Company to initiate Phase 1 study of Graft versus Host Disease (GvHD) prevention in patients undergoing hematopoietic stem cell transplantation in Q2 2024Second IND application for refractory Crohn's disease expected in Q3 2024Highly scalable platform enables efficient pipeline expansion and opportunity beyond first two indicationsSAN DIEGO, April 10, 2024 /PRNewswire/ -- Tr1X, Inc., an autoimmune and inflammatory disease cell therapy company focused on the development of novel allogeneic regulatory T cell therapies (Allo-Tregs) and allogeneic regulatory T cells expressing Chimeric Antigen Receptors (Allo-CAR Tregs), today announced the U.S. Food and Drug Administration (FDA) accepted the company's Investigational New Drug (IND) application for TRX103 for the prevention of Graft versus Host Disease (GvHD) in patients undergoing HLA-mismatched hematopoietic stem cell transplantation (HSCT). The company plans to initiate a Phase 1 study of TRX103, an investigational allogeneic off-the-shelf Tr1 Treg therapy, for this indication in the second quarter of 2024. Additionally, the company is on track to submit an IND for TRX103 for patients with refractory Crohn's disease in the third quarter of 2024."The FDA's clearance of our IND for TRX103, the first ever allogeneic engineered Tr1 regulatory T cell product, is an important milestone that could quickly provide us with proof-of-concept data while we continue to develop TRX103 for multiple autoimmune and inflammatory diseases, including Crohn's disease," said Maria Grazia Roncarolo M.D., Co-Founder, President and Head of R&D at Tr1X. "Donor-derived autologous Tr1 cells have shown clinical promise in improving immune reconstitution and reducing GvHD but have limited potential due to lack of feasibility and high cost. TRX103, an off-the-shelf product with unique biological properties compared to other Treg and CAR-T cell therapies, has the potential to reduce inflammation, suppress pathogenic cells, and reset the immune system

Cell therapy startup Tr1X emerges from stealth with $75M Series A.