Shanghai Pharmaceuticals Group Co., Ltd. (SHA: 601607)’s biotech subsidiary has announced that its investigational ‘CD19 and CD22 targeting chimeric antigen receptor T cell injection’ has received renewed acceptance for its Investigational New Drug (IND) application by the relevant authorities. Known under the development code B019, this cellular therapy candidate has already seen its IND accepted last August and was approved for clinical trials in November, primarily indicated for the treatment of relapsed or refractory B-cell lymphoma.
The chimeric antigen receptor structure of B019 utilizes a dual-cistronic vector, enabling the expression of two distinct chimeric antigen receptors on T cells, which can bind to CD19 or CD22 proteins on the surface of B lymphocytes, thereby exerting an anti-tumor effect. Despite the global approval and market presence of several CD19 CAR-T therapies, some patients may still experience disease progression and relapse post-treatment. This can occur as certain tumor cells, under the threat of CD19 CAR-T treatment, may begin to express the CD22 protein to evade destruction. Consequently, the dual-targeting CAR-T cell therapy of CD19 and CD22 is theoretically capable of reducing the risk of tumor escape due to the loss of a single target, further lowering the likelihood of disease relapse.
Research indicates that both CD19 and CD22 are crucial for B-cell survival, making the simultaneous loss of both antigens highly unlikely. The combination therapy targeting these two antigens can address various cellular subsets in patients with primary and recurrent B-cell malignancies. The dual-targeting approach can enhance cooperative activation when both antigens are present, and even in the event of the loss of one target molecule, it retains the cytotoxic capability of CAR-T cells, significantly reducing the survival rate of antigen-loss tumor cells.
The re-acceptance of the IND application for Shanghai Pharmaceuticals’ CD19/CD22 dual-targeting CAR-T therapy signifies another advancement for the company in the field of CAR-T therapy. It is anticipated that Shanghai Pharmaceuticals will expedite the clinical trial process, hastening the delivery of innovative treatment solutions to patients and fulfilling unmet clinical needs. – Flcube.com
