TAIPEI, Taiwan & CHICAGO--(BUSINESS WIRE)--Taiwan Bio Therapeutics, Inc. and TRACT Therapeutics, Inc. are pleased to announce the successful transfer of TRACT Therapeutics’ innovative regulatory T cell (TregCelTM) platform technology to Taiwan Bio’s state-of-the-art GMP cell manufacturing facility. This critical milestone is a significant step forward as the companies prepare for the initiation of a global Phase 2 clinical trial in living donor kidney transplant patients and is an exciting development for SOT patients seeking new therapeutic options to improve their quality of life.
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.”
The companies announced their strategic partnership in December 2023 to leverage Taiwan Bio’s expertise in cellular therapy manufacturing and TRACT Therapeutics’ pioneering immune-modulating regulatory T cell therapy platform, called TregCelTM. The technology transfer was completed by a dedicated and collaborative team led by Carrie Wu, PhD from Taiwan Bio and Cheryl Stratton, MS from TRACT Therapeutics. Their expertise and teamwork were instrumental in achieving this important milestone.
The upcoming Phase 2 clinical trial, running concurrently at sites in Taiwan and the US, 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.
Further updates on the trial’s progress will be shared in the coming months.
About Taiwan Bio
Taiwan Bio Therapeutics, Inc. is a one-stop, total solution cell therapy CDMO focusing on accelerating the translation of early-stage cell therapies to clinical products. Its cell engineering and cGMP manufacturing technology platforms streamline “vein-to-vein” process design and allow thorough product characterization. Taiwan Bio is where cutting-edge science meets world-class manufacturing, helping innovators to convert their bench side discoveries into bed side therapies in record time. Discover more at: https://twbio-thera.com/language/en/about-us/
About TRACT Therapeutics
TRACT Therapeutics, Inc. is a clinical stage biotechnology company developing a novel therapeutic approach to restoring immune balance in organ transplantation and autoimmune disease. Its proprietary platform technology, using autologous polyclonal expanded regulatory T cells, was developed at Northwestern University by pioneer, Joseph R Leventhal, MD, PhD, Fowler McCormick Professor of Surgery at Northwestern University, and his research colleagues. For additional information, visit our website at www.tracttherapeutics.com.
This press release contains forward-looking statements that express the belief, potential anticipation, or expectation, as well as other statements which are not historical fact, and statements related to clinical trials and their results, design, FDA product approvals or other marketing approvals, features, functionality, and performance. These statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected in these forward-looking statements.
