Biosyngen Submits Prospectus for BRL03, a First-in-Class TCR-T Therapy Targeting Multiple Advanced Solid Tumors Including Lung and Gastric Cancers

On October 25, 2023, according to the CDE official website, the IND application for BRL03 Injection, submitted by BioGend Therapeutics, was officially accepted (Acceptance No.: CXSL2300726) for the treatment of various advanced solid tumors (including lung cancer, gastric cancer, etc.).

BRL03 is the first TCR-T product independently developed by BioRay Biotech to enter clinical trials. On September 9 this year, the U.S. FDA approved the Phase I/II clinical trial application for BRL03. The formal acceptance by the CDE this time marks another significant advancement for BioRay Biotech.

Biotheus' self-developed IDENTIFIER® platform provides solid support for antigen, antibody, and TCR discovery and identification. Currently, thanks to a database of TCRs and tumor proteomes from thousands of individuals, Biotheus can achieve screening to optimization within two weeks to meet different therapeutic needs and identify suitable development assets. Through this platform, Biotheus has screened TCRs with broad target populations that possess both high specificity and high affinity against various solid tumors.

Moreover, based on another MSE-T® platform independently developed by Biotheus, BRL03 also enhances the persistence of T cells in the solid tumor microenvironment through additional functional module components, thereby exerting a more durable anti-tumor effect.

Moreover, BRL03 is also the third globally pioneering exclusive product pipeline of Biotheus. Biotheus will continue to adhere to its mission of always serving unmet clinical needs of patients and developing world-leading original drugs.

About BRL03

Lung cancer is the leading cause of cancer-related deaths globally, with 2.21 million new cases and 1.8 million deaths in 2020. Lung cancer is a heterogeneous disease, broadly divided into two main types: small cell lung cancer (SCLC) and non-small cell lung cancer (NSCLC). Gastric cancer accounts for approximately 1.27 million new cases and 957,000 deaths annually worldwide, ranking third among all malignant tumors. Gastric cancer is also one of the most common malignant tumors in China, with its incidence and mortality accounting for 42.6% and 45.0% of the global total, respectively.

BRL03 Injection, developed by Baiji Biotech, is a gene-modified TCR-T cell product targeting various solid tumors such as advanced lung cancer and gastric cancer. It belongs to adoptive immune cell therapy technology. The basic principle involves collecting immune cells from the patient's blood, genetically engineering them in vitro to enhance the T cells' specific recognition and killing efficacy against tumor cells. After being infused back into the patient’s body, these modified cells can directly kill tumors or indirectly stimulate the body's immune function to attack tumors. Its safety and efficacy have been preliminarily validated in exploratory clinical trials.

About BioGevity

BioSyngen is an innovative pharmaceutical company with international competitiveness, specializing in cell and gene therapy. The company is primarily dedicated to research and innovation in the field of immune cell therapy, striving to provide the best treatment solutions for cancer patients.

Biotheus gathers top scientific research talents from six countries across three regions: Singapore, China, Germany, Australia, France, and the United States. In the Ph.D. R&D team, 80% of members graduated from universities ranked in the global top 50. The company owns the largest private GMP cell production and R&D base in South China (located in Guangzhou) and the largest private one in Singapore. With a foothold in Asia and a vision for the world, it has currently laid out product markets with a scale exceeding 50 billion US dollars.

Biotheus has world-first/best-in-class products in the treatment of nasopharyngeal carcinoma, various gastrointestinal tumors, liver cancer, lung cancer, EBV-positive hematologic diseases, and other solid and hematologic tumors. Its globally exclusive first-in-class BRG01 injection has officially received clinical trial authorization (IND) from the Center for Drug Evaluation of China's National Medical Products Administration and Phase I/II clinical trial approval from the U.S. Food and Drug Administration (FDA). The immunocellular therapeutic drug BRG01 for nasopharyngeal carcinoma has been granted "Orphan Drug Designation" (ODD) and Fast Track Designation (FTD) by the U.S. FDA. Additionally, BRL03 has also received Phase I/II clinical trial approval from the U.S. FDA. Biotheus is also a leading biotech company with a product pipeline that covers various cutting-edge immunocellular therapeutic fields such as CAR-T, TCR-T, and TIL.

Baiji Biotech has its headquarters in Singapore and Guangzhou, China respectively. It has established close research cooperation relationships with the Agency for Science, Technology and Research (A*STAR) in Singapore, Helmholtz Zentrum München in Munich, Hannover Medical School in Germany, Sun Yat-sen University Cancer Center, the First Affiliated Hospital of Zhengzhou Medical University (listed in no particular order), as well as more than ten tertiary hospitals. Multi-pipeline products are undergoing clinical trials in countries such as Singapore, Australia, and China.

Biotheus has established mature technology R&D and transformation platforms in Singapore and Guangzhou. Its technical innovation and accumulation capabilities span the entire drug development cycle, including druggability research, preclinical research, clinical research, and production transformation. The company owns dual GMP manufacturing and new drug R&D bases both in China and internationally, achieving an integrated full-industry-chain layout encompassing R&D, production, and sales.

Editor: Bai Ji

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