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FI3294333T4 - Klaudiini-18.2-spesifiset immunoreseptorit ja t-soluepitoopit - Google Patents

Klaudiini-18.2-spesifiset immunoreseptorit ja t-soluepitoopit Download PDF

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Publication number
FI3294333T4
FI3294333T4 FIEP16721176.2T FI16721176T FI3294333T4 FI 3294333 T4 FI3294333 T4 FI 3294333T4 FI 16721176 T FI16721176 T FI 16721176T FI 3294333 T4 FI3294333 T4 FI 3294333T4
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amino acid
acid residues
seo
cell receptor
cell
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Ugur Sahin
Özlem Türeci
Petra Simon
Tana Omokoko
Andrea Breitkreuz
Karolina Anna Mroz
Lisa Hebich
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Biontech Cell&Gene Therapies Gmbh
Tron Translationale Onkologie An Der Universitaetsmedizin Der Johannes Gutenberg Universitaet Mainz
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    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K39/00—Medicinal preparations containing antigens or antibodies
    • A61K39/0005—Vertebrate antigens
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    • 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
    • A61K40/31—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
    • 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
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
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    • A61P37/02—Immunomodulators
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    • 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
    • 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
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    • 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
    • C07K14/70503—Immunoglobulin superfamily
    • C07K14/70539—MHC-molecules, e.g. HLA-molecules
    • 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
    • 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
    • C—CHEMISTRY; METALLURGY
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    • C07K—PEPTIDES
    • C07K7/00—Peptides having 5 to 20 amino acids in a fully defined sequence; Derivatives thereof
    • C07K7/04—Linear peptides containing only normal peptide links
    • C07K7/06—Linear peptides containing only normal peptide links having 5 to 11 amino acids
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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
    • A—HUMAN NECESSITIES
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    • 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
    • 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
    • A61K2039/575—Medicinal preparations containing antigens or antibodies characterised by the type of response, e.g. Th1, Th2 humoral response
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2317/00—Immunoglobulins specific features
    • C07K2317/30—Immunoglobulins specific features characterized by aspects of specificity or valency
    • C07K2317/34—Identification of a linear epitope shorter than 20 amino acid residues or of a conformational epitope defined by amino acid residues
    • 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
    • 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
    • C07K2317/70—Immunoglobulins specific features characterized by effect upon binding to a cell or to an antigen
    • C07K2317/76—Antagonist effect on antigen, e.g. neutralization or inhibition of binding
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/01—Fusion polypeptide containing a localisation/targetting motif
    • C07K2319/02—Fusion polypeptide containing a localisation/targetting motif containing a signal sequence
    • 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
    • C07K2319/01—Fusion polypeptide containing a localisation/targetting motif
    • C07K2319/035—Fusion polypeptide containing a localisation/targetting motif containing a signal for targeting to the external surface of a cell, e.g. to the outer membrane of Gram negative bacteria, GPI- anchored eukaryote proteins
    • C—CHEMISTRY; METALLURGY
    • C07—ORGANIC CHEMISTRY
    • C07K—PEPTIDES
    • C07K2319/00—Fusion polypeptide
    • C07K2319/30—Non-immunoglobulin-derived peptide or protein having an immunoglobulin constant or Fc region, or a fragment thereof, attached thereto
    • 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

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Claims (8)

PATENTTIVAATIMUKSET
1. Peptidi, joka koostuu aminohapposekvenssistä, joka on valittu ryhmästä, joka koos- tuu seuraavista SEO ID NO:t 6 ja 7, käytettäväksi CD4+ auttaja-T-soluvasteen ja/tai CD8+T-soluvasteen herättämiseen CLDN18.2:ta vastaan.
2. Nukleiinihappo käytettäväksi CD4+ auttaja-T-soluvasteen ja/tai CD8+ T-soluvas- teen herättämiseen CLDN18.2:ta vastaan käsittäen patenttivaatimuksen 1 mukaista pepti- diä koodaavan nukleotidisekvenssin, jolloin edullisesti nukleiinihappo on yhdistel- —mänukleiinihappo.
3. T-solureseptori, joka kykenee tunnistamaan HLA-A*02-restriktioituneita epitoop- peja, jotka on valittu SEO ID NO:iden 6 ja 7 ryhmästä, käytettäväksi terapiassa, jolloin T-solureseptori on valittu ryhmästä, jonka muodostavat: (DT-solureseptori, joka käsittää: (1) — T-solureseptorin a-ketjun, joka käsittää variaabelin alueen, johon sisältyy SEQ ID NO:n x T-solureseptorin a-ketjun CDR1, CDR2 ja CDR3 (järjestyk- sessä N-terminaalista C-terminaaliin), ja (11) T-solureseptorin B-ketjun, joka käsittää variaabelin alueen, johon sisältyy SEO ID NO:n x+1 T-solureseptorin B-ketjun CDR1, CDR2 ja CDR3 (järjes- tyksessä N-terminaalista C-terminaaliin); jolloin x on valittu ryhmästä, jonka muodostavat 8, 10, 12 ja 14, ja jolloin (1) SEO ID NO: 8:n CDRI koostuu aminohappotähteistä TTYLTIA, SEO ID NO: 8:n CDR2 koostuu aminohappotähteistä SSTDNKR, SEO ID NO: 8:n CDR3 koostuu aminohappotähteistä CALMDSNYQLIW, SEO ID NO: 9:n CDRI koostuu aminohappotähteistä -NNHDY, SEO ID NO: 9:n CDR2 koostuu aminohappotähteistä SYVADS, SEO ID NO: 9:n CDR3 koostuu aminohappotähteistä CASSINERLFF; (2) SEO ID NO: 10 CDRI koostuu aminohappotähteistä ASGYPA, SEO ID NO: 10 CDR2 koostuu aminohappotähteistä ASRDKEK, SEO ID NO: 10 CDR3 koostuu aminohappotähteistä CALGDYAOGLTF, SEO ID NO: 11 CDRI koostuu aminohappotähteistä LGHNA,
SEO ID NO: 11 CDR2 koostuu aminohappotähteistä YSYOKL, SEQ ID NO: 11 CDR3 koostuu aminohappotähteistä CASSQEWGGYEQYF; (3) SEO ID NO: 12 CDRI koostuu aminohappotähteistä ASGYPT, SEO ID NO: 12 CDR2 koostuu aminohappotähteistä ASRDKEK, SEO ID NO: 12 CDR3 koostuu aminohappotähteistä CALSVDYANKMIF, SEO ID NO: 13 CDRI koostuu aminohappotähteistä NSOYPW, SEQ ID NO: 13 CDR2 koostuu aminohappotähteistä LRSPGD, SEQ ID NO: 13 CDR3 koostuu aminohappotähteistä CTCSPLTGSYEQYF; (4) SEO ID NO: 14 CDRI koostuu aminohappotähteistä TYTTV, SEO ID NO: 14 CDR2 koostuu aminohappotähteistä IRSNERE, SEO ID NO: 14 CDR3 koostuu aminohappotähteistä CATDNRIFF, SEO ID NO: 15 CDRI koostuu aminohappotähteistä KGHTA, SEO ID NO: 15 CDR2 koostuu aminohappotähteistä FONOOP, SEQ ID NO: 15 CDR3 koostuu aminohappotähteistä CSSSOSGGYEOYF; ja (IT) T-solureseptori, joka käsittää: (1) T-solureseptorin a-ketjun, joka käsittää SEO ID NO:n x T-solureseptorin a- ketjusekvenssin, ja (11) T-solureseptorin B-ketjun, joka käsittää SEO ID NO:n x+1 T-solureseptorin [3- ketjusekvenssin; jolloin x on valittu ryhmästä, jonka muodostavat 8, 10, 12 ja 14.
4. Nukleiinihappo, joka käsittää nukleotidisekvenssin, joka koodaa patenttivaatimuk- sen 3 mukaisa T-solureseptoria, käytettäväksi terapiassa.
5. Solu, johon sisältyy patenttivaatimuksen 3 mukaista T-solureseptoria ja/tai johon sisältyy nukleiinihappoa, joka käsittää nukleiinihapposekvenssin, joka koodaa T-solure- septoria, käytettäväksi terapiassa.
6. Peptidi käytettäväksi patenttivaatimuksen 1 mukaisesti, nukleiinihappo käytettäväksi patenttivaatimuksen 2 tai 4 mukaisesti, solu käytettäväksi patenttivaatimuksen 5 mu- kaisesi tai T-solureseptori käytettäväksi patenttivaatimuksen 3 mukaisesti, jolloin peptidi, nukleiinihappo, solu tai T-solureseptori sisältyy farmaseuttiseen koostumukseen.
7. Peptidi käytettäväksi, nukleiinihappo käytettäväksi, solu käytettäväksi tai T-solu- käytettäväksi patenttivaatimuksen 6 mukaisesti, jolloin käyttöön sisältyy, että: (a) menetelmä syövän hoitamiseksi tai ehkäisemiseksi käsittää farmaseuttisen koostu- muksen antamisen potilaalle; tai — (b) menetelmä immuunivasteen käynnistämiseksi kohteessa käsittää farmaseuttisen koos- tumuksen antamisen kohteelle.
8. Menetelmä immuunivasteen määrittämiseksi kohteessa, joka menetelmä, käsittäen T- solujen määrittämisen, jotka reagoivat peptidin kanssa, joka koostuu aminohapposek- — venssistä, joka on valittu ryhmästä, jonka muodostaa SEO ID NO:t 6 ja 7, kohteesta eris- tetyssä biologisesta näytteestä.
FIEP16721176.2T 2015-05-11 2016-05-09 Klaudiini-18.2-spesifiset immunoreseptorit ja t-soluepitoopit FI3294333T4 (fi)

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Application Number Priority Date Filing Date Title
PCT/EP2015/060357 WO2016180468A1 (en) 2015-05-11 2015-05-11 Claudin-18.2-specific immunoreceptors and t cell epitopes
PCT/EP2016/060337 WO2016180782A1 (en) 2015-05-11 2016-05-09 Claudin-18.2-specific immunoreceptors and t cell epitopes

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FI3294333T4 true FI3294333T4 (fi) 2025-07-02

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US (2) US11713346B2 (fi)
EP (3) EP3294333B9 (fi)
JP (3) JP6942059B2 (fi)
KR (2) KR102703764B1 (fi)
CN (2) CN115109141A (fi)
AU (2) AU2016259730B2 (fi)
CA (1) CA2982422C (fi)
CY (1) CY1125347T1 (fi)
DK (2) DK3294333T5 (fi)
ES (2) ES2921801T3 (fi)
FI (1) FI3294333T4 (fi)
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MX (2) MX389021B (fi)
PL (2) PL3795177T3 (fi)
PT (2) PT3294333T (fi)
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SI (2) SI3294333T2 (fi)
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CN120137055A (zh) 2014-07-17 2025-06-13 恺兴生命科技(上海)有限公司 靶向cld18a2的t淋巴细胞及其制备方法和应用
WO2016180468A1 (en) * 2015-05-11 2016-11-17 Biontech Cell & Gene Therapies Gmbh Claudin-18.2-specific immunoreceptors and t cell epitopes
SG11201908659RA (en) * 2017-03-27 2019-10-30 Noile Immune Biotech Inc Chimeric antigen receptor
KR102828999B1 (ko) 2018-02-11 2025-07-04 메모리얼 슬로안 케터링 캔서 센터 비-hla 제한된 t 세포 수용체 및 이의 용도
AU2019232762B2 (en) * 2018-03-08 2023-11-16 Phanes Therapeutics, Inc. Anti-claudin 18.2 antibodies and uses thereof
WO2019170147A1 (zh) * 2018-03-09 2019-09-12 科济生物医药（上海）有限公司 用于治疗肿瘤的方法和组合物
KR102340989B1 (ko) * 2018-03-28 2021-12-20 에이비온 주식회사 클라우딘 3의 ecl-2에 특이적으로 결합하는 항체, 이의 단편 및 이들의 용도
CN111867630B (zh) * 2018-06-17 2023-10-13 上海健信生物医药科技有限公司 靶向cldn18.2的抗体、双特异性抗体、adc和car及其应用
US12054543B2 (en) 2018-07-25 2024-08-06 Accurus Biosciences, Inc. CLDN 18.2-specific monoclonal antibodies and methods of use thereof
CN110857322A (zh) 2018-08-22 2020-03-03 瑞阳(苏州)生物科技有限公司 抗人claudin 18.2单克隆抗体及其应用
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