Immuthera Announces Global Exclusive License from City of Hope for First-in-Class CD6/CTLA-4 CAR-Treg Platform for Autoimmune and Inflammatory Diseases

• Global exclusivity for Type 1 Diabetes, Rheumatoid Arthritis, 8 Dermatological Autoimmune diseases, and 13 Neuroinflammatory Autoimmune diseases.
• Six patients with Chronic Graft versus Host Disease treated to-date with a favorable safety profile and signs of clinical efficacy.
• The first and only CAR-Treg in development with a CTLA-4 Treg specific signaling domain to enhance function.
• The IND for a Phase 1 clinical trial in Stage 3 Type 1 Diabetic patients has been accepted by the FDA.

WILMINGTON, DE, USA, January 12, 2026 / Biotech Newswire / -- Immuthera, the U.S. subsidiary of PolTREG S.A., a leader in innovative immunological therapies, today announces that it signed, on January 1, 2026, a global exclusive license agreement with City of Hope®, one of the largest and most advanced cancer research and treatment organizations in the United States and a leading biomedical research center for diabetes and other life-threatening illnesses, covering a novel, best-in-class, clinical-stage CD6/CTLA-4 CAR-T regulatory cell (Treg) technology and therapy.

The CD6/CTLA-4 CAR-Treg* represents a first-in-class, universal CAR Treg approach targeting pathogenic T cells and is currently under clinical evaluation for multiple unmet needs in inflammatory and autoimmune diseases. This trailblazer CAR-Treg is allowed to proceed for clinical evaluation in the USA by the FDA. To date, 6 patients have been treated with this CAR-Treg in Graft versus Host Disease with an excellent safety profile and early signs of clinical efficacy. It is also the only CAR-Treg currently in clinical development with a Treg specific (CTLA-4) signaling domain. An IND for the evaluation of the CD6/CTLA-4 CAR-Treg in a Phase 1 clinical trial in Stage 3 (clinically diagnosed) Type 1 Diabetes was allowed to proceed by the FDA in November 2025.

This innovative platform, developed at City of Hope by Drs. Enrique Montero, Christine Brown, and others, combines a CD6-targeted chimeric antigen receptor (CAR) with the potent and Treg-specific immunoregulating CTLA-4 signaling domain, creating a highly suppressive local microenvironment in organs damaged by rampant inflammation. The CD6 antigen-specific regulatory T cells are designed to restore immune tolerance while preserving protective immunity. The technology represents a new class of engineered Treg therapy with the potential to precisely control pathological immune responses in transplant-related, inflammatory, and autoimmune conditions.

Under the terms of the license agreement, Immuthera has worldwide rights to develop, manufacture, and commercialize the CD6/CTLA-4 CAR-Treg platform across multiple therapeutic indications, including type 1 diabetes, rheumatoid arthritis, and various neuroinflammatory and dermatological indications, including multiple sclerosis, amyotrophic lateral sclerosis [ALS], myelin oligodendrocyte glycoprotein antibody-associated disease) [MOGAD], vitiligo, alopecia areata, atopic dermatitis, and psoriasis.

The utility of this therapeutic platform comes from the targeting specificity of CD6 along with the unique and Treg-specific CTLA-4 signaling pathway. CD6 is a key surface receptor involved in T-cell activation and tissue trafficking. Targeting pathogenic T-cells prevents progression of disease while localizing the cells and enabling bystander suppression of B-cells and antigen-presenting cells (APCs). CTLA-4 is a master regulator of immune checkpoint control, which is constitutively expressed in Tregs, but prevents T-effector and APCs activation. By integrating these pathways into Tregs, the City of Hope-developed platform delivers localized and specific immune regulation of overactivated inflammatory T cells.

This program complements Immuthera and PolTREG’s PTG-007 Treg cell therapy and our ongoing Phase 2 clinical trial in Stage 1 (presymptomatic) children, down to three years old, in Europe. These two modalities allow Immuthera and PolTREG to pursue our “entirety of T1D” commercial strategy: deploying PTG-007 in young, presymptomatic children where its established safety record (over 105 patients treated with up to 12 years of follow up) is critical, and deploying CD6/CTLA-4 CAR-Treg in older diagnosed patients where a more robust treatment is necessary.

City of Hope has already initiated a First-in-Human clinical trial in Graft versus Host Disease with the CD6/CTLA-4 CAR-Treg; it is the first FDA-approved clinical trial with CAR-Tregs in the US. To date, six patients have been dosed; three of them twice. Interim data from this study was recently presented as an oral presentation at the American Society of Hematology Meeting in December (https://www.sciencedirect.com/science/article/pii/S0006497125028514) and was published in the journal “Blood”. The treatments were well tolerated with no CRS or ICANS, and five out of the six patients had partial responses that did not require salvage therapy. Additionally, five of the six patients exhibited scleroderma with good resolution and CAR-Tregs were detectable in skin biopsies two months after treatment.

“Patients deserve therapies that restore immune balance. In collaboration with Immuthera, City of Hope is advancing our CD6/CTLA4 CAR-Treg platform toward clinical evaluation — including in type 1 diabetes — aiming to modulate inflammatory T cells and translate bold science into care that improves lives,” said Enrique Montero, M.D., Ph.D., research professor of the Arthur Riggs Diabetes & Metabolism Research Institute at City of Hope. 

“This exclusive license represents a major milestone for Immuthera and significantly strengthens our leadership in engineered Treg therapeutics. The CD6/CTLA-4 CAR-Treg platform brings together two powerful immune-regulatory mechanisms into a single, programed cell therapy, enabling targeted and durable immune tolerance. This platform has the potential to transform treatment of autoimmune and inflammatory diseases,” said Professor Piotr Trzonkowski, MD, Chief Executive Officer of Immuthera.

This license agreement further expands Immuthera’s growing portfolio of internally generated Treg, engineered CAR-Treg, multi-edited/allogeneic CAR-Treg, and in-vivo generated antigen-specific Treg therapies, reinforcing the company’s mission to build and deploy the world’s most advanced pipeline of modalities for prevention, treatment, and restoration of immune tolerance in autoimmune and inflammatory diseases.

* City of Hope and the inventors of this technology are entitled to a percentage of any royalties and other commercialization revenues received by City of Hope under the agreement.