Research Triangle Park, NC — Kincell Bio, a leading U.S. cell therapy contract development and manufacturing organization (CDMO), today announced a new collaboration with RegCell, a biotechnology company developing first‑in‑class immune tolerance platform based on epigenetically reprogrammed regulatory T cells (Tregs). Under the partnership, Kincell Bio will provide comprehensive CMC development and GMP manufacturing support to accelerate RegCell’s lead Treg program toward clinical trial evaluation.

As part of the collaboration, RegCell will transfer its lead Treg program to Kincell Bio for process and analytical transfer and development, optimization of a scalable manufacturing process, and GMP clinical material supply to support IND‑enabling activities and clinical trials.  The collaboration is designed to streamline development timelines and ensure robust clinical supply for RegCell’s novel epigenetic reprogramming platform, aligning closely with Kincell’s mission to accelerate CMC development and clinical manufacturing for cell therapy innovators.

RegCell’s platform converts disease-driving CD4+ T cells into lineage-stable, antigen-matched Tregs by recapitulating critical epigenetic features involved in Treg imprinting and stability.  RegCell was founded by Professor Shimon Sakaguchi,  Distinguished Professor of Osaka University, Professor Emeritus of Kyoto University, who shared the 2025 Nobel Prize for Physiology or Medicine for his contributions to understanding immune tolerance and the role of Tregs.  Notably, RegCell’s platform does not require gene editing or viral DNA reagents, substantially reducing manufacturing complexity and enabling automation and potential point-of-care access. 

“Our relationship with Kincell Bio is a critical part of our US strategic plan and enables us to access leading capabilities in T-cell manufacturing, as well as to focus on creating a commercially viable manufacturing process at an early stage of clinical development,” said Michael McCullar, Ph.D., Chief Executive Officer of RegCell. 

“I’m excited for Kincell Bio to support RegCell as they advance a deeply innovative therapeutic approach rooted in decades of foundational immunology,” said Bruce Thompson, PhD, President and Chief Technology Officer of Kincell Bio. “RegCell’s science represents a significant advancement in the treatment of autoimmune disorders, and our team is committed to providing the technical solutions and GMP execution required for clinical success.”

Kincell excels at CMC development and clinical supply for innovators by providing industry-leading process and analytical development, and early clinical and late-stage clinical cGMP manufacturing capabilities that are serving the needs of biotech and pharmaceutical companies.  Kincell is committed to advancing the field of cell therapy with tailored solutions that empower innovators to bring their therapies to market efficiently and effectively.

“We are proud to partner with RegCell in advancing this groundbreaking new category of cell therapy,” said Larry Pitcher, Chief Executive Officer at Kincell Bio. “RegCell’s vision for restoring immune tolerance through precisely engineered Tregs aligns perfectly with Kincell’s mission to empower pioneering cell therapy developers with agile, reliable, and high‑quality CMC and manufacturing support.”

About Kincell Bio

Kincell Bio engineers cells into therapies. With manufacturing facilities located in Research Triangle Park, NC, and Gainesville, FL, Kincell Bio is a contract development and manufacturing organization (CDMO) with the mission to streamline CMC development, with expertise in analytical and process development and GMP manufacturing, testing and release from early clinical, to pivotal studies, and product launch. Kincell Bio is focused on supporting innovative companies developing immune cell therapies, including autologous and allogeneic CAR-T, TCRs, Tregs, and CAR-NK programs, as well as developing expertise in stem cell products and iPSCs.

For more information, visit www.kincellbio.com, and follow us on LinkedIn.

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. RegCell’s 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.

For more information, visit http://www.regcellbio.com/ and follow us on LinkedIn and Twitter.

Media Contact:

Ignacio Guerrero-Ros, Ph.D., or Tierney Sovic, MSc
Russo Partners LLC
ignacio.guerrero-ros@russopartnersllc.com
tierney.sovic@russopartnersllc.com