Tr1X Announces FDA Clearance of IND Application for TRX319, a First-in-Class Allogeneic CAR-Tr1 Treg Cell Therapy for Progressive Multiple Sclerosis, and $50 Million in Additional Financing

On track to initiate TRX319 Phase 1/2a dose-escalation trial in early 2026

TRX319 is an allogeneic CAR-Tr1 Treg cell therapy designed to pair targeted B-cell control with active anti-inflammatory signaling and pathogenic T-cell modulation in a CNS-penetrant package

$50 million in venture financing extends cash runway into 2027, 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

SAN DIEGO, Oct. 14, 2025 (GLOBE NEWSWIRE) -- Tr1X, a clinical-stage biopharmaceutical company developing first-in-class allogeneic engineered type 1 regulatory (Tr1 Treg) and CAR-Tr1 Treg cell therapies with the potential to cure autoimmune and inflammatory diseases, today announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for TRX319 in progressive multiple sclerosis. The Company also announced a $50 million financing that extends its cash runway into 2027.

“We are pleased to receive IND clearance for TRX319 and to advance our second program into the clinic in early 2026,” said David de Vries, co-founder and CEO of Tr1X. “We are also encouraged by early safety, PK/PD, and clinical signals from our ongoing TRX103 studies in refractory Crohn’s disease and mismatched hematopoietic stem cell transplant, and we plan to share initial data from these trials in the coming months. This financing further underscores investor confidence in our differentiated allogeneic Tr1 and CAR-Tr1 Treg strategy, the progress and data generated to date, and our continued capital efficiency.”

“Progressive MS remains a major clinical challenge—patients can accumulate disability outside of relapses, and therapeutic options are limited,” said Jennifer Graves, M.D., Ph.D., M.A.S., Vice Chair of Human Research and Division Head of Neuroimmunology at University of California San Diego. “The exploration of new approaches, such as this first-in-human study of an allogeneic CAR-Tr1 Treg cell therapy that carefully evaluates its potential with clear safety and pharmacodynamic objectives is timely and important.”

TRX319 is an allogeneic, off-the-shelf CAR-Tr1 Treg cell therapy designed to pair targeted B-cell control with active anti-inflammatory signaling and T-cell regulation, with the goal of restoring immune balance while leveraging scalable, commercially viable manufacturing. The multicenter, open-label, dose-escalation Phase 1/2a study in progressive multiple sclerosis (MS) will evaluate safety and tolerability as primary objectives, with pharmacodynamic, clinical disability, and biomarker assessments as secondary and exploratory measures. In preclinical studies, TRX319 demonstrated robust central nervous system (CNS) penetration and CD19-specific cytotoxicity along with IL-10–associated regulatory activity on both self-reactive T cells and activated microglia, and suppression of key pro-inflammatory cytokines—all features consistent with a Tr1 phenotype.

“An approach that targets B-cell biology while actively modulating inflammatory signaling within a regulatory cell-therapy framework is a distinct and promising hypothesis in progressive MS,” said Bruce Cree, M.D., Ph.D., M.A.S., the George A. Zimmermann Endowed Professor in Multiple Sclerosis in the Department of Neurology at the University of California San Francisco. “I look forward to studying TRX319 in this dose-escalation trial to further understand the potential of this cell therapy.”

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 type 1 regulatory (Tr1) cells, called TRX cells. Tr1X is developing TRX103 for the treatment of several immune and inflammatory disorders, including graft-versus-host disease (GvHD), autoimmune uveitis, and refractory Crohn’s disease. TRX103 is designed to dampen inflammation and help restore immune tolerance, benefiting from off-the-shelf manufacturing and a product profile designed to avoid lymphodepletion associated with other cell therapies.

About Tr1X

Tr1X is a clinical-stage biotechnology company pioneering a new class of cell therapies designed to fundamentally reset the immune system in patients with autoimmune and inflammatory diseases. Founded by leading scientists who discovered Tr1 cells, Tr1X develops off-the-shelf, allogeneic Tr1 and CAR-Tr1 Treg cell therapies engineered for superior safety, scalability and accessibility, eliminating the need for standard lymphodepletion and enabling durable restoration of immune tolerance. Tr1X is supported by top-tier investors including The Column Group, NEVA SGR and Alexandria Venture Investments, and backed by grant funding from the California Institute for Regenerative Medicine (CIRM). For more information, visit www.tr1x.bio.

Investor Contact:
Tr1X Investor Relations
investors@tr1x.bio

Media Contact:
Julie Normart
jnormart@realchemistry.com

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