On October 26, 2023, Biosyngen’s TIL therapy BST02 for liver cancer was granted an approval for clinical trial by the US FDA. BST02, a breakthrough product in the field of cell and gene therapy, represents the world's first TIL therapy designed for the treatment of all types of liver cancer to progress into the clinical stage.

TIL therapy involves the isolation of natural infiltrating lymphocytes from tumor tissue, followed by in vitro amplification in a controlled laboratory environment to enhance their functionality. These optimized lymphocytes are subsequently re-infused into the patient. TIL therapy offers several notable advantages, including the presence of multiple TCR clones, enhanced tumor homing capabilities, and reduced targeted toxicity. As a result, TIL therapy brings significant promise and benefit in the treatment of solid tumors.

The approval of the BST02 (TIL therapy) is another significant achievement for Biosyngen, as it marks the fourth first-in-class product in the company’s pipeline that secured IND. This milestone has been made possible through the utilization of Biosyngen’s distinct and effective global integrated R&D translational system. Over the course of the past nine months, Biosyngen has obtained IND approval in both China and the United States for four innovative products. This accomplishment solidifies the company’s position as an emerging biotech with in-house R&D capabilities, specializing in CAR-T, TCR-T, and TIL therapies in the field of T cell therapy.

The utilization of tumor-specific T cells, such as CAR-T, TCR-T, and TIL therapies, signifies a significant advancement in the treatment of solid tumors. While these therapies share a common development trajectory, they also diverge in terms of technological approaches; development and manufacturing process also may vary.

Currently, Biosyngen has established comprehensive technology platforms and database, including IDENTIFIER®, which serve as a robust foundation for the discovery and recognition of antigens, antibodies, and TCR, as well as the design of various specialized therapeutic products. Through diligent, consistent and sustainable efforts, , Biosyngen is able to address unmet clinical demands and advance development of innovative immunotherapy drugs that hold significant value, ultimately benefiting patients worldwide.

About BST02

Primary liver cancer, which includes hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC), is a prevalent malignant tumor of the digestive system globally. Recent data from GLOBOCAN 2020 reveals that liver cancer has become the seventh most common malignant tumor, with an estimated 906,000 new cases annually. Furthermore, it ranks as the second leading cause of cancer-related deaths, with approximately 830,000 fatalities each year. In China, primary liver cancer is the fourth most prevalent malignant tumor and the second most lethal form of cancer. Despite China's population accounting for 18.6% of the global population, the country experiences a disproportionately high burden of liver cancer, with 410,000 new cases and 391,000 deaths annually. These figures represent 45.3% and 47.1% of the global incidence and mortality rates, respectively. Consequently, liver cancer poses a significant threat to the well-being of Chinese population.

BST02 is a novel adoptive immune cell therapy that involves the expansion of tumor infiltrating lymphocytes derived from the patient's own cells. This therapy is specifically designed for the treatment of liver cancer, including hepatocellular carcinoma and cholangiocarcinoma.

The fundamental principle involves the collection and enrichment of lymphocytes that possess specific recognition of antigens found in tumor cells from the patient's own tumor tissue. These lymphocytes are then induced to undergo rapid proliferation in vitro through the use of cytokines, the stemness of these lymphocytes is also maintained. This process aims to maximize the expansion of T cells that possess anti-tumor functionality. Subsequently, these T cells are reintroduced into the patient, with the capability to effectively eliminate tumors. However, the application of traditional TIL drugs is subject to certain limitations. For instance, the production of these drugs must be conducted in close proximity to the clinical center, and their clinical use necessitates high doses of interleukin-2, which may pose certain safety risks.

BST02 overcame the limitations mentioned above – through cryopreservation, it addresses the constraints of distance and it eliminates the need for high levels of interleukin-2. Preliminary findings from exploratory clinical trials have demonstrated evidence of its safety and efficacy.