Biosyngen's BRG01 Enters Phase II Trial for Nasopharyngeal Carcinoma

Biosyngen, a pioneering biotechnology company, has announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in China has approved the commencement of a pivotal Phase II clinical trial for BRG01. This therapy, which is an autologous Epstein-Barr virus (EBV) specific chimeric antigen receptor T-cell (CAR-T) treatment, is designed for patients with recurrent or metastatic EBV-positive nasopharyngeal carcinoma. This milestone marks BRG01 as the first CAR-T therapy for solid tumors to receive clinical trial approvals in both China and the U.S.

Professor Zhang Li, the principal investigator for the BRG01 clinical trial, highlighted the importance of this approval. He noted that the robust preclinical data and promising early clinical results underscore the potential of BRG01 to offer meaningful clinical benefits to patients with challenging EBV-positive tumors.

The Phase I clinical trial of BRG01, which included patient enrollment in both China and the U.S., concluded in January. All participants received BRG01 infusions, and the study successfully completed assessments of dose-limiting toxicity (DLT) and preliminary efficacy in nine patients with advanced nasopharyngeal carcinoma who had previously been treated with at least one immune checkpoint inhibitor. Initial data from this study demonstrated excellent safety and encouraging clinical activity. Specifically, 75% of high-dose patients experienced local tumor shrinkage and reduced metabolic activity, with some achieving complete remission of their tumor lesions. Furthermore, the treatment showed significant reductions in peripheral blood EBV viral load, emphasizing its potential in tumor and antiviral therapy.

BRG01 is an autologous T cell immunotherapy engineered to express chimeric receptors targeting the EBV antigen on T cells. This innovative therapy represents a new generation of CAR-T cell treatments specifically designed to target EBV. The therapy received Phase I clinical trial approval from the CDE in China in December 2022 and from the FDA in the U.S. in February 2023. Additionally, the FDA granted BRG01 orphan drug designation (ODD) and fast track designation (FTD) in mid-2023.

Biosyngen's preclinical research on BRG01 was presented at the annual Meeting of the American Society of Gene and Cell Therapy (ASGCT) in May and published in Frontiers in Immunology. Further insights were shared at the Gordon Research Conference (GRC) on Nasopharyngeal Carcinoma in Switzerland in June by Professor Renata Stripecke, a key scientist and pipeline inventor at Biosyngen.

While significant advancements have been made in cell therapy drugs for hematological malignancies, progress in solid tumor treatments has been slower. However, the accelerated approval of Iovance's tumor-infiltrating lymphocyte (TIL) therapy, lifileucel, for advanced melanoma has bolstered confidence in the commercial potential of solid tumor cell therapies. This underscores the need for a unique and comprehensive approach to address the challenges posed by solid tumors, including considerations of technology, target selection, and clinical needs.

Nasopharyngeal carcinoma, an epithelial carcinoma linked to EBV infection, remains a significant health issue, particularly in regions like South China. Existing treatments such as immune checkpoint inhibitors have limited efficacy, with overall response rates below 30%, highlighting the urgent need for new therapies.

Biosyngen's CAR-T cell therapy for nasopharyngeal carcinoma leverages the EBV target, showing significant potential in treating EBV-positive lymphoma as well. In April 2023, BRG01 received approvals for clinical trials in this new indication from both the CDE and FDA, with Phase I clinical studies currently underway.

Dr. Michelle Chen, Co-Founder and CEO of Biosyngen, emphasized the importance of the Phase II clinical trial approval for BRG01, viewing it as a major milestone that reaffirms the company's commitment to developing cell therapies for solid tumors. She expressed optimism about the rapid progress and potential new treatment options that could arise from continued investment in research and development.

With Biosyngen's efficient operations and focus on innovation, there is hope for significant advancements in solid tumor cell therapies, offering new possibilities and hope to patients in the near future.