Tr1X, a clinical-stage biopharmaceutical company, received an $8 million grant from the California Institute for Regenerative Medicine (CIRM) to support its Phase 1/2a clinical trial of TRX103. TRX103 is an engineered Tr1 Treg cell therapy designed to prevent graft-versus-host disease (GvHD) in blood cancer patients undergoing mismatched stem cell transplants. This grant follows a previous $4 million award from CIRM in 2024 for preclinical research that enabled TRX103 to advance to human trials.
This funding is crucial because it accelerates the development of a potentially life-saving therapy for patients undergoing mismatched stem cell transplants, a population often facing limited treatment options. GvHD is a serious complication arising from donor cells attacking the recipient’s tissues, frequently leading to life-threatening consequences. Current GvHD treatments suppress the immune system, increasing susceptibility to infections and potentially hindering cancer treatment effectiveness. TRX103 offers a promising alternative by aiming to prevent GvHD occurrence, thereby improving patient outcomes and expanding access to stem cell transplants.
The ongoing Phase 1/2a clinical trial, led by Dr. Maria Grazia Roncarolo, is enrolling patients at major stem cell transplant centers. Initial data from the first two patient cohorts indicate positive persistence and safety profiles, with further data expected in 2025. TRX103 is also under investigation in a separate Phase 1/2a trial for treatment-refractory Crohn’s Disease, demonstrating its potential applicability across multiple conditions. The therapy utilizes allogeneic, off-the-shelf engineered T cells derived from healthy donors, making it a potentially scalable and accessible treatment option.
This continued investment in TRX103 signifies a substantial advancement in the field of stem cell transplantation. Successful trial results could lead to a paradigm shift in GvHD prevention and significantly improve the safety and accessibility of stem cell transplants for a broader patient population. This holds promise not only for enhancing patient outcomes but also for paving the way for personalized cell therapies to become a more readily available treatment option for various autoimmune and inflammatory diseases.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
