Taiwan Bio Therapeutics announced on the 12th that it has signed a Letter of Intent (LOI) with the world-renowned Mayo Clinic. The two parties will jointly establish an innovation hub in Phoenix, Arizona, focusing on the development of groundbreaking cell therapy manufacturing technologies. This collaboration will cover the entire process from cell preparation to clinical infusion—a comprehensive needle-to-needle production workflow. Leveraging Taiwan Bio’s proprietary FAST CGT platform, the goal is to create a new generation of advanced cell therapy products.

Cyrus Yang, CEO of Taiwan Bio Therapeutics, explained that the collaboration aligns with current global geopolitical trends and the growing movement to bring manufacturing back to the United States. The innovative technologies developed through this partnership will heavily incorporate decentralized and automated production concepts, effectively reducing the high labor costs and workforce shortages that challenge the U.S. healthcare manufacturing industry. Moving forward, Taiwan Bio will adopt a Therapeutics Design & Manufacturing (TDM) business model, which focuses on product design and development. By collaborating with Mayo Clinic and its spin-off startups, the partnership aims not only to develop innovative cell therapy products for clients but also to enhance production efficiency, lower costs, and shorten manufacturing cycles. The ultimate goal is to increase the accessibility and affordability of cell therapies, benefiting a broader patient population.

On the new drug development front, in February of this year, Taiwan Bio received approval from Taiwan’s Food and Drug Administration (TFDA) to initiate Phase II clinical trials for its novel cell therapy drug TregCel (TRK-001), which is designed to prevent post-kidney transplant rejection. The company passed the GTP audit with no major deficiencies, and after completing supplemental submissions, patient enrollment has begun in both Taiwan and the U.S., with the first patient expected to be treated in April. Taiwan Bio is fully committed to advancing the clinical development of its pipeline therapies this year.

Thanks to steady and continued growth in its CDMO business, Taiwan Bio reported a record consolidated revenue of NT$105 million in 2023, a 22.99% increase year-over-year. However, due to increased R&D spending on its new drug pipeline, which remains in clinical development, the company recorded a net loss after tax of NT$351.8 million, with a loss per share of NT$4.81. To accelerate its clinical trials and expand its investments in the U.S. market, the company’s board has approved a plan to raise funds through private placement, issuing up to 30 million new shares. The proposal will be submitted for shareholder approval, authorizing the board to execute the plan based on market conditions and the company’s operational needs.

Looking ahead to this year, Chairman Hsu-Sung Kuo stated that Taiwan Bio will accelerate clinical trials for its cell therapy products, initiate investments in the U.S. to build advanced cell therapy manufacturing capabilities, and work closely with partners to actively expand its presence in the U.S. cell therapy market.

Resource: 攻美製造商機 台寶攜手梅約於鳳凰城打造新一代細胞治療產品