SINGAPORE, Feb. 1, 2024 /PRNewswire/ — Biosyngen is proud to announce that its latest groundbreaking product, BST02, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA) for the treatment of all types of liver cancer, including hepatocellular carcinoma and cholangiocarcinoma.
Fast track is a process designed to facilitate development, and accelerate the review of drugs to treat serious or life-threatening conditions and fill an unmet medical need. This designation is anticipated to expedite the advancement of clinical trials and the registration of pharmaceutical products for marketing purposes.
BST02 has received approval from the FDA for Phase I/II clinical trial in October 2023 and has also been approved by the Center for Drug Evaluation (CDE) of the China National Drug Administration in January, 2024. This marks the first TIL cell therapy drug for liver cancer to progress to the clinical stage globally. Furthermore, another product from Biosyngen, BRG01, was granted fast track designation in July 2023.
Michelle Chen, co-founder and CEO of Biosyngen, expressed gratitude towards the FDA for acknowledging the company’s fourth product. She emphasized the company’s commitment to advancing cell therapy for cancer globally and providing innovative treatment solutions for diverse patient populations. Michelle reiterated Biosyngen’s dedication to leveraging its advanced technology platforms to offer more effective and accessible treatment options for patients worldwide.
BST02, a T cell therapy based on the expansion of the patient’s own tumor infiltrating lymphocytes, falls within the category of adoptive immune cell therapy technology. It holds promise for the treatment of all types of liver cancer, offering new hope for patients. In contrast to traditional TIL therapies, BST02 offers numerous benefits, including the ability to overcome distance constraints due to its cryopreserved form and the reduced need for high doses of interleukin-2.
Biosyngen is dedicated to the R&D of innovative pharmaceutical products aimed at addressing unmet clinical need in oncology. Moving forward, Biosyngen intends to maintain its emphasis on conducting research in this domain for the betterment of patients globally.