Tr1x

What Tr1x does

Tr1X, Inc. is a clinical-stage biopharmaceutical company headquartered in San Diego, California, developing allogeneic Type 1 regulatory T (Tr1) cell therapies for patients with autoimmune and inflammatory diseases. The company's TRX platform engineers Tr1 cells — a regulatory T-cell subset distinct from conventional Foxp3+ Tregs — to restore immune tolerance rather than broadly suppress immunity. Engineered Tr1 cells express chemokine receptors enabling trafficking to sites of inflammation, secrete suppressive cytokines (e.g., IL-10) directly within inflamed tissue, inhibit the NLRP3 inflammasome, remain phenotypically stable under inflammatory conditions, and induce formation of de-novo regulatory T cells. The pipeline comprises TRX103 (allogeneic Tr1 Treg in Phase 1/2a for graft-versus-host disease prevention and treatment-refractory Crohn's disease, with Orphan Drug Designation), TRX319 (allogeneic CAR-Tr1 Treg in Phase 1/2a for progressive multiple sclerosis, with FDA Fast Track Designation), and TRX501 (preclinical in-vivo Tr1 program). Manufacturing is modular, scalable, and closed-system, supporting off-the-shelf administration.

The company is pre-revenue. Future revenue is intended to come from commercialization of approved cell therapy products; today, the income model consists primarily of non-dilutive grant funding such as the $8M CIRM award supporting TRX103 development. The go-to-market motion is event- and science-led: Tr1X presents clinical and preclinical data at scientific conferences (ASGCT, ASTCT), publishes in peer-reviewed journals, runs webinars (e.g., Cell & Gene Therapy Insights), and conducts clinical trials directly through leading US academic medical centers including Mayo Clinic, UCSF, Cleveland Clinic, Washington University, and Penn. Customers in the current stage are clinical trial investigators and enrolled patients across indications such as treatment-refractory Crohn's disease, HLA-mismatched hematopoietic stem cell transplant recipients, and progressive multiple sclerosis patients with EDSS 2.5–6.5. The company is venture-backed, with $75M Series A (January 2024, led by The Column Group) and a subsequent $50M financing extension (October 2025) extending cash runway into 2027.

Name

Tr1x

Legal name

Tr1X, Inc.

Website

https://tr1x.bio

Company type

Private

Founded year

2023

Operating status

Operating

Headcount range

11–50 employees

Short description

Tr1X is a clinical-stage biopharmaceutical company developing allogeneic Type 1 regulatory T (Tr1) cell therapies to cure autoimmune and inflammatory diseases, with lead programs TRX103 in graft-versus-host disease and Crohn's disease and TRX319 in progressive multiple sclerosis.

Ownership category

akta.pro rank

Product category

Cell Therapy Biopharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414)

SIC

Biological Products, (No Disgnostic Substances) (2836)

akta.pro primary industry

Cell Therapy Developers (Allogeneic/Off-the-shelf) (HLAAABAB)

akta.pro secondary industry

Rare Immunology, Autoimmune & Autoinflammatory Therapies (HLAIAIAE)

Keywords

• Allogeneic cell therapy
• Regulatory T cell therapy
• Autoimmune disease therapeutics
• Cell therapy platform
• Biopharmaceutical drug development

Headquarters

HQ city

San Diego

HQ country

United States

HQ region

North America

Offices1 record

Markets served

GTM type

B2B

Offering type

Services

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Allogeneic Cell Therapy Development & Commercialization: Tr1X is a clinical-stage biopharmaceutical company developing allogeneic Tr1 regulatory T cell therapies. Revenue will be generated through commercialization of approved cell therapy products. The company is not yet revenue-generating as all programs are in clinical development.
2. Government Grants & Non-Dilutive Funding: Tr1X receives non-dilutive funding such as the $8M CIRM grant to support clinical trials for TRX103. These grants support clinical development costs without equity dilution.

Go-to-market motion2 records

Distribution channels1 record

Marketing channels6 records

Core offering

Tr1X develops allogeneic, off-the-shelf Type 1 regulatory T (Tr1) cell therapies for patients with autoimmune and inflammatory diseases. Its lead clinical-stage candidates are TRX103 (an allogeneic Tr1 Treg cell therapy for graft-versus-host disease prevention and treatment-refractory Crohn's disease) and TRX319 (an allogeneic CAR-Tr1 Treg for progressive multiple sclerosis), with TRX501 (an in-vivo Tr1 program) in earlier research. Products are administered via physician-supervised intravenous infusion at clinical trial sites in the United States.

Product overview

Tr1X is developing a novel class of regulatory T cell-based therapies, specifically Type 1 regulatory T (Tr1) cell therapies, to cure autoimmune and inflammatory diseases. The company's product portfolio includes TRX103 (an allogeneic engineered Tr1 Treg cell therapy for GvHD prevention and Crohn's disease), TRX319 (an allogeneic CAR-Tr1 Treg cell therapy for progressive multiple sclerosis with Fast Track Designation), and TRX501 (an in-vivo Tr1 program). The company operates clinical trials including the RESTORE trial for Crohn's disease and the IMPACT-MS trial for progressive multiple sclerosis. The platform combines cutting-edge genetic engineering with deep immunology expertise to create scalable curative therapies.

Differentiator

Problem solved

Functional benefit

Products and services

• TRX103 TRX103 is an allogeneic, off-the-shelf, non-antigen-specific Tr1 regulatory T cell therapy designed to prevent graft-versus-host disease (GvHD) in patients undergoing HLA-mismatched or haploidentical hematopoietic stem cell transplants and to treat moderate-to-severe treatment-refractory Crohn's disease. It is administered intravenously to enrolled trial participants at US clinical sites including Mayo Clinic, UCSF, Cleveland Clinic, and Northwestern.
• TRX319 TRX319 is a first-in-class allogeneic CAR-Tr1 Treg cell therapy designed to target and deplete pathogenic B cells while providing active Tr1-mediated anti-inflammatory signaling in a CNS-penetrant product. It is in development for progressive multiple sclerosis and has received FDA Fast Track Designation for primary or secondary PMS.
• TRX501 TRX501 is Tr1X's in-vivo Tr1 program in research stage, designed to generate Tr1 cells directly in vivo for undisclosed autoimmune indications beyond Tr1X's lead Crohn's disease, MS, and GvHD programs.

Quantifiable outcome

• Tr1 cells detectable in patient peripheral blood up to 1 year after administration, demonstrating long-term persistence and stability (Chen et al., Sci Transl Med 2021)
• +4 more outcomes

Named customers3 records

Segments2 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature5 records

Scale indicators6 records

Recent moves6 records

Expansion highlights6 records

Direct peers

• Sonoma Biotherapeutics: Clinical-stage biotech developing regulatory T cell (Treg) therapies for autoimmune and inflammatory diseases. Directly comparable to Tr1X as both pursue engineered Treg cell approaches for autoimmune indications, with overlapping leadership alumni (Tr1X's CTO previously led manufacturing at Sonoma).
• Kyverna Therapeutics: Clinical-stage cell therapy company developing CAR-T cell therapies for autoimmune diseases. Comparable to Tr1X in targeting autoimmune indications with engineered cell therapies, though Kyverna focuses on conventional CAR-T rather than Tr1/Treg biology.
• Quell Therapeutics: Cell therapy company developing engineered Treg cell therapies for autoimmune and inflammatory diseases and transplant tolerance. Directly comparable to Tr1X as a Treg-focused cell therapy peer targeting similar indications including GvHD prevention.

Broad incumbents

• Fate Therapeutics: Clinical-stage cell therapy company with an off-the-shelf, iPSC-derived NK and T-cell therapy platform for cancer and autoimmune diseases. Comparable to Tr1X in pursuing allogeneic off-the-shelf cell therapies, though with broader modality scope.
• Allogene Therapeutics: Clinical-stage cell therapy company developing allogeneic CAR-T cell therapies. Comparable to Tr1X in allogeneic cell therapy manufacturing scale-up, though focused on oncology rather than autoimmune indications.
• Bristol-Myers Squibb: Large pharmaceutical company with established cell therapy franchises (Breyanzi, Abecma) and significant autoimmune/inflammation portfolio. Comparable to Tr1X as a potential strategic acquirer/partner given overlap in autoimmune disease focus and cell therapy capabilities (Tr1X's CMO previously held senior roles at BMS).
• Novartis: Large pharmaceutical company with leading cell therapy franchise (Kymriah) and active autoimmune disease pipeline. Comparable to Tr1X as a potential strategic acquirer/partner given Tr1X's CMO previously led global autoimmunity translational medicine at Novartis.

Emerging players

• Century Therapeutics: Clinical-stage cell therapy company developing allogeneic iPSC-derived immune cell therapies for cancer and autoimmune diseases. Comparable to Tr1X in allogeneic cell therapy platform approach with emerging autoimmune programs.
• ATARA Biotherapeutics: Cell therapy company developing allogeneic T-cell and Treg therapies for autoimmune diseases and oncology. Comparable to Tr1X in allogeneic cell therapy approach targeting autoimmune indications including MS.
• Tevogen Bio: Clinical-stage cell therapy company developing allogeneic virus-specific T cell therapies, with expansion into autoimmune and infectious disease indications. Comparable to Tr1X in off-the-shelf allogeneic cell therapy approach.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat3 records

Key risks6 records

Key highlights6 records

Customer concentration

• LinkedInlinkedin.com/company/tr1x

Compliance3 records

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds4 records

Investors4 records

Funding detail is available on the Subscription and Enterprise plan.Contact sales →

M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about Tr1x