TRX103 / Tr1X - LARVOL DELTA

Tr1X Announces…$50 Million in Additional Financing (Yahoo Finance) - "...Allowing Tr1X to advance the TRX319 Phase 1/2a study and the ongoing TRX103 Phase 1/2a trial for patients with refractory Crohn’s disease."

Financing • Crohn's disease • Multiple Sclerosis

DEVELOPMENT OF ALLOGENEIC ENGINEERED TYPE I REGULATORY T CELLS (TRX103) TO MODULATE INFLAMMATION AND PATHOGENIC T CELLS IN REFRACTORY CROHN'S DISEASE. (DDW 2025) - No abstract available

Crohn's disease • Gastroenterology • Immunology • Inflammation • Inflammatory Bowel Disease

Tr1X Awarded $8 Million CIRM Grant to Support TRX103 Phase 1/2a Clinical Trial for Graft-Versus-Host Disease (GlobeNewswire) - "Tr1X, Inc...today announced that the California Institute for Regenerative Medicine (CIRM) has awarded the Company an $8 million grant to support its ongoing Phase 1/2a clinical trial of TRX103...This award follows a $4 million CIRM grant received by Tr1X in early 2024 for late-stage preclinical research that helped to advance TRX103 to human trials....The Company has reported positive initial persistence and safety data in the first two patient cohorts, with additional data anticipated to be reported in 2025."

Financing • P1/2 data • Graft versus Host Disease

Treatment of Moderate to Severe Refractory Crohn's Disease (clinicaltrials.gov) - P1/2 | N=22 | Recruiting | Sponsor: Tr1X, Inc. | Not yet recruiting ➔ Recruiting

Enrollment open • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

A Phase I, First in Human Open Label Study to Evaluate the Safety and Tolerability of TRX103 Cell Infusion in Subjects with Hematological Malignancies Undergoing HLA-Mismatched Related or Unrelated Hematopoietic Stem Cell Transplantation (HSCT). (TCT-ASTCT-CIBMTR 2025) - "Use of post-transplant Cyclophosphamide (PTCy) for patients undergoing allogeneic hematopoietic stem cell transplantation (HSCT) has reduced the incidence of graft versus host disease (GvHD), and expanded donor options for patients to include haploidentical and mismatched unrelated donors...In addition to PTCy, MMF and sirolimus are administered as GvHD prophylaxis...All subjects have engrafted, with 100% donor chimerism achieved by all patients by day 42 post HSCT. PK assessments demonstrate the presence of TRX103 in peripheral blood (Figure 1) for more than one week after administration, while PD studies show associated immunomodulatory activity."

Clinical • P1 data • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Oncology • Transplantation • CD4 • IL10 • NGFR

Treatment of Moderate to Severe Refractory Crohn's Disease (clinicaltrials.gov) - P1/2 | N=22 | Not yet recruiting | Sponsor: Tr1X, Inc.

New P1/2 trial • Crohn's disease • Gastroenterology • Genetic Disorders • Immunology • Inflammatory Bowel Disease

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

Clinical protocol • IND • Crohn's disease • Immunology • Inflammatory Bowel Disease

Tr1X Announces First Patient Dosed in Proof of Concept GvHD Trial Evaluating TRX103, a First-in-Class Type 1 Treg (Tr1) Cell Therapy (GlobeNewswire) - "Tr1X...announced the successful dosing of the first patient in the company’s TRX103-01 proof of concept trial for prevention of Graft versus Host Disease (GvHD) and improved outcomes in patients with hematologic malignancies undergoing mismatched hematopoietic stem cell transplantation (HSCT). The study’s primary goal is to determine the safety, pharmacokinetics and pharmacodynamics of TRX103. The secondary goal of the study is to create immune tolerance to prevent GvHD and improve HSCT outcomes. The first patient had no serious adverse events, and the multi-center dose escalation trial continues to enroll....Tr1X also plans to file an IND for TRX103 for treatment-refractory Crohn’s Disease in the second half of 2024."

IND • Trial status • Crohn's disease • Graft versus Host Disease

Prevention of GvHD in Participants With Hematological Malignancies Undergoing Hematopoietic Stem Cell Transplant (HSCT) (clinicaltrials.gov) - P1 | N=36 | Recruiting | Sponsor: Tr1X, Inc.

New P1 trial • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • Acute Myelogenous Leukemia • Adult T-Cell Leukemia-Lymphoma • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Chronic Myelomonocytic Leukemia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Leukemia • Myelodysplastic Syndrome • Oncology • T Acute Lymphoblastic Leukemia • Transplantation

Preclinical Development of TRX103 as an Off-the-Shelf IL-10 Engineered CD4+T Cell Product for the Prevention of Graft-versus-Host Disease (ASGCT 2024) - "In addition, TRX103 suppressed the expansion of human effector T cells and prevented the onset of GvHD in a humanized mouse model. Furthermore, the administration of high doses of TRX103 alone or in combination with allogeneic effector T cells in this humanized mouse model did not result in any remarkable pathological findings in the target organs.Together, these data describe the preclinical efficacy and safety of a novel off-the-shelf IL-10 engineered, Tr1-based cell therapy and support a first-in-human Phase 1 clinical study for the prevention of GvHD."

Preclinical • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Oncology • Transplantation • CD4 • CD8 • IFNG • IL10 • IL2 • IL4 • NGFR • TGFB1

Tr1X Announces FDA Clearance of First Investigational New Drug Application for TRX103, an Allogeneic Regulatory T-Cell Therapy to Treat Autoimmune Diseases (PRNewswire) - "Tr1X, Inc....today announced the U.S. Food and Drug Administration (FDA) accepted the company's Investigational New Drug (IND) application for TRX103 for the prevention of Graft versus Host Disease (GvHD) in patients undergoing HLA-mismatched hematopoietic stem cell transplantation (HSCT). The company plans to initiate a Phase 1 study of TRX103, an investigational allogeneic off-the-shelf Tr1 Treg therapy, for this indication in the second quarter of 2024. Additionally, the company is on track to submit an IND for TRX103 for patients with refractory Crohn's disease in the third quarter of 2024."

IND • New P1 trial • Acute Graft versus Host Disease • Crohn's disease • Graft versus Host Disease