Kaidi Medical Receives China's First IND Approval for NKG2DL-Targeting CAR-T Therapy KD-025
KAEDI
Developer of Novel Cell Therapies
On March 17, 2023, Nanjing Kaidi Biotechnology Co., Ltd. (referred to as "Kaidi Biotech") independently developed a Class 1 biologic product, NKG2D.CAR-T(KD-025) Cell Injection, Clinical Trial Application (IND) Approved by National Medical Products AdministrationManagementChina's Center for Drug Evaluation (CDE) has granted clinical trial approval, marking the first cell therapy product targeting NKG2DL to be approved in China.
This cell therapy is indicated for NKG2DL-positive solid tumors, includingColorectal Cancer、Liver Cancer`, glioma, etc., both`DiagnosisFor NKG2DL-positive advanced solid tumors without standard treatment (Acceptance No.: CXSL2200592).
KD-025 Cell Injection is an autologous CAR-T cell product targeting NKG2DL. NKG2D ligands are basically not expressed in normal cells but show high-level expression on the surface of various tumor cells from different sources (such as colorectal cancer, liver cancer, glioma, etc.). After KD-025 CAR-T cells bind to NKG2DLs on the surface of tumor cells, they can trigger the activation of signaling pathways within the CAR-T cells, thereby exerting their tumor cell-killing effect.
The Kaidi team has extensive research accumulation and experience in this project. The IIT clinical study of KD-025 cell injection was previously led by Director Jianming Xu of the Department of Medical Oncology at 301 Hospital. To date, the low-dose escalation has been completed, and preliminary clinical data shows that this product has good safety and anti-tumor efficacy in subjects. Its clinical safety and efficacy are superior to domestic and international competitors targeting the same site. It is anticipated that, with the support of an excellent clinical team, the numerous advantages of KD-025 cell injection can bring clinical benefits to more patients with solid tumors.