- Kincell Bio has entered into a collaboration with RegCell to provide CMC development and GMP manufacturing support for RegCell’s lead regulatory T cell (Treg) program.
- The partnership covers process and analytical transfer, scalable manufacturing optimisation, and GMP clinical supply to support IND-enabling activities and clinical trials.
Kincell Bio has announced a new collaboration with RegCell, a biotechnology company developing an immune tolerance platform based on epigenetically reprogrammed regulatory T cells. Under the agreement, Kincell Bio will provide comprehensive CMC development and GMP manufacturing support to advance RegCell’s lead Treg program toward clinical trial evaluation.
RegCell will transfer its lead program to Kincell Bio for process and analytical transfer and development, optimisation of a scalable manufacturing process, and GMP clinical material supply. The work is intended to support IND-enabling activities and subsequent clinical trials. The companies stated that the collaboration is designed to streamline development timelines and ensure clinical supply for RegCell’s platform.
RegCell’s technology converts disease-driving CD4+ T cells into lineage-stable, antigen-matched Tregs by recapitulating epigenetic features involved in Treg imprinting and stability. The company noted that its platform does not require gene editing or viral DNA reagents, which it said reduces manufacturing complexity and enables automation and potential point-of-care access.
“Our relationship with Kincell Bio is a critical part of our US strategic plan and enables us to access leading capabilities in T-cell manufacturing, as well as to focus on creating a commercially viable manufacturing process at an early stage of clinical development.”
Michael McCullar, Ph.D., Chief Executive Officer of RegCell
Kincell Bio stated that it provides CMC development and clinical contract manufacturing services, including process and analytical development and early- and late-stage cGMP manufacturing, to biotechnology and pharmaceutical companies developing cell therapies.
