来源: Pharmaceutical Technology
来源: Pharmaceutical Technology
The designation will accelerate the clinical trial process and marketing registration for BST02. BST02 utilises adoptive immune cell therapy technology, expanding the patient’s own tumour-infiltrating lymphocytes. This approach offers potential benefits over standard tumour-infiltrating lymphocyte (TIL) therapies, including the ability to be cryopreserved and transported and a reduced requirement for high doses of interleukin-2. In October 2023, the company received FDA approval to commence the Phase I/II clinical trials of the cell therapy.
来源: Pharmaceutical Technology
来源: Pharmaceutical Technology
This marks a significant milestone as BST02 becomes the first TIL cell therapy drug for liver cancer to enter clinical stages globally. The FTD for BST02 follows a similar designation for another Biosyngen product, BRG01, in July 2023. Biosyngen aims to continue its research efforts to improve patient outcomes worldwide. Biosyngen co-founder and CEO Michelle Chen expressed her gratitude to the FDA for recognising the company’s fourth product. She highlighted the company’s commitment to advancing cancer cell therapy across the globe and offering new treatments for a diverse patient population. Chen reaffirmed the company’s dedication to using its advanced technology platforms to deliver accessible therapies for patients around the world.
Cell & Gene Therapy coverage on Pharmaceutical Technology is supported by Cytiva.
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