Cell and gene therapy (CGT) specialist Biosyngen Pte Ltd has announced receiving approval from the US FDA to initiate a Phase I/II clinical study for its BRG01, an autologous T cell therapy for the treatment of relapsed/metastatic nasopharyngeal cancer (NPC). This marks a significant milestone in the development of innovative treatments for NPC, a condition that affects many patients globally.
Prior Approvals and IND Submission
Prior to the FDA approval, BRG01 was given the green light for clinical trials by China’s Center for Drug Evaluation (CDE) on December 14, 2022. Additionally, the CDE has acknowledged the company’s investigational new drug (IND) submission for another indication, targeting Epstein-Barr virus (EBV)-related lymphoma. These approvals and recognitions highlight the potential of BRG01 in addressing significant unmet medical needs.
Biosyngen’s Technology Platforms and Pipeline
Biosyngen, a clinical-stage biotech with headquarters in Singapore and Guangzhou, China, is known for its proprietary technology platforms, including IDENTIFIER, SUPER-T, and MSE-T. The company has multiple products in development, with several expected to enter Phase I/II clinical studies in the near future. These studies will focus on various cancers, including liver, colorectal, gastric, esophageal, and pancreatic cancer, demonstrating Biosyngen’s commitment to advancing cell and gene therapies across multiple disease areas.-Fineline Info & Tech
