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Biosyngen's BST02 Secures FDA Approval for Investigational New Drug (IND) in Liver Cancer TIL Therapy, a Historic Milestone

Friday, October 27, 2023

Biosyngen has received approval from the US FDA to conduct clinical trials for their TIL therapy, BST02, aimed at treating liver cancer. This therapy is a groundbreaking advancement in cell and gene therapy, making it the first TIL therapy designed for various types of liver cancer to advance to the clinical trial stage.

TIL therapy is centered on the extraction of natural infiltrating lymphocytes from tumor tissue. These lymphocytes are then amplified in a controlled laboratory environment to enhance their functionality before being reintroduced into the patient. This approach offers several significant benefits, including the presence of multiple TCR clones, improved tumor targeting abilities, and reduced harm to healthy tissues. Consequently, TIL therapy holds substantial promise for the treatment of solid tumors.

This milestone marks the fourth first-in-class product in Biosyngen's pipeline to secure IND approval. It underscores the strength of the company's global integrated R&D translational system, as they obtained IND approval for four innovative products in both China and the United States over the past nine months. This achievement solidifies Biosyngen's status as an emerging biotech company with in-house R&D capabilities, specializing in CAR-T, TCR-T, and TIL therapies in the field of T cell therapy.

The use of tumor-specific T cells, including CAR-T, TCR-T, and TIL therapies, represents a significant advancement in solid tumor treatment. While these therapies follow a common development trajectory, they differ in terms of technological approaches and manufacturing processes.

Biosyngen has established robust technology platforms and databases, including IDENTIFIER®, to facilitate the discovery of antigens, antibodies, and TCR, as well as the design of specialized therapeutic products. Through dedicated and consistent efforts, Biosyngen can address unmet clinical demands and advance the development of innovative immunotherapy drugs that offer significant value, ultimately benefiting patients worldwide.

Primary liver cancer, including hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC), is a prevalent malignancy in the digestive system worldwide. Recent data from GLOBOCAN 2020 reveals that liver cancer is now the seventh most common malignant tumor, with approximately 906,000 new cases annually. It also ranks as the second leading cause of cancer-related deaths, with around 830,000 fatalities each year.

In China, primary liver cancer is the fourth most common malignant tumor and the second most deadly form of cancer. Despite China's population accounting for 18.6% of the global population, the country bears a disproportionately high burden of liver cancer, with 410,000 new cases and 391,000 deaths annually. This represents 45.3% and 47.1% of the global incidence and mortality rates, respectively, posing a significant threat to the well-being of the Chinese population.

BST02 is an innovative adoptive immune cell therapy designed for liver cancer treatment, encompassing hepatocellular carcinoma and cholangiocarcinoma.

The core principle involves collecting and enriching lymphocytes that recognize specific antigens in the patient's tumor cells. These lymphocytes are then induced to rapidly proliferate in vitro using cytokines while maintaining their effectiveness. The goal is to maximize the expansion of T cells with anti-tumor properties, which are subsequently reintroduced into the patient to effectively eliminate tumors. Traditional TIL therapies face certain limitations, such as the need for proximity to the clinical center for production and the requirement for high doses of interleukin-2, which can have safety risks.

BST02 overcomes these limitations through cryopreservation, eliminating distance constraints and the need for high levels of interleukin-2. Preliminary findings from exploratory clinical trials have indicated both safety and efficacy in its use.




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