Pipeline

We are building pipelines with S/F-iTreg technologies to treat a broad spectrum of autoimmune and inflammatory diseases and transplantation. We are accomplishing this with a best-in-class manufacturing operation for a robust generation of S/F-iTregs based on tens of years of process development and innovation pioneered by our founders and research staff.

Target & status: Undisclosed, in the pre-clinical stage in Japan and other countries

Although autoimmune diseases are generally anticipated to apply to our antigen-specific Treg therapy, it seems crucial to select specific target diseases and partners to obtain POC early. Undisclosed indications that meet the following requirements have been selected as some of the first targets of the clinical trial:

• Diseases with known antigens (easy to evaluate the antigen specificity of Tregs).
• Diseases for which the efficacy of treatment can rather easily be confirmed (rapid response according to efficacy is possible).
• Severe and refractory disease (high potential need in the market).

In parallel with the preparation of cell production mentioned below, we have started pre-clinical and preliminary studies for clinical trials. We are currently evaluating the efficacy of Treg cell therapy in mouse models of the target disease. We are making steady progress in obtaining POC demonstrating the effectiveness of Treg cell therapy, including suppression of inflammation by Treg administration, stability of the administered Tregs, and accumulation of Tregs at the site of inflammation.

We are planning R&D collaboration with undisclosed partners. For instance, we expect partners to leverage our proprietary technologies of S/F-iTregs, which could boost the stability & functionality of the partners’ pipelines of cell therapy.

We have established a protocol for robust induction of highly functional and stable iTreg cells from mouse T cells and have achieved high induction efficiency. Based on this knowledge, we have also developed a protocol for the induction of highly functional and stable iTreg cells in human cells. Furthermore, we have identified issues in CPC production of cells for clinical use and completed the establishment of SOPs suitable for CPC production.