Compositions and methods for in vitro cultivation and/or expansion of regulatory T cells
Inventors
WILKINSON, Daniel Stephen • Mannie, Mark D.
Assignees
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Publication Number
US-11384336-B2
Publication Date
2022-07-12
Expiration Date
Abstract
FOXP3+ regulatory T cells (Tregs) can represent powerful adoptive immunotherapies for autoimmune diseases, metabolic diseases, and other chronic inflammatory diseases. The present invention is related to the ability to maintain and expand stable Treg lines and can provide insight into FOXP3+ Treg physiology and can enable feasible strategies of Treg-based immunotherapy.
Core Innovation
The disclosed invention concerns an in vitro method for preparing and propagating a regulatory T-cell population using IL-2 together with an anti-CD25 antibody or fragment thereof. Differential CD25 expression provides a window in which regulatory T cells are preferentially supported over conventional T cells. The resulting population demonstrates increased representation and maintenance of FOXP3-positive cells.
The regulatory T-cell population maintains phenotypic Treg markers during long-term propagation and retains suppressive activity in vitro. Adoptive transfer of the resulting population reduces experimental autoimmune encephalomyelitis severity, while TGF-β supports stability during antigen-driven reactivation. Because the background section is not included in the provided content, the underlying technical problem is not explicitly described in the patent.
Claims Coverage
The claim coverage identifies one independent claim with one inventive feature directed to an in vitro method of preparing a regulatory T-cell population.
In vitro preparation and propagation of a regulatory T-cell population
The independent claim recites exposing T cells to and propagating them in a medium comprising IL-2 and an anti-CD25 antibody or fragment thereof to provide the regulatory T-cell population. Dependent claim elements further specify cytokine and inhibitor characteristics, regulatory T-cell phenotypic markers, and administration of the resulting population to a subject.
The claim coverage centers on preparing a regulatory T-cell population in vitro using IL-2 and an anti-CD25 antibody or fragment thereof, with dependent claim elements specifying cell population characteristics and subsequent administration.
Stated Advantages
The described culture conditions produce a population reported to contain over 90% FOXP3-positive cells.
The regulatory T-cell population maintains Treg markers during long-term propagation and retains suppressive activity in vitro.
Adoptive transfer of the regulatory T cells is reported to reduce experimental autoimmune encephalomyelitis severity.
Documented Applications
In vitro preparation, expansion, and maintenance of regulatory T-cell populations.
Administration of the prepared regulatory T-cell population to a subject, including use to elicit a tolerogenic response.
Adoptive transfer and administration of regulatory T cells in experimental autoimmune encephalomyelitis to reduce disease severity.
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