▎Edited by the WuXi AppTec content team

On October 26, the FDA approved the Phase 1/2 clinical trial application for BST02, another innovative product from BioGy Biotech in the field of solid tumors, for the treatment of all types of liver cancer.BST02 Injection is a product derived from the patient's own tumor-infiltrating lymphocytes.（TIL）The T-cell therapeutic products obtained through expansion belong to adoptive immune cell therapy technology.。

Primary Liver Cancer (PLC), commonly referred to 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 globally has 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 the lives and health of patients.

TIL therapy refers to isolating naturally infiltrating lymphocytes from tumor tissue, expanding them in vitro and optimizing their function, and then reinfusing them back into the patient's body.. 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.

BST02 is a TIL therapy, whichBasic PrinciplesYes: Lymphocytes with the specific ability to recognize tumor cell antigens are collected and enriched from the patient's own tumor tissue. These cells are then rapidly expanded in vitro through cytokine induction while maintaining their stemness, to maximize the expansion of T cells with anti-tumor function. They are subsequently reinfused into the patient’s body to ultimately achieve a tumoricidal effect.

The study found that there are some limitations to the application of traditional TIL products, such as requiring the drug manufacturing site to be close to the clinical center, and the need for high-dose interleukin-2 in clinical use, which may bring certain safety risks. According to the press release from Biotheus, their developedBST02 is a cryopreserved product that breaks through the limitations of distance and does not require high-dose interleukin-2 as concomitant medication. Its safety and efficacy have been preliminarily validated in exploratory clinical trials.。

BioG Biotech stated in its press release that as the company's fourth innovative product pipeline, the successful approval of the BST02 clinical trial application marks another significant milestone achieved by BioG Biotech through its globally integrated R&D and commercialization system.Within the past 10 months, four innovative pipelines have successively received IND approval from both China and the U.S., simultaneously covering the three major T-cell therapy fields: CAR-T, TCR-T, and TIL.。