The board (the ?Board?) of directors (the ?Directors?) of Immunotech Biopharm Ltd. (the ?Company?, together with its subsidiaries, the ?Group?) announced that the Company has received an approval of the Investigational New Drug Application (?IND?) for Phase I clinical trial from the Centre for Drug Evaluation (the ?CDE?) of the National Medical Products Administration for the aT19 injection (the ?aT19 Injection?). The aT19 Injection is an injection of CD19-targeted chimeric antigen receptor T cells (?CAR-T cells?) for sequential use after treatment of relapsed refractory B-cell-derived acute lymphoblastic leukemia (?B-ALL?) for the prevention of CD19-positive relapses for patients under the age of 25. The goal of this injection is to address the pain point of possible CD19-positive relapse after CD19-targeted CAR-T cells for B-ALL treatment.

The Group submitted the IND application to the CDE in November 2023. The Phase I clinical trial for the aT19 Injection are expected to start in the year end of 2024. The active component of the company aT19 Injection product candidate is autologous T cells genetically modified to express CD19.

The gene introduced therein is an encoded gene structure that can express human CD19 protein. The reinfusion of the aT19 Injection after injecting the CAR-T-19 Injection has the potential to reactivate CAR-T cells, restart the proliferation of CAR-T cells, and induce more immune memory cells, thereby increasing the chance of killing trace amounts of residual CD19-positive tumour cells and of preventing recurrence. Through multiple stimulations from CD19 antigen, the number of CAR-T cells with immune memory function may also increase, thereby prolonging the immune surveillance duration of CAR-T cells and reducing the probability of recurrence of CD19-positive tumours.

The aT19 Injection has certain commonality with the company CAR-T-19 Injection product candidate (both of them are products based on the genetic modification by T cells via lentiviral vectors), so the previous process can be applied in the pharmaceutical process development, thereby shortening the product development period.