Regcell

The company's core technology is a proprietary platform that epigenetically reprograms a patient's own T-cells into stable, functional, and antigen-specific Tregs (S/F-iTregs). This process converts disease-driving T-cells into therapeutic Tregs designed to restore the body's immune tolerance. A key advantage of this approach is that it does not require genetic modification or viral DNA reagents, which simplifies the manufacturing process, enhances safety, and allows for scalable production. This method can also address diseases driven by unknown or multiple pathogenic antigens.

Initially founded in Japan, RegCell transitioned to a U.S.-based corporation with headquarters in Emeryville, California, to gain better access to international talent, capital, and partnerships. Its core scientific operations remain in Japan. In March 2025, the company announced it had secured $45.8 million in funding, consisting of an $8.5 million oversubscribed seed round and $37.3 million in non-dilutive funding from Japan's Agency for Medical Research and Development (AMED). This capital is intended to advance its epigenetic reprogramming platform into first-in-human clinical trials, which are planned for 2025. The initial clinical trial will target pemphigus vulgaris, a serious autoimmune skin disease. RegCell has established partnerships with contract development and manufacturing organizations (CDMOs) like GeneFab and Kincell Bio to support technology transfer and clinical-grade manufacturing for its U.S. trials.