IND Application of Biosyngen's Cell Therapy (BRG01) for Nasopharyngeal Cancer Approved by China NMPA

GUANGZHOU,China,Dec. 15,2022 -- On Dec. 14th,2022,Guangzhou Biosyngen Co.,Ltd. (hereinafter as "Biosyngen") made an announcement on the approval granted by the Center for Drug Evaluation (CDE) of China's National Medical Products Administration (NMPA) for the company's IND application for BRG01 Therapy. BRG01 Therapy 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.

(CDE: https://www.cde.org.cn/main/xxgk/listpage/4b5255eb0a84820cef4ca3e8b6bbe20c)

"The IND approval of BRG01 Therapy marks a significant milestone for the company and in nasopharyngeal cancer treatment." said Joan Zhang,Chairman of Biosyngen. "As a biopharmaceutical company in immunotherapy,Biosyngen is committed to deliver more effective cancer therapy to address unmet needs for the benefit of cancer patients. Following this milestone,based on the company's pipeline,Biosyngen has begun planning for multiple sponsor-initiated clinical trials which will lead to IND applications in China,the US and Singapore in the course of 2023. The indications targeted are hepatocellular cancer,colorectal cancer,gastric cancer,esophageal cancer and pancreatic cancer. Looking ahead,Biosyngen is assessing the marco environment in preparation for IPO within the next 18 months."

About BRG01

EBV is a human herpesvirus and has infected about 95% of population worldwide. 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.

Though,existing practice such as immune checkpoint inhibitor has been applied in second-line and beyond treatment of nasopharyngeal cancer,overall response rates were mostly below 30%. In another words,more than 70% patients did not benefit from the existing therapy. Therefore,it is imperative to explore new approaches to improve efficacy and satisfy unmet medical needs.

BRG01 Therapy 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 the 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 greatly improved the company's capability to overcome challenges in antigen identification,antibody TCR screening and identification of immune cell function.

Abou Biosyngen

With R&D powered by scientists from Singapore,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,gastrointestinal cancer and EBV-positive hematological malignancies. Biosyngen is also one of a few biopharmaceutical companies that possess a pipeline portfolio covering CART,TCRT,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,Sun Yat-Sen University Cancer Center to advance R&D and conduct clinical trials in Singapore,Australia and China.

Utilizing our strong R&D capability and translational medicine platform,we have been able to engage the end-to-end cycle of drug development including lead identification,preclinical studies,cell production,quality control,regulatory filing and clinical studies - integrating the entire chain of R&D,clinical,manufacturing and commercialization.