Kincell Bio Enters into Partnership with RegCell to Progress Treg Cell Therapy into Clinical Trials
Wednesday, February 11, 2026
Kincell Bio has entered into a collaboration with RegCell to support the advancement of regulatory T cell (Treg) therapies for autoimmune diseases into clinical development.
Under the agreement, Kincell Bio will provide comprehensive chemistry, manufacturing and controls (CMC) development and GMP manufacturing services for RegCell’s lead Treg programme. The partnership will focus on process and analytical transfer, optimisation of a scalable manufacturing process, and supply of GMP clinical material to support IND-enabling studies and upcoming clinical trials. The aim is to accelerate development timelines and ensure a reliable clinical supply.
RegCell is developing an immune tolerance platform based on epigenetically reprogrammed regulatory T cells. Its approach converts disease-causing CD4+ T cells into stable, antigen-matched Tregs by replicating key epigenetic features responsible for Treg stability and function.
The platform does not rely on gene editing or viral DNA reagents, which may help reduce manufacturing complexity and support automation, with potential for future point-of-care use.
Through this collaboration, RegCell aims to strengthen its US development strategy while establishing a commercially viable manufacturing process early in clinical development. Kincell Bio will contribute its expertise in T-cell process development, analytical services, and both early- and late-stage cGMP manufacturing.
The partnership reflects a shared focus on advancing innovative cell therapies and supporting developers with efficient and high-quality manufacturing solutions to bring new treatments to patients.
Source: kincellbio.com
