Taiwan Bio and TRACT Therapeutics, Inc. Announce Strategic Partnership to Advance a Novel Therapeutic Approach for Preventing Rejection in Solid Organ Transplant

CHICAGO & TAIPEI, Taiwan--()--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 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 profile and 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: 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.



Lisa Juang, Lisa.Juang@twbio-thera.com, +886-2-26956382


Lisa Juang, Lisa.Juang@twbio-thera.com, +886-2-26956382