TriArm Therapeutics Announces FDA IND Clearance for Non-Viral, Rapidly Manufactured FIT-CD19 CAR-T Therapy for Non-Hodgkin Lymphoma

Recently, TriArm Therapeutics (Stardust Bio) announced its non-viral rapid preparation FIT-CD19CAR-TImmunityTherapy for Non-Hodgkin'sLymphomaHas obtained the U.S. Food and DrugManagementBureau (FDA) The approval of the IND application marks the official entry into the clinical trial stage.

Dr. Jie Zhang, CEO of TriArm, expressed his thoughts in Shanghai: "This is a milestone in the development history of TriArm and 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 extend my special thanks to every team member who has worked hard for this achievement, as well as to 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 costs 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 Therapeutics, 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 blood-related diseases.TumorThese 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 treatment can be as high as $400,000. Currently, only 10% of patients who could potentially use this type of CAR-T therapy actually receive treatment.

Despite the fact that, 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 it 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 adopted 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.

About TriArm Therapeutics

TriArm Therapeutics, Stardust Bio is a research and development company focusing 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.Tumor ImmunologyBring innovation and breakthroughs to the field of treatment.