Biosyngen has announced that its investigational new drug (IND) filing for the first-in-class (FIC) drug candidate BRG01 has been accepted for review by the Center for Drug Evaluation (CDE). This marks a significant milestone in the development of BRG01, an innovative therapy for the treatment of relapsed/metastatic nasopharyngeal cancer (NPC).
BRG01: Autologous T Cell Therapy
BRG01 is an autologous T cell therapy designed to treat relapsed/metastatic nasopharyngeal cancer. The therapy involves genetically modifying patients’ own T cells to express an additional receptor for Epstein-Barr virus (EBV) antigen recognition and T cell activation upon engagement with EBV-positive tumor cells. The process includes isolating and genetically modifying the patients’ T cells in a GMP-compliant facility to enhance their ability to recognize and attack specific antigens on cancer cells. The modified T cells are then expanded ex vivo and infused back into the patient, where they can bind to specific antigens on cancer cells to mediate tumor killing.
Company Overview and Collaborations
Biosyngen holds exclusive licenses and patented therapies targeting multiple solid tumors and hematological malignancies, including nasopharyngeal cancer, gastric cancer, lymphoma, and posttransplant lymphoproliferative disorders. The company collaborates closely with leading biomedical research and clinical institutes worldwide, such as A*STAR, Helmholtz Zentrum München, Hannover Medical School, and Sun Yat-Sen University Cancer Center, to advance the R&D process and conduct clinical trials in Singapore, Australia, and China.-Fineline Info & Tech
