Biosyngen Pte Ltd, a cell and gene therapy (CGT) biotech with operations in Singapore and Guangzhou, China, has announced receiving Investigational New Drug (IND) approval from the US FDA for its second pipeline product, a T-cell redirection therapy designed for the treatment of EBV-positive lymphoma. This approval follows closely on the heels of the IND application for the same therapy being approved by the National Medical Products Administration (NMPA) of China just a week prior.
Clinical Trial Progress and Global Reach
A few months prior, the company’s first product, BRG01, which targets relapsed/metastatic nasopharyngeal cancer, was cleared to start clinical trials by both the US FDA and China’s NMPA. An IND filing for this product is currently under review by Singapore’s Health Sciences Authority (HSA). Biosyngen plans to submit a series of IND applications for other pipeline products throughout the year, focusing on lung cancer, liver cancer, and digestive track cancers, with a strategic focus on key regions including Singapore, the US, and China.
Therapeutic Approach and Preliminary Clinical Data
The therapy developed by Biosyngen is an engineered T cell therapy, a form of adoptive immune cell therapy, aimed at treating nasopharyngeal cancer and EBV-positive lymphoma. The process involves isolating patients’ T cells and genetically modifying them 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 then infused back into the patient, where they bind to specific antigens on the cancer cells to mediate tumor killing. Preliminary safety and efficacy of BRG01 Therapy have been demonstrated in data from exploratory clinical trials, showcasing the potential of this therapeutic approach.-Fineline Info & Tech
