Shanghai-based S丹赛 Bio Successfully Completes FDA Pre-IND Meeting for ICTCAR014, Advancing U.S. Clinical Development of Dual-Targeting CAR-T Therapy for Non-Hodgkin Lymphoma

Recently, Shanghai Si Dan Race BioTechnology Co., Ltd. (hereinafter referred to as “ICT”), located in Zhangjiang Science City, successfully completed its Pre-IND meeting with the U.S. Food and Drug Administration (FDA). During the meeting, the FDA provided positive feedback.

The main agenda of the conference was ICT’s plan to conduct clinical trials of its CAR-T candidate product, ICTCAR014, under an Investigational New Drug (IND) application in the United States. ICTCAR014 is ICT’s flagship CAR-T product in the U.S., targeting CD19 and PD-1 for the treatment of non-Hodgkin lymphoma. Preclinical studies for non-Hodgkin lymphoma are currently underway in the United States, with results indicating that PD-1 inhibition may enhance CAR-T cell function.

To facilitate the clinical development of ICTCAR014 in the United States, ICT recently established a new headquarters in Maryland, USA. Meanwhile, it has partnered with a U.S.-based CDMO to manufacture CAR-T cell products for clinical trials conducted across the country. To ensure the smooth progress of Phase III clinical trials and the Biologics License Application (BLA), ICT is also laying a solid foundation for the commercial manufacturing capacity of its CAR-T technology in the United States.

Dr. Xiao Lei, Chairman and CEO of ICT, stated, “The positive feedback we received from the FDA during the Pre-IND meeting is encouraging and aligns with our plan to submit an Investigational New Drug (IND) application for ICTCAR014 to the FDA in the second quarter of 2019. We greatly appreciate the FDA’s support and guidance, as our goal is to bring novel and targeted immunotherapies to cancer patients in greatest need.”

Victor Lu, former FDA expert and current Senior Vice President and Head of Regulatory Affairs at ICT, stated, “The FDA has supported our detailed plan for clinical studies in the United States and provided valuable feedback on the quality assurance and comparability studies we proposed. We have adhered to these recommendations and are ensuring compliance with the FDA’s regulatory standards for gene-modified cell products. Based on the FDA’s feedback, we have developed a clear and detailed plan and are proceeding with the IND application process according to our original timeline.”

It is reported that ICT’s primary CD19-targeted CAR-T product in China, ICTCAR003, for the treatment of B-cell acute lymphoblastic leukemia, has received domestic IND approval for clinical trials. Meanwhile, ICT also possesses a diverse portfolio of CAR-T products primarily targeting other hematologic malignancies, liquid tumors, and solid tumors.