WO2015188228A1 - Method of producing leukocytes using ptpn2 inhibition for adoptive cell transfer - Google Patents

Method of producing leukocytes using ptpn2 inhibition for adoptive cell transfer Download PDF

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Publication number
WO2015188228A1
WO2015188228A1 PCT/AU2015/050318 AU2015050318W WO2015188228A1 WO 2015188228 A1 WO2015188228 A1 WO 2015188228A1 AU 2015050318 W AU2015050318 W AU 2015050318W WO 2015188228 A1 WO2015188228 A1 WO 2015188228A1
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cells
ptpn2
cell
cancer
leukocyte
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English (en)
French (fr)
Inventor
Tony Tiganis
Florian WIEDE
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Monash University
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Monash University
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Priority claimed from AU2014902203A external-priority patent/AU2014902203A0/en
Application filed by Monash University filed Critical Monash University
Priority to JP2016572566A priority Critical patent/JP2017524348A/ja
Priority to US15/317,197 priority patent/US20170224731A1/en
Priority to AU2015274242A priority patent/AU2015274242A1/en
Priority to EP15807341.1A priority patent/EP3154555A4/en
Publication of WO2015188228A1 publication Critical patent/WO2015188228A1/en
Anticipated expiration legal-status Critical
Priority to US17/014,737 priority patent/US20210052648A1/en
Ceased legal-status Critical Current

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    • 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
    • C12N5/0638—Cytotoxic T lymphocytes [CTL] or lymphokine activated killer cells [LAK]
    • 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
    • A61K40/20—Cellular immunotherapy characterised by the effect or the function of the cells
    • A61K40/22—Immunosuppressive or immunotolerising
    • 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
    • A61K40/30—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
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    • 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
    • A61K40/416—Antigens related to auto-immune diseases; Preparations to induce self-tolerance
    • 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
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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
    • A61P35/04—Antineoplastic agents specific for metastasis
    • A—HUMAN NECESSITIES
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    • 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
    • C12N15/11—DNA or RNA fragments; Modified forms thereof; Non-coding nucleic acids having a biological activity
    • C12N15/113—Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing
    • C12N15/1137—Non-coding nucleic acids modulating the expression of genes, e.g. antisense oligonucleotides; Antisense DNA or RNA; Triplex- forming oligonucleotides; Catalytic nucleic acids, e.g. ribozymes; Nucleic acids used in co-suppression or gene silencing against enzymes
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    • C12N9/00—Enzymes; Proenzymes; Compositions thereof; Processes for preparing, activating, inhibiting, separating or purifying enzymes
    • C12N9/14—Hydrolases (3)
    • C12N9/16—Hydrolases (3) acting on ester bonds (3.1)
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    • C12N9/14—Hydrolases (3)
    • C12N9/16—Hydrolases (3) acting on ester bonds (3.1)
    • C12N9/22—Ribonucleases [RNase]; Deoxyribonucleases [DNase]
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    • C12Y301/00—Hydrolases acting on ester bonds (3.1)
    • C12Y301/03—Phosphoric monoester hydrolases (3.1.3)
    • C12Y301/03048—Protein-tyrosine-phosphatase (3.1.3.48)
    • 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
    • A61K2035/124—Materials from mammals; Compositions comprising non-specified tissues or cells; Compositions comprising non-embryonic stem cells; Genetically modified cells the cells being hematopoietic, bone marrow derived or blood cells
    • 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
    • A61K2039/57—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2
    • A61K2039/572—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 cytotoxic response
    • 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
    • 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
    • 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
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    • C12N2310/00—Structure or type of the nucleic acid
    • C12N2310/10—Type of nucleic acid
    • C12N2310/14—Type of nucleic acid interfering nucleic acids [NA]
    • C—CHEMISTRY; METALLURGY
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    • C12N2310/00—Structure or type of the nucleic acid
    • C12N2310/50—Physical structure
    • C12N2310/53—Physical structure partially self-complementary or closed
    • C12N2310/531—Stem-loop; Hairpin
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    • 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)
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    • C12N2501/00—Active agents used in cell culture processes, e.g. differentation
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    • C12N2501/70—Enzymes
    • C12N2501/73—Hydrolases (EC 3.)

Definitions

  • the present invention generally relates to methods of preparing cells ex vivo for use in immunotherapy, particularly cancer immunotherapy. More specifically, the invention relates to methods for the preparation of leukocytes, particularly T cells, exhibiting cytotoxic properties for use in adoptive cell transfer. The invention also relates to cells and compositions including them for cancer immunotherapy. The invention also relates to methods of immunotherapy, particularly cancer immunotherapy.
  • the present invention relates to a method of promoting regression of a cancer in a subject having cancer including the steps of:
  • the present invention also provides a method for proliferating, enriching or expanding a composition of cells including a CD8+ T cell, the method including culturing a composition of cells in a medium, the medium including a PTPN2 inhibitor, wherein the PTPN2 inhibitor is provided in the medium to permit contact with a CD8+ T cell during culture.
  • the proliferating, enriching or expanding will result in a doubling of the number of CD8+ T cells that exhibit at least one cytotoxic T cell property. More preferably the cell expansion result in 3x or 4x number of CD8+ T cells that exhibit at least one cytotoxic T cell property.
  • the expansion of CD8+ T cells may be 5x, 6x, 7x, 8x, 9x or over 10x.
  • the method may also increase the relative number of CD8+ T cells in the composition that exhibit at least one cytotoxic T cell property.
  • T cells with auto-reactive potential are a critical task that is synergistically mediated by both thymic and peripheral tolerance mechanisms.
  • the majority of auto-reactive T cells are eliminated in the thymus through negative selection; a process that is facilitated by the ability of the thymic medullary cells to ectopically express peripheral tissue antigens. Nonetheless, the few highly autoreactive T cells that might escape this selection are subsequently eliminated by peripheral tolerance mechanisms.
  • exemplary shRNA include: TRCN0000002781 , with a target sequence of G ATG AC C AAG AGATG CTGTTT beginning at position 582 of PTPN2 sequence from NM_001207013.1 and a hairpin sequence of:
  • the cytotoxic CD8+ T cell effector function is increased when cells have a function which is at least 10%, 20%, 30%, 40%, 50%, 60%, 70%, 80%, 90%, 95%, or 100% higher, than an appropriate control, such as, for example, the performance of a sample of cells in a particular assay in the absence of a particular event or condition.
  • an appropriate control such as, for example, the performance of a sample of cells in a particular assay in the absence of a particular event or condition.
  • in vivo function or the presence of a cell population in vivo may be measured using cells isolated from a subject in in vitro assays.
  • Subjects requiring treatment include those already having a benign, precancerous, or non-metastatic tumour as well as those in which the occurrence or recurrence of cancer is to be prevented.
  • Subjects may have metastatic cells, including metastatic cells present in the ascites fluid and/or lymph node.
  • the objective or outcome of treatment may be to reduce the number of cancer cells; reduce the primary tumour size; inhibit (i.e., slow to some extent and preferably stop) cancer cell infiltration into peripheral organs; inhibit (i.e., slow to some extent and preferably stop) tumour metastasis; inhibit, to some extent, tumour growth; and/or relieve to some extent one or more of the symptoms associated with the disorder.
  • Efficacy of treatment can be measured by assessing the duration of survival, time to disease progression, the response rates (RR), duration of response, and/or quality of life.
  • animals requiring treatment include those having a benign, pre-cancerous, non-metastatic tumour.
  • the cancer is pre-cancerous or pre -neoplastic.
  • PTPN2-deficiency enhances antigen-induced OT-I CD8+ T cell activation and IL-2-mediated differentiation in vitro
  • PTPN2 levels are elevated in naive T cells leaving the thymus and that increases in PTPN2 directly correlate with TCR affinity (as monitored by CD5 levels), so that higher affinity T cells, responding more robustly to self-antigen in the context of lymphopenia, have increased PTPN2.
  • naive CD8+ T cells undergo fast-paced TCR-mediated proliferation in a lymphopenic environment, acquire the characteristics of antigen-experienced effector cells, and promote the development of autoimmunity.
  • PTPN2-deficiency allowed CD8+ T cells cross-primed by ⁇ cell self-antigens to escape tolerance and acquire CTL activity and thus promote ⁇ cell destruction and the development of type 1 diabetes.
  • Ptpn2 ff/ff and Lck-Cre For the generation of Ptpn2 ff/ff and Lck-Cre; Ptpn2 ff/ff and the corresponding OT-I TCR transgenic mice, Ptpn2 ff/ff and Lck-Cre; Ptpn2 ff/ff mice or OT- 1 ; Ptpn2 ff/ff and OT-1 ;Lck-Cre; Ptpn2 ff/f mice were mated. For the generation of CD45.1 /2 mice, C57BL/6 and CD45.1 mice were mated. The Lck-Cre (originating from James D.

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PCT/AU2015/050318 2014-06-10 2015-06-10 Method of producing leukocytes using ptpn2 inhibition for adoptive cell transfer Ceased WO2015188228A1 (en)

Priority Applications (5)

Application Number Priority Date Filing Date Title
JP2016572566A JP2017524348A (ja) 2014-06-10 2015-06-10 養子細胞移入のためのｐｔｐｎ２阻害を用いた白血球の産生方法
US15/317,197 US20170224731A1 (en) 2014-06-10 2015-06-10 Method of producing leukocytes using ptpn2 inhibition for adoptive cell transfer
AU2015274242A AU2015274242A1 (en) 2014-06-10 2015-06-10 Method of producing leukocytes using PTPN2 inhibition for adoptive cell transfer
EP15807341.1A EP3154555A4 (en) 2014-06-10 2015-06-10 Method of producing leukocytes using ptpn2 inhibition for adoptive cell transfer
US17/014,737 US20210052648A1 (en) 2014-06-10 2020-09-08 Method of producing leukocytes using ptpn2 inhibition for adoptive cell transfer

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
AU2014902203A AU2014902203A0 (en) 2014-06-10 Method of producing cells for adoptive cell transfer
AU2014902203 2014-06-10
AU2015901171 2015-03-31
AU2015901171A AU2015901171A0 (en) 2015-03-31 Method of producing cells for adoptive cell transfer (2)

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US15/317,197 A-371-Of-International US20170224731A1 (en) 2014-06-10 2015-06-10 Method of producing leukocytes using ptpn2 inhibition for adoptive cell transfer
US17/014,737 Continuation US20210052648A1 (en) 2014-06-10 2020-09-08 Method of producing leukocytes using ptpn2 inhibition for adoptive cell transfer

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Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2018148378A1 (en) * 2017-02-08 2018-08-16 Dana-Farber Cancer Institute, Inc. Modulating biomarkers to increase tumor immunity and improve the efficiacy of cancer immunotherapy
WO2019036815A1 (en) * 2017-08-24 2019-02-28 The Royal Institution For The Advancement Of Learning/Mcgill University ENHANCEMENT OF CD8 + T LYMPHOCYTES FOR ADOPTIVE CELL THERAPY BY INHIBITING PTPN1 (PTP1B) AND PTPN2 (TC-PTP))
US10406177B2 (en) 2015-07-31 2019-09-10 Regents Of The University Of Minnesota Modified cells and methods of therapy
WO2020072126A3 (en) * 2018-08-07 2020-08-27 Dana-Farber Cancer Institute, Inc. Modulating ptpn2 to increase immune responses and perturbing gene expression in hematopoietic stem cell lineages
US10851073B2 (en) 2019-03-14 2020-12-01 Abbvie Inc. Protein tyrosine phosphatase inhibitors and methods of use thereof
CN112041433A (zh) * 2018-03-15 2020-12-04 Ksq治疗公司 用于改进的免疫疗法的基因调控组合物和方法
US10912797B2 (en) 2016-10-18 2021-02-09 Intima Bioscience, Inc. Tumor infiltrating lymphocytes and methods of therapy
US10954202B2 (en) 2018-06-21 2021-03-23 Abbvie Inc. Protein tyrosine phosphatase inhibitors and methods of use thereof
US11098325B2 (en) 2017-06-30 2021-08-24 Intima Bioscience, Inc. Adeno-associated viral vectors for gene therapy
US11111493B2 (en) 2018-03-15 2021-09-07 KSQ Therapeutics, Inc. Gene-regulating compositions and methods for improved immunotherapy
EP3801573A4 (en) * 2018-06-01 2022-03-02 Monash University Methods of activating cells via ptp 1b inhibition
US12188045B2 (en) 2019-06-07 2025-01-07 KSQ Therapeutics, Inc. Guide RNA combinations and methods of use

Families Citing this family (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US11261428B2 (en) 2018-03-15 2022-03-01 KSQ Therapeutics, Inc. Gene-regulating compositions and methods for improved immunotherapy
MX2021009357A (es) * 2019-02-04 2021-11-17 Ksq Therapeutics Inc Dianas de genes de combinacion para mejorar la inmunoterapia.
CN115003387A (zh) * 2019-11-25 2022-09-02 Ksq治疗公司 用于活化和扩增肿瘤浸润淋巴细胞的方法
US20230355670A1 (en) * 2019-12-04 2023-11-09 Monash University Methods of activating cytotoxic leukocytes using PTP1B and PTPN2 inhibitors
JP2023506227A (ja) * 2019-12-12 2023-02-15 カムクワット バイオサイエンシーズ インコーポレイテッド 免疫活性を強化するための組成物および方法
CN113827727B (zh) * 2020-06-24 2025-04-29 上海交通大学医学院附属瑞金医院 Ptpn2抑制剂在kras突变肿瘤中的应用
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US20210052648A1 (en) 2021-02-25

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