Tr1X Announces FDA IND Clearance for Allogeneic Treg Cell Therapy TRX103 in Refractory Crohn’s Disease

Recently, Tr1X announced that the U.S. FDA has approved itsTRX103The IND application, intended for the treatment ofRefractory Crohn's DiseaseTRX103 is a product under research by Tr1X.GeneralType T Cell Therapy。

The press release noted that Tr1X plans to initiate a Phase 1/2a study for refractory Crohn's disease and aims to administer the first dose to a participant before the end of 2024. Additionally, the IND for TRX103, intended to prevent graft-versus-host disease (GvHD) in patients, was approved in April and has now entered Phase 1/2a clinical trials.

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Crohn's disease is aChronic autoimmune intestinal inflammatory disease of unknown etiology, is a globally developing disease commonly seen in young populations, mainly characterized by abdominal pain, diarrhea, abdominal masses, fistula formation, and intestinal obstruction, accompanied by systemic multisystem complications. Approximately 50% of Crohn's disease patients will experience intestinal fibrosis characterized by intestinal strictures.Most patients with fibrosis require surgical intervention, but half of them will relapse within 10 years.Despite certain advances in the treatment of Crohn's disease with existing biologics and targeted therapies, many patients still face significant challenges due to non-response or recurrence. Currently,Effective treatment options for Crohn's disease are limited., especially in the treatment of refractory patients, there is an urgent need for new, more efficient, and safer therapies.

TRX103 is a product developed by Tr1X.Off-the-shelf T-cell therapy based on CD4-positive cells donated by healthy donorsThese CD4-positive T cells have been modified to generate cells that mimic the function of Tr1 regulatory T cells, becoming TRX cells. The uniqueness of TRX103 lies inCapable of targeting inflammatory sites in the intestine by reducing inflammatory cytokines, controlling harmful T-cell responses, and inducing immune tolerance., thereby alleviating intestinal inflammation, promoting tissue repair, and restoring immune homeostasis. In multiple preclinical disease models, TRX103 has demonstrated good tolerability and efficacy, showing potential to restore the immune system to a healthy state.

Maria Grazia Roncarolo, Ph.D., Co-founder, President, and Head of R&D at Tr1X, stated: "Tr1 Tregs were validated for the first time in preclinical studies using animal models of inflammatory bowel disease, demonstrating their anti-inflammatory and immunomodulatory effects. It is highly significant for us to be able to test these allogeneic engineered Tr1 cells for the first time in the context of Crohn’s disease and to demonstrate their importance in restoring and maintaining intestinal homeostasis."

Earlier this year, Tr1X announced the completion of a $75 million Series A financing round, coming out of stealth mode to focus on developing novel allogeneic Treg and CAR-Treg cell therapies for autoimmune and inflammatory diseases. TRX103, as an off-the-shelf drug, differs from other Treg and CAR-T cell therapies in that...Has the potential to reduce inflammation, inhibit pathogenic cells, and reset the immune systemIt is reported that TRX103 is currently being mass-produced in a fully closed end-to-end system in a cost-effective and efficient manner. The process used can generate billions of cells in a single production run, which is expected to enable Tr1X to develop more candidate drugs.

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