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Biosyngen Gets FDA Permission to Start Phase I/II TCR-T Trial

NEW YORK – Biosyngen on Saturday said the US Food and Drug Administration has cleared its investigational new drug application allowing it to begin a Phase I/II trial for BRL03, an autologous T-cell receptor-engineered T-cell (TCR-T) therapy, in patients with lung, gastric, and other solid tumors.

BRL03 is Biosyngen's first TCR-T product to enter clinical trials. It is an adoptive immune cell therapy, in which a patient's own T cells are isolated and genetically modified to better recognize and attack antigens on cancer cells, then reinfused back into the patient.

The Singapore-based firm developed BRL03 using its IDENTIFIER and MSE-T technologies. According to Biosyngen, IDENTIFIER allows it to quickly select T-cell receptors with high specificity and affinity for various solid tumors, while MSE-T makes T cells less easily depleted in solid tumor environments and adds functional components to T cells to enhance their tumor-suppressing features. 

In addition to the TCR-T therapy, Biosyngen is also developing an Epstein-Barr virus CAR T-cell treatment, BRG01, and a tumor-infiltrating lymphocyte treatment, BRL03. The company is studying BRG01 in nasopharyngeal cancer in a Phase I trial in China slated to read out by year-end and in a Phase I/II trial starting in the US. Biosyngen intends to begin studying BRG01 as a treatment for EBV-positive lymphoma in these countries as well and is readying to file an IND-application seeking permission to begin a trial for BRL03.