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The IND application of Biosyngen BRG01 Therapy was accepted by CDE

2022-09-28 18:05 2109

GUANGZHOU, China, Sept. 28, 2022 /PRNewswire/ -- The IND application of Biosyngen BRG01 Therapy has been accepted for review by the Center for Drug Evaluation, China (CXSL2200487)(https://www.cde.org.cn/main/xxgk/listpage/9f9c74c73e0f8f56a8bfbc646055026d). BRG01 Therapy is autologous T cell therapy for relapsed/metastatic nasopharyngeal cancer (NPC) treatment. The principle of the autologous T cell therapy is to genetically modify patients' own T cells to express the additional receptor for Epstein-Barr virus (EBV) antigen recognition and T cell activation upon EBV+ tumor cell engagement.

Dr. Han Deping, CEO and CMO of Biosyngen, said, "The acceptance of IND filing for BRG01 Therapy marks a milestone in nasopharyngeal cancer treatment. With its good safety and preliminary efficacy profile, BRG01 Therapy brings hope and gives a second chance to cancer patients and their families."

EBV is a human herpesvirus and has infected ~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, in 2020, there were about 133,000 new cases of nasopharyngeal cancer worldwide, 50% of which was diagnosed in China. South China provinces like Guangdong and Guangxi provinces makes up for more than 60% of nasopharyngeal cancer patient population.

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 the GMP-compliant facility to enhance their ability to recognize and attack specific antigens on cancer cells. The modified T cells are then expanded ex vivo and infused back to the patient. The infused T cells could bind to the specific antigen on the cancer cells to mediate tumor killing.

About Biosyngen

With R&D powered by scientists from Singapore, China, Germany, Australia, France, and America, Biosyngen is dedicated to give cancer patients a second chance by developing first-in-class and best-in-class innovative immunotherapies. Aiming for the global market with dual R&D centers and GMP facilities set in Singapore and China, Biosyngen owns a product portfolio with potential global market of more than 50 billion USD.

Biosyngen possesses exclusive licenses and patented therapies targeting multiple solid tumors and hematological malignancies including nasopharyngeal cancer, gastric cancer, lymphoma and posttransplant lymphoproliferative disorders. We 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 our R&D process 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 and quality control, regulatory filing and clinical studies, thus integrating R&D, manufacturing and commercialization.

Source: Biosyngen
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