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Biosyngen Announces FDA Approval of Phase I/II Clinical Trials for BRL03

Monday, September 11, 2023

Biosyngen has received clearance from the U.S. FDA to proceed with an investigational new drug (IND) application for Phase I/II clinical trials of BRL03, a promising treatment for lung cancer, gastric cancer, and other advanced solid tumours.

BRL03 marks a significant milestone as the first TCR-T (T cell receptor-engineered T cell) product to advance into clinical trials. This therapy involves genetically modifying patients' T cells within a GMP-compliant facility to boost their ability to identify and target specific antigens found on cancer cells. 

These genetically modified T cells are then expanded outside the patient's body (ex vivo) before being reintroduced into the patient. These engineered T cells have the capability to bind to specific antigens present on cancer cells, facilitating the destruction of tumours. Preliminary data from exploratory clinical trials have already shown promising results in terms of both safety and efficacy for BRL03.

BRG01 has also received U.S. FDA approval for commencing Phase I/II clinical trials for the same indications. The Phase I clinical trial for BRG01 is anticipated to be completed by the end of 2023.

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