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 Singapore, China 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.
EBV, the first oncovirus identified, is a human herpesvirus and has infected ~95% of global population. It has been listed as Group 1 carcinogen ("Carcinogenic to humans") by World Health Organization (WHO) and proved to be associated with a range of diseases including nasopharyngeal cancer, EBV-positive gastric cancers, lymphoma and lymphoproliferative diseases. As one of the most common head and neck tumors, nasopharyngeal cancer - an epithelial carcinoma arising from the nasopharyngeal mucosal lining, is closely related to EBV infection. According to WHO, an estimated number of 133,000 new cases of nasopharyngeal cancer worldwide was reported in 2020; 50% of which was diagnosed in China. South China provinces such as Guangdong and Guangxi provinces make up for more than 60% of nasopharyngeal cancer patient population in China.
Though existing practice such as immune checkpoint inhibitor has been applied in second-line treatment of nasopharyngeal cancer, overall response rates were generally below 30%. In another words, more than 70% patients did not benefit from existing therapy. Therefore, it is imperative to explore new approaches to improve efficacy and satisfy unmet medical needs.
BRG01 developed by Biosyngen is an engineered T cell therapy, also known as a type of adoptive immune cell therapy for nasopharyngeal cancer treatment. Patients' T cells were isolated and genetically modified in a GMP-compliant facility to enhance their ability to recognize and attack specific antigens on cancer cells. The modified T cells are expanded ex vivo and infused back into the patient. The infused T cells would bind to specific antigen on the cancer cells to mediate tumor killing. The preliminary safety and efficacy of BRG01 Therapy have been demonstrated in data from exploratory clinical trials.
The scientific direction of Biosyngen is focused on targeting multiple solid tumors and hematological tumors. The company has independently developed a number of exclusive technical platforms specifically for cancer immunotherapy, including IDENTIFIER, SUPER-T and MSE-T. These platforms are designed for improved safety and efficacy, equipping the company with capabilities to overcome challenges in antigen identification, antibody TCR screening and identification of immune cell function.
Biosyngen is a clinical stage biotechnology company. With a multinational R&D team, powered by scientists from Singapore, China, Germany, Australia, France and the USA. Biosyngen is dedicated to give cancer patients a second chance by developing first-in-class and best-in-class immunotherapies. Positioned to serve global needs with dual R&D centers and GMP facilities in Singapore and China, Biosyngen's product pipeline potentially addresses an estimated value of 50 billion USD in the global oncology market.
Biosyngen possesses exclusive licenses and patented therapies targeting multiple solid tumors and hematological malignancies including nasopharyngeal cancer, gastric cancer, gastrointestinal cancer and EBV-positive hematological malignancies. Biosyngen is also one of a few biopharmaceutical companies that possess a pipeline portfolio consisting of CAR-T, TCR-T, TIL and multi-specific antibodies.
Based in Singapore and Guangzhou, Biosyngen collaborate closely with the world's leading biomedical research and clinical institutes including A*STAR, Helmholtz Zentrum München, Hannover Medical School and Sun Yat-Sen University Cancer Center to advance R&D, develop products and conduct clinical trials in Singapore, Australia and China.
Through our R&D capability and translational medicine platform, Biosyngen have been able to engage the end-to-end cycle in drug development from lead identification, preclinical studies, cell production, quality control, regulatory filing, to clinical studies - integrating the entire chain of R&D, clinical trial, GMP manufacturing and commercialization.