SINGAPORE, July 12, 2023 /PRNewswire/ — On July 6, 2023, Biosyngen received an official notification from the U.S. Food and Drug Administration (FDA) granting Fast Track Designation (FTD) to its revolutionary first-in-class immunotherapy, BRG01, for the treatment of relapsed/metastatic nasopharyngeal carcinoma.
Fast Track Designation (FTD) aims to facilitate the development of drugs targeting severe or life-threatening diseases that have the potential to address unmet clinical needs. This designation enables expedited approval processes and streamlined market access for the drug.
BRG01, an immunotherapy drug developed by Biosyngen, has received regulatory approvals from both the China National Medical Products Administration (NMPA) on December 14, 2022, and the U.S. Food and Drug Administration (FDA) on February 16, 2023 respectively; as an Investigational New Drug (IND) for the treatment of relapsed/metastatic nasopharyngeal carcinoma. Further to that, it was granted Orphan Drug Designation (ODD) by the FDA on June 1, 2023. With this latest news, FDA’s granting of Fast Track Designation to BRG01 signifies a significant acknowledgment of Biosyngen’s advanced technology and product, demonstrating Biosyngen’s strong commitment to developing groundbreaking products with a global market focus. This achievement marks another noteworthy milestone for Biosyngen.
Biosyngen remains steadfast in its commitment to addressing unmet clinical needs and advancing its product pipeline through rigorous and high-quality development. In line with this dedication, the company is on track in Investigational New Drug (IND) applications for innovative therapies targeting lung cancer and liver cancer indications in both China and the United States.
EBV is a human herpesvirus and has infected about 95% of population worldwide. It has been listed as Group 1 carcinogen (“Carcinogenic to humans”) by World Health Organization (WHO) and proved to be associated with a range of diseases including nasopharyngeal cancer, EBV-positive gastric cancers, lymphoma and lymphoproliferative diseases. As one of the most common head and neck tumors, nasopharyngeal cancer, an epithelial carcinoma arising from the nasopharyngeal mucosal lining, is closely related to EBV infection. According to WHO, an estimated number of 133,000 new cases of nasopharyngeal cancer worldwide was reported in 2020; 50% of which was diagnosed in China. South China provinces such as Guangdong and Guangxi provinces make up for more than 60% of nasopharyngeal cancer patient population.
BRG01 Therapy developed by Biosyngen is an engineered T cell therapy, also known as a type of adoptive immune cell therapy for nasopharyngeal cancer treatment. Patients’ T cells were isolated and genetically modified in a GMP-compliant facility to enhance their ability to recognize and attack specific antigens on cancer cells. The modified T cells are expanded ex vivo and infused back into the patient. The infused T cells would bind to the specific antigen on the cancer cells to mediate tumor killing. The preliminary safety and efficacy of BRG01 Therapy have been demonstrated in data from exploratory clinical trials.