PE20210553A1 - Variantes e isoformas de anticuerpos con actividad biologica reducida - Google Patents

Variantes e isoformas de anticuerpos con actividad biologica reducida

Info

Publication number
PE20210553A1
PE20210553A1 PE2020000451A PE2020000451A PE20210553A1 PE 20210553 A1 PE20210553 A1 PE 20210553A1 PE 2020000451 A PE2020000451 A PE 2020000451A PE 2020000451 A PE2020000451 A PE 2020000451A PE 20210553 A1 PE20210553 A1 PE 20210553A1
Authority
PE
Peru
Prior art keywords
heavy chain
numbering
cysteine
isoforms
variants
Prior art date
Application number
PE2020000451A
Other languages
English (en)
Inventor
Kensaku Hosoguchi
Maki Kuwayama
Chifumi Seida
Yosuke Watanabe
Nobuyuki Tanaka
Original Assignee
Chugai Pharmaceutical Co Ltd
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 Chugai Pharmaceutical Co Ltd filed Critical Chugai Pharmaceutical Co Ltd
Publication of PE20210553A1 publication Critical patent/PE20210553A1/es

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Classifications

    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/36—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against blood coagulation factors
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • C07K16/468—Immunoglobulins having two or more different antigen binding sites, e.g. multifunctional 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
    • A61K39/395—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/06—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies from serum
    • C07K16/065—Purification, fragmentation
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/46—Hybrid immunoglobulins
    • 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
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • 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
    • G01N33/53—Immunoassay; Biospecific binding assay; Materials therefor
    • G01N33/574—Immunoassay; Biospecific binding assay; Materials therefor for cancer
    • 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
    • G01N33/6854—Immunoglobulins
    • 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
    • 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
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/31—Immunoglobulins specific features characterized by aspects of specificity or valency multispecific
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/51—Complete heavy chain or Fd fragment, i.e. VH + CH1
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/56—Immunoglobulins specific features characterized by immunoglobulin fragments variable (Fv) region, i.e. VH and/or VL
    • C07K2317/565—Complementarity determining region [CDR]
    • 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
    • C07K2317/71—Decreased effector function due to an Fc-modification
    • 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
    • C07K2317/94—Stability, e.g. half-life, pH, temperature or enzyme-resistance

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Engineering & Computer Science (AREA)
  • Molecular Biology (AREA)
  • Medicinal Chemistry (AREA)
  • Hematology (AREA)
  • General Health & Medical Sciences (AREA)
  • Urology & Nephrology (AREA)
  • Organic Chemistry (AREA)
  • Biomedical Technology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Pathology (AREA)
  • General Physics & Mathematics (AREA)
  • Analytical Chemistry (AREA)
  • Physics & Mathematics (AREA)
  • Food Science & Technology (AREA)
  • Biotechnology (AREA)
  • Biophysics (AREA)
  • Cell Biology (AREA)
  • Genetics & Genomics (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Epidemiology (AREA)
  • Mycology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Oncology (AREA)
  • Hospice & Palliative Care (AREA)
  • Peptides Or Proteins (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)

Abstract

Referido a variantes e isoformas de anticuerpos biespecifico, Emicizumab con actividad biologica reducida. Una variante de un anticuerpo CARACTERIZADA PORQUE comprende una region variable que comprende la secuencia de aminoacidos SISPSGQSTYYRREVKG (SEQ ID NO: 2), en donde se elimina: (a) el residuo de aminoacido R en la 12ava posicion desde el lado N terminal de la secuencia; o (b) los residuos de aminoacido YYR entre la 10ma y la 12ava posicion desde el lado N terminal de la secuencia; y se escinde la region variable en el sitio de eliminacion. Tambien se refiere a una isoforma de un anticuerpo biespecifico CARACTERIZADA PORQUE comprende una primera cadena pesada y una segunda cadena pesada, en donde se forman puentes disulfuro en las siguientes posiciones: (1a) entre la cisteina de la posicion 144 de acuerdo con la numeracion EU de la primera cadena pesada y la cisteina de la posicion 200 de acuerdo con la numeracion EU de la segunda cadena pesada; y (1b) entre la cisteina de la posicion 200 de acuerdo con la numeracion EU de la primera cadena pesada y la cisteina de la posicion 144 de acuerdo con la numeracion EU de la segunda cadena pesada; o en donde se forman puentes disulfuro en las siguientes posiciones: (2a) entre la cisteina de la posicion 226 de acuerdo con la numeracion EU de la primera cadena pesada y la cisteina de la posicion 229 de acuerdo con la numeracion EU de la segunda cadena pesada; y (2b) entre la cisteina de la posicion 229 de acuerdo con la numeracion EU de la primera cadena pesada y la cisteina de la posicion 226 de acuerdo con la numeracion EU de la segunda cadena pesada. Estas variantes e isoformas de anticuerpos tienen una actividad mimetica de FVIII reducida en comparacion con el Emicizumab. Ademas, se refiere a metodos de deteccion y metodos de analisis para las variantes e isoformas de anticuerpos.
PE2020000451A 2017-11-01 2018-10-31 Variantes e isoformas de anticuerpos con actividad biologica reducida PE20210553A1 (es)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
JP2017212179 2017-11-01
PCT/JP2018/040436 WO2019088143A1 (ja) 2017-11-01 2018-10-31 生物活性が低下した抗体バリアントおよびアイソフォーム

Publications (1)

Publication Number Publication Date
PE20210553A1 true PE20210553A1 (es) 2021-03-17

Family

ID=66331990

Family Applications (1)

Application Number Title Priority Date Filing Date
PE2020000451A PE20210553A1 (es) 2017-11-01 2018-10-31 Variantes e isoformas de anticuerpos con actividad biologica reducida

Country Status (18)

Country Link
US (1) US20200283544A1 (es)
EP (1) EP3705496A4 (es)
JP (2) JPWO2019088143A1 (es)
KR (1) KR20200074209A (es)
CN (1) CN111479829A (es)
AR (1) AR113816A1 (es)
AU (1) AU2018361430A1 (es)
BR (1) BR112020008393A2 (es)
CA (1) CA3079053A1 (es)
CL (1) CL2020001113A1 (es)
CR (1) CR20200229A (es)
IL (1) IL274265A (es)
MA (1) MA50534A (es)
MX (1) MX2020003472A (es)
PE (1) PE20210553A1 (es)
SG (1) SG11202003833TA (es)
TW (1) TW201930352A (es)
WO (1) WO2019088143A1 (es)

Families Citing this family (8)

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DK2202245T3 (en) 2007-09-26 2016-11-21 Chugai Pharmaceutical Co Ltd A method of modifying an antibody isoelectric point VIA amino acid substitution in CDR
TWI505838B (zh) 2010-01-20 2015-11-01 Chugai Pharmaceutical Co Ltd Stabilized antibody solution containing
TWI700300B (zh) 2014-09-26 2020-08-01 日商中外製藥股份有限公司 中和具有第ｖｉｉｉ凝血因子（ｆｖｉｉｉ）機能替代活性的物質之抗體
CN108368166B (zh) 2015-12-28 2023-03-28 中外制药株式会社 提高含fc区多肽纯化效率的方法
CN109661241A (zh) 2016-09-06 2019-04-19 中外制药株式会社 使用识别凝血因子ix和/或活化凝血因子ix以及凝血因子x和/或活化凝血因子x的双特异性抗体的方法
BR112020008393A2 (pt) 2017-11-01 2020-11-03 Chugai Seiyaku Kabushiki Kaisha variante e isoforma de anticorpos com atividade biológica reduzida
TW202340249A (zh) * 2021-12-22 2023-10-16 日商中外製藥股份有限公司 生物活性降低之抗體變體
CN114544839A (zh) * 2022-01-20 2022-05-27 未名生物医药有限公司 一种抗人神经生长因子抗体的电荷变异体检测方法

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AU2003271174A1 (en) 2003-10-10 2005-04-27 Chugai Seiyaku Kabushiki Kaisha Double specific antibodies substituting for functional protein
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CN101460622A (zh) * 2006-03-31 2009-06-17 中外制药株式会社 用于纯化双特异性抗体的抗体修饰方法
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BR112020008393A2 (pt) 2017-11-01 2020-11-03 Chugai Seiyaku Kabushiki Kaisha variante e isoforma de anticorpos com atividade biológica reduzida

Also Published As

Publication number Publication date
BR112020008393A2 (pt) 2020-11-03
SG11202003833TA (en) 2020-05-28
IL274265A (en) 2020-06-30
EP3705496A4 (en) 2021-12-08
CN111479829A (zh) 2020-07-31
CA3079053A1 (en) 2019-05-09
KR20200074209A (ko) 2020-06-24
AR113816A1 (es) 2020-06-17
US20200283544A1 (en) 2020-09-10
AU2018361430A1 (en) 2020-06-11
RU2020117440A3 (es) 2022-04-01
CL2020001113A1 (es) 2020-11-20
MX2020003472A (es) 2020-08-03
JPWO2019088143A1 (ja) 2020-11-12
WO2019088143A1 (ja) 2019-05-09
RU2020117440A (ru) 2021-12-01
MA50534A (fr) 2020-09-09
TW201930352A (zh) 2019-08-01
CR20200229A (es) 2020-07-12
JP2024037761A (ja) 2024-03-19
EP3705496A1 (en) 2020-09-09

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