Hengrunda Sheng's CD19/CD22 Dual-Targeting CAR-T Therapy Receives IND Approval for Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

Source: Medicine Review

On January 7, the latest public notice on the website of the Center for Drug Evaluation (CDE) under China’s National Medical Products Administration indicated that Hengrun Dasheng’s Class 1 novel biologic drug, anti-human CD19-CD22 T-cell injection, has received implicit approval for clinical trials. It is intended for development in the treatment of relapsed/refractory B-cell acute lymphoblastic leukemia.

Source: CDE Official Website

According to the press release previously issued by Shanghai Hengrun Dasheng Biotechnology Co., Ltd., Anti-human CD19-CD22 T Cell Injection is a genetically engineered autologous CAR-T cell product targeting CD19 and CD22. Its mechanism of action involves ex vivo genetic modification via a retroviral vector, enabling T cells to carry chimeric antigen receptor (CAR) components. These components facilitate the expression of anti-CD19 and anti-CD22 antibodies on the T cell surface, allowing for specific recognition and binding to CD19 and CD22 molecules on B cells. This interaction triggers activation signals, thereby exerting targeted cytotoxic effects against cells expressing CD19 and/or CD22.

Among them, CD19 is an antigen widely expressed in B-cell malignancies. It enhances B-cell receptor-mediated signaling pathways, supports B-cell survival, and serves as a critical target for the treatment of B-cell cancers.

CD22 is one of the inhibitory co-receptors on the surface of B cells. It is expressed on the surface of most B-cell malignancy cells, making it a popular target for the treatment of this type of cancer.

Studies have shown that CD19 and CD22 promote B-cell survival, making the simultaneous loss of both antigens highly unlikely. Combination therapy targeting both CD19 and CD22 can cover various cell subpopulations in patients with primary and relapsed B-cell malignant hematologic tumors. Simultaneous engagement of both antigens promotes synergistic activation with enhanced functionality; correspondingly, CAR-T cells retain their cytotoxic activity even after the loss of one target antigen, significantly reducing the survival rate of tumor cells that have lost one antigen.

Acute lymphoblastic leukemia (ALL) is a rapidly progressive hematologic malignancy that accounts for 80% of acute leukemias in children, with a peak incidence between the ages of 3 and 7 years. B-cell ALL predisposes children to increased susceptibility to infections, as the malignant B cells fail to perform their normal immune functions. ALL can also occur in adults, representing 20% of all adult leukemia cases. Although current therapies can cure the majority of patients with ALL, prognosis deteriorates rapidly upon relapse, particularly among those with high-risk disease.

Congratulations to Shanghai Hengrun Dasheng Biotechnology Co., Ltd. on the approval of its CD19/CD22 dual-target CAR-T therapy for clinical trials. We hope that this product will progress smoothly in clinical research and benefit more cancer patients as soon as possible.

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