Tr1X Announces FDA Clearance of IND Application for TRX103, an Allogeneic Engineered Tr1 Treg Cell Therapy for Treatment-Refractory Crohn’s Disease

Tr1X Plans to Initiate a Phase 1/2a study and Dose the First Patient by the End of 2024

/EIN News/ -- SAN DIEGO, Aug. 07, 2024 (GLOBE NEWSWIRE) -- Tr1X, Inc. (pronounced “Trix”), a biopharmaceutical company specializing in allogeneic engineered Treg and CAR-Treg cell therapies with the potential to cure autoimmune and inflammatory diseases, announced that the US Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for TRX103, an engineered Tr1 Treg cell therapy for treatment-refractory Crohn’s Disease. TRX103 is currently being tested in a Phase 1/2a trial in patients undergoing hematopoietic stem cell transplant (HSCT) for hematological malignancies.

TRX103, a first-in-class Type 1 Treg (Tr1) cell therapy, is designed to home to the gut, reduce inflammation, promote tissue healing and repair, and reset immune homeostasis in patients with inflammatory bowel diseases, including Crohn’s. This therapy aims to address the high unmet need in patients who have failed multiple targeted therapies and have limited treatment options.

“Despite the advances in biological and targeted therapies in Crohn’s disease, many of our patients do not achieve remission or relapse on treatment. This suggests a therapeutic ceiling for current anti-inflammatory therapies and novel approaches are needed,” said Florian Rieder, MD, Vice Department Chair and Co-Director of the Inflammatory Bowel Diseases (IBD) Section at the Cleveland Clinic. “TRX103 is a novel and exciting Tr1 Treg cell therapeutic that combines anti-inflammatory and immunomodulating activities. It has the potential to reset the immune system to improve long-term outcomes for these patients.”

“Tr1 Tregs were first validated preclinically in animal models of inflammatory bowel disease, where they demonstrated their important anti-inflammatory and immunomodulatory effects,” said Maria Grazia Roncarolo, MD, President and Head of R&D of Tr1X. “It is a full-circle moment for us to be able to test these allogeneic engineered Tr1 cells for the first time in the setting of Crohn’s disease, and to prove their importance in restoring and maintaining gut homeostasis for the benefit of patients worldwide.”

The Phase 1/2a study for TRX103 will be a dose-escalation and confirmation study designed to evaluate the safety, tolerability, and clinical activity of TRX103. This multi-center, US-based trial will enroll subjects with moderate to severe Crohn’s Disease who have failed two or more advanced therapies.

TRX103 leverages the unique properties of Tr1 cells, including their ability to traffic to inflamed tissues and lymph nodes, lower inflammatory cytokines, control harmful T cell responses, and create immune tolerance. Unlike other cell therapies such as effector CAR-T cells, TRX103 Treg cells aim to treat autoimmune diseases with fewer side effects and potentially without the need for lymphodepletion. These cells are naturally shielded from the immune system, enhancing their persistence and minimizing potentially dangerous immune responses.

About TRX103
TRX103 is an investigational allogeneic off-the-shelf engineered T cell product generated from CD4+ cells sourced from healthy donors. These CD4+ cells are engineered to become cells that mimic the function of Tr1 regulatory T cells, called TRX cells. Tr1X is developing TRX103 for the treatment of several immune and inflammatory disorders. Multiple preclinical studies have shown TRX103 to be tolerable and effective and to have the potential to reset the immune system to a healthy state. TRX103 has the potential to overcome major limitations of current cell therapies for autoimmune diseases, which include limited persistence and side effects including cytokine release syndrome (CRS) and neurotoxicity.

About Tr1X
Tr1X is a private biotechnology company focused on curing immune mediated and inflammatory diseases. Founded by industry experts, including the scientists who discovered Tr1 cells, the company is developing a pipeline of off-the-shelf allogeneic cell therapies to treat and potentially cure autoimmune diseases with high unmet medical need. The company is supported by leading investors, including The Column Group, NEVA SGR, and Alexandria Venture Investments, and has received additional grant support from the California Institute for Regenerative Medicine (CIRM). For more information, visit www.tr1x.bio.

Investor/Media Contacts:
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Chuck Padala
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