Tr1X, Inc. 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).
SAN 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. TRX103 is currently produced cost effectively at scale in a fully closed end-to-end system using a process that yields billions of cells in a single campaign. This should enable Tr1X to develop further pipeline candidates that address even larger patient populations with equally unmet medical needs.” “Allogeneic stem cell transplantation is the only curative treatment for many advanced blood cancers and genetic and acquired diseases. However, there remains a burden of morbidity and mortality related to GvHD and its complications, including severe infections,” said Monzr M. Al Malki, M.D., lead investigator of the Phase 1 study, Associate Professor in the Department of Hematology & Hematopoietic Cell Transplantation, and Director of the Unrelated Donor, Haploidentical and Cord Blood Transplant Programs at City of Hope National Medical Center. “As a result, innovative treatments are urgently needed. We look forward to starting this first-in-human trial to evaluate the safety, tolerability and clinical activity of these allogeneic Tr1 Treg cells and their potential to benefit patients in this setting.” About TRX103 About Tr1X Investor Contact: Media Contact:
SOURCE Tr1X, Inc. |
View original content to download multimedia:
