Biosyngen receives US FDA Nod to begin phase lI trial of Cell therapy

Biosyngen, a company focused on immuno-oncology, stated that its EBV-specific CAR-T cell therapy, BRG01, has received approval from the US Food and Drug Administration (FDA) to advance into a crucial phase II clinical trial. This is the initial cell therapy to advance to phase II trials in the US and China for relapsed/metastatic EBV-positive nasopharyngeal carcinoma, showing a significant advancement in solid tumor therapy.

Approval for the important phase II clinical trial of BRG01 was previously granted by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China. The phase I clinical trial in China and the US started enrolling patients in late January this year, and all participants have already received the BRG01 infusion. The first phase of the study has finished observing dose-limited toxicity (DLT) and evaluating efficacy in nine patients with advanced nasopharyngeal carcinoma who received at least one previous treatment of immune checkpoint inhibitors, such as PD-1 antibodies.

Initial data suggests that BRG01 shows outstanding safety and early effectiveness. All patients have advanced-stage cancer and have not responded to standard treatment, including checkpoint inhibitors. BRG01 was well received and showed no dose-limiting toxicity in the patient population. Enhanced disease management and reduced tumor size were seen with increasing the dosage. 75% of patients in the high dosage group exhibited necrosis and metabolic decrease in tumor lesions as identified through PET-CT imaging.

Biosyngen's goal is to accelerate the clinical progression and global release of BRG01, bringing a new potential for patients with nasopharyngeal cancer. The FDA approval highlights BRG01's promise in cancer and antiviral treatments and acknowledges Biosyngen's advancements in cellular immunotherapy research and development.