other languages
English (en)
Inventor
James Keck
Chunting Ye
Original Assignee
Jackson Lab
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Publication of DK4080209T3 publication Critical patent/DK4080209T3/da

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    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/5005—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells
    • G01N33/5008—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics
    • G01N33/5044—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving human or animal cells for testing or evaluating the effect of chemical or biological compounds, e.g. drugs, cosmetics involving specific cell types
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01K—ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
    • A01K67/00—Rearing or breeding animals, not otherwise provided for; New or modified breeds of animals
    • A01K67/027—New or modified breeds of vertebrates
    • A01K67/0271—Chimeric vertebrates, e.g. comprising exogenous cells
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01K—ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
    • A01K67/00—Rearing or breeding animals, not otherwise provided for; New or modified breeds of animals
    • A01K67/027—New or modified breeds of vertebrates
    • A01K67/0275—Genetically modified vertebrates, e.g. transgenic
    • A01K67/0278—Knock-in vertebrates, e.g. humanised vertebrates
    • 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
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2809—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against the T-cell receptor (TcR)-CD3 complex
    • 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
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily
    • C07K16/2818—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against the immunoglobulin superfamily against CD28 or CD152
    • 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
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2887—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • 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
    • C07K16/28—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2893—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD52
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6863—Cytokines, i.e. immune system proteins modifying a biological response such as cell growth proliferation or differentiation, e.g. TNF, CNF, GM-CSF, lymphotoxin, MIF or their receptors
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N33/00—Investigating or analysing materials by specific methods not covered by groups G01N1/00 - G01N31/00
    • G01N33/48—Biological material, e.g. blood, urine; Haemocytometers
    • G01N33/50—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing
    • G01N33/68—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids
    • G01N33/6893—Chemical analysis of biological material, e.g. blood, urine; Testing involving biospecific ligand binding methods; Immunological testing involving proteins, peptides or amino acids related to diseases not provided for elsewhere
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01K—ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
    • A01K2207/00—Modified animals
    • A01K2207/12—Animals modified by administration of exogenous cells
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01K—ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
    • A01K2217/00—Genetically modified animals
    • A01K2217/15—Animals comprising multiple alterations of the genome, by transgenesis or homologous recombination, e.g. obtained by cross-breeding
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01K—ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
    • A01K2227/00—Animals characterised by species
    • A01K2227/10—Mammal
    • A01K2227/105—Murine
    • A—HUMAN NECESSITIES
    • A01—AGRICULTURE; FORESTRY; ANIMAL HUSBANDRY; HUNTING; TRAPPING; FISHING
    • A01K—ANIMAL HUSBANDRY; AVICULTURE; APICULTURE; PISCICULTURE; FISHING; REARING OR BREEDING ANIMALS, NOT OTHERWISE PROVIDED FOR; NEW BREEDS OF ANIMALS
    • A01K2267/00—Animals characterised by purpose
    • A01K2267/03—Animal model, e.g. for test or diseases
    • A01K2267/0306—Animal model for genetic diseases
    • A01K2267/0325—Animal model for autoimmune diseases
    • G—PHYSICS
    • G01—MEASURING; TESTING
    • G01N—INVESTIGATING OR ANALYSING MATERIALS BY DETERMINING THEIR CHEMICAL OR PHYSICAL PROPERTIES
    • G01N2800/00—Detection or diagnosis of diseases
    • G01N2800/24—Immunology or allergic disorders

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Immunology (AREA)
  • Chemical & Material Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Biochemistry (AREA)
  • Medicinal Chemistry (AREA)
  • Urology & Nephrology (AREA)
  • Hematology (AREA)
  • Cell Biology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biotechnology (AREA)
  • Environmental Sciences (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Analytical Chemistry (AREA)
  • Food Science & Technology (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Microbiology (AREA)
  • Physics & Mathematics (AREA)
  • Animal Behavior & Ethology (AREA)
  • Biodiversity & Conservation Biology (AREA)
  • Zoology (AREA)
  • Animal Husbandry (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Toxicology (AREA)
  • Tropical Medicine & Parasitology (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Investigating Or Analysing Biological Materials (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
DK22173216.7T 2017-04-17 2018-04-17 Method of determining toxicity of an immunomodulatory drug for use in humans DK4080209T3 (en)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US201762486441P 2017-04-17 2017-04-17
US201762521617P 2017-06-19 2017-06-19
EP18725680.5A EP3612840B1 (en) 2017-04-17 2018-04-17 Method of determining toxicity of an immunomodulatory drug for use in humans

Publications (1)

Publication Number Publication Date
DK4080209T3 true DK4080209T3 (en) 2024-07-08

Family

ID=62196678

Family Applications (1)

Application Number Title Priority Date Filing Date
DK22173216.7T DK4080209T3 (en) 2017-04-17 2018-04-17 Method of determining toxicity of an immunomodulatory drug for use in humans

Country Status (9)

Country Link
US (3) US11959925B2 (da)
EP (3) EP4361637A3 (da)
JP (3) JP7179013B2 (da)
CN (1) CN110770582A (da)
AU (2) AU2018254420B2 (da)
DK (1) DK4080209T3 (da)
ES (2) ES2937797T3 (da)
FI (2) FI4080209T3 (da)
WO (1) WO2018195027A1 (da)

Families Citing this family (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
ES2937797T3 (es) 2017-04-17 2023-03-31 Jackson Lab Método de determinación de la toxicidad de un fármaco inmunomodulador para el uso en seres humanos
WO2020041174A1 (en) * 2018-08-20 2020-02-27 The Jackson Laboratory Method of determining toxicity of an immunomodulatory drug
CN115803027A (zh) * 2020-04-30 2023-03-14 百时美施贵宝公司 治疗细胞因子相关的不良事件的方法
KR20230074758A (ko) * 2020-09-24 2023-05-31 더 잭슨 래보라토리 면역 세포 요법을 평가하기 위한 인간화 마우스 모델
JP7826449B2 (ja) * 2021-07-13 2026-03-09 ジェネンテック， インコーポレイテッド サイトカイン放出症候群を予測する多変量モデル
WO2023075539A1 (ko) * 2021-10-29 2023-05-04 서울대학교 산학협력단 면역억제물질 예측용 유전자 집단의 선별방법 및 이를 이용한 면역억제능 평가방법
AU2024328044A1 (en) * 2023-08-18 2026-03-26 The Jackson Laboratory Murine models of human development and disease
KR102725830B1 (ko) * 2023-12-29 2024-11-06 서울대학교산학협력단 약물의 독성 스크리닝을 위한 형질전환 마우스 모델 및 그 제조 방법

Family Cites Families (17)

* Cited by examiner, † Cited by third party
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US7105158B1 (en) * 1992-11-16 2006-09-12 The Corporation Of Mercer University Methods of administering microencapsulated materials for immune modulated diseases
US20110082091A1 (en) 2009-09-28 2011-04-07 Theramab Gmbh Method for Preclinical Testing of Immunomodulatory Drugs
EP4502152A3 (en) 2009-10-06 2025-04-30 Regeneron Pharmaceuticals, Inc. Genetically modified mice and engraftment
EP2422618A1 (en) 2010-08-27 2012-02-29 Technologie Integrale Ltd. Animal model for the evaluation of the efficacy of an HIV vaccine
SG10202008003VA (en) 2011-02-15 2020-10-29 Regeneron Pharma Humanized m-csf mice
CN104160272A (zh) * 2011-12-06 2014-11-19 麻省理工学院 利用人源化的小鼠来确定毒性
CN103304669A (zh) * 2012-03-12 2013-09-18 复旦大学 人源化肿瘤免疫细胞因子tntil2及其制备方法和用途
ES2664352T3 (es) * 2013-03-22 2018-04-19 Imperial Innovations Ltd Método in vitro para evaluar respuestas de tormenta de citoquinas
US20150282460A1 (en) 2014-04-04 2015-10-08 Crown Bioscience Inc. (Taicang) Animal model with human immune system
HK1255123A1 (zh) 2015-06-23 2019-08-02 The Jackson Laboratory 具有患者衍生异种移植物的非hla匹配的人源化nsg小鼠模型
WO2017040930A2 (en) 2015-09-03 2017-03-09 The Trustees Of The University Of Pennsylvania Biomarkers predictive of cytokine release syndrome
ES2937797T3 (es) 2017-04-17 2023-03-31 Jackson Lab Método de determinación de la toxicidad de un fármaco inmunomodulador para el uso en seres humanos
US20190091310A1 (en) 2017-09-26 2019-03-28 Stephen E. Wright Nonreleased il-12 for therapy of cancer
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US20220389092A1 (en) 2019-04-05 2022-12-08 The Regents Of The University Of California Methods and compositions involving chimeric binding polypeptides
KR20230074758A (ko) 2020-09-24 2023-05-31 더 잭슨 래보라토리 면역 세포 요법을 평가하기 위한 인간화 마우스 모델

Also Published As

Publication number Publication date
CA3059923A1 (en) 2018-10-25
US12510548B2 (en) 2025-12-30
US11959926B2 (en) 2024-04-16
JP7437482B2 (ja) 2024-02-22
ES2983677T3 (es) 2024-10-24
US20230417763A1 (en) 2023-12-28
ES2937797T3 (es) 2023-03-31
EP3612840B1 (en) 2022-11-23
EP4361637A2 (en) 2024-05-01
AU2024202008A1 (en) 2024-04-18
EP4361637A3 (en) 2024-07-17
AU2018254420A1 (en) 2019-10-31
JP7179013B2 (ja) 2022-11-28
WO2018195027A1 (en) 2018-10-25
FI4080209T3 (fi) 2024-06-24
US20220003781A9 (en) 2022-01-06
EP4080209A1 (en) 2022-10-26
AU2018254420B2 (en) 2024-01-11
JP2024040343A (ja) 2024-03-25
US11959925B2 (en) 2024-04-16
EP3612840A1 (en) 2020-02-26
EP4080209B1 (en) 2024-04-03
JP2020516902A (ja) 2020-06-11
JP2023022092A (ja) 2023-02-14
FI3612840T3 (fi) 2023-03-22
JP7652953B2 (ja) 2025-03-27
CN110770582A (zh) 2020-02-07
US20210132080A1 (en) 2021-05-06
US20240288445A1 (en) 2024-08-29

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