JP7374544B2 - 標識部-抗ヒト抗体Fabフラグメント複合体を含む医薬組成物 - Google Patents

標識部-抗ヒト抗体Fabフラグメント複合体を含む医薬組成物 Download PDF

Info

Publication number
JP7374544B2
JP7374544B2 JP2020551190A JP2020551190A JP7374544B2 JP 7374544 B2 JP7374544 B2 JP 7374544B2 JP 2020551190 A JP2020551190 A JP 2020551190A JP 2020551190 A JP2020551190 A JP 2020551190A JP 7374544 B2 JP7374544 B2 JP 7374544B2
Authority
JP
Japan
Prior art keywords
fab fragment
antibody fab
seq
human
pharmaceutical composition
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.)
Active
Application number
JP2020551190A
Other languages
English (en)
Japanese (ja)
Other versions
JPWO2020075746A1 (ja
JPWO2020075746A5 (https=
Inventor
純平 末光
恵 池田
萌 河野
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.)
Astellas Pharma Inc
Original Assignee
Astellas Pharma Inc
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 Astellas Pharma Inc filed Critical Astellas Pharma Inc
Publication of JPWO2020075746A1 publication Critical patent/JPWO2020075746A1/ja
Publication of JPWO2020075746A5 publication Critical patent/JPWO2020075746A5/ja
Application granted granted Critical
Publication of JP7374544B2 publication Critical patent/JP7374544B2/ja
Active legal-status Critical Current
Anticipated expiration legal-status Critical

Links

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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6801Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • 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
    • A61K47/02Inorganic compounds
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/10Alcohols; Phenols; Salts thereof, e.g. glycerol; Polyethylene glycols [PEG]; Poloxamers; PEG/POE alkyl ethers
    • 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
    • A61K47/08Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • A61K47/12Carboxylic acids; Salts or anhydrides thereof
    • 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
    • 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
    • A61K47/20Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing sulfur, e.g. dimethyl sulfoxide [DMSO], docusate, sodium lauryl sulfate or aminosulfonic acids
    • 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
    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6851Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
    • 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
    • A61K47/50Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment
    • A61K47/6835Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site
    • A61K47/6851Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent the modifying agent being an antibody, an immunoglobulin or a fragment thereof, e.g. an Fc-fragment the modifying agent being an antibody or an immunoglobulin bearing at least one antigen-binding site the antibody targeting a determinant of a tumour cell
    • A61K47/6853Carcino-embryonic antigens
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/02Preparations containing radioactive substances for use in therapy or testing in vivo characterised by the carrier, i.e. characterised by the agent or material covalently linked or complexing the radioactive nucleus
    • A61K51/04Organic compounds
    • A61K51/041Heterocyclic compounds
    • A61K51/044Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine, rifamycins
    • A61K51/0446Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine, rifamycins having five-membered rings with one nitrogen as the only ring hetero atom, e.g. sulpiride, succinimide, tolmetin, buflomedil
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/02Preparations containing radioactive substances for use in therapy or testing in vivo characterised by the carrier, i.e. characterised by the agent or material covalently linked or complexing the radioactive nucleus
    • A61K51/04Organic compounds
    • A61K51/08Peptides, e.g. proteins, carriers being peptides, polyamino acids, proteins
    • A61K51/10Antibodies or immunoglobulins; Fragments thereof, the carrier being an antibody, an immunoglobulin or a fragment thereof, e.g. a camelised human single domain antibody or the Fc fragment of an antibody
    • A61K51/1045Antibodies or immunoglobulins; Fragments thereof, the carrier being an antibody, an immunoglobulin or a fragment thereof, e.g. a camelised human single domain antibody or the Fc fragment of an antibody against animal or human tumor cells or tumor cell determinants
    • A61K51/1048Antibodies or immunoglobulins; Fragments thereof, the carrier being an antibody, an immunoglobulin or a fragment thereof, e.g. a camelised human single domain antibody or the Fc fragment of an antibody against animal or human tumor cells or tumor cell determinants the tumor cell determinant being a carcino embryonic antigen
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/02Preparations containing radioactive substances for use in therapy or testing in vivo characterised by the carrier, i.e. characterised by the agent or material covalently linked or complexing the radioactive nucleus
    • A61K51/04Organic compounds
    • A61K51/08Peptides, e.g. proteins, carriers being peptides, polyamino acids, proteins
    • A61K51/10Antibodies or immunoglobulins; Fragments thereof, the carrier being an antibody, an immunoglobulin or a fragment thereof, e.g. a camelised human single domain antibody or the Fc fragment of an antibody
    • A61K51/1045Antibodies or immunoglobulins; Fragments thereof, the carrier being an antibody, an immunoglobulin or a fragment thereof, e.g. a camelised human single domain antibody or the Fc fragment of an antibody against animal or human tumor cells or tumor cell determinants
    • A61K51/1051Antibodies or immunoglobulins; Fragments thereof, the carrier being an antibody, an immunoglobulin or a fragment thereof, e.g. a camelised human single domain antibody or the Fc fragment of an antibody against animal or human tumor cells or tumor cell determinants the tumor cell being from breast, e.g. the antibody being herceptin
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K51/00Preparations containing radioactive substances for use in therapy or testing in vivo
    • A61K51/02Preparations containing radioactive substances for use in therapy or testing in vivo characterised by the carrier, i.e. characterised by the agent or material covalently linked or complexing the radioactive nucleus
    • A61K51/04Organic compounds
    • A61K51/08Peptides, e.g. proteins, carriers being peptides, polyamino acids, proteins
    • A61K51/10Antibodies or immunoglobulins; Fragments thereof, the carrier being an antibody, an immunoglobulin or a fragment thereof, e.g. a camelised human single domain antibody or the Fc fragment of an antibody
    • A61K51/1093Antibodies or immunoglobulins; Fragments thereof, the carrier being an antibody, an immunoglobulin or a fragment thereof, e.g. a camelised human single domain antibody or the Fc fragment of an antibody conjugates with carriers being antibodies
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/08Solutions
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61KPREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00Medicinal preparations characterised by special physical form
    • A61K9/14Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19Particulate 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
    • 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
    • C07K16/2803Immunoglobulins [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
    • 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
    • C07K16/30Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3007Carcino-embryonic Antigens
    • 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
    • C07K16/30Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells
    • C07K16/3076Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells against structure-related tumour-associated moieties
    • C07K16/3092Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants from tumour cells against structure-related tumour-associated moieties against tumour-associated mucins
    • 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
    • A61K2039/505Medicinal preparations containing antigens or antibodies comprising antibodies
    • A61K2039/507Comprising a combination of two or more separate antibodies
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/50Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/55Fab or Fab'
    • CCHEMISTRY; METALLURGY
    • C07ORGANIC CHEMISTRY
    • C07KPEPTIDES
    • C07K2317/00Immunoglobulins specific features
    • C07K2317/70Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/71Decreased effector function due to an Fc-modification
    • 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)
  • Pharmacology & Pharmacy (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Immunology (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Organic Chemistry (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Cell Biology (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Oncology (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Genetics & Genomics (AREA)
  • Biophysics (AREA)
  • Physics & Mathematics (AREA)
  • Optics & Photonics (AREA)
  • Mycology (AREA)
  • Microbiology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Inorganic Chemistry (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Peptides Or Proteins (AREA)
  • Medicinal Preparation (AREA)
JP2020551190A 2018-10-10 2019-10-09 標識部-抗ヒト抗体Fabフラグメント複合体を含む医薬組成物 Active JP7374544B2 (ja)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
JP2018191605 2018-10-10
JP2018191605 2018-10-10
PCT/JP2019/039793 WO2020075746A1 (ja) 2018-10-10 2019-10-09 標識部-抗ヒト抗体Fabフラグメント複合体を含む医薬組成物

Publications (3)

Publication Number Publication Date
JPWO2020075746A1 JPWO2020075746A1 (ja) 2021-09-09
JPWO2020075746A5 JPWO2020075746A5 (https=) 2022-07-21
JP7374544B2 true JP7374544B2 (ja) 2023-11-07

Family

ID=70163703

Family Applications (1)

Application Number Title Priority Date Filing Date
JP2020551190A Active JP7374544B2 (ja) 2018-10-10 2019-10-09 標識部-抗ヒト抗体Fabフラグメント複合体を含む医薬組成物

Country Status (12)

Country Link
US (2) US12065503B2 (https=)
EP (1) EP3865154A4 (https=)
JP (1) JP7374544B2 (https=)
KR (1) KR20210074284A (https=)
CN (2) CN112839683B (https=)
CA (1) CA3115747A1 (https=)
MX (1) MX2021004146A (https=)
MY (1) MY205764A (https=)
PH (1) PH12021550770A1 (https=)
SG (1) SG11202103670XA (https=)
TW (1) TWI835880B (https=)
WO (1) WO2020075746A1 (https=)

Families Citing this family (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
TWI780082B (zh) 2016-11-18 2022-10-11 日商安斯泰來製藥股份有限公司 新穎抗人類MUC1抗體Fab片段
TWI795415B (zh) 2017-07-07 2023-03-11 日商安斯泰來製藥股份有限公司 新穎的抗人類CEACAM5抗體Fab片段
MX2020012351A (es) * 2018-05-17 2021-01-29 Astellas Pharma Inc Complejo que tiene fragmento fab de anticuerpo anti-muc1 de humano, enlazador peptido y/o ligando.
CA3115747A1 (en) 2018-10-10 2020-04-16 Astellas Pharma Inc. Pharmaceutical composition containing tagged site-antihuman antibody fab fragment complex
KR102735988B1 (ko) 2019-02-18 2024-12-03 일라이 릴리 앤드 캄파니 치료 항체 제제
CA3174082A1 (en) 2020-03-04 2021-09-10 Nihon Medi-Physics Co., Ltd. Compound and radioactive labeling compound
KR20230154183A (ko) 2021-03-04 2023-11-07 니혼 메디피직스 가부시키가이샤 화합물 및 방사성 표지 화합물
PH12023500022A1 (en) * 2021-03-29 2024-03-11 Daiichi Sankyo Co Ltd Stable multispecific molecule and use thereof
WO2023100852A1 (ja) * 2021-11-30 2023-06-08 日本メジフィジックス株式会社 安定化放射性医薬組成物
WO2023150820A1 (en) * 2022-02-10 2023-08-17 The University Of Melbourne Process for the synthesis of radiolabelled biological polymers

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005086875A2 (en) 2004-03-11 2005-09-22 City Of Hope A humanized anti-cea t84.66 antibody and uses thereof
WO2018092885A1 (ja) 2016-11-18 2018-05-24 アステラス製薬株式会社 新規な抗ヒトMUC1抗体Fabフラグメント

Family Cites Families (41)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
IL162181A (en) 1988-12-28 2006-04-10 Pdl Biopharma Inc A method of producing humanized immunoglubulin, and polynucleotides encoding the same
CA2371427A1 (en) 1999-04-28 2000-11-09 Yamanouchi Pharmaceutical Co., Ltd. Parenteral pharmaceutical composition containing humanized monoclonal antibody fragment and stabilizing method thereof
WO2001075110A2 (en) 2000-03-30 2001-10-11 Dyax Corp. Mucin-1 specific binding members and methods of use thereof
DE10303664A1 (de) 2003-01-23 2004-08-12 Nemod Immuntherapie Ag Erkennungsmoleküle zur Behandlung und Detektion von Tumoren
US20100111856A1 (en) 2004-09-23 2010-05-06 Herman Gill Zirconium-radiolabeled, cysteine engineered antibody conjugates
WO2007019232A2 (en) * 2005-08-03 2007-02-15 Immunogen, Inc. Immunoconjugate formulations
EA015860B1 (ru) * 2005-10-13 2011-12-30 Хьюман Дженом Сайенсиз, Инк. Способы лечения аутоиммунных заболеваний при использовании антагониста нейтрокина-альфа
EP2083868A2 (en) 2006-10-04 2009-08-05 Københavns Universitet Generation of a cancer-specific immune response toward muc1 and cancer specific muc1 antibodies
JP5773352B2 (ja) 2008-10-28 2015-09-02 塩野義製薬株式会社 抗muc1抗体
EP2196476A1 (en) 2008-12-10 2010-06-16 Novartis Ag Antibody formulation
CA2803520C (en) 2009-07-08 2019-10-22 Lantheus Medical Imaging, Inc. N-alkoxyamide conjugates as imaging agents
EP2281844A1 (en) 2009-07-31 2011-02-09 Glycotope GmbH MUC 1 antibodies
EP3009455A1 (en) 2009-09-16 2016-04-20 Immunomedics Inc. Class i anti-cea antibodies and uses thereof
KR101809761B1 (ko) 2009-09-24 2017-12-15 가부시키가이샤 진 테크노 사이언스 세포 외 기질 단백질의 아미노산 서열 rgd에 특이적인 인간화된 항체 및 그의 용도
EP2347769A1 (en) 2010-01-20 2011-07-27 Glycotope GmbH Cancer stem cell markers and uses thereof
EP2565268A4 (en) 2010-04-28 2013-10-09 Shionogi & Co NEW MUC1 ANTIBODY
CN101928347B (zh) 2010-05-05 2013-03-27 上海海抗中医药科技发展有限公司 抗癌胚抗原抗体及其应用
WO2012015912A1 (en) * 2010-07-30 2012-02-02 Medimmune, Llc Method for purifying active polypeptides or immunocojugates
RS56793B1 (sr) 2011-03-02 2018-04-30 Roche Glycart Ag Cea antitela
WO2013081091A1 (ja) 2011-12-01 2013-06-06 国立大学法人 千葉大学 非特異的腎集積が低減された放射性標識ポリペプチド作製用薬剤
HUE033369T2 (en) 2012-11-20 2017-11-28 Sanofi Sa Anti-ceacam5 antibodies and uses thereof
US9429584B2 (en) 2013-02-28 2016-08-30 National Cancer Center Antibody against insoluble fibrin
TWI679019B (zh) 2013-04-29 2019-12-11 法商賽諾菲公司 抗il-4/抗il-13之雙特異性抗體調配物
NL1040254C2 (en) * 2013-05-17 2014-11-24 Ablynx Nv Stable formulations of immunoglobulin single variable domains and uses thereof.
KR102313341B1 (ko) 2013-08-26 2021-10-18 바이오엔테크 리서치 앤드 디벨롭먼트 인코포레이티드 시알릴-루이스 a에 대한 사람 항체 코드화 핵산
TWI541022B (zh) 2013-12-18 2016-07-11 應克隆公司 針對纖維母細胞生長因子受體-3(fgfr3)之化合物及治療方法
CN106132434A (zh) * 2014-04-07 2016-11-16 西雅图基因公司 抗‑cd19抗体和抗体‑药物偶联物的稳定制剂
AU2015254257B2 (en) 2014-04-28 2021-02-25 Medicinal Chemistry Pharmaceuticals, Co., Ltd. Anti-MUC1 antibody or antigen-binding fragment of same, and use thereof
TWI738632B (zh) * 2014-11-07 2021-09-11 瑞士商諾華公司 穩定的含有高濃度抗vegf抗體之蛋白質溶液調配物
CA2976089C (en) 2015-02-10 2026-01-13 Minerva Biotechnologies Corporation Humanized anti-muc1* antibodies
MX2018007520A (es) * 2015-12-18 2018-08-01 Astellas Pharma Inc Composicion farmaceutica que comprende un anticuerpo receptor de linfopoyetina estromal timica antihumano.
JOP20170017B1 (ar) * 2016-01-25 2021-08-17 Amgen Res Munich Gmbh تركيب صيدلي يتضمن تركيبات جسم مضاد ثنائي الاختصاص
WO2017150549A1 (ja) 2016-03-01 2017-09-08 国立大学法人 千葉大学 放射性標識薬剤
JPWO2017164349A1 (ja) * 2016-03-25 2019-02-07 アステラス製薬株式会社 PEG化抗ヒトNGF抗体Fab’フラグメント含有医薬組成物
GEP20217249B (en) * 2016-06-30 2021-04-26 Inc Celltrion Stable liquid pharmaceutical preparation
US10758632B2 (en) 2017-02-06 2020-09-01 City Of Hope NIR-conjugated tumor-specific antibodies and uses thereof
TWI795415B (zh) 2017-07-07 2023-03-11 日商安斯泰來製藥股份有限公司 新穎的抗人類CEACAM5抗體Fab片段
JP7207740B2 (ja) 2017-09-26 2023-01-18 国立大学法人千葉大学 放射性薬剤
MX2020012351A (es) 2018-05-17 2021-01-29 Astellas Pharma Inc Complejo que tiene fragmento fab de anticuerpo anti-muc1 de humano, enlazador peptido y/o ligando.
CA3115747A1 (en) 2018-10-10 2020-04-16 Astellas Pharma Inc. Pharmaceutical composition containing tagged site-antihuman antibody fab fragment complex
JPWO2020145228A1 (ja) 2019-01-07 2021-11-11 アステラス製薬株式会社 配位子及びCEACAM5抗体Fabフラグメントからなる複合体

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2005086875A2 (en) 2004-03-11 2005-09-22 City Of Hope A humanized anti-cea t84.66 antibody and uses thereof
WO2018092885A1 (ja) 2016-11-18 2018-05-24 アステラス製薬株式会社 新規な抗ヒトMUC1抗体Fabフラグメント

Non-Patent Citations (6)

* Cited by examiner, † Cited by third party
Title
PERK LR et al.,p-Isothiocyanatobenzyl-desferrioxamine: a new bifunctional chelate for facile radiolabeling of monoclonal antibodies with zirconium-89 for immuno-PET imaging,European Journal of Nuclear Medicine and Molecular Imaging,2010年,Vol.37, No.2,p.250-259,doi: 10.1007/s00259-009-1263-1, ISSN 1619-7070
VAN DE WATERING FC et al.,Zirconium-89 labeled antibodies: a new tool for molecular imaging in cancer patients,BioMed Research International,2014年,Vol.2014,Article ID 203601, 13 pages,doi: 10.1155/2014/203601, ISSN 2314-6141
今堀 和友, 山川 民夫 監修,生化学辞典,第3版,株式会社 東京化学同人,2002年07月01日,p.1267,ISBN 4-8079-0480-9
内山 進 ほか,抗体医薬品の溶液物性,薬剤学,2014年01月,第74巻, 第1号,p.12-18,ISSN 0372-7629
内山 進,バイオ医薬品の分析のコツ 品質評価のための基礎と応用 第6回 タンパク質溶液の性質,PHARM TECH JAPAN,2018年01月,第34巻, 第1号,p.109-120,ISSN 0910-4739
荒川 力,凍結操作において添加物はどのようにして蛋白質を安定化するのか,蛋白質 核酸 酵素,1992年07月01日,第37巻, 第9号,p.1517-1523,ISSN 0039-9450

Also Published As

Publication number Publication date
SG11202103670XA (en) 2021-05-28
US20250009897A1 (en) 2025-01-09
MX2021004146A (es) 2021-06-08
TW202034961A (zh) 2020-10-01
EP3865154A1 (en) 2021-08-18
TWI835880B (zh) 2024-03-21
US12065503B2 (en) 2024-08-20
CN117752825A (zh) 2024-03-26
CA3115747A1 (en) 2020-04-16
JPWO2020075746A1 (ja) 2021-09-09
PH12021550770A1 (en) 2021-10-11
EP3865154A4 (en) 2022-11-09
MY205764A (en) 2024-11-12
CN112839683A (zh) 2021-05-25
CN112839683B (zh) 2023-11-14
US20210355233A1 (en) 2021-11-18
WO2020075746A1 (ja) 2020-04-16
KR20210074284A (ko) 2021-06-21

Similar Documents

Publication Publication Date Title
JP7374544B2 (ja) 標識部-抗ヒト抗体Fabフラグメント複合体を含む医薬組成物
JP7414370B2 (ja) 配位子、スペーサー、ペプチドリンカーおよび生物分子からなる複合体
US11679166B2 (en) Anti-human MUC1 antibody Fab fragment
US11667724B2 (en) Anti-human CEACAM5 antibody Fab fragment
EP3795590A1 (en) Complex having anti-human muc1 antibody fab fragment, peptide linker and/or ligand
HK40104413A (zh) 含有标记部-抗人抗体fab片段复合物的药物组合物
RU2800924C2 (ru) Фармацевтическая композиция, содержащая комплекс маркирующий сайт - fab-фрагмент античеловеческого антитела
HK40050259B (zh) 含有标记部-抗人抗体fab片段复合物的药物组合物
HK40050259A (en) Pharmaceutical composition containing tagged site-antihuman antibody fab fragment complex
CA3068691C (en) Anti-human ceacam5 antibody fab fragment
HK40021278B (en) Novel anti-human ceacam5 antibody fab fragment

Legal Events

Date Code Title Description
A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20220712

A621 Written request for application examination

Free format text: JAPANESE INTERMEDIATE CODE: A621

Effective date: 20220712

A131 Notification of reasons for refusal

Free format text: JAPANESE INTERMEDIATE CODE: A131

Effective date: 20230526

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A523

Effective date: 20230721

A521 Request for written amendment filed

Free format text: JAPANESE INTERMEDIATE CODE: A821

Effective date: 20230721

TRDD Decision of grant or rejection written
A01 Written decision to grant a patent or to grant a registration (utility model)

Free format text: JAPANESE INTERMEDIATE CODE: A01

Effective date: 20231017

A61 First payment of annual fees (during grant procedure)

Free format text: JAPANESE INTERMEDIATE CODE: A61

Effective date: 20231023

R150 Certificate of patent or registration of utility model

Ref document number: 7374544

Country of ref document: JP

Free format text: JAPANESE INTERMEDIATE CODE: R150