NEW YORK – Biosyngen on Thursday said the US Food and Drug Administration granted approval for a clinical trial of its tumor infiltrating lymphocyte (TIL) therapy BST02 in liver cancer.
The Singapore-based firm developed BST02 using the IDENTIFIER platform, which finds the most suitable antigens in a tumor and rapidly screens antibodies and T-cell receptors against them. Treatment involves isolating natural tumor infiltrating lymphocytes from the patient's tumor, amplifying those with the identified tumor antigens, and re-infusing them into the patient. Biosyngen's TIL therapy comprises multiple T-cell receptor clones, which, according to the company, enhance the cell's ability to target the tumor and reduce toxicity.
The product is the company's fourth TIL therapy to receive investigational new drug approval in the US and China. The company is also developing the autologous CAR T-cell therapy BRG01 in nasopharyngeal cancer and Epstein Barr virus-positive hematologic malignancies, BRL03 in lung cancer, and BGT007 in colorectal, gastric, esophageal, and pancreatic cancer.
Liver cancer is the second-leading cause of cancer death with about 906,000 new cases per year around the world and about 830,000 fatalities. The burden of liver cancer is disproportionately high in China, where there are 410,000 new cases and 391,000 deaths annually, accounting for 45.3 percent of global cases and 47.1 percent of global mortality, respectively.