What we're building
We are building pipelines with S/F-iTreg technologies to treat a wide spectrum of autoimmune and inflammatory diseases, as well as transplantation. We are accomplishing this with a best-in-class manufacturing operation for 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, under pre-clinical stage in Japan and other countries
Although autoimmune diseases are assumed to be the applicable cases for our antigen-specific Treg therapy, it seems to be important to select specific target diseases and partners to obtain POC at an early stage. Undisclosed indications are selected as one of the first targets of the clinical trial that meet the following requirements: 1) disease with known antigens (easy to evaluate antigen specificity of Tregs); 2) diseases for which the efficacy of treatment can rather easily be confirmed (rapid response according to the efficacy is possible); 3) severe and refractory disease (high potential need in the market).
In parallel with the preparation of the 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 that demonstrate the efficacy of Treg cell therapy, including the suppression of inflammation by Treg administration, stability of the administered Tregs, and accumulation of the Tregs at the site of inflammation.
Platform business overview
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 partner’s 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, and have also developed a protocol for induction of highly functional and stable iTreg cells in human cells based on this knowledge. Furthermore, we have identified issues in CPC production of cells for clinical use and have completed the establishment of SOPs suitable for CPC production. We are currently confirming whether tech transfer to the CMO for the production of S/F-iTreg cells has been done.