HRP20220890T1 - Postupci za povećanje učinkovitosti terapijskih imunosnih stanica - Google Patents
Postupci za povećanje učinkovitosti terapijskih imunosnih stanica Download PDFInfo
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- HRP20220890T1 HRP20220890T1 HRP20220890TT HRP20220890T HRP20220890T1 HR P20220890 T1 HRP20220890 T1 HR P20220890T1 HR P20220890T T HRP20220890T T HR P20220890TT HR P20220890 T HRP20220890 T HR P20220890T HR P20220890 T1 HRP20220890 T1 HR P20220890T1
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- 210000002865 immune cell Anatomy 0.000 title claims 17
- 238000000034 method Methods 0.000 title claims 3
- 230000002708 enhancing effect Effects 0.000 title 1
- 230000001225 therapeutic effect Effects 0.000 title 1
- 206010028980 Neoplasm Diseases 0.000 claims 6
- 108020003175 receptors Proteins 0.000 claims 6
- 102000005962 receptors Human genes 0.000 claims 6
- 108010019670 Chimeric Antigen Receptors Proteins 0.000 claims 5
- 238000010353 genetic engineering Methods 0.000 claims 5
- 229940045513 CTLA4 antagonist Drugs 0.000 claims 4
- 102100039498 Cytotoxic T-lymphocyte protein 4 Human genes 0.000 claims 4
- 101000889276 Homo sapiens Cytotoxic T-lymphocyte protein 4 Proteins 0.000 claims 4
- 101000946860 Homo sapiens T-cell surface glycoprotein CD3 epsilon chain Proteins 0.000 claims 4
- 102100040678 Programmed cell death protein 1 Human genes 0.000 claims 4
- 101710089372 Programmed cell death protein 1 Proteins 0.000 claims 4
- 108091008874 T cell receptors Proteins 0.000 claims 4
- 102000016266 T-Cell Antigen Receptors Human genes 0.000 claims 4
- 102100035794 T-cell surface glycoprotein CD3 epsilon chain Human genes 0.000 claims 4
- 210000001744 T-lymphocyte Anatomy 0.000 claims 4
- 210000004027 cell Anatomy 0.000 claims 4
- 102000039446 nucleic acids Human genes 0.000 claims 4
- 108020004707 nucleic acids Proteins 0.000 claims 4
- 150000007523 nucleic acids Chemical class 0.000 claims 4
- 239000002773 nucleotide Substances 0.000 claims 4
- 125000003729 nucleotide group Chemical group 0.000 claims 4
- 101000945371 Homo sapiens Killer cell immunoglobulin-like receptor 2DL2 Proteins 0.000 claims 3
- 101150069255 KLRC1 gene Proteins 0.000 claims 3
- 102100033599 Killer cell immunoglobulin-like receptor 2DL2 Human genes 0.000 claims 3
- 101100404845 Macaca mulatta NKG2A gene Proteins 0.000 claims 3
- 102100022682 NKG2-A/NKG2-B type II integral membrane protein Human genes 0.000 claims 3
- 210000002472 endoplasmic reticulum Anatomy 0.000 claims 3
- 102000017420 CD3 protein, epsilon/gamma/delta subunit Human genes 0.000 claims 2
- 108050005493 CD3 protein, epsilon/gamma/delta subunit Proteins 0.000 claims 2
- 101150046249 Havcr2 gene Proteins 0.000 claims 2
- 102100034458 Hepatitis A virus cellular receptor 2 Human genes 0.000 claims 2
- 101000777628 Homo sapiens Leukocyte antigen CD37 Proteins 0.000 claims 2
- 108060003951 Immunoglobulin Proteins 0.000 claims 2
- 102100031586 Leukocyte antigen CD37 Human genes 0.000 claims 2
- 201000011510 cancer Diseases 0.000 claims 2
- 230000028993 immune response Effects 0.000 claims 2
- 102000018358 immunoglobulin Human genes 0.000 claims 2
- 238000001802 infusion Methods 0.000 claims 2
- 230000004807 localization Effects 0.000 claims 2
- 230000014759 maintenance of location Effects 0.000 claims 2
- 102100022089 Acyl-[acyl-carrier-protein] hydrolase Human genes 0.000 claims 1
- 101000964894 Bos taurus 14-3-3 protein zeta/delta Proteins 0.000 claims 1
- -1 CD3ζ Proteins 0.000 claims 1
- 206010066476 Haematological malignancy Diseases 0.000 claims 1
- 208000002250 Hematologic Neoplasms Diseases 0.000 claims 1
- 102100031573 Hematopoietic progenitor cell antigen CD34 Human genes 0.000 claims 1
- 102100022132 High affinity immunoglobulin epsilon receptor subunit gamma Human genes 0.000 claims 1
- 108091010847 High affinity immunoglobulin epsilon receptor subunit gamma Proteins 0.000 claims 1
- 102100026122 High affinity immunoglobulin gamma Fc receptor I Human genes 0.000 claims 1
- 101000824278 Homo sapiens Acyl-[acyl-carrier-protein] hydrolase Proteins 0.000 claims 1
- 101000777663 Homo sapiens Hematopoietic progenitor cell antigen CD34 Proteins 0.000 claims 1
- 101000913074 Homo sapiens High affinity immunoglobulin gamma Fc receptor I Proteins 0.000 claims 1
- 101001027081 Homo sapiens Killer cell immunoglobulin-like receptor 2DL1 Proteins 0.000 claims 1
- 101000917826 Homo sapiens Low affinity immunoglobulin gamma Fc region receptor II-a Proteins 0.000 claims 1
- 101000917824 Homo sapiens Low affinity immunoglobulin gamma Fc region receptor II-b Proteins 0.000 claims 1
- 101000917858 Homo sapiens Low affinity immunoglobulin gamma Fc region receptor III-A Proteins 0.000 claims 1
- 101000917839 Homo sapiens Low affinity immunoglobulin gamma Fc region receptor III-B Proteins 0.000 claims 1
- 101000716102 Homo sapiens T-cell surface glycoprotein CD4 Proteins 0.000 claims 1
- 101000914514 Homo sapiens T-cell-specific surface glycoprotein CD28 Proteins 0.000 claims 1
- 101000611023 Homo sapiens Tumor necrosis factor receptor superfamily member 6 Proteins 0.000 claims 1
- 101000851370 Homo sapiens Tumor necrosis factor receptor superfamily member 9 Proteins 0.000 claims 1
- 101000851007 Homo sapiens Vascular endothelial growth factor receptor 2 Proteins 0.000 claims 1
- 102100037363 Killer cell immunoglobulin-like receptor 2DL1 Human genes 0.000 claims 1
- 102100029204 Low affinity immunoglobulin gamma Fc region receptor II-a Human genes 0.000 claims 1
- 102100029185 Low affinity immunoglobulin gamma Fc region receptor III-B Human genes 0.000 claims 1
- 102100036011 T-cell surface glycoprotein CD4 Human genes 0.000 claims 1
- 102100027213 T-cell-specific surface glycoprotein CD28 Human genes 0.000 claims 1
- 101710165473 Tumor necrosis factor receptor superfamily member 4 Proteins 0.000 claims 1
- 102100022153 Tumor necrosis factor receptor superfamily member 4 Human genes 0.000 claims 1
- 102100036856 Tumor necrosis factor receptor superfamily member 9 Human genes 0.000 claims 1
- 102100033177 Vascular endothelial growth factor receptor 2 Human genes 0.000 claims 1
- 241000607479 Yersinia pestis Species 0.000 claims 1
- 125000003275 alpha amino acid group Chemical group 0.000 claims 1
- 150000001413 amino acids Chemical class 0.000 claims 1
- 210000004443 dendritic cell Anatomy 0.000 claims 1
- 239000012634 fragment Substances 0.000 claims 1
- 238000002513 implantation Methods 0.000 claims 1
- 238000000338 in vitro Methods 0.000 claims 1
- 238000002347 injection Methods 0.000 claims 1
- 239000007924 injection Substances 0.000 claims 1
- 238000001361 intraarterial administration Methods 0.000 claims 1
- 238000007913 intrathecal administration Methods 0.000 claims 1
- 238000001990 intravenous administration Methods 0.000 claims 1
- 210000002540 macrophage Anatomy 0.000 claims 1
- 210000001616 monocyte Anatomy 0.000 claims 1
- 210000000822 natural killer cell Anatomy 0.000 claims 1
- 230000010412 perfusion Effects 0.000 claims 1
- 238000001356 surgical procedure Methods 0.000 claims 1
Classifications
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- 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
- C07K16/2803—Immunoglobulins [IGs], 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 [IGs], 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
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K2239/46—Indexing codes associated with cellular immunotherapy of group A61K39/46 characterised by the cancer treated
- A61K2239/48—Blood cells, e.g. leukemia or lymphoma
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/46—Cellular immunotherapy
- A61K39/461—Cellular immunotherapy characterised by the cell type used
- A61K39/4611—T-cells, e.g. tumor infiltrating lymphocytes [TIL], lymphokine-activated killer cells [LAK] or regulatory T cells [Treg]
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- A61K39/00—Medicinal preparations containing antigens or antibodies
- A61K39/46—Cellular immunotherapy
- A61K39/461—Cellular immunotherapy characterised by the cell type used
- A61K39/4613—Natural-killer cells [NK or NK-T]
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- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
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- A61K39/46—Cellular immunotherapy
- A61K39/463—Cellular immunotherapy characterised by recombinant expression
- A61K39/4631—Chimeric Antigen Receptors [CAR]
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- A61K39/46—Cellular immunotherapy
- A61K39/464—Cellular immunotherapy characterised by the antigen targeted or presented
- A61K39/4643—Vertebrate antigens
- A61K39/4644—Cancer antigens
- A61K39/464402—Receptors, cell surface antigens or cell surface determinants
- A61K39/464411—Immunoglobulin superfamily
- A61K39/464412—CD19 or B4
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- A61K39/4643—Vertebrate antigens
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- A61K39/464402—Receptors, cell surface antigens or cell surface determinants
- A61K39/464429—Molecules with a "CD" designation not provided for elsewhere
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P37/00—Drugs for immunological or allergic disorders
- A61P37/02—Immunomodulators
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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
- C07K14/705—Receptors; Cell surface antigens; Cell surface determinants
- C07K14/70503—Immunoglobulin superfamily
- C07K14/7051—T-cell receptor (TcR)-CD3 complex
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- 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
- C07K16/2803—Immunoglobulins [IGs], 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
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- C07—ORGANIC CHEMISTRY
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- 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
- C07K16/2803—Immunoglobulins [IGs], 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
- C07K16/2833—Immunoglobulins [IGs], 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 MHC-molecules, e.g. HLA-molecules
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- 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
- C07K16/289—Immunoglobulins [IGs], e.g. monoclonal or polyclonal antibodies against material from animals or humans against receptors, cell surface antigens or cell surface determinants against CD45
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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
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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
- C12N5/0646—Natural killers cells [NK], NKT cells
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- C07K2317/50—Immunoglobulins specific features characterized by immunoglobulin fragments
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- 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)
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- 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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- C07K2319/00—Fusion polypeptide
- C07K2319/01—Fusion polypeptide containing a localisation/targetting motif
- C07K2319/04—Fusion polypeptide containing a localisation/targetting motif containing an ER retention signal such as a C-terminal HDEL motif
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Claims (13)
1. Genetskim inženjerstvom promijenjena imunosna stanica, naznačena time, da sadrži prvu nukleinsku kiselinu koja sadrži nukleotidni slijed koji kodira kimerni receptor antigena (CAR) i drugu nukleinsku kiselinu koja sadrži nukleotidni slijed koji kodira protutijelo vezano na lokalizirajuću domenu,
pri čemu se protutijelo veže na:
faktor u kompleksu CD3/receptor T stanice (TCR) odabranom iz skupine koja se sastoji od CD3ε, TCRα, TCRβ, TCR7, TCRδ, CD3δ, CD37, ili CD3ζ; ili
receptor koji silazno regulira imunosni odgovor odabran iz skupine koju čine protein 1 programirane smrti stanice (PD-1), citotoksični protein 4 povezan s T limfocitima (CTLA-4), imunoglobulin T stanice i koji sadrži domenu mucina 3 (Tim3), receptor ubojice nalik na imunoglobulin (KIR) 2DL1, KIR2DL2/DL3, i NKG2A; i
pritom protutijelo koje je vezano na lokalizirajuću domenu silazno regulira ekspresiju stanične površine faktora ili receptora.
2. Genetskim inženjerstvom promijenjena imunosna stanica prema patentnom zahtjevu 1, naznačena time, da se kod inženjerstvom promijenjene imunosne stanice radi o inženjerstvom promijenjenoj T stanici, inženjerstvom promijenjenoj prirodnoj stanici ubojici (NK), inženjerstvom promijenjenoj NK/T stanici, inženjerstvom promijenjenom monocitu, inženjerstvom promijenjenom makrofagu, ili inženjerstvom promijenjenoj dendritičkoj stanici.
3. Genetskim inženjerstvom promijenjena imunosna stanica prema patentnom zahtjevu 1, naznačena time, da CAR jest anti-CD19-4-1BB-CD3ζ CAR.
4. Genetskim inženjerstvom promijenjena imunosna stanica prema patentnom zahtjevu 1, naznačena time, da protutijelo je varijabilni fragment jednostrukog lanca (scFv).
5. Genetskim inženjerstvom promijenjena imunosna stanica prema patentnom zahtjevu 1 ili 4, naznačena time, da protutijelo ili scFv koje veže CD3ε, sadrži varijabilni teški lanac (VH) koji je najmanje 85% identičan slijedu SEQ ID NO: 12 i varijabilni laki lanac (VL) koji je najmanje 85% identičan slijedu SEQ ID NO: 13.
6. Genetskim inženjerstvom promijenjena imunosna stanica prema patentnom zahtjevu 1 ili 4, naznačena time, da protutijelo ili scFv koje veže NKG2A, sadrži varijabilni teški lanac (VH) koji je najmanje 85% identičan slijedu SEQ ID NO: 32 i varijabilni laki lanac (VL) koji je najmanje 85% identičan slijedu SEQ ID NO: 33.
7. Genetskim inženjerstvom promijenjena imunosna stanica prema patentnom zahtjevu 1 ili 4, naznačena time, da protutijelo ili scFv koje veže KIR2DL1 i KIR2DL2/DL3, sadrži varijabilni teški lanac (VH) koji je najmanje 85% identičan slijedu SEQ ID NO: 36 i varijabilni laki lanac (VL) koji je najmanje 85% identičan slijedu SEQ ID NO: 37.
8. Genetskim inženjerstvom promijenjena imunosna stanica prema patentnom zahtjevu 1, naznačena time, da lokalizirajuća domena sadrži endoplazmatski retikulum (ER) ili Golgijev retencijski slijed; slijed lokaliziranja proteosoma; slijed transmembranske domene izveden iz CD8α, CD8β, 4-1BB, CD28, CD34, CD4, FcεRIγ, CD16, OX40, CD3ζ, CD3ε, CD3γ, CD3δ, TCRα, CD32, CD64, VEGFR2, FAS, ili FGFR2B.
9. Genetskim inženjerstvom promijenjena imunosna stanica prema patentnom zahtjevu 8, naznačena time, da ER ili Golgijev retencijski slijed sadrži aminokiselinski slijed KDEL (SEQ ID NO 4), KKXX (SEQ ID NO: 9), KXD/E (SEQ ID NO: 10), ili YQRL (SEQ ID NO: 11), pri čemu X je bilo koja aminokiselina ili lokalizirajući slijed proteosoma sadrži PEST motiv.
10. Genetskim inženjerstvom promijenjena imunosna stanica prema patentnom zahtjevu 1, naznačena time, da je za uporabu u liječenju raka kod pojedinca.
11. Genetskim inženjerstvom promijenjena imunosna stanica za uporabu prema patentnom zahtjevu 10, naznačena time, da je stanica prikladna za primjenu kod pojedinca putem intravenozne infuzije, intra-arterijske infuzije, direktne injekcije u tumor i/ili perfuzije ležišta tumora nakon kirurškog zahvata, implantacije na mjestu tumora na umjetnom podiju, intratekalne primjene, ili intraokularne primjene.
12. Genetskim inženjerstvom promijenjena imunosna stanica za uporabu prema patentnom zahtjevu 10, naznačena time, da rak je solidni tumor ili hematološka malignost.
13. Postupak in vitro za proizvodnju genetskim inženjerstvom promijenjene imunosne stanice prema patentnom zahtjevu 1, naznačen time, da postupak obuhvaća:
uvođenje u imunosnu stanicu nukleinske kiseline koja sadrži nukleotidni slijed koji kodira kimerni receptor antigena i nukleinske kiseline koja sadrži nukleotidni slijed koji kodira protutijelo vezano na lokalizirajuću domenu, pri čemu se protutijelo veže na:
faktor u kompleksu CD3/receptor T stanice (TCR) odabranom iz skupine koja se sastoji od CD3ε, TCRα, TCRβ, TCR7, TCRδ, CD3δ, CD37, ili CD3ζ; ili
receptor koji silazno regulira imunosni odgovor odabran iz skupine koju čine protein 1 programirane smrti stanice (PD-1), citotoksični protein 4 povezan s T limfocitima (CTLA-4), imunoglobulin T stanice i koji sadrži domenu mucina 3 (Tim3), receptor ubojice nalik na imunoglobulin (KIR) 2DL1, KIR2DL2/DL3, i NKG2A; i
pritom protutijelo koje je vezano na lokalizirajuću domenu silazno regulira ekspresiju stanične površine faktora ili receptora,
čime se proizvodi genetskim inženjerstvom promijenjena imunosna stanica.
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| US201562112765P | 2015-02-06 | 2015-02-06 | |
| US201562130970P | 2015-03-10 | 2015-03-10 | |
| EP16746922.0A EP3253865B1 (en) | 2015-02-06 | 2016-02-05 | Methods for enhancing efficacy of therapeutic immune cells |
| PCT/SG2016/050063 WO2016126213A1 (en) | 2015-02-06 | 2016-02-05 | Methods for enhancing efficacy of therapeutic immune cells |
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