Pharma Focus Asia

Biosyngen Receives US FDA Fast Track Designation for BRG01

Wednesday, July 12, 2023

Biosyngen's BRG01 therapy has received Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA) for the treatment of relapsed/metastatic nasopharyngeal carcinoma. 

BRG01 Therapy is an innovative form of immunotherapy known as engineered T cell therapy or adoptive immune cell therapy. In this treatment approach, patients' T cells are isolated and genetically modified in a GMP-compliant facility to enhance their ability to recognise and attack specific antigens present on cancer cells. 

These modified T cells are then expanded outside the body and infused back into the patient. Once infused, the modified T cells bind to the specific antigen on the cancer cells and work to destroy them.

The preliminary safety and efficacy data from exploratory clinical trials have shown promising results, leading to regulatory approvals from both the China National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) as an Investigational New Drug (IND).

These approvals indicate that BRG01 has met the necessary requirements to proceed with further clinical development and evaluation for the treatment of relapsed/metastatic nasopharyngeal carcinoma.

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