Biosyngen has obtained FDA IND clearance of BRG01 for Phase I/II clinical trials against Nasopharyngeal Cancer

18 February 2023 | Saturday | News

February 16th, 2023, Biosyngen Pte Ltd (hereinafter as "Biosyngen") was granted approval by US FDA for the company's IND application for BRG01 cell therapy, path the way for Phase I/II clinical trial. BRG01 is an autologous T cell therapy for relapsed/metastatic nasopharyngeal cancer (NPC) treatment. The principle of autologous T cell therapy is to genetically modify patients' own T cells to express additional receptors for Epstein-Barr virus (EBV) antigen recognition and T cell activation upon EBV+ tumor cell engagement, targeting cancer indications.

Prior to this approval from the US FDA, Biosyngen's BRG01 was granted IND by China CDE on December 14th, 2022. In addition, China CDE has acknowledged the company's IND submission for another indication, targeting EBV+ Lymphoma.

"FDA's approval is a significant milestone to Biosyngen. This is the first in our pipeline to be granted IND approval by FDA, our team is proud of this achievement." Dr Han, Biosyngen VP of Regulatory Affairs with 18-year experience working in FDA. He added, "multi-center clinical trials will be conducted in Singapore and China, these Phase 1 trials will path Biosyngen's entry into various key markets in future."

"BRG01 is an innovative, engineered T cell therapy targeting EBV-associated cancers like nasopharyngeal cancer. We are looking forward to its clinical performance in upcoming Phase I/II studies", said Dr. Darren Wan-Teck Lim, Senior Consultant, Division of Medical Oncology, National Cancer Centre Singapore and Senior Principal Investigator, Institute of Molecular and Cell Biology, A*STAR who is leading clinical studies for BRG01 in Singapore.

Following this milestone, other products in Biosyngen's portfolio are projected to enter IIT/Phase I in 2023, across SingaporeChina and the US. The indications targeted are hepatocellular cancer, colorectal cancer, gastric cancer, esophageal cancer and pancreatic cancer.

Biosyngen is founded in Singapore with an ambition to be a global leader in cell and gene therapy, to address unmet needs and bring superior treatment to patients.

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