Taiwan Bio Therapeutics Co., Ltd.

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 (TregCel TM ) 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 TregCel TM . 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.

CHICAGO & TAIPEI, Taiwan--( BUSINESS WIRE )--TRACT Therapeutics and Taiwan Bio Therapeutics are pleased to announce a poster presentation at the 2024 annual meeting of the American Transplant Congress (ATC) taking place June 1-5, 2024, in Philadelphia, PA. TRACT Therapeutics, a clinical-stage biotechnology company, and Taiwan Bio Therapeutics, a world-class expert in cell therapy manufacturing, formed a strategic partnership in Nov 2023 to advance a novel regulatory T cell (Treg) therapy approach to preventing rejection in solid organ transplants. Together, the companies will launch a Phase 2 clinical trial investigating the ability of Treg therapy to reduce the use of immunosuppressant drugs in living donor kidney transplant recipients. Research centers will be located in the United States and Taiwan. Joseph R Leventhal, MD, PhD, Fowler McCormick Professor of Surgery at Northwestern University and Scientific Founder of TRACT Therapeutics stated, “Developing more effective treatments for patients facing an organ transplant is a pressing need and the ATC provides a dynamic platform for professionals to exchange insights on their work and experiences in the field of transplantation medicine. TRACT’s regulatory T cell therapy has the potential to make a significant impact on treatment paradigms, improving patient outcomes and quality of life, and we look forward to sharing our Phase 2 trial design and methods at the conference.” Details of the poster presentation are as follows: Abstract Title: “A Phase 2 Study of Regulatory T Cell Therapy to Achieve Immunosuppression (IS) Reduction in Living Donor Kidney Transplant (LDKTx) Recipients: The RETIRE Trial” Authors: J Leventhal, C Stratton, J Mathew, C Yang, S Murray Category: Clinical Trials 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 . About Taiwan Bio Therapeutics Taiwan Bio Therapeutics Co., Ltd. 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/ . 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.

CHICAGO & TAIPEI, Taiwan--(BUSINESS WIRE)-- Taiwan Bio and TRACT Therapeutics are pleased to announce a new strategic partnership to advance a cellular therapy to revolutionize the prevention of allograft rejection in solid organ transplant. The partners will launch a multi-center Phase 2 clinical trial investigating the reduction of immunosuppressant drugs in living donor kidney transplant recipients in both the United States and Taiwan. This press release features multimedia. View the full release here: This partnership leverages Taiwan Bio’s world-class expertise in cellular therapy manufacturing and TRACT Therapeutics’ innovative immune modulating regulatory T cell therapy platform. By combining their strengths, the companies are set to explore new frontiers in enabling allogeneic tissue transplant with a focus on enhanced patient outcomes and improved quality of life. The upcoming Phase 2 trial builds upon the promising results from a Phase 1 study which demonstrated an excellent safety pro encouraging efficacy signals with TRACT’s autologous Treg product, TregCelTM. "We believe that this collaboration holds tremendous promise for patients seeking better therapeutic options," said Cyrus Yang, COO of Taiwan Bio. "Together with TRACT Therapeutics, we can bring a synergy of technology and experience to accelerate the development of transformational Treg therapies." John Flavin, CEO of Portal Innovations member company, TRACT Therapeutics, added, “Our collaboration with Taiwan Bio is a strategic milestone that paves the way for mutual success. TRACT recognizes the importance of a state-of-the art GMP cell manufacturing facility to advance the development of our Treg therapy and found the best-in-class capabilities of the Taiwan Bio manufacturing team aligns perfectly with our needs. By working with Taiwan Bio, we are bringing the best of both worlds together—manufacturing excellence and a cutting-edge, personalized cellular therapy for patients. Our Phase 2 trial represents a significant step forward in our mission to provide solid organ transplant patients with better treatment options." Joseph R Leventhal, MD, PhD, Fowler McCormick Professor of Surgery at Northwestern University and Scientific Founder of TRACT Therapeutics, stated, “There is a critical need to develop better treatments for patients undergoing a solid organ transplant. TRACT’s regulatory T cell therapy platform holds the promise to revolutionize our approach to organ transplantation by not only preventing organ rejection but also enabling us to reduce the reliance on toxic immunosuppressive drugs. By harnessing the power of regulatory T cells, we can provide our patients with the potential for long-term, rejection-free transplant success while minimizing the adverse effects associated with traditional immunosuppression.” Matthew Cooper, MD, Chief of Transplantation at the Medical College of Wisconsin added, “This therapy represents a potential pivotal shift in the field of transplantation, offering new hope for improved outcomes and enhanced quality of life for all patients receiving solid organ transplants." The Phase 2 clinical trial represents the first collaborative effort between the two companies, and further updates on the trial's progress will be shared in the coming months. About Taiwan Bio Taiwan Bio Therapeutics Co., Ltd. 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: 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 . 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.