FDA Approves Phase II Trial for Biosyngen's BRG01

SINGAPORE, Aug. 12, 2024 -- Biosyngen has announced that the U.S. Food and Drug Administration (FDA) has given the green light to its BRG01, an EBV-specific CAR-T cell therapy, to advance into pivotal Phase II clinical trials. This significant milestone marks the first cell therapy to reach Phase II trials in both the U.S. and China for treating relapsed or metastatic EBV-positive nasopharyngeal carcinoma, paving the way for advancements in solid tumor treatment.

The Center for Drug Evaluation (CDE) of the National Medicinal Product Administration (NMPA) in China had earlier granted approval for the same pivotal Phase II clinical trial of BRG01. Patient enrollment for the Phase I clinical trial in both China and the U.S. commenced in late January this year, and all participating patients have now completed the BRG01 infusion. The Phase I trial has successfully passed the dose-limited toxicity (DLT) observation and efficacy evaluation stages in nine patients with advanced nasopharyngeal carcinoma, all of whom had previously undergone at least one treatment with immune checkpoint inhibitors, including PD-1 antibodies.

Initial data from these trials indicate that BRG01 exhibits remarkable safety and preliminary efficacy. The patients involved were all in late stages of cancer and had not responded to standard treatments, including checkpoint inhibitors. BRG01 was well tolerated by patients and showed no signs of dose-limiting toxicity. Improved disease control and tumor reduction effects were observed as doses were increased. In the high-dose group, PET-CT scans showed that 75% of the patients experienced tumor necrosis and metabolic reduction of their tumor lesions.

Biosyngen plans to expedite the clinical development and commercial release of BRG01, offering new hope for patients suffering from nasopharyngeal cancer around the globe. The FDA's approval emphasizes BRG01's potential in both tumor and antiviral therapies and recognizes Biosyngen's innovative capabilities and research and development expertise in cellular immunotherapy.

Biosyngen has positioned itself as a leading biotechnology company with a portfolio of cell therapies, including CAR-T, TCRT, and TIL, aimed at treating various solid tumors and hematologic malignancies. The company has received multiple approvals to proceed with Phase I/II clinical trials in both the U.S. and China for various solid tumors, including lung and liver cancer.

Looking forward, Biosyngen, with its efficient execution and rapid progress in development, expects to achieve further clinical breakthroughs in solid tumor cell therapies. These advancements promise to provide new treatment options and renewed hope for patients battling these challenging conditions.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!