Interested in licensing this patent?
MTEC can help explore whether this patent might be available for licensing for your application.
Publication Number
US-11911414-B2
Publication Date
2024-02-27
Expiration Date
Abstract
The present is directed to compositions comprising regulatory T cell epitopes, wherein said epitopes comprises a polypeptide comprising at least a portion of SEQ NOS: 1-124 (and/or fragments and variants thereof), and optionally 1 to 12 additional amino acids distributed in any ratio on the N-terminus and/or C-terminus of the polypeptide of SEQ ID NOS: 1-124, as well as methods of producing and using the same.
Core Innovation
The invention relates to Tregitope compositions comprising one or more isolated T-cell epitope polypeptides, including an amino acid sequence corresponding to SEQ ID NOS: 1-124, optionally with 1-12 terminal flanking amino acids, as well as fragments, variants, concatemeric constructs, and fusion/chimeric polypeptides. The compositions are directed to inducing regulatory T-cells to suppress immune response in a subject, with a therapeutically effective amount of the T-cell epitope composition.
The disclosed immune regulatory function includes selective engagement and activation of naturally occurring regulatory T-cells, including natural and/or adaptive regulatory T cells characterized as CD4+/CD25+/FoxP3+. The description also includes shifting antigen-presenting cells and dendritic cells toward regulatory phenotypes and suppressing immune responses across innate, adaptive, effector, helper, memory, and B-cell/NKT responses.
The disclosure further includes Tregitope conjugates and chimeric or fusion polypeptides in which Tregitopes are attached to antibody or Fc domains and/or conjugated to blood components, preferably albumin, to extend in vivo half-life and protect from degradation and clearance. The document also includes formulation and delivery concepts for Tregitopes, including nucleic acids, vectors, cells, and pharmaceutical compositions, and references immune cell delivery and antigen presentation, including via MHC class II.
Claims Coverage
The claim coverage centers on one independent method claim to induce regulatory T-cells to suppress an immune response by administering a therapeutically effective amount of a T-cell epitope composition containing at least one isolated polypeptide with the amino acid sequence of SEQ ID NO: 7. Dependent claims add specific sequence content, optional antigen/allergen components, and further specify natural regulatory T cells and immune response outputs such as cytokine secretion and B-cell response.
Regulatory T-cell induction via SEQ ID NO: 7 epitope composition
A method of inducing regulatory T-cells to suppress immune response in a subject by administrating a therapeutically effective amount of a T-cell epitope composition comprising one or more isolated T-cell epitope polypeptides, wherein at least one isolated T-cell epitope polypeptide consists of the amino acid sequence of SEQ ID NO: 7.
SEQ ID epitope expansion with additional isolated polypeptides
The method further comprises including at least one isolated T-cell epitope polypeptide having an amino acid sequence selected from SEQ ID NOS: 1-6 and 8-124 in addition to SEQ ID NO: 7.
Optional inclusion of antigens and/or allergens
The method is carried out such that the T-cell epitope composition includes an effective amount of one or more antigens and/or allergens.
Immune suppression mediated by natural regulatory T cells
The method is carried out such that the immune-suppressive effect is mediated by natural regulatory T cells.
Suppression of cytokine secretion by effector T-cells
The T-cell epitope composition suppresses cytokine secretion by effector T-cells.
Suppression of B-cell response
The method includes a T-cell epitope composition that suppresses a B-cell response.
Overall claim coverage centers on administration of a therapeutically effective T-cell epitope composition containing an isolated SEQ ID NO: 7 polypeptide to induce regulatory T-cells and suppress an immune response, with further coverage for adding additional SEQ ID epitope polypeptides, optionally including antigens and/or allergens, and specifying natural regulatory T cells, cytokine secretion by effector T-cells, and B-cell responses.
Stated Advantages
Induces suppression of an immune response via regulatory T-cells in a subject.
Supports immunogenicity decrease and tolerogenicity enhancement.
Extends in vivo half-life and protects from degradation and clearance for disclosed conjugates and carriers.
Enables immune cell delivery and antigen presentation, including via MHC class II as described.
Documented Applications
Allergy.
Transplantation and GVHD.
Autoimmunity.
Diabetes.
HBV (hepatitis B virus).
SLE (systemic lupus erythematosus).
Interested in licensing this patent?