Biosyngen received FDA approval for Phase I/II Clinical Trials for BRL03, targeting Lung Cancer, Gastric Cancer and other advanced Solid Tumors

12 September 2023

Biosyngen Pte Ltd (referred to as "Biosyngen") has announced that the U.S. FDA has granted clearance for the Investigational New Drug (IND) application for the Phase I/II clinical trial of BRL03. This clinical trial aims to evaluate the efficacy of BRL03 in the treatment of lung cancer, gastric cancer, and other advanced solid tumors. The approval of the IND application for BRL03, the company's third first-in-class therapy, represents a significant achievement in the field of cell and gene therapy (CGT).

Notably, BRL03 is Biosyngen's first TCR-T (T-cell receptor T-cell) product to enter clinical trials. This milestone is attributed to the company's advanced technology and extensive experience and resources accumulated over the years.

The company's IDENTIFIER technology platform, developed independently by Biosyngen, plays a crucial role in the discovery and identification of antigens, antibodies, and TCRs (T-cell receptors). Using TCR and tumor proteome databases from thousands of individuals, Biosyngen can rapidly screen and optimize TCRs to meet various therapeutic needs. With the IDENTIFIER platform, Biosyngen has selected TCRs with high specificity and affinity for a wide range of solid tumors, making them suitable for a broad patient population. Additionally, the company's MSE-T technology platform allows T cells to persistently exert tumor-suppressing effects in the solid tumor microenvironment through additional functional module components, making them less susceptible to depletion.

Biosyngen has achieved significant milestones in recent months, including the approval of BRG01, an EBV-targeted CAR-T cell therapy for nasopharyngeal cancer, for Phase I/II clinical trials by the U.S. FDA and NMPA. It is anticipated that the Phase I clinical trial of BRG01 will conclude by the end of 2023.

Furthermore, the IND application for the use of BRG01 in the treatment of EBV-positive lymphoma received approval from NMPA and the U.S. FDA in April of this year.

The successful submission of the IND application for BRL03 underscores the company's strategy of maintaining a diverse pipeline of therapies. In addition to CAR-T therapies, BRL03 will become Biosyngen's flagship asset in the TCR-T field, with ongoing advancements in clinical studies and regulatory consultations.

Biosyngen is currently in the process of submitting the IND application for BST02, its fourth therapy in the company's pipeline. With the addition of this TIL (tumor-infiltrating lymphocyte) therapy, Biosyngen solidifies its position as a promising biopharmaceutical company with global ambitions, boasting assets in all three major T-cell therapy types: CAR-T, TCR-T, and TIL.

Biosyngen remains dedicated to its mission of addressing unmet clinical needs and striving to become a global leader in the development of innovative drugs.