Taiwan Bio Therapeutics announced on the 13th that it has signed a merger agreement with its partner, TRACT Therapeutics, Inc. Through its wholly owned U.S. subsidiary, Taiwan Bio Holding LLC, the company will acquire 100% equity in TRACT for US$3.5 million in cash. The transaction will be completed following approval by relevant authorities, officially bringing TRACT under the Taiwan Bio Therapeutics Group.
The company stated that the acquisition marks an important milestone in its strategy to enter the U.S. market and establish itself as a global leader in cell therapy.
Through this deal, Taiwan Bio Therapeutics will obtain full rights to TRK-001, a novel regulatory T-cell (Treg) therapy. This will not only accelerate patient enrollment for its ongoing Phase II clinical trial in preventing solid organ transplant rejection, but also enable the company to expand development into autoimmune and immune-mediated diseases. By offering a long-acting, one-time treatment, TRK-001 aims to gradually replace conventional immunosuppressants, which are often associated with significant side effects, thereby enhancing the overall economic value of the therapy and strengthening the company’s global competitiveness.
CEO Cyrus Yang emphasized that regulatory T cells (Treg) restore immune tolerance and promote tissue repair with strong safety and broad applicability, making them highly suitable as frontline therapies. This approach could expand clinical applications and market potential, overcoming the limitation of CAR-T therapies, which are currently restricted to later-line treatment in autoimmune diseases. Autoimmune diseases are increasingly recognized as the next major opportunity in immune cell therapy after oncology.
Globally, investment in Treg therapies is on the rise. TRK-001 is among the most advanced candidates in this field, with an ongoing Phase II multinational clinical trial in Taiwan and the U.S. for kidney transplant rejection, targeting 34 patients. With full rights secured, Taiwan Bio Therapeutics will accelerate trial enrollment and expects to obtain Phase II data within two to three years. The company plans to seek Regenerative Medicine Advanced Therapy (RMAT) designation in the U.S. to expedite the path to market, with the goal of positioning TRK-001 as a one-time therapy to replace lifelong immunosuppressants.
In addition, once Phase II results are available, the company intends to pursue conditional approval under Taiwan’s Regenerative Medicine Act to benefit local patients at the earliest stage possible.
Yang further stated that Taiwan Bio Therapeutics has transformed into a new drug company focused on Treg research and development. By fully acquiring this leading-edge Treg technology and leveraging its proprietary FAST CGT platform, the company will significantly improve cell therapy efficiency and cost-effectiveness. Combined with research resources from leading institutions such as Harvard University, Johns Hopkins University, and Mayo Clinic, Taiwan Bio Therapeutics plans to advance the development of gene-modified Treg with stronger functionality and broader applications, consolidating its global leadership in this field.
Resource: 進軍美國傳捷報 台寶全資收購TRACT公司 拓展移植排斥與自體免疫市場
