The Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has granted clearance for Biosyngen’s Phase II clinical trial of BRG01 to treat recurrent or metastatic Epstein-Barr virus (EBV)-positive nasopharyngeal carcinoma.
BRG01 is an autologous EBV-specific chimeric antigen receptor T-cell (CAR-T) therapy.
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It is engineered to express chimeric receptors to target the EBV antigen on the T-cell surface.
BRG01 is claimed to be the first CAR-T therapy for a solid tumour to receive clinical trial approvals in both China and the US.
The Phase I trial, which concluded subject enrolment in January, has shown promising results with a 75% response rate in high-dose patients.
This study assessed dose-limiting toxicity and preliminary efficacy in nine subjects, all of whom had previously received immune checkpoint inhibitors.
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By GlobalDataThe therapy demonstrated safety, with significant tumour remission and anti-EBV activity in some patients.
After receiving Phase I approval from the CDE in December 2022 and the US FDA in February 2023, the cell therapy was also granted orphan drug and fast-track designations by the FDA last year.
The therapy’s potential extends beyond nasopharyngeal carcinoma, with ongoing Phase I studies for EBV-positive lymphoma following approvals from both the CDE and FDA.
Biosyngen co-founder and CEO Dr Michelle Chen said: “The approval of BRG01 for a pivotal Phase ll clinical trial is a major milestone for Biosyngen and underscores our commitment to developing innovative cell therapies to address significant unmet needs in solid tumours.
“We plan to continue investing in research and development to expedite the clinical progress and market availability of BRG01, offering more effective treatment options for patients worldwide.”
