Patent application EP19177859A (EP), filed 2019-06-03
Publication number: EP3747904A1
Title: CD25-SPECIFIC CHIMERIC ANTIGEN RECEPTORS AND THEIR USES
Abstract: The present invention relates to proteins which comprise (i) a CD25-specific binding domain, (ii) a linker domain, connecting domain (i) and domain (iii), (iii) a transmembrane domain, and (iv) a signalling domain. The present invention furthermore relates to nucleic acids encoding the proteins, expression constructs for expressing the protein in a host cell and host cells. The present invention further relates to pharmaceutical compositions comprising said protein(s), nucleic acid(s), expression construct(s) or host cell(s). The proteins of the invention are CD25-specific chimeric antigen receptors that are suitable for generating CD25-specific immune cells, which can be used e.g. in the treatment of inflammation.
IPC codes: A61K  35/    17            A I
A61P  37/    00            A I
C07K  14/   705            A I
C07K  14/   725            A I
C07K  16/    28            A I
C12N   5/  0783            A I
Claims: number: 1
text: A protein comprising
number: 2
text: The protein of claim 1, wherein the signalling domain (iv) is derived from
number: 3
text: The protein of claim 1 or 2, wherein the extracellular CD25-specific binding domain (i) is an anti-CD25 single chain Fv (scFv) fragment,
preferably comprising the amino acid sequence of SEQ ID NO.1,
or wherein the extracellular CD25-specific binding domain (i) is derived from or comprises IL-2.
number: 4
text: The protein of any one of claims 1 to 3, wherein the linker domain (ii) is human IgG1 Fc domain or a domain derived therefrom,
preferably comprising the amino acid sequence of SEQ ID NOs. 2 or 3.
number: 5
text: The protein of any one of claims 1 to 4, further comprising an N-terminal secretion signal peptide, preferably immunoglobulin heavy chain signal peptide, such as the IgG kappa light chain leader sequence.
number: 6
text: The protein of any one of claims 1 to 5, comprising an amino acid sequence selected from SEQ ID NOs. 4 to 6,
or an amino acid sequence that has at least 85%, preferably 90% or 95 % sequence identity to an amino acid sequence of SEQ ID NOs. 4 to 6.
number: 7
text: A nucleic acid encoding the protein of any one of claims 1 to 6.
number: 8
text: The nucleic acid of claim 7, comprising the nucleic acid encoding for the amino acid sequence of SEQ ID NO. 1 or
comprising the nucleic acid sequence of SEQ ID NO. 7 or their complementary sequences or sequences that have at least 85%, preferably 90% or 95 % sequence identity,
and/or comprising the nucleic acid encoding for the amino acid sequence of SEQ ID NOs. 2 or 3,
comprising the nucleic acid sequence of SEQ ID NOs. 8 or 9, or their complementary sequences or sequences that have at least 85%, preferably 90% or 95 % sequence identity.
number: 9
text: The nucleic acid of claim 7 or 8, comprising the nucleic acid encoding for an amino acid sequence selected from SEQ ID NOs. 4 to 6 or a nucleic acid sequence selected from SEQ ID NOs. 10 to 12 or their complementary sequences or sequences that have at least 85%, preferably 90% or 95 % sequence identity.
number: 10
text: An expression construct for expressing the protein of any one of claims 1 to 6 in a cell.
number: 11
text: A host cell expressing a protein of any one of claims 1 to 6 or comprising a nucleic acid of any of claims 7 to 9 or an expression construct of claim 10,
which is preferably selected from cells of the immune system, more preferably T cells or regulatory T (Treg) cells.
number: 12
text: Use of a protein of claims 1 to 6, a nucleic acid of claims 7 to 9 or an expression construct of claim 10 for generating CD25-specific immune cells, preferably CD25-specific T cells or CD25-specific regulatory T (Treg) cells.
number: 13
text: A pharmaceutical composition, comprising
number: 14
text: The protein of claims 1 to 6, the nucleic acid of claims 7 to 9, the expression construct of claim 10 or the host cell of claim 11 for use as a medicament.
number: 15
text: The protein of claims 1 to 6, the nucleic acid of claims 7 to 9, the expression construct of claim 10 or the host cell of claim 11 for use in the treatment of inflammation,
wherein inflammation comprises chronic inflammation, in particular in autoimmune diseases, such as multiple sclerosis, inflammatory bowel disease including Crohn's disease and ulcerative colitis, type-1 diabetes, psoriasis, rheumatoid arthritis, systemic lupus erytematosus, Hashimoto's thyreoiditis, Addison's disease, Graves' disease, Sjögren's syndrome, myastenia gravis, auto-immune vasculitis, pernicious anemia, and celiac disease,
preferably comprising reducing or supressing the inflammatory reaction in tissues,
or the protein of claims 1 to 6, the nucleic acid of claims 7 to 9, the expression construct of claim 10 or the host cell of claim 11 for use in target-cell specific immunotherapy.
Office action: search_report, dated 2020-12-09
Rejection reasons: novelty_epc_54
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ref_type: npl
severity: background
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ref_type: npl
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ref_type: npl
severity: background
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severity: background
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ref_type: npl
severity: background
ref_id: WO2015124715
ref_type: patent
severity: novelty_destroying
ref_id: WO2016008973
ref_type: patent
severity: novelty_destroying
ref_id: WO2017222593
ref_type: patent
severity: novelty_destroying
ref_id: WO2018191748
ref_type: patent
severity: novelty_destroying
ref_id: - BARTH S ET AL, "CONSTRUCTION AND IN VITRO EVALUATION OF RFT5(SCFV)-ETA', A NEW RECOMBINANT SINGLE-CHAIN IMMUNOTOXIN WITH SPECIFIC CYTOTOXICITY TOWARD CD25+ HODGKIN-DERIVED CELL LINES", INTERNATIONAL JOURNAL OF MOLECULAR MEDICINE, SPANDIDOS PUBLICATIONS, GR, (19980101), vol. 1, no. 1, ISSN 1107-3756, pages 249 - 256, XP000990405 [AD] 1-15 * the whole document *
ref_type: npl
severity: background
Final disposition: pending (2020-12-09)