KR20230165828A - 항-MUC16 x 항-CD3 이중특이적 항체를 함유하는 안정화된 제형 - Google Patents

항-MUC16 x 항-CD3 이중특이적 항체를 함유하는 안정화된 제형 Download PDF

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Publication number
KR20230165828A
KR20230165828A KR1020237037903A KR20237037903A KR20230165828A KR 20230165828 A KR20230165828 A KR 20230165828A KR 1020237037903 A KR1020237037903 A KR 1020237037903A KR 20237037903 A KR20237037903 A KR 20237037903A KR 20230165828 A KR20230165828 A KR 20230165828A
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South Korea
Prior art keywords
pharmaceutical formulation
seq
amino acid
acid sequence
concentration
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Pending
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KR1020237037903A
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English (en)
Korean (ko)
Inventor
더글라스 카멘
텡치에 양
샤오빈 슈
하이보 치우
케네스 그레이엄
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리제너론 파아마슈티컬스, 인크.
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Publication of KR20230165828A publication Critical patent/KR20230165828A/ko
Pending legal-status Critical Current

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    • 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
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K16/00—Immunoglobulins [IG], 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
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K33/00—Medicinal preparations containing inorganic active ingredients
    • 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
    • A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
    • 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
    • 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
    • A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
    • 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
    • A61K9/08—Solutions
    • 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
    • C07K16/30—Immunoglobulins [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
    • C07K16/3076—Immunoglobulins [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
    • C07K16/3092—Immunoglobulins [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
    • 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
    • C07K2317/10—Immunoglobulins specific features characterized by their source of isolation or production
    • C07K2317/14—Specific host cells or culture conditions, e.g. components, pH or temperature
    • 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
    • C07K2317/56—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
    • C07K2317/90—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)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • Biophysics (AREA)
  • Genetics & Genomics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Epidemiology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Microbiology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Cell Biology (AREA)
  • Mycology (AREA)
  • Inorganic Chemistry (AREA)
  • Medicinal Preparation (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • General Chemical & Material Sciences (AREA)
  • Oil, Petroleum & Natural Gas (AREA)
  • Peptides Or Proteins (AREA)
KR1020237037903A 2021-04-02 2022-04-01 항-MUC16 x 항-CD3 이중특이적 항체를 함유하는 안정화된 제형 Pending KR20230165828A (ko)

Applications Claiming Priority (5)

Application Number Priority Date Filing Date Title
US202163170320P 2021-04-02 2021-04-02
US63/170,320 2021-04-02
US202263313927P 2022-02-25 2022-02-25
US63/313,927 2022-02-25
PCT/US2022/023122 WO2022212885A1 (en) 2021-04-02 2022-04-01 Stabilized formulations containing anti-muc16 x anti-cd3 bispecific antibodies

Publications (1)

Publication Number Publication Date
KR20230165828A true KR20230165828A (ko) 2023-12-05

Family

ID=81579790

Family Applications (1)

Application Number Title Priority Date Filing Date
KR1020237037903A Pending KR20230165828A (ko) 2021-04-02 2022-04-01 항-MUC16 x 항-CD3 이중특이적 항체를 함유하는 안정화된 제형

Country Status (13)

Country Link
US (1) US20220332849A1 (cg-RX-API-DMAC10.html)
EP (1) EP4313008A1 (cg-RX-API-DMAC10.html)
JP (1) JP2024513835A (cg-RX-API-DMAC10.html)
KR (1) KR20230165828A (cg-RX-API-DMAC10.html)
AU (1) AU2022246687A1 (cg-RX-API-DMAC10.html)
BR (1) BR112023019096A2 (cg-RX-API-DMAC10.html)
CA (1) CA3213546A1 (cg-RX-API-DMAC10.html)
CL (1) CL2023002922A1 (cg-RX-API-DMAC10.html)
CO (1) CO2023014918A2 (cg-RX-API-DMAC10.html)
IL (1) IL306042A (cg-RX-API-DMAC10.html)
MX (1) MX2023011469A (cg-RX-API-DMAC10.html)
TW (1) TW202304507A (cg-RX-API-DMAC10.html)
WO (1) WO2022212885A1 (cg-RX-API-DMAC10.html)

Families Citing this family (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR102531251B1 (ko) * 2016-09-23 2023-05-15 리제너론 파아마슈티컬스, 인크. 이특이적 항-muc16-cd3 항체 및 항-muc16 약물 접합체

Family Cites Families (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0747045B2 (ja) 1986-10-15 1995-05-24 株式会社大協精工 積層した注射器用滑栓
JP3100727B2 (ja) 1992-01-23 2000-10-23 株式会社大協精工 変性ポリシロキサン組成物及び該組成物を被覆した衛生ゴム製品
JP3172057B2 (ja) 1995-04-05 2001-06-04 株式会社大協精工 ラミネートゴム栓
JP3512349B2 (ja) 1999-01-29 2004-03-29 株式会社大協精工 柱状ゴム要素の成形型
JP2002209975A (ja) 2001-01-19 2002-07-30 Daikyo Seiko Ltd 医薬バイアル用ラミネートゴム栓
AU2003251592A1 (en) * 2002-06-21 2004-01-06 Biogen Idec Inc. Buffered formulations for concentrating antibodies and methods of use thereof
MX366337B (es) * 2010-10-06 2019-07-05 Regeneron Pharma Formulaciones estabilizadas que contienen anticuerpos anti-receptor de interleucina-4 (il-4r).
WO2016036678A1 (en) * 2014-09-02 2016-03-10 Medimmune, Llc Formulations of bispecific antibodies
EP3411401A1 (en) * 2016-02-03 2018-12-12 Oncobiologics, Inc. Buffer formulations for enhanced antibody stability
KR102531251B1 (ko) * 2016-09-23 2023-05-15 리제너론 파아마슈티컬스, 인크. 이특이적 항-muc16-cd3 항체 및 항-muc16 약물 접합체

Also Published As

Publication number Publication date
WO2022212885A1 (en) 2022-10-06
CA3213546A1 (en) 2022-10-06
MX2023011469A (es) 2024-02-01
EP4313008A1 (en) 2024-02-07
CL2023002922A1 (es) 2024-03-08
JP2024513835A (ja) 2024-03-27
AU2022246687A1 (en) 2023-10-12
AU2022246687A9 (en) 2023-10-26
US20220332849A1 (en) 2022-10-20
BR112023019096A2 (pt) 2023-12-05
CO2023014918A2 (es) 2023-11-20
TW202304507A (zh) 2023-02-01
IL306042A (en) 2023-11-01

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Patent event date: 20231102

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Patent event code: PA02012R01D

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