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Groundbreaking Progress in GvHD Treatment: Tr1X Successfully Doses First Patient in TRX103 Trial

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In an exciting development for autoimmune and inflammatory disorders, Tr1X, Inc. has announced the successful dosing of the first patient in its TRX103-01 proof-of-concept trial. This trial is a significant step forward in the fight against Graft versus Host Disease (GvHD), a serious condition affecting patients undergoing mismatched hematopoietic stem cell transplantation (HSCT).

TRX103 represents a first-in-class Type 1 Treg (Tr1) cell therapy. This innovative treatment aims to reset the immune system, improve clinical outcomes, and potentially cure patients suffering from a range of autoimmune and inflammatory disorders. Here are the key highlights from the recent press release:

  • First Patient Successfully Dosed: The initial patient has cleared the safety period without experiencing any serious adverse events, marking a promising start for the trial.
  • Trial Goals: The primary goal is to assess the safety, pharmacokinetics, and pharmacodynamics of TRX103. The secondary goal is to establish immune tolerance to prevent GvHD and improve HSCT outcomes.
  • Unique Approach: TRX103 is designed to reduce inflammation, prevent harmful T cell proliferation, and create immune tolerance. It offers a potential treatment with fewer side effects compared to other cell therapies, potentially eliminating the need for lymphodepletion.
  • Manufacturing Success: Tr1X has successfully produced enough clinical doses using its proprietary closed process to complete the trial, which aims to treat up to 36 patients with a one-time infusion of TRX103.

Maria Grazia Roncarolo, Co-founder, President, and Head of Research and Development at Tr1X, emphasized the significance of this achievement, stating, “This is a key step in advancing our pipeline. We believe our allogeneic Tr1 Treg and CAR-Treg therapies can overcome the limitations of current treatments by controlling harmful T cells and B cells and creating immune tolerance, potentially curing a wide range of autoimmune and inflammatory disorders.”

Looking Ahead: Tr1X is also planning to file an Investigational New Drug (IND) application for TRX103 for the treatment of refractory Crohn’s Disease in the second half of 2024. This underscores their commitment to expanding the therapeutic potential of TRX103 to other challenging immune and inflammatory conditions.

About Tr1X: Tr1X is a pioneering biotechnology company focused on developing allogeneic cell therapies to treat and potentially cure autoimmune diseases with high unmet medical needs. Supported by leading investors and grant support from the California Institute for Regenerative Medicine (CIRM), Tr1X is at the forefront of innovation in cell and gene therapy.

For more information, visit Tr1X Bio.

By making significant strides in the field of cell therapy, Tr1X is not only advancing the treatment of GvHD but also paving the way for new approaches to a variety of autoimmune and inflammatory diseases. Stay tuned for more updates as this promising trial progresses.

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