Biosyngen's Fourth-Generation TCR-T Therapy BRL03 Receives CDE IND Acceptance Following FDA Approval for Multiple Solid Tumors

Oct 26, 2023 07:19 CST Updated 07:20

Biosyngen

Developer of Innovative Immune Cell Technology Products

On October 25, 2023, according to the CDE official website, the Investigational New Drug (IND) application for BRL03 Injection submitted by Biotheus was formally 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 BioGend to enter clinical trials. On September 9 this year,The U.S. FDA Approved the Phase I/II Clinical Trial Application for BRL03。This formal acceptance by the CDE marks another significant advancement for Biotheus.

Baiji Bio's Independent Innovation Technology Platform IDENTIFIER^®The platform provides solid support for the discovery and identification of antigens, antibodies, and TCRs. Currently, thanks to a database of TCRs and tumor proteomes from thousands of individuals, BioGyt can achieve screening to optimization within two weeks to meet different therapeutic needs and identify suitable development assets. Through this platform, BioGyt has screened TCRs with broad target audiences, high specificity, and high affinity for various solid tumors.

And based on another MSE-T independently developed by Biotheus.^®Platform, BRL03 also enhances the durability of T cells in the solid tumor microenvironment through additional functional module components, making them less prone to exhaustion and thus exerting a more sustained 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 Biotheus, 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 reinfused 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

Biotheus 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 options 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 its R&D team with PhDs, 80% graduated from universities ranked in the global top 50. It owns the largest private GMP cell production and R&D bases in South China (in Guangzhou) and the largest private one in Singapore. With a base in Asia and a vision for the world, Biotheus 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 approval (IND) from the Center for Drug Evaluation of the National Medical Products Administration in China and Phase I/II clinical trial approval from the U.S. Food and Drug Administration (FDA). The immunotherapy 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 biotechnology company with a product pipeline covering multiple cutting-edge immune cell therapy fields such as CAR-T, TCR-T, and TIL.

Biotheus has its headquarters in Singapore and Guangzhou, China respectively. It has established close research collaborations with A*STAR (Singapore’s Agency for Science, Technology and Research), Helmholtz Zentrum München (Munich, Germany), Hannover Medical School (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 other tertiary hospitals. Multi-pipeline products are currently undergoing clinical trials in Singapore, Australia, China, and other countries.

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

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