EP4153635A4 - Anti-her2-antikörper oder antigenbindendes fragment davon und chimärer antigenrezeptor damit - Google Patents

Anti-her2-antikörper oder antigenbindendes fragment davon und chimärer antigenrezeptor damit Download PDF

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Publication number
EP4153635A4
EP4153635A4 EP21809551.1A EP21809551A EP4153635A4 EP 4153635 A4 EP4153635 A4 EP 4153635A4 EP 21809551 A EP21809551 A EP 21809551A EP 4153635 A4 EP4153635 A4 EP 4153635A4
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EP
European Patent Office
Prior art keywords
antigen
binding fragment
her2 antibody
receptor therefor
antigen receptor
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.)
Pending
Application number
EP21809551.1A
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English (en)
French (fr)
Other versions
EP4153635A1 (de
Inventor
Jong-Seo Lee
Kyu-Tae Kim
Young-Ha Lee
In-Sik Hwang
Bong-Kook Ko
Eunji Choi
You-Sun Kim
Jeongmin Kim
Miyoung Jung
Hoyong Lim
Sungyoo CHO
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.)
GC Cell Corp
Original Assignee
GC Cell Corp
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
Priority claimed from US16/881,650 external-priority patent/US11649294B2/en
Application filed by GC Cell Corp filed Critical GC Cell Corp
Publication of EP4153635A1 publication Critical patent/EP4153635A1/de
Publication of EP4153635A4 publication Critical patent/EP4153635A4/de
Pending legal-status Critical Current

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    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/46—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates
    • C07K14/47—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals
    • C07K14/4701—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans from vertebrates from mammals not used
    • C07K14/4748—Tumour specific antigens; Tumour rejection antigen precursors [TRAP], e.g. MAGE
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K35/00—Medicinal preparations containing materials or reaction products thereof with undetermined constitution
    • A61K35/12—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells
    • A61K35/14—Blood; Artificial blood
    • A61K35/17—Lymphocytes; B-cells; T-cells; Natural killer cells; Interferon-activated or cytokine-activated lymphocytes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K38/00—Medicinal preparations containing peptides
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K40/00—Cellular immunotherapy
    • A61K40/10—Cellular immunotherapy characterised by the cell type used
    • A61K40/15—Natural-killer [NK] cells; Natural-killer T [NKT] cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K40/00—Cellular immunotherapy
    • A61K40/30—Cellular immunotherapy characterised by the recombinant expression of specific molecules in the cells of the immune system
    • A61K40/31—Chimeric antigen receptors [CAR]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K40/00—Cellular immunotherapy
    • A61K40/40—Cellular immunotherapy characterised by antigens that are targeted or presented by cells of the immune system
    • A61K40/41—Vertebrate antigens
    • A61K40/42—Cancer antigens
    • A61K40/4202—Receptors, cell surface antigens or cell surface determinants
    • A61K40/4203—Receptors for growth factors
    • A61K40/4205—Her-2/neu/ErbB2, Her-3/ErbB3 or Her 4/ ErbB4
    • 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
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70503—Immunoglobulin superfamily
    • C07K14/7051—T-cell receptor (TcR)-CD3 complex
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70503—Immunoglobulin superfamily
    • C07K14/70517—CD8
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70503—Immunoglobulin superfamily
    • C07K14/70521—CD28, CD152
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70575—NGF/TNF-superfamily, e.g. CD70, CD95L, CD153, CD154
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/70578—NGF-receptor/TNF-receptor superfamily, e.g. CD27, CD30, CD40, CD95
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K14/00—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
    • C07K14/435—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
    • C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
    • C07K14/71—Receptors; Cell surface antigens; Cell surface determinants for growth factors; for growth regulators
    • 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
    • C07K16/32—Immunoglobulins [IG], e.g. monoclonal or polyclonal antibodies against material from animals or humans against translation products of oncogenes
    • 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
    • C12N5/00—Undifferentiated human, animal or plant cells, e.g. cell lines; Tissues; Cultivation or maintenance thereof; Culture media therefor
    • C12N5/06—Animal cells or tissues; Human cells or tissues
    • C12N5/0602—Vertebrate cells
    • C12N5/0634—Cells from the blood or the immune system
    • C12N5/0646—Natural killers cells [NK], NKT cells
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K40/00
    • A61K2239/31—Indexing codes associated with cellular immunotherapy of group A61K40/00 characterized by the route of administration
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K40/00
    • A61K2239/38—Indexing codes associated with cellular immunotherapy of group A61K40/00 characterised by the dose, timing or administration schedule
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K2239/00—Indexing codes associated with cellular immunotherapy of group A61K40/00
    • A61K2239/46—Indexing codes associated with cellular immunotherapy of group A61K40/00 characterised by the cancer treated
    • A61K2239/53—Liver
    • 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
    • C07K2317/60—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments
    • C07K2317/62—Immunoglobulins specific features characterized by non-natural combinations of immunoglobulin fragments comprising only variable region components
    • C07K2317/622—Single chain antibody (scFv)
    • 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
    • C07K2319/00—Fusion polypeptide
    • C07K2319/01—Fusion polypeptide containing a localisation/targetting motif
    • C07K2319/03—Fusion polypeptide containing a localisation/targetting motif containing a transmembrane segment
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/33—Fusion polypeptide fusions for targeting to specific cell types, e.g. tissue specific targeting, targeting of a bacterial subspecies
    • 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
    • C12N2510/00—Genetically modified cells

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Immunology (AREA)
  • Genetics & Genomics (AREA)
  • Zoology (AREA)
  • Engineering & Computer Science (AREA)
  • Medicinal Chemistry (AREA)
  • Biochemistry (AREA)
  • Cell Biology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Animal Behavior & Ethology (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Toxicology (AREA)
  • Biotechnology (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Wood Science & Technology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Hematology (AREA)
  • Microbiology (AREA)
  • General Engineering & Computer Science (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Oncology (AREA)
  • Developmental Biology & Embryology (AREA)
  • Virology (AREA)
  • Peptides Or Proteins (AREA)
  • Medicines Containing Antibodies Or Antigens For Use As Internal Diagnostic Agents (AREA)
EP21809551.1A 2020-05-22 2021-05-21 Anti-her2-antikörper oder antigenbindendes fragment davon und chimärer antigenrezeptor damit Pending EP4153635A4 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US16/881,650 US11649294B2 (en) 2017-11-14 2020-05-22 Anti-HER2 antibody or antigen-binding fragment thereof, and chimeric antigen receptor comprising same
PCT/KR2021/006361 WO2021235894A1 (en) 2020-05-22 2021-05-21 Anti-HER2 Antibody or Antigen-binding Fragment thereof, and Chimeric Antigen Receptor Comprising Same

Publications (2)

Publication Number Publication Date
EP4153635A1 EP4153635A1 (de) 2023-03-29
EP4153635A4 true EP4153635A4 (de) 2024-06-26

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP21809551.1A Pending EP4153635A4 (de) 2020-05-22 2021-05-21 Anti-her2-antikörper oder antigenbindendes fragment davon und chimärer antigenrezeptor damit

Country Status (5)

Country Link
EP (1) EP4153635A4 (de)
KR (1) KR20230024911A (de)
CA (1) CA3184449A1 (de)
IL (1) IL298326A (de)
WO (1) WO2021235894A1 (de)

Families Citing this family (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP3567049A4 (de) 2016-12-28 2020-08-26 Green Cross Lab Cell Corporation Chimärer antigenrezeptor und natürliche killerzellen zur expression davon
EP3633029A4 (de) 2017-05-26 2021-06-09 Green Cross Lab Cell Corporation Verfahren zur entwicklung einer natürlichen killerzelle unter verwendung einer t-zelle
KR102774451B1 (ko) 2017-11-14 2025-02-28 앱클론(주) 항-her2 항체 또는 그의 항원 결합 단편, 및 이를 포함하는 키메라 항원 수용체
AU2019381526B2 (en) 2018-11-14 2023-02-23 Green Cross Lab Cell Corporation Method for culturing cord blood-derived natural killer cells using transformed T-cells
US20250222029A1 (en) 2022-04-08 2025-07-10 Fate Therapeutics, Inc. Chimeric antigen receptor for tumor targeting
US20250228943A1 (en) 2022-04-08 2025-07-17 Fate Therapeutics, Inc. Cells having solid tumor targeting backbone and use thereof
CN116444672B (zh) * 2023-06-13 2023-11-03 上海偌妥生物科技有限公司 人表皮生长因子3的抗体、其制备方法及其应用
CN118754989B (zh) * 2023-07-19 2026-03-27 康立泰生物医药(青岛)有限公司 一种抗her2纳米抗体及其制备方法和应用
CN118146380B (zh) * 2024-04-12 2025-12-02 上海交通大学 基于ai从头设计筛选合成的her2蛋白特异性结合抗体及其应用
WO2025237420A1 (en) * 2024-05-17 2025-11-20 Utc Therapeutics (Shanghai) Co., Ltd. Her2 targetting antibodies, chimeric antigen receptors, and uses thereof
CN119462944B (zh) * 2024-12-02 2025-12-09 中国人民解放军军事科学院军事医学研究院 人表皮生长因子受体2单克隆抗体及其用途
CN119735686B (zh) * 2024-12-26 2025-07-22 贵州省人民医院 一种针对her2抗原的人源化抗体及其应用

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WO2017079694A2 (en) * 2015-11-04 2017-05-11 Priceman Saul J Chimeric antigen receptors targeting her2
WO2020096646A1 (en) * 2018-11-06 2020-05-14 Nantkwest, Inc. Chimeric antigen receptor-modified nk-92 cells

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BR122020002986A8 (pt) * 2012-08-20 2023-04-18 Seattle Childrens Hospital Dba Seattle Childrens Res Inst Método e composições para imunoterapia celular
GB201518136D0 (en) * 2015-10-14 2015-11-25 Glaxosmithkline Ip Dev Ltd Novel chimeric antigen receptors
SG10201801219VA (en) * 2018-02-13 2019-09-27 Agency Science Tech & Res Anti-HER2 Antibodies

Patent Citations (2)

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WO2017079694A2 (en) * 2015-11-04 2017-05-11 Priceman Saul J Chimeric antigen receptors targeting her2
WO2020096646A1 (en) * 2018-11-06 2020-05-14 Nantkwest, Inc. Chimeric antigen receptor-modified nk-92 cells

Non-Patent Citations (7)

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Title
CONGCONG ZHANG: "ErbB2/HER2-Specific NK Cells for Targeted Therapy of Glioblastoma", JOURNAL OF THE NATIONAL CANCER INSTITUTE, vol. 108, no. 5, 6 December 2015 (2015-12-06), GB, XP093160504, ISSN: 0027-8874, DOI: 10.1093/jnci/djv375 *
DANIEL ABATE-DAGA ET AL: "CAR models: next-generation CAR modifications for enhanced T-cell function", MOLECULAR THERAPY - ONCOLYTICS, vol. 3, 1 January 2016 (2016-01-01), pages 16014, XP055564170, ISSN: 2372-7705, DOI: 10.1038/mto.2016.14 *
KRUSCHINSKI ANNA ET AL: "Engineering antigen-specific primary human NK cells against HER-2 positive carcinomas", PROCEEDINGS OF THE NATIONAL ACADEMY OF SCIENCES, vol. 105, no. 45, 11 November 2008 (2008-11-11), pages 17481 - 17486, XP055911709, ISSN: 0027-8424, DOI: 10.1073/pnas.0804788105 *
KURT SCHÖNFELD ET AL: "Selective Inhibition of Tumor Growth by Clonal NK Cells Expressing an ErbB2/HER2-Specific Chimeric Antigen Receptor", MOLECULAR THERAPY, vol. 23, no. 2, 6 November 2014 (2014-11-06), US, pages 330 - 338, XP055265087, ISSN: 1525-0016, DOI: 10.1038/mt.2014.219 *
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Publication number Publication date
IL298326A (en) 2023-01-01
CA3184449A1 (en) 2021-11-25
WO2021235894A1 (en) 2021-11-25
KR20230024911A (ko) 2023-02-21
EP4153635A1 (de) 2023-03-29

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