Tr1X to Present New Clinical and Preclinical Data on Engineered Tr1 Treg Cell Therapies at ASGCT 2026

• Oral presentations highlight first-in-human data for TRX103 and novel CAR-Tr1 Treg therapy TRX319
• Data underscore potential of Tr1 Treg platform to address immune dysregulation in transplantation and autoimmune diseases

SAN DIEGO--(BUSINESS WIRE)--Tr1X, Inc., a clinical-stage autoimmune and inflammatory disease company developing Type 1 regulatory T (Tr1) cell therapies, today announced two oral presentations at the American Society of Gene and Cell Therapy Annual Meeting 2026, May 11-15, 2026, in Boston.

The oral presentations will feature new clinical and preclinical data from Tr1X’s pipeline of engineered Type 1 regulatory T (Tr1) cell therapies, including its lead program TRX103 and next-generation CAR-Tr1 candidate TRX319.

“We are excited to present data across our allogeneic engineered Tr1 platform that highlight the potential of these therapies to reprogram the immune system in a precise and durable way,” said Dr. Maria Grazia Roncarolo, Co-Founder, President and Head of R&D, Tr1X. “These results reinforce our belief that Tr1 regulatory cell therapies represent a differentiated approach to treating immune-mediated diseases, from transplantation to treatment-refractory Crohn’s Disease and Multiple Sclerosis.”

Oral Presentation Details:

Title: Allogenic Off-the-Shelf, Engineered Tr1 Treg cells (TRX103) Exhibit Dose-Dependent Persistence and Establish a Tolerogenic Environment for the Prevention of GvHD in Patients Undergoing HLA-Mismatched Hematopoietic Stem Cell Transplantation

Session: Late-Breaking Abstracts II

Date/Time: Friday, May 15, 2026, 8:00 – 9:45 AM PT

Data from a first-in-human Phase 1 study demonstrate that expansion of TRX103, an off-the-shelf engineered Tr1 regulatory cell therapy, is well tolerated with no dose-limiting toxicities observed. The therapy showed dose-dependent persistence and expansion, along with induction of a tolerogenic immune environment characterized by increased IL-10, an increase in certain dendritic cell sub-types and reduced pro-inflammatory cytokines.

Title: TRX319 is a novel CAR-Tr1 Treg cell therapy with dual targeting of B cells and T cells for the treatment of progressive multiple sclerosis

Session: Transforming immune modulation with gene-modified regulatory T-cells

Date/Time: Thursday, May 14, 2026, 8:15 AM – 8:30 AM PT

Preclinical data demonstrate that allogeneic off-the shelf TRX319 combines CD19 CAR-driven B cell depletion with Tr1-mediated immunoregulation, enabling simultaneous targeting of key drivers of progressive multiple sclerosis. The therapy showed potent elimination of B cells, suppression of autoreactive T cells, and reduction of inflammatory microglial activity, supporting its advancement into clinical evaluation.

The oral presentations will be available in the resources section of our website following the meeting: https://tr1x.bio/resources.

About Tr1X

Tr1X is a clinical-stage biotechnology company developing engineered Tr1 cell therapies to restore immune balance in autoimmune and inflammatory diseases. Leveraging the unique biology of Tr1 cells, the company is advancing a pipeline of off-the-shelf allogeneic and in vivo CAR-Tr1 therapies designed to deliver targeted immunoregulation and address diseases driven by immune dysfunction, including transplant-related complications. Founded by pioneers in the discovery of Tr1 cells, Tr1X is focused on developing durable, potentially curative therapies for conditions with high unmet medical need. For more information, visit www.tr1x.bio.