Gelonghui, February 19 | Yongtai Bio-B (06978.HK) announced that the company has received approval from the Drug Evaluation Center (Drug Evaluation Center) of the China Drug Administration (Drug Evaluation Center) for the Phase 1 Clinical Trial (IND) application for aT19 injection.

AT19 injection is an injection targeting CD19 chimeric antigen receptor T cells (CAR-T cells) used sequentially to prevent CD19 positive recurrence in patients under 25 with recurrent refractory B-cell-derived acute lymphocytic leukemia (B-ALL). The goal of this injection is to address the pain point where CD19-targeting CAR-T cells may recur after B-ALL treatment. The Group submitted an IND application to the Drug Evaluation Center in November 2023. It is expected that aT19 injections will begin phase 1 clinical trials at the end of 2024.

The active ingredients in the company's AT19 injection products are autologous T cells genetically modified to express CD19. The gene introduced is a coding gene structure that can express human CD19 protein. Infusing AT19 injection after injecting CAR-T-19 may reactivate CAR-T cells, restart the proliferation of CAR-T cells, induce more immune memory cells, thereby increasing the chance of killing trace remaining CD19-positive tumor cells and preventing recurrence. Through multiple stimulation of CD19 antigen, the number of CAR-T cells with immune memory function will also increase, thereby extending the immune monitoring time of CAR-T cells and reducing the probability of recurrence of CD19 positive tumors.

AT19 injection has several commonalities with the company's CarT-19 injection products currently being developed (they are all products based on genetically modifying T cells through lentiviral vectors), so the previous process can be applied to pharmaceutical process development, thereby shortening the product development cycle.