TriArm Therapeutics Announces FDA IND Approval for Non-Viral, Rapid-Prep FIT-CD19 CAR-T Therapy for Non-Hodgkin Lymphoma

TriArm Therapeutics, Starchain Biotechnology (Shanghai) announced that its non-viral rapid preparation FIT-CD19 CAR-T immunotherapy for the treatment of non-Hodgkin's lymphoma has received approval from the U.S. Food and Drug Administration (FDA) for its IND application, officially entering the clinical trial stage.

CEO Dr. Zhang Jie expressed his thoughts in Shanghai: "This is a milestone in the development history of TriArm, and also a great recognition of our team's relentless efforts. It is an important step towards the broader and more effective application of CAR-T therapy. I would like to especially thank every team member who has worked hard for this, as well as our investors and peers in the industry for their support."

The uniqueness of this innovative therapy lies in the adoption of non-viral preparation technology, which shortens the preparation time to just two days, with the cost being only a fraction of currently available products. The successful application of this breakthrough technology not only enhances production efficiency and reduces treatment costs but also provides a more convenient and economical treatment option for a broader range of patients.

Dr. Jin Hua Lu, Chief Scientist of TriArm, stated: "We are very proud of the approval of FIT-CD19 CAR-T, and this success is inseparable from the close collaboration of the teams in both locations. This is a non-viral preparation technology platform that we are proud of, which can be quickly expanded to many cell therapy applications, making CAR-T cell therapy faster, more economical, and expected to bring benefits to more patients."

Currently, there are seven CAR-T cell products that have been launched internationally, all of which use virally gene-modified autologous cells to combat hematologic tumors. These cell therapies have two major drawbacks: one is that the preparation process takes about 1-2 months; the other is that the cost of a single course of treatment is as high as $400,000. Currently, only 10% of patients who are eligible for this type of CAR-T therapy actually receive treatment.

Although, according to the latest data from the global CAR-T market, YESCARTA is currently the best-selling CAR-T product worldwide. Its sales reached $1.16 billion in 2022. The global CAR-T market size that year was $18.61 billion and is projected to soar to $93.78 billion by 2030, with an annual compound growth rate of 22.4%.

The rapid production speed and low manufacturing cost of FIT-CD19 CAR-T make this treatment more likely to be widely accessible in various medical fields. In the future, TriArm Therapeutics will continue to strive for technological innovation in this field, providing patients with more efficient and cost-effective treatment options.

TriArm Therapeutics, Stardust Bio is a research and development company focused on non-viral preparation of CAR-T cell therapy solutions, while also developing multiple innovative cell therapy products. The company is committed to providing patients with efficient and cost-effective treatment options, bringing innovation and breakthroughs to the field of tumor immunotherapy.