RegCell Announces Two Peer-Reviewed Publications Supporting its Robust Scientific Foundation on Antigen-Specific Tolerance to Treat Autoimmune Diseases

Conventional T cells epigenetically reprogrammed into stable, antigen-specific regulatory T cells achieved long-lasting immune regulation in models of inflammatory bowel disease and graft-versus-host disease.

Successful conversion of disease-causing T cells into stable, antigen-specific regulatory T cells selectively suppressed autoimmune responses in pemphigus vulgaris without systemic immunosuppression.

EMERYVILLE, Calif., Nov. 13, 2025 /PRNewswire/ -- RegCell, Inc. a biotechnology company developing first-in-class therapies for autoimmune diseases and transplantation with its epigenetic reprogramming platform leveraging the natural biology of regulatory T cells (Tregs), today announced the publications of two studies in Science Translational Medicine from its scientific founder and member of its Board of Directors, Shimon Sakaguchi, MD, Ph.D., demonstrating, for the first time, the production of stable, antigen-specific T regulatory (Treg) cells from pathogenic T cells. The results from these research studies provide further scientific support for the epigenetic reprogramming approach taken by RegCell to engineer novel, lineage-stable Treg cells to treat autoimmune diseases.

The first study, "Generating functionally stable and antigen-specific Treg cells from effector T cells for cell therapy of inflammatory diseases", described a method to create stable, antigen-specific Tregs with strong Foxp3 expression and established Treg-specific epigenetic programs from conventional T cells to achieve targeted immunosuppression. Both naïve and effector/memory CD4+ T cells were induced into Tregs that closely resemble natural Tregs in function and stability, effectively suppressing inflammatory bowel disease and graft-versus-host disease in mouse models.

"Our findings demonstrate that it is possible to reprogram harmful T cells into stable, regulatory cells that restore specific suppression without broadly suppressing the immune system," said Dr. Shimon Sakaguchi, senior author of the study, scientific founder and board member of RegCell, and winner of the 2025 Nobel Prize in Physiology or Medicine. "By converting conventional T cells into antigen-specific regulatory T cells, we move closer to a new class of precision immunotherapies that could one day provide lasting, disease-specific control for autoimmune and inflammatory conditions."

The second study, "Conversion of pathogenic T cells into functionally stabilized Treg cells for antigen-specific immunosuppression in pemphigus vulgaris", presented a targeted immunotherapy approach for the autoimmune skin disorder pemphigus vulgaris. Researchers converted pathogenic CD4+ T cells into stable, functional regulatory T cells. In animal models, these cells localized to skin-draining lymph nodes, suppressed antigen-specific helper T and B cell activity, and reduced harmful antibody production without broad immunosuppression. Cells from human patients were also generated and showed similar functionality, suggesting the potential for antigen-specific, disease-targeted therapy for this autoimmune condition.

"These studies clearly show that it is possible to take the very immune cells that drive autoimmunity and disease and convert them into cells that instead protect against it, which is the foundational approach that RegCell employs," said Dr. Michael McCullar, Chief Executive Officer of RegCell. "By reprogramming disease-causing T cells into stable, antigen-specific regulatory T cells, we are now able to target and suppress the root causes of autoimmunity rather than broadly suppressing the immune system, opening the door to truly disease-specific immunotherapies."

About RegCell  

RegCell is a global biotechnology company based in the U.S. and built on the pioneering discoveries of Co-Founder Professor Shimon Sakaguchi in regulatory T-cell biology. RegCell is pioneering cell therapies for autoimmune diseases and transplantation, with a first indication in autoimmune hepatitis. RegCell has developed a best-in-class proprietary platform to generate stable, epigenetically reprogrammed, antigen-specific Tregs to restore antigen-specific immune tolerance. By addressing unknown or multiple pathogenic antigens, RegCell's platform addresses key limitations that have thus far prevented the development of cell therapies for unmet needs in autoimmune diseases, which are typically managed with drugs that broadly suppress the immune system rather than target the underlying cause. RegCells' approach does not require genetic modifications, allowing for simplified manufacturing, enhanced safety, and expanded scalability to address a broad spectrum of autoimmune patients. Driven by a vision to redefine self-tolerance, RegCell is committed to delivering safe, life-changing cell therapies that can reverse autoimmune disorders and overcome challenges in transplantation.   

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Media Contact:  

Ignacio Guerrero-Ros, Ph.D. or Rob Haney, Ph.D.
Russo Partners LLC 
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Investor Contact: 

James Ahlers 
RegCell, Inc. 
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SOURCE RegCell, Inc.