Shanghai UniCAR-Therapy Bio-Medicine Technology Co., Ltd, a leading biopharmaceutical company based in China, is on track to secure breakthrough therapy designation (BTD) for its innovative autologous CD19 targeted chimeric antigen receptor (CAR) T-cell therapy. This therapy features a unique function of silencing interleukin-6 (IL-6) expression and is intended for the treatment of refractory/relapsed acute lymphoblastic leukemia.
The product’s design allows for the simultaneous expression of CAR structures and IL-6 silencing elements, significantly reducing the release of IL-6 factors. This innovative approach can further decrease monocyte activation and the release of pro-inflammatory cytokines. Proactively, it has the potential to reduce the incidence of severe cytokine release syndrome (CRS) and severe immune effector cell-related neurotoxicity syndrome (ICANS), thereby enhancing the safety profile of CAR-T cell therapies.
Previously, the company obtained clinical trial approval in China for the treatment of central nervous system leukemia, and it has also been granted orphan drug designation in the United States.- Flcube.com