Biosyngen's TIL Therapy BST02 Granted FDA Fast Track Designation for All Types of Liver Cancer

Feb 01, 2024 16:58 CST Updated 16:58

Biosyngen

Developer of Innovative Immune Cell Technology Products

▎Edited by the WuXi AppTec content team

On February 1, Biotheus announced that the companyInnovative TIL TherapyBST02 Injection Granted Fast Track Designation by U.S. FDAUsed to treat all types of liver cancer (including hepatocellular carcinoma and cholangiocarcinoma). For this indication,BST02Was approved for clinical use in the United States in October 2023.

Primary liver cancer, abbreviated as liver cancer, is a common malignant tumor of the digestive system worldwide, including hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC), among others. According to new data released by GLOBOCAN 2020, the annual number of new cases of liver cancer worldwide reached 906,000, ranking 7th among malignant tumors, with 830,000 deaths, ranking 2nd among malignant tumors. Primary liver cancer is particularly prevalent in China, being a common malignant tumor and a leading cause of cancer-related death, posing a serious threat to patients' lives and health.

BST02 Injection is a T-cell therapeutic product expanded from a patient’s own tumor-infiltrating lymphocytes (TIL), belonging to adoptive immunotherapy technology.。Since TIL hasMultiple TCR Clonality、Selective Tumor Homing AbilityAndLower non-tumor-targeted toxicityTIL therapy has certain advantages in the field of cellular immunotherapy for solid tumors.

According toAccording to publicly available information from Baiji Bio,BST02'sBasic PrinciplesIt involves collecting and enriching lymphocytes with the ability to specifically recognize tumor cell antigens from the patient's own tumor tissue, rapidly expanding them in vitro through cytokine induction while maintaining their stemness, to maximize the expansion of T cells with anti-tumor function, which are then reinfused into the patient’s body to ultimately achieve a therapeutic effect against tumors.BST02Has the potential to treat all types of liver cancer, offering new hope to patients with liver cancer.Compared with traditional TIL drugs, BST02 has more advantages, such as being a cryopreserved product, breaking the distance limitation, and not requiring high-dose interleukin-2 adjuvant therapy, etc.

Co-founder and Chief Executive Officer (CEO) of BioGevityDr. Michelle Chen YijingExpressed gratitude to the FDA for once again highly recognizing BioGena's fourth drug, which is a great encouragement for their relentless efforts. BioGena will continue to uphold its original mission and spare no effort to bring more innovative treatment options to patients from different populations. It will continue to leverage its globally leading technology platform in the biopharmaceutical field, striving to provide global patients with more effective and accessible treatment choices.

References:

[1] Major Release | BioGyt BST02: After Receiving Clinical Approvals in China and the US, Granted Fast Track Designation. Retrieved Feb 1, 2024, from https://mp.weixin.qq.com/s/PbdMegJ5gzOpEDA9ysux1g

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