Taiwan Bio Therapeutics and TRACT Therapeutics report the successful transfer of Tract Therapeutics’ regulatory T cell (TregCelTM) platform technology to Taiwan Bio’s GMP cell manufacturing facility. TRACT company officials call the move a critical milestone and a significant step forward as the companies prepare for the initiation of a global Phase II clinical trial in living donor kidney transplant patients. They also view it as an exciting development for solid organ transplant patients seeking new therapeutic options to improve their quality of life.
“This achievement underscores our commitment to advancing cutting-edge cellular therapies and highlights our capabilities in high-quality cell therapy manufacturing,” said Cyrus Yang, CEO of Taiwan Bio. “We look forward to supporting the upcoming Phase II 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.”
“The collaboration with Taiwan Bio has been exceptional, and their manufacturing excellence aligns perfectly with our mission to develop transformative therapies,” added Joseph Leventhal, MD, scientific founder, TRACT Therapeutics. “We are excited to continue our work towards improving outcomes and quality of life for transplant patients.”
The companies began their strategic partnership last December to leverage Taiwan Bio’s expertise in cellular therapy manufacturing and TRACT Therapeutics’ immune-modulating regulatory T cell therapy platform, called TregCell. The technology transfer was completed by a collaborative team led by Carrie Wu, PhD, from Taiwan Bio and Cheryl Stratton, from TRACT Therapeutics.
The upcoming Phase II clinical trial, running concurrently at sites in Taiwan and the U.S., builds on the results from a Phase I 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, according to Leventhal.
