Kincell Bio Partners with RegCell to Support Clinical Development of Treg Cell Therapies for Autoimmune Diseases
Wednesday, February 11, 2026
Kincell Bio, a U.S.-based cell therapy contract development and manufacturing organisation (CDMO), has announced a collaboration with RegCell, a biotechnology company developing an immune tolerance platform based on epigenetically reprogrammed regulatory T cells (Tregs).
Under the agreement, Kincell Bio will provide full chemistry, manufacturing and controls (CMC) development and GMP manufacturing support to help advance RegCell’s lead Treg programme into clinical trials.
As part of the partnership, RegCell will transfer its lead Treg candidate to Kincell Bio for process and analytical transfer, further development and optimisation of a scalable manufacturing process. Kincell will also supply GMP clinical material to support investigational new drug (IND)-enabling studies and clinical trials. The collaboration aims to shorten development timelines and secure reliable clinical supply.
RegCell’s platform is designed to convert disease-driving CD4+ T cells into stable, antigen-matched Tregs by recreating key epigenetic features responsible for Treg stability and function. The company was founded by Professor Shimon Sakaguchi, Distinguished Professor at Osaka University and Professor Emeritus at Kyoto University, who shared the 2025 Nobel Prize in Physiology or Medicine for his work on immune tolerance and Tregs.
The platform does not require gene editing or viral DNA reagents. This approach is intended to reduce manufacturing complexity and support automation, with the potential for future point-of-care use.
Kincell Bio provides process and analytical development, along with early and late-stage cGMP manufacturing services, to biotech and pharmaceutical companies. Through this partnership, the company expands its support for innovative cell therapy developers working in autoimmune diseases.
Source: businesswire.com
