Pipeline

We are building pipelines with S/F-iTreg technologies to treat a wide spectrum of autoimmune and inflammatory diseases, as well as prevention of rejection in organ transplantation. We are accomplishing this endeavor with a best-in-class manufacturing operation for robust generation of S/F-iTregs based on many years of process developments and innovations pioneered by our founders and research staff.

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

Autoimmune diseases are the first target of our antigen-specific Treg therapy. it seems important to select specific target diseases among various autoimmune diseases and partners to obtain POC at an early stage. Undisclosed indications have been selected as some of the first targets of our clinical trials that meet the following requirements: 1) diseases with known target antigens (easy to evaluate antigen specificity of Tregs); 2) diseases for which the efficacy of treatment can easily be confirmed (rapid responses are possible depending on the efficacy); 3) severe and refractory diseases (high potential need in the market).
In parallel with the preparation of the S/F-iTreg cell production mentioned below, we have started pre-clinical and preliminary clinical studies for expected clinical trials. We are currently evaluating the efficacy of Treg cell therapy in mouse models of the target diseases. We are making steady progress in obtaining POC that demonstrates the efficacy of Treg cell therapy, including suppression of inflammation by in vivo Treg administration, stability of the administered Tregs, and accumulation of the transferred Tregs at the site of the 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 partner’s pipelines of Treg 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, and, based on the mouse results, developed a protocol for induction of highly functional and stable iTreg cells from human T cells. Furthermore, we have evaluated various problems accompanying CPC production of cells for clinical use and completed the establishment of SOPs suitable for CPC production. We are currently transferring our technology to CMO for the production of S/F-iTreg cells.