Kactus Biosystems' GMP-Grade Cas9 Powers Bioheng's FDA-Approved IND for Off-the-Shelf CD7 UCAR-T Therapy CTD402

Kactus Biosystems (Shanghai) Co., Ltd. extends its sincere congratulations to its strategic partner, Nanjing Bioheng Biotech Co., Ltd.! Their innovative UCAR-T cell therapy project, CTD402, has officially received FDA IND approval in the United States, marking an important step for this therapy towards international clinical development and bringing new hope to patients worldwide.

Source of the image:https://www.bioheng.com/News_Details/27.html

CTD402 is an allogeneic CAR-T (UCAR-T) cell therapy product targeting CD7 derived from healthy donors, intended for the treatment of T-ALL/LBL. This product avoids fratricide, graft-versus-host disease (GvHD), and host-versus-graft rejection (HvG) through genetic modification while enhancing anti-tumor activity. CTD402 enables single-batch production for multi-patient use, providing an "off-the-shelf" solution for patients in need of CAR-T cell therapy.

In this project, Kactus Biosystems (Shanghai) Co., Ltd. provided high-activity Cas9 protein compliant with GMP standards and corresponding IND application support.Currently, Kactus Biosystems' GMP-grade Cas9 protein has been successfully applied in multiple IND clinical pipelines due to its high activity and excellent batch-to-batch consistency.

In the future, Kactus Biosystems will continue to deepen process development and quality control, empowering partners to accelerate CGT therapy development with more agile responses and more stable supply, jointly promoting the innovative development of the global CGT industry.

Nanjing Bioheng Biotech Co., Ltd. is a clinical-stage company focused on the development of allogeneic "off-the-shelf" universal CAR-T therapies. Established in 2017, the company is committed to developing world-leading allogeneic cell therapy platforms and products to address significant unmet clinical needs in areas such as hematologic malignancies and autoimmune diseases.

Kactus Biosystems is an innovation-driven recombinant protein and protease raw material company, dedicated to serving the development and production of biopharmaceuticals. Kactus Biosystems owns self-built GMP facilities and a certified quality system. In the field of cell and gene therapy, it has laid out products including GMP-grade Cas9 protein and high-fidelity hfCas12Max.^®(HuiDa Gene self-developed), GMP-grade cytosine base editor Accubase^®(Independently developed by Bestanco) and the new tool YolCas12^TM(Yao Tang Biotechnology's self-developed) and other gene editing tool enzymes, among which the GMP-grade Cas9 protein has completed FDA DMF filing and provided support for IND applications of multiple projects.