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DK3480215T5 - Anti-her2-antistof og konjugat deraf - Google Patents

Anti-her2-antistof og konjugat deraf Download PDF

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Publication number
DK3480215T5
DK3480215T5 DK18204950.2T DK18204950T DK3480215T5 DK 3480215 T5 DK3480215 T5 DK 3480215T5 DK 18204950 T DK18204950 T DK 18204950T DK 3480215 T5 DK3480215 T5 DK 3480215T5
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DK
Denmark
Prior art keywords
conjugate
her2 antibody
her2
antibody
Prior art date
Application number
DK18204950.2T
Other languages
English (en)
Other versions
DK3480215T3 (da
Inventor
Jianmin Fang
Changjiang Huang
Jing Jiang
Xuejing Yao
Hongwen Li
Qiaoyu Xu
Zhuanglin Li
Original Assignee
Remegen 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 Remegen Co Ltd filed Critical Remegen Co Ltd
Publication of DK3480215T3 publication Critical patent/DK3480215T3/da
Application granted granted Critical
Publication of DK3480215T5 publication Critical patent/DK3480215T5/da

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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
    • C07K16/28—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants
    • C07K16/2896—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against molecules with a "CD"-designation, not provided for elsewhere
    • 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
    • C07K16/32—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • 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
    • 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
    • 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
    • A61K39/39533—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals
    • A61K39/39558—Antibodies; Immunoglobulins; Immune serum, e.g. antilymphocytic serum against materials from animals against tumor tissues, cells, antigens
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 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
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 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
    • A61K47/6801—Drug-antibody or immunoglobulin conjugates defined by the pharmacologically or therapeutically active agent
    • A61K47/6803—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates
    • A61K47/6805—Drugs conjugated to an antibody or immunoglobulin, e.g. cisplatin-antibody conjugates the drug being a vinca alkaloid
    • 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
    • A61K47/50—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates
    • A61K47/51—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 the non-active ingredient being chemically bound to the active ingredient, e.g. polymer-drug conjugates the non-active ingredient being a modifying agent
    • A61K47/68—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 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
    • A61K47/6835—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 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
    • A61K47/6851—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 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
    • A61K47/6855—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 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 the tumour determinant being from breast cancer cell
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P35/00—Antineoplastic agents
    • C—CHEMISTRY; METALLURGY
    • C12—BIOCHEMISTRY; BEER; SPIRITS; WINE; VINEGAR; MICROBIOLOGY; ENZYMOLOGY; MUTATION OR GENETIC ENGINEERING
    • C12N—MICROORGANISMS OR ENZYMES; COMPOSITIONS THEREOF; PROPAGATING, PRESERVING, OR MAINTAINING MICROORGANISMS; MUTATION OR GENETIC ENGINEERING; CULTURE MEDIA
    • C12N15/00—Mutation or genetic engineering; DNA or RNA concerning genetic engineering, vectors, e.g. plasmids, or their isolation, preparation or purification; Use of hosts therefor
    • C12N15/09—Recombinant DNA-technology
    • C12N15/63—Introduction of foreign genetic material using vectors; Vectors; Use of hosts therefor; Regulation of expression
    • 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
    • C07K2317/92—Affinity (KD), association rate (Ka), dissociation rate (Kd) or EC50 value

Landscapes

  • Health & Medical Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Medicinal Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Organic Chemistry (AREA)
  • Epidemiology (AREA)
  • Genetics & Genomics (AREA)
  • Cell Biology (AREA)
  • Oncology (AREA)
  • Molecular Biology (AREA)
  • Biochemistry (AREA)
  • Biophysics (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Microbiology (AREA)
  • Biomedical Technology (AREA)
  • Zoology (AREA)
  • Wood Science & Technology (AREA)
  • Biotechnology (AREA)
  • General Engineering & Computer Science (AREA)
  • Mycology (AREA)
  • General Chemical & Material Sciences (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Physics & Mathematics (AREA)
  • Plant Pathology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
  • Medicinal Preparation (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
  • Preparation Of Compounds By Using Micro-Organisms (AREA)
DK18204950.2T 2013-11-19 2014-11-18 Anti-her2-antistof og konjugat deraf DK3480215T5 (da)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
CN201310586326 2013-11-19
EP14864053.5A EP3072907B1 (en) 2013-11-19 2014-11-18 Anti-her2 antibody and conjugate thereof

Publications (2)

Publication Number Publication Date
DK3480215T3 DK3480215T3 (da) 2021-07-05
DK3480215T5 true DK3480215T5 (da) 2021-08-16

Family

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Family Applications (2)

Application Number Title Priority Date Filing Date
DK18204950.2T DK3480215T5 (da) 2013-11-19 2014-11-18 Anti-her2-antistof og konjugat deraf
DK14864053.5T DK3072907T3 (da) 2013-11-19 2014-11-18 Anti-her2- antistof og konjugat deraf

Family Applications After (1)

Application Number Title Priority Date Filing Date
DK14864053.5T DK3072907T3 (da) 2013-11-19 2014-11-18 Anti-her2- antistof og konjugat deraf

Country Status (19)

Country Link
US (1) US10087260B2 (da)
EP (2) EP3072907B1 (da)
JP (2) JP6326137B2 (da)
KR (3) KR101936697B1 (da)
CN (3) CN109320612B (da)
AU (1) AU2014352475B2 (da)
CA (1) CA2919359C (da)
CY (1) CY1124651T1 (da)
DK (2) DK3480215T5 (da)
ES (1) ES2879799T3 (da)
HR (1) HRP20211023T1 (da)
HU (1) HUE055269T2 (da)
LT (1) LT3480215T (da)
PL (1) PL3480215T3 (da)
PT (1) PT3480215T (da)
RS (1) RS62157B1 (da)
RU (1) RU2656161C1 (da)
SI (1) SI3480215T1 (da)
WO (1) WO2015074528A1 (da)

Families Citing this family (18)

* Cited by examiner, † Cited by third party
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US10087260B2 (en) * 2013-11-19 2018-10-02 Remegen, Ltd. Anti-HER2 antibody and conjugate thereof
KR101796277B1 (ko) 2016-04-12 2017-11-13 앱클론(주) 안정성이 개선된 ｈｅｒ２에 특이적으로 결합하는 항체
CN111655295B (zh) * 2018-08-29 2024-05-28 荣昌生物制药(烟台)股份有限公司 抗her2抗体药物偶联物在治疗尿路上皮癌中的用途
CN111433188B (zh) 2018-12-17 2023-08-01 荣昌生物制药(烟台)股份有限公司 一种用于抗体药物偶联物的连接子及其应用
CN109498816A (zh) * 2019-01-07 2019-03-22 合肥瀚科迈博生物技术有限公司 一种抗体偶联药物的制备方法
EP3842460A1 (en) * 2019-03-01 2021-06-30 RemeGen Co., Ltd. Antibody for her2 concomitant diagnosis immunohistochemical detection and application thereof
HUE065177T2 (hu) * 2019-03-26 2024-05-28 Remegen Co Ltd Anti-HER2 antitest-konjugátum gyógyszerkészítmény
WO2020233534A1 (zh) * 2019-05-17 2020-11-26 百奥泰生物制药股份有限公司 抗体-药物偶联物制剂、制备方法及应用
AU2020381495A1 (en) 2019-11-15 2022-05-19 Seagen Inc. Methods of treating HER2 positive breast cancer with tucatinib in combination with an anti-HER2 antibody-drug conjugate
US20230109218A1 (en) * 2020-01-23 2023-04-06 Bioatla, Inc. Conditionally Active Anti-Her2 Antibodies, Antibody Fragments Their Immunoconjugates And Uses Thereof
CN112402616A (zh) * 2020-11-23 2021-02-26 荣昌生物制药(烟台)股份有限公司 一种含环丙沙星和抗体药物偶联物的药物组合物及其应用
CN112353947A (zh) * 2020-11-23 2021-02-12 荣昌生物制药(烟台)股份有限公司 一种含二甲双胍和抗体药物偶联物的药物组合物及其应用
CN114796519A (zh) * 2021-01-27 2022-07-29 南开大学 一种蛋白质偶联小分子药物的制备和应用
IL305095A (en) * 2021-02-18 2023-10-01 Remegen Co Ltd Use of a HER2-targeted antibody-drug conjugate in the treatment of specific breast cancer
CN115845078A (zh) * 2021-09-24 2023-03-28 沃肽生物科技(山东)有限公司 基于相分离的肿瘤靶向药物递送系统
US11814394B2 (en) * 2021-11-16 2023-11-14 Genequantum Healthcare (Suzhou) Co., Ltd. Exatecan derivatives, linker-payloads, and conjugates and thereof
CN114736300B (zh) * 2022-06-09 2022-08-19 苏州百道医疗科技有限公司 一种抗her2重组兔单克隆抗体及其应用
WO2024191826A1 (en) 2023-03-10 2024-09-19 Seagen Inc. Methods of treating cancer using anti-her2 antibody-drug conjugates and her2 kinase inhibitors

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HU230586B1 (hu) 1999-06-25 2017-02-28 Genentech, Inc. Anti-ErbB antitest/maytansinoid konjugátumok alkalmazása rákos betegségek kezelésére szolgáló gyógyszer előállítására
US20040132101A1 (en) * 2002-09-27 2004-07-08 Xencor Optimized Fc variants and methods for their generation
CN109045307A (zh) 2004-06-01 2018-12-21 健泰科生物技术公司 抗体-药物偶联物和方法
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US10087260B2 (en) * 2013-11-19 2018-10-02 Remegen, Ltd. Anti-HER2 antibody and conjugate thereof

Also Published As

Publication number Publication date
KR101993136B1 (ko) 2019-06-26
CN105008398B (zh) 2018-10-16
CY1124651T1 (el) 2022-07-22
EP3072907A4 (en) 2017-06-14
LT3480215T (lt) 2021-08-25
DK3480215T3 (da) 2021-07-05
KR20160065972A (ko) 2016-06-09
EP3072907B1 (en) 2019-02-20
CN110240655B (zh) 2023-05-16
RU2016106339A (ru) 2017-12-25
JP6326137B2 (ja) 2018-05-16
US10087260B2 (en) 2018-10-02
WO2015074528A1 (zh) 2015-05-28
AU2014352475B2 (en) 2017-08-17
EP3480215B8 (en) 2021-07-28
RU2656161C1 (ru) 2018-05-31
RS62157B1 (sr) 2021-08-31
KR20180050423A (ko) 2018-05-14
JP6728264B2 (ja) 2020-07-22
EP3480215B1 (en) 2021-06-23
BR112016002752A2 (pt) 2017-11-21
CN109320612A (zh) 2019-02-12
CA2919359A1 (en) 2015-05-28
HRP20211023T1 (hr) 2021-09-17
AU2014352475A1 (en) 2016-02-18
DK3072907T3 (da) 2019-04-01
CN110240655A (zh) 2019-09-17
US20160304621A1 (en) 2016-10-20
SI3480215T1 (sl) 2021-12-31
KR20190002716A (ko) 2019-01-08
ES2879799T3 (es) 2021-11-23
JP2016528902A (ja) 2016-09-23
CN109320612B (zh) 2020-10-27
HUE055269T2 (hu) 2021-11-29
PT3480215T (pt) 2021-07-05
BR112016002752A8 (pt) 2023-02-28
KR101854443B1 (ko) 2018-06-15
EP3072907A1 (en) 2016-09-28
JP2018138034A (ja) 2018-09-06
EP3480215A1 (en) 2019-05-08
KR101936697B1 (ko) 2019-01-10
CN105008398A (zh) 2015-10-28
PL3480215T3 (pl) 2021-12-13
CA2919359C (en) 2019-01-15

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