Biosyngen has announced that its first-in-class CAR-T therapy, BRG01, targeting Epstein-Barr virus (EBV) antigens, has entered a pivotal Phase II clinical trial for the treatment of nasopharyngeal carcinoma (NPC). This follows the presentation of promising Phase I clinical data at the European Society for Medical Oncology (ESMO) Annual Congress in Barcelona, Spain.
Phase I Trial Highlights
The Phase I trial of BRG01 included nine patients with advanced NPC who had previously undergone platinum-based chemotherapy and failed at least one immune checkpoint inhibitor, including PD-1 antibodies. Preliminary data indicated exceptional safety, with no dose-limiting toxicity, neurotoxicity, or grade 2 or higher cytokine release syndrome observed. The most common grade 3 adverse event was transient leukopenia related to the lymphodepletion regimen.
In terms of efficacy, 75% of patients experienced a sustained reduction in tumor burden and diminished metabolic activity, with some lesions achieving complete response (CR) with 100% tumor reduction. Patients treated with BRG01 showed a progression-free survival exceeding six months post-infusion, demonstrating significantly extended antitumor effects compared to checkpoint inhibitors. BRG01 also exhibited remarkable antiviral efficacy, with a significant reduction in EBV viral load in peripheral blood to normal levels post-infusion.
Expert Commentary
Professor Zhang Li, the principal investigator of the Phase I clinical trial and Director of the Phase I Unit at Sun Yat-sen University Cancer Center, stated, "BRG01 has the potential to be a 'first-in-class' T cell therapy for EBV-positive tumors. Its unique mechanism and robust Phase I data instill confidence in its Phase II clinical performance. We look forward to establishing its clinical efficacy through further studies, offering new hope for more patients."
BRG01: A Novel CAR-T Therapy
BRG01 is an autologous T cell immunotherapy that expresses a chimeric receptor targeting EBV antigens through genetic modification. It represents Biosyngen's innovation in next-generation CAR-T cell therapy specifically for EBV. The therapy received clinical trial approval from the CDE in December 2022 and the FDA in February 2023. Subsequently, it was granted orphan drug designation (ODD) and fast track designation (FTD) by the FDA in June and July 2023, respectively.
Biosyngen's Broader Pipeline
Biosyngen is committed to solid tumor cell therapies, with a portfolio that includes CAR-T, TCR-T, and TIL therapies targeting both solid and hematologic tumors. Their product pipelines have achieved regulatory submissions and approvals in both the U.S. and China, covering various solid tumors, including lung and liver cancer.
Company Vision
Dr. Michelle Chen, co-founder and CEO of Biosyngen, stated, "BRG01 is the result of years of hard work by our team and a testament to the recognition of our core technology and research capabilities. Biosyngen is committed to developing innovative drugs that address unmet clinical needs in oncology. In the future, we will continue to increase our R&D investments and expedite the clinical trial and commercialization processes for BRG01, providing more effective and accessible treatment options for patients worldwide."
