FDA Grants Biosyngen's Innovative Liver Cancer Therapy Fast Track Designation

Biosyngen has achieved a milestone with its pioneering liver cancer treatment, BST02, receiving Fast Track Designation (FTD) from the U.S. Food and Drug Administration (FDA). This designation, marks a pivotal moment in the fight against all types of liver cancer, including hepatocellular carcinoma and cholangiocarcinoma. It represents an important step forward for liver cancer treatment, leveraging innovative adoptive immune cell therapy technology to offer new possibilities for patients.

Michelle Chen, co-founder and CEO of Biosyngen, expressed her gratitude towards the FDA for recognizing the potential of the company's fourth product. She highlighted the company's commitment to advancing cell therapy across the globe and developing innovative treatments for a diverse range of patients.

BST02, which is based on adoptive immune cell therapy technology, utilizes the expansion of patients' own tumor infiltrating lymphocytes. This method represents a groundbreaking approach in the treatment of liver cancer, promising new avenues of hope for patients afflicted by the disease. 

Unlike traditional TIL therapies, BST02 offers significant advantages, including its cryopreserved form that overcomes logistical challenges and a reduced necessity for high doses of interleukin-2, making it a more feasible option for widespread use.

BST02 was approved for Phase I/II clinical trials by the FDA in October 2023, and by the Center for Drug Evaluation (CDE) of the China National Drug Administration in January 2024. This approval heralds BST02 as the first TIL (tumor infiltrating lymphocytes) cell therapy drug for liver cancer to reach the clinical stage worldwide. Notably, another of Biosyngen's products, BRG01, also received Fast Track Designation in July 2023, underscoring the company's ongoing contributions to cancer therapy.

Fast Track Designation is part of the FDA's efforts to hasten the development and review process for drugs that treat serious or life-threatening conditions, thereby addressing unmet medical needs. BST02's receipt of this status is expected to streamline the clinical trial phases and the pharmaceutical product's registration for marketing, potentially bringing this innovative treatment to patients more swiftly.