Biosyngen's Global First-in-Class TIL Therapy BST02 Receives IND Approval from CDE for All Hepatocellular Carcinoma Types, Following FDA Clearance

Nov 06, 2023 07:20 CST Updated 07:20

Biosyngen

Developer of Innovative Immune Cell Technology Products

On November 3, 2023, according to the CDE official website, the IND application for BST02 Injection, submitted by BioGy Biotech, was officially accepted for the treatment of all types of liver cancer.

On October 26 this year,The U.S. FDA Approved the IND Application for BST02's Phase I/II Clinical Trial(Recommended reading original link). The formal acceptance by the CDE marks another significant advancement in BioGend's IND application milestone. BST02 is the world's first TIL cell therapy drug for liver cancer to enter the clinical stage.

TIL therapy refers to the process of isolating naturally infiltrating lymphocytes from tumor tissue, followed by in vitro expansion and functional optimization, and then reinfusing them into the patient’s body. Due to its diverse TCR clonality, selective tumor homing ability, and low off-tumor toxicity, TIL therapy holds significant advantages in the field of cellular immunotherapy for solid tumors.

BST02 is a new generation of TIL therapy developed based on BioGend's globally leading independent innovation technology platform. Compared with traditional TIL therapy, the end-product cells of BST02 exhibit a phenotype with a high proportion of memory T cells and a low proportion of regulatory T cells, demonstrating more sustained tumor-killing capabilities both in vivo and in vitro. Additionally, a low dose of interleukin-2 as an adjuvant treatment can significantly activate its anti-tumor efficacy.

Biotheus will continue to adhere to the mission of always serving unmet clinical needs of patients and developing globally leading original drugs.

About BST02

Primary Liver Cancer (PLC), commonly referred to as liver cancer, is a prevalent malignant tumor of the digestive system worldwide, including hepatocellular carcinoma (HCC) and intrahepatic cholangiocarcinoma (ICC). According to new data released by GLOBOCAN 2020, the annual number of new cases of liver cancer globally reached 906,000, ranking 7th among malignant tumors, with 830,000 deaths, placing it 2nd among causes of cancer-related mortality. Primary liver cancer occurs particularly frequently in China, where it is the 4th most common malignant tumor and the 2nd leading cause of cancer-related deaths. Although China’s population accounts for only 18.6% of the global population, the country sees 410,000 new cases and 391,000 deaths from liver cancer annually, representing 45.3% and 47.1% of the global totals respectively. Liver cancer poses a serious threat to the lives and health of the Chinese people.

BST02 Injection, developed by Bio-Gene, is a T-cell therapy product expanded from the patient's own tumor-infiltrating lymphocytes, used for the treatment of liver cancer (including hepatocellular carcinoma and cholangiocarcinoma), and belongs to adoptive immune cell therapy technology.

The basic principle is to collect and enrich lymphocytes with the ability to specifically recognize tumor cell antigens from the patient's own tumor tissue. These lymphocytes are rapidly expanded in vitro through cytokine induction while maintaining their stemness, to maximize the expansion of T cells with anti-tumor function. These cells are then reinfused into the patient’s body to ultimately achieve a cytotoxic effect on tumors as a form of cellular therapeutic drug. Traditional TIL drugs have certain limitations in application, such as requiring the drug manufacturing site to be close to the clinical center, and the need for high-dose interleukin-2 during clinical use, which may pose potential safety risks.

Baiji Bio's BST02 is a cryopreserved product, which has broken the distance limitation and does not require high-dose interleukin-2 as an adjuvant therapy. Its safety and efficacy have been preliminarily validated in exploratory clinical trials.

About BioGevity

BioSyngen is an innovative pharmaceutical company with international competitiveness, focusing on cell and gene therapy. The company is mainly 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. Within its 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 bases in South China (located 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 global first-in-class/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 new drug clinical trial (IND) has officially received implied permission for clinical trials from the Center for Drug Evaluation of the National Medical Products Administration and Phase I/II clinical trial approval from the U.S. Food and Drug Administration (FDA). The immunocellular therapeutic 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 in the industry with a product pipeline that covers multiple cutting-edge immune cell therapy 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 collaborations 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 other 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. It owns 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.