IMMUNOTHERAPY FOR INFLAMMATORY BOWEL DISEASE AND/OR CANCER

Smart overview of the Invention

Compositions and methods are presented for treating gastrointestinal inflammatory diseases and cancers, focusing on the role of regulatory T cells (Tregs) expressing the transcription factor ZBTB20. An isolated cell containing a nucleic acid vector encoding ZBTB20 linked to a promoter is central to the treatment approach, enhancing the immune response against inflammatory conditions.

Background Information

Tregs are crucial for regulating immune responses and maintaining tolerance in the digestive tract. They help balance the immune system's reaction to pathogens while tolerating food and gut bacteria. Disturbances in Treg function are linked to immune disorders, including inflammatory bowel diseases (IBDs), which affect a significant portion of the U.S. adult population. There is a pressing need for therapies that restore proper immune regulation and address associated chronic health conditions.

Therapeutic Composition

The described methods involve creating an isolated cell that expresses ZBTB20, which can enhance IL-10 production, an anti-inflammatory cytokine. Various embodiments detail how these cells can be derived from mammals, including humans and mice, and how they can be administered through different routes such as intravenous or subcutaneous injections. The therapeutic composition aims to treat or prevent gastrointestinal inflammatory diseases like IBD, Crohn's disease, and ulcerative colitis.

Methods for Treatment

A detailed method outlines isolating a cell from a subject, introducing the nucleic acid vector to elevate ZBTB20 expression, and administering the modified cell back to the subject. Additionally, methods are provided for assessing ZBTB20 expression levels in tissue samples to determine the risk of developing inflammatory diseases or to evaluate cancer patients' candidacy for anti-PD-1 therapy based on ZBTB20 levels.

Immunotherapy Applications

The application extends to cancer treatment by isolating and modifying a patient's immune cells to enhance their response against tumors. This includes combining modified immune cells with anti-PD-1 therapies for improved treatment outcomes in various cancers, such as melanoma and lung cancer. The methods aim to create a more effective immunotherapy strategy by leveraging the role of ZBTB20 in regulating immune responses.