EP4165190A4 - Zusammensetzungen und verfahren zur herstellung autologer t-zelltherapien - Google Patents

Zusammensetzungen und verfahren zur herstellung autologer t-zelltherapien Download PDF

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Publication number
EP4165190A4
EP4165190A4 EP21821421.1A EP21821421A EP4165190A4 EP 4165190 A4 EP4165190 A4 EP 4165190A4 EP 21821421 A EP21821421 A EP 21821421A EP 4165190 A4 EP4165190 A4 EP 4165190A4
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EP
European Patent Office
Prior art keywords
compositions
methods
cell therapies
autologous
manufacturing
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.)
Withdrawn
Application number
EP21821421.1A
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English (en)
French (fr)
Other versions
EP4165190A1 (de
Inventor
Ines MENDE
Ramya H. TUNUGUNTLA
Nathaniel R. TZIZIK-SWANSON
Gregory S. YEDINAK
Stefanie MANDL-CASHMAN
Kyle JACOBY
Martin Giedlin
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.)
Adoc SSF LLC
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Adoc SSF LLC
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Filing date
Publication date
Application filed by Adoc SSF LLC filed Critical Adoc SSF LLC
Publication of EP4165190A1 publication Critical patent/EP4165190A1/de
Publication of EP4165190A4 publication Critical patent/EP4165190A4/de
Withdrawn legal-status Critical Current

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    • 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
    • C12N15/87—Introduction of foreign genetic material using processes not otherwise provided for, e.g. co-transformation
    • C12N15/90—Stable introduction of foreign DNA into chromosome
    • C12N15/902—Stable introduction of foreign DNA into chromosome using homologous recombination
    • C12N15/907—Stable introduction of foreign DNA into chromosome using homologous recombination in mammalian cells
    • 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
    • A61K40/11—T-cells, e.g. tumour infiltrating lymphocytes [TIL] or regulatory T [Treg] cells; Lymphokine-activated killer [LAK] 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
    • A61K40/32—T-cell receptors [TCR]
    • 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
    • A61K40/4201—Neoantigens
    • 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
    • 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
    • C12N5/0636—T lymphocytes
    • 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
    • C12N2310/00—Structure or type of the nucleic acid
    • C12N2310/10—Type of nucleic acid
    • C12N2310/20—Type of nucleic acid involving clustered regularly interspaced short palindromic repeats [CRISPR]
    • 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
    • C12N2501/00—Active agents used in cell culture processes, e.g. differentation
    • C12N2501/20—Cytokines; Chemokines
    • C12N2501/23—Interleukins [IL]
    • C12N2501/2307—Interleukin-7 (IL-7)
    • 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
    • C12N2501/00—Active agents used in cell culture processes, e.g. differentation
    • C12N2501/20—Cytokines; Chemokines
    • C12N2501/23—Interleukins [IL]
    • C12N2501/2315—Interleukin-15 (IL-15)
    • 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
    • C12N2501/00—Active agents used in cell culture processes, e.g. differentation
    • C12N2501/50—Cell markers; Cell surface determinants
    • C12N2501/51—B7 molecules, e.g. CD80, CD86, CD28 (ligand), CD152 (ligand)
    • 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
    • C12N2501/00—Active agents used in cell culture processes, e.g. differentation
    • C12N2501/50—Cell markers; Cell surface determinants
    • C12N2501/515—CD3, T-cell receptor complex
    • 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)
  • Genetics & Genomics (AREA)
  • Chemical & Material Sciences (AREA)
  • Organic Chemistry (AREA)
  • General Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Zoology (AREA)
  • Immunology (AREA)
  • Veterinary Medicine (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Wood Science & Technology (AREA)
  • Biotechnology (AREA)
  • Animal Behavior & Ethology (AREA)
  • Public Health (AREA)
  • Biochemistry (AREA)
  • Molecular Biology (AREA)
  • General Engineering & Computer Science (AREA)
  • Cell Biology (AREA)
  • Epidemiology (AREA)
  • Biophysics (AREA)
  • Microbiology (AREA)
  • Medicinal Chemistry (AREA)
  • General Chemical & Material Sciences (AREA)
  • Hematology (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Toxicology (AREA)
  • Gastroenterology & Hepatology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Proteomics, Peptides & Aminoacids (AREA)
  • Mycology (AREA)
  • Physics & Mathematics (AREA)
  • Plant Pathology (AREA)
  • Micro-Organisms Or Cultivation Processes Thereof (AREA)
  • Medicines Containing Material From Animals Or Micro-Organisms (AREA)
EP21821421.1A 2020-06-12 2021-06-11 Zusammensetzungen und verfahren zur herstellung autologer t-zelltherapien Withdrawn EP4165190A4 (de)

Applications Claiming Priority (3)

Application Number Priority Date Filing Date Title
US202063038516P 2020-06-12 2020-06-12
US202163161283P 2021-03-15 2021-03-15
PCT/US2021/037012 WO2021252898A1 (en) 2020-06-12 2021-06-11 Compositions and methods of manufacturing autologous t cell therapies

Publications (2)

Publication Number Publication Date
EP4165190A1 EP4165190A1 (de) 2023-04-19
EP4165190A4 true EP4165190A4 (de) 2024-09-25

Family

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Family Applications (1)

Application Number Title Priority Date Filing Date
EP21821421.1A Withdrawn EP4165190A4 (de) 2020-06-12 2021-06-11 Zusammensetzungen und verfahren zur herstellung autologer t-zelltherapien

Country Status (4)

Country Link
EP (1) EP4165190A4 (de)
AU (1) AU2021288213A1 (de)
CA (1) CA3181117A1 (de)
WO (1) WO2021252898A1 (de)

Families Citing this family (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
KR20240137075A (ko) * 2022-01-28 2024-09-19 주노 쎄러퓨티크스 인코퍼레이티드 세포 조성물의 제조 방법
US20250361472A1 (en) * 2022-11-10 2025-11-27 National Resilience, Inc. Systems, Methods, and Compositions for Generation of Therapeutic Cells
KR20250121325A (ko) * 2022-12-12 2025-08-12 제넨테크, 인크. T 세포 조작을 개선하기 위한 인슐린 치료
EP4633762A1 (de) * 2022-12-16 2025-10-22 Flaskworks, LLC Verfahren zum sammeln von zelltypen

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019089610A1 (en) * 2017-10-30 2019-05-09 Pact Pharma, Inc. Primary cell gene editing

Family Cites Families (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
SG11201803419PA (en) * 2015-10-30 2018-05-30 The Regents Of The Universtiy Of California Methods of generating t-cells from stem cells and immunotherapeutic methods using the t-cells
CA3100050A1 (en) * 2018-05-11 2019-11-14 Lupagen, Inc. Systems and methods for closed loop, real-time modifications of patient cells

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2019089610A1 (en) * 2017-10-30 2019-05-09 Pact Pharma, Inc. Primary cell gene editing

Non-Patent Citations (6)

* Cited by examiner, † Cited by third party
Title
FOY S P ET AL: "Non-viral precision T cell receptor replacement for personalized cell therapy", NATURE, vol. 615, no. 7953, 10 November 2022 (2022-11-10), pages 687 - 696, XP093150088, ISSN: 0028-0836, DOI: 10.1038/s41586-022-05531-1 *
JIN J ET AL: "Enhanced clinical-scale manufacturing of TCR transduced T-cells using closed culture system modules", JOURNAL OF TRANSLATIONAL MEDICINE, vol. 16, no. 1, 13, 24 January 2018 (2018-01-24), XP055517154, DOI: 10.1186/s12967-018-1384-z *
OKADA K ET AL: "Development of a large-scale H3.3K27M-specific TCR-transduced T cell manufacturing method for adoptive cell therapy in HLA-A2+ patients with diffuse midline glioma", CYTOTHERAPY, vol. 21, no. 5, Suppl., 97, 24 May 2019 (2019-05-24), ISCT 2019; Melbourne, Australia; 29 May-1 June 2019, pages S36, XP093187198, ISSN: 1465-3249, DOI: 10.1016/j.jcyt.2019.03.367 *
PUIG-SAUS C ET AL: "Neoantigen-targeted CD8+ T cell responses with PD-1 blockade therapy", NATURE, vol. 615, no. 7953, 8 March 2023 (2023-03-08), pages 697 - 704, XP093186743, ISSN: 0028-0836, DOI: 10.1038/s41586-023-05787-1 *
See also references of WO2021252898A1 *
SILVA D N ET AL: "High efficiency protocol for lymphocytes gene modification by lentiviral vector within an automated closed system", CYTOTHERAPY, vol. 22, no. 5, Suppl., 425, 23 May 2020 (2020-05-23), ISCT 2020 Annual Meeting; Paris, France; 28-29 May 2020, pages S202, XP093187196, ISSN: 1465-3249, DOI: 10.1016/j.jcyt.2020.04.076 *

Also Published As

Publication number Publication date
WO2021252898A1 (en) 2021-12-16
AU2021288213A1 (en) 2023-02-02
EP4165190A1 (de) 2023-04-19
CA3181117A1 (en) 2021-12-16

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