WO2022022464A8 - 新型双特异性抗cd3/cd20多肽复合物配制剂 - Google Patents

新型双特异性抗cd3/cd20多肽复合物配制剂 Download PDF

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WO2022022464A8
WO2022022464A8 PCT/CN2021/108455 CN2021108455W WO2022022464A8 WO 2022022464 A8 WO2022022464 A8 WO 2022022464A8 CN 2021108455 W CN2021108455 W CN 2021108455W WO 2022022464 A8 WO2022022464 A8 WO 2022022464A8
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formulation
polypeptide complex
bispecific anti
novel bispecific
antigen
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PCT/CN2021/108455
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English (en)
French (fr)
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WO2022022464A1 (zh
Inventor
朱友伟
李盈淳
程艳菊
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正大天晴药业集团股份有限公司
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Priority to US18/007,012 priority Critical patent/US20230279138A1/en
Priority to EP21849910.1A priority patent/EP4190352A1/en
Priority to CA3217391A priority patent/CA3217391A1/en
Priority to CN202180041422.1A priority patent/CN115715200A/zh
Publication of WO2022022464A1 publication Critical patent/WO2022022464A1/zh
Publication of WO2022022464A8 publication Critical patent/WO2022022464A8/zh

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • 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
    • A61K39/39591—Stabilisation, fragmentation
    • A—HUMAN NECESSITIES
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    • A61K47/12—Carboxylic acids; Salts or anhydrides thereof
    • 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
    • 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
    • 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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2803—Immunoglobulins [IGs], 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 [IGs], 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 [IGs], e.g. monoclonal or polyclonal antibodies
    • C07K16/18—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2887—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD20
    • 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
    • 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
    • A61K2039/545—Medicinal preparations containing antigens or antibodies characterised by the dose, timing or administration schedule
    • C—CHEMISTRY; METALLURGY
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    • 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
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/522—CH1 domain
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
    • C07K2317/52—Constant or Fc region; Isotype
    • C07K2317/53—Hinge
    • 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
    • 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
    • C07K2317/73—Inducing cell death, e.g. apoptosis, necrosis or inhibition of cell proliferation
    • 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
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value
    • 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

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  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Immunology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Organic Chemistry (AREA)
  • Animal Behavior & Ethology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Epidemiology (AREA)
  • Biochemistry (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Molecular Biology (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Microbiology (AREA)
  • Mycology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Medicinal Preparation (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)

Abstract

本发明提供一种含有第一抗原结合部分和第二抗原结合部分的新型双特异性抗CD3/CD20多肽复合物配制剂，具体而言，其包括液体配制剂和冻干配制剂。
PCT/CN2021/108455 2020-07-27 2021-07-26 新型双特异性抗cd3/cd20多肽复合物配制剂 WO2022022464A1 (zh)

Priority Applications (4)

Application Number Priority Date Filing Date Title
US18/007,012 US20230279138A1 (en) 2020-07-27 2021-07-26 Novel bispecific anti-cd3/cd20 polypeptide complex formulation
EP21849910.1A EP4190352A1 (en) 2020-07-27 2021-07-26 Formulation of novel bispecific anti-cd3/cd20 polypeptide complex
CA3217391A CA3217391A1 (en) 2020-07-27 2021-07-26 Formulation of novel bispecific anti-cd3/cd20 polypeptide complex
CN202180041422.1A CN115715200A (zh) 2020-07-27 2021-07-26 新型双特异性抗cd3/cd20多肽复合物配制剂

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN202010733597 2020-07-27
CN202010733597.6 2020-07-27

Publications (2)

Publication Number Publication Date
WO2022022464A1 WO2022022464A1 (zh) 2022-02-03
WO2022022464A8 true WO2022022464A8 (zh) 2022-03-03

Family

ID=80037593

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Application Number Title Priority Date Filing Date
PCT/CN2021/108455 WO2022022464A1 (zh) 2020-07-27 2021-07-26 新型双特异性抗cd3/cd20多肽复合物配制剂

Country Status (5)

Country Link
US (1) US20230279138A1 (zh)
EP (1) EP4190352A1 (zh)
CN (1) CN115715200A (zh)
CA (1) CA3217391A1 (zh)
WO (1) WO2022022464A1 (zh)

Family Cites Families (8)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EA201170940A1 (ru) 2009-01-16 2012-02-28 ГЛЭКСОСМИТКЛАЙН ЭлЭлСи Лечение рака с использованием комбинации бендамустина и анти-cd20-антитела
US20140004037A1 (en) 2012-01-19 2014-01-02 Therapeutic Proteins, Inc. Stabilization of the anti-cd20 antibody rituximab
TWI754319B (zh) 2014-03-19 2022-02-01 美商再生元醫藥公司 用於腫瘤治療之方法及抗體組成物
MY199530A (en) * 2017-09-21 2023-11-03 Wuxi Biologics Ireland Ltd Anti-cd3epsilon antibodies
EP3752196A4 (en) * 2018-02-15 2022-03-23 MacroGenics, Inc. VARIANT DOMAINS OF CD3 BINDING AND THEIR USE IN MULTITHERAPIES FOR THE TREATMENT OF A DISEASE
US20210380710A1 (en) * 2018-05-29 2021-12-09 WuXi Biologics Ireland Limited A novel anti-cd3/anti-cd20 bispecific antibody
WO2020084608A1 (en) * 2018-10-22 2020-04-30 Explore Bio 1 Ltd Precursor bispecific antibody constructs and methods of use thereof
WO2020088164A1 (zh) * 2018-11-01 2020-05-07 山东新时代药业有限公司 双特异性抗体及其用途

Also Published As

Publication number Publication date
US20230279138A1 (en) 2023-09-07
CN115715200A (zh) 2023-02-24
EP4190352A1 (en) 2023-06-07
CA3217391A1 (en) 2022-02-03
WO2022022464A1 (zh) 2022-02-03

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