Clinical Report: Development of Allogeneic Type 1 Regulatory T Cells
Overview
TRX103, an engineered allogeneic Tr1 cell therapy, is designed to restore immune tolerance and prevent disease in models of graft-versus-host disease (GvHD) and Crohn's disease. Its production method addresses previous limitations in Tr1 cell therapies.
Background
Type 1 regulatory T (Tr1) cells are crucial for maintaining immune tolerance and controlling inflammatory responses. Autologous Tr1 cell therapies have shown potential in treating conditions like graft-versus-host disease (GvHD), but scaling production has been challenging.
Data Highlights
TRX103 demonstrated the following in preclinical studies:
Suppressed effector T cell proliferation.
Inhibited pro-inflammatory cytokine production by monocytes from healthy donors and Crohn’s disease patients.
Homed to intestinal tissues in vivo.
Prevented disease development in a xenogeneic GvHD model.
Key Findings
TRX103 is generated from pooled engineered CD4+ T cells from three healthy donors.
It is transduced with a lentiviral vector encoding human IL-10 and CD271.
TRX103 has a distinct immunomodulatory profile with reduced activation marker expression.
It exhibits minimal allogeneic stimulatory capacity.
Currently evaluated in Phase 1/2a and Phase I clinical studies for Crohn’s disease and GvHD prevention.
Clinical Implications
The scalable production of TRX103 may facilitate clinical applications for Tr1 cell therapies in treating immune-mediated diseases.
Conclusion
TRX103 represents a development in the field of allogeneic Tr1 cell therapies, with applications in immune-mediated disorders.
by Molly Javier Uyeda, Audrey Re, Chunyi Tang, Melissa McLaughlin, Daryl Humes, Steven Sexton, Robert Freeborn, Isaura Villalba, Kevin Nugent, James Adams, Jie Wei, Matt Breton, Xavier Paliard, Maximilian Richter, Maria Grazia Roncarolo, Ryan Bjordahl
