Taiwan Bio Therapeutics, Inc. and TRACT Therapeutics, Inc. have successfully transferred TRACT Therapeutics’ regulatory T cell (TregCel) platform technology to Taiwan Bio’s GMP cell manufacturing facility. This milestone advances the companies’ efforts to prepare for the initiation of a global Phase 2 trial in living donor kidney transplant patients seeking new therapeutic options to improve quality of life.
 
The companies partnered in December 2023 to leverage Taiwan Bio’s expertise in cellular therapy manufacturing and TRACT Therapeutics’ immune-modulating regulatory T cell therapy platform, called TregCel. 
 
The Phase 2 clinical trial, running concurrently at sites in Taiwan and the U.S., builds on the promising results from a Phase 1 study, which demonstrated an excellent safety profile and encouraging efficacy indicators with TRACT’s autologous Treg product and has the potential to change the treatment paradigm for transplant patients by reducing the reliance on immunosuppressant drugs.
 
Cyrus Yang, CEO of Taiwan Bio Therapeutics, stated, “We are extremely excited about the successful transfer of TRACT Therapeutics’ Treg cellular product to our facility. This achievement underscores our commitment to advancing cutting-edge cellular therapies and highlights our capabilities in high-quality cell therapy manufacturing. We look forward to supporting the upcoming Phase 2 clinical trial and the global manufacturing needs of this innovative cellular therapy. We are optimistic about the potential impact of this therapy on patients undergoing kidney transplants.”
 
Dr. Joseph Leventhal, Scientific Founder of TRACT Therapeutics, added, “This successful technology transfer represents a crucial step in our journey to bring our regulatory T cell therapy to patients in need. The collaboration with Taiwan Bio has been exceptional, and their manufacturing excellence aligns perfectly with our mission to develop transformative therapies. We are excited to continue our work towards improving outcomes and quality of life for transplant patients.”