US2023104151A1PendingUtilityA1

A method for treating disease using foxp3+cd4+ t cells

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Assignee: KYVERNA THERAPEUTICS INCPriority: Nov 10, 2020Filed: Nov 2, 2022Published: Apr 6, 2023
Est. expiryNov 10, 2040(~14.3 yrs left)· nominal 20-yr term from priority
Inventors:Ashley MahneJohn LeeLih-Yun HsuJeffrey Greve
A61K 40/416A61K 40/22A61K 40/11C12N 5/0637C12N 5/0636A61K 39/3955A61K 38/1793A61K 38/1774C07K 16/248C07K 14/4703C12N 2501/60A61K 38/1709C07K 16/2866C07K 2317/622C12N 15/63C07K 14/4705A61K 48/0066A61K 38/177A61K 35/17
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Claims

Abstract

This document relates to methods and materials for treating a mammal having an autoimmune disease. For example, materials and methods for producing a T cell comprising a FOXP3 polypeptide and one or more transcription factors are provided herein. Methods and materials for treating a mammal having an autoimmune disease comprising administering to a mammal having an autoimmune disease an effective amount of a T cell are also provided herein.

Claims

exact text as granted — not AI-modified
What is claimed is: 
     
         1 . A vector comprising:
 (i) a first nucleic acid sequence encoding a FOXP3 polypeptide; and   (ii) a second nucleic acid sequence encoding one or more transcription factor(s) selected from the group consisting of: ID2, ID3, GATA1, GATA3, XBP1, and SATB1.   
     
     
         2 . The vector of  claim 1 , wherein the one or more transcription factor(s), when present in a human cell, elicit(s) a T reg phenotype in the human cell as compared to when the one or more transcription factor(s) is/are not present in the human cell. 
     
     
         3 . The vector of  claim 1 , wherein the one or more transcription factor(s) is ID2. 
     
     
         4 . The vector of  claim 1 , wherein the one or more transcription factor(s) is ID3. 
     
     
         5 . The vector of  claim 1 , wherein the one or more transcription factor(s) is GATA1. 
     
     
         6 . The vector of  claim 1 , wherein the one or more transcription factor(s) is GATA3. 
     
     
         7 . The vector of  claim 1 , wherein the one or more transcription factor(s) is XBP1. 
     
     
         8 . The vector of  claim 1 , wherein the one or more transcription factor(s) is SATB1. 
     
     
         9 . The vector of  claim 1 , wherein the vector further comprises a promoter operably linked to the first nucleic acid sequence. 
     
     
         10 . The vector of  claim 1 , wherein the first nucleic acid sequence is positioned 5′ relative to the second nucleic acid sequence in the vector. 
     
     
         11 . The vector of  claim 10 , wherein the vector further comprises an additional nucleic acid sequence between the first nucleic acid sequence and the second nucleic acid sequence, wherein the additional nucleic acid sequence operably links the second nucleic acid sequence to the first nucleic acid sequence, and the additional nucleic acid sequence (i) encodes an internal ribosome entry site (IRES) sequence or a self-cleaving amino acid, or (ii) comprises a promoter or an enhancer. 
     
     
         12 . The vector of  claim 1 , wherein the second nucleic acid sequence is positioned 5′ relative to the first nucleic acid sequence in the vector, and the second nucleic acid sequence is operably linked to a promoter. 
     
     
         13 . The vector of  claim 12 , wherein the vector further comprises an additional nucleic acid sequence between the second nucleic acid sequence and the first nucleic acid sequence, wherein the additional nucleic acid sequence operably links the first nucleic acid sequence to the second nucleic acid sequence, and the additional nucleic acid sequence (i) encodes an internal ribosome entry site (IRES) sequence or a self-cleaving amino acid, or (ii) comprises a promoter or an enhancer. 
     
     
         14 . The vector of  claim 1 , wherein the vector further comprises a third nucleic acid sequence encoding a therapeutic gene product. 
     
     
         15 . The vector of  claim 14 , wherein the therapeutic gene product is an antibody or antigen-binding fragment that is capable of specifically binding to an IL-6, an IL-16R, an IFN alpha receptor, or a TGF beta receptor polypeptide. 
     
     
         16 . The vector of  claim 14 , wherein the third nucleic acid sequence is operably linked to a promoter. 
     
     
         17 . The vector of  claim 14 , wherein the vector further comprises a fourth nucleic acid sequence encoding a binding agent, wherein the binding agent is an antibody, an antigen-binding fragment, or a chimeric antigen receptor. 
     
     
         18 . The vector of  claim 17 , wherein the fourth nucleic acid sequence is operably linked to a promoter. 
     
     
         19 . The vector of  claim 17 , wherein the chimeric antigen receptor comprises an extracellular domain, a transmembrane domain, and an intracellular domain, wherein the extracellular domain comprises an antibody or antigen-binding fragment that is capable of specifically binding to an antigen on an autoimmune cell, and the intracellular domain comprises a cytoplasmic signaling domain and one or more co-stimulatory domain(s). 
     
     
         20 . The vector of  claim 19 , wherein the extracellular domain specifically binds to a cell adhesion molecule selected from the group consisting of: ICAM-1, VCAM-1, and MAdCAM-1. 
     
     
         21 . The vector of  claim 19 , wherein the cytoplasmic signaling domain is a CD3 zeta domain and the one or more co-stimulatory domain(s) comprise(s) at least one of a CD48 domain, a 4-1BB domain, an ICOS domain, an OX-40 domain, and a CD27 domain. 
     
     
         22 . The vector of  claim 1 , wherein the vector comprises a viral vector selected from the group consisting of: a lentiviral vector, a retroviral vector, an adenoviral vector, and an adeno-associated viral (AAV) vector. 
     
     
         23 . A composition comprising:
 (i) a first vector comprising a first nucleic acid sequence encoding a FOXP3 polypeptide and a promoter operably linked to the first nucleic acid sequence; and   (ii) a second vector comprising a second nucleic acid sequence encoding one or more transcription factor(s) selected from the group consisting of: ID2, ID3, GATA1, GATA3, XBP1, and SATB1, and a promoter operably linked to the second nucleic acid sequence.   
     
     
         24 . The composition of  claim 23 , wherein the one or more transcription factor(s), when present in a human cell, elicit(s) a T reg phenotype in the human cell as compared to when the one or more transcription factor(s) is/are not present in the human cell. 
     
     
         25 . The composition of  claim 1 , wherein the one or more transcription factor(s) is ID2. 
     
     
         26 . The composition of  claim 1 , wherein the one or more transcription factor(s) is ID3. 
     
     
         27 . The composition of  claim 1 , wherein the one or more transcription factor(s) is GATA1. 
     
     
         28 . The composition of  claim 1 , wherein the one or more transcription factor(s) is GATA3. 
     
     
         29 . The composition of  claim 1 , wherein the one or more transcription factor(s) is XBP1. 
     
     
         30 . The composition of  claim 1 , wherein the one or more transcription factor(s) is SATB1.

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