On January 2, SCG (SCG SCIENCE (DALIAN) CO., LTD) announced that the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) had approved the Investigational New Drug (IND) application for its next-generation human papillomavirus (HPV)-specific T-cell receptor (TCR) engineered T-cell therapy—SCG142—for the treatment of HPV-related malignant tumors, including cervical cancer, oropharyngeal cancer, head and neck cancer, vaginal cancer, vulvar cancer, and penile cancer.
Human Papillomavirus (HPV) is a virus that can infect the skin and mucous membranes of the human body, leading to various malignant tumors. It is mainly transmitted through sexual contact but can also be transmitted vertically from mother to child. Approximately 5% of cancers worldwide are caused by HPV infection. Taking cervical cancer as an example, nearly 100% of cervical cancer cases are caused by HPV infection. Globally, there are about 660,000 new cases of cervical cancer each year, with approximately 350,000 deaths, making it one of the most common malignant tumors among women worldwide.[1,2]At the same time, HPV-related tumors in men are also rapidly increasing worldwide but lack attention and emphasis. Currently, patients with advanced HPV-related tumors still lack effective treatment options, representing a significant unmet clinical need.SCG142, developed by SCG SCIENCE (DALIAN) CO., LTD, is a highly differentiated "next-generation" TCR-T cell therapy product based on the company's globally leading GianTCR technology.TMExclusive Technical Platform Successfully Screens Ultra-High Affinity Fully Natural HPV-Specific TCR, Paired with SCG Science’s Self-Developed Novel Chimeric Switch Receptor Pluripotent T Cell Enhancement Module. This Breakthrough Innovation Offers Unparalleled Advantages Compared to Traditional TCR-T Cell Therapy, Enabling T Cells to Overcome the Suppressive Tumor Microenvironment While Further Enhancing the Proliferation and Tumor-Killing Effects of CD8+ and CD4+ TCR-T Cells—A Critical Factor for Achieving Breakthrough Efficacy in Solid Tumors.In May 2024, at the 27th Annual Meeting of the American Society of Gene and Cell Therapy held in Baltimore, USA, SCG SCIENCE (DALIAN) CO., LTD presented the preclinical data of SCG142 in an oral presentation, immediately drawing widespread attention and strong reactions from the industry. The research data shows that the new generation SCG142, through chimeric switch receptor enhancement technology, can effectively dual-activate CD8+ and CD4+ TCR-T cells without relying on CD8 co-receptor signals. In a highly immunosuppressive tumor microenvironment, it exhibits potent anti-tumor activity and promotes the long-term persistence of memory T cells, ensuring durable and significant therapeutic effects of the immune cell therapy. Additionally, the high-affinity characteristics of SCG142 enable it to simultaneously recognize various HPV virus-related tumors, including cervical cancer and head and neck cancer associated with HPV-16 and HPV-52 genotypes, significantly increasing patient population coverage.
Susanne Wilde, Ph.D., Global Vice President of R&D, SCG SCIENCE (DALIAN) CO., LTDDr. Ke Zhang, Chief Scientific Officer of SCG SCIENCE (DALIAN) CO., LTD, stated:
SCG142, as the world's first "next-generation" cell therapy product based on innovative chimeric switch receptor technology, has been approved for clinical trials. This marks a continuous breakthrough and steady progress of SCG SCIENCE （DALIAN）CO.,LTD in the frontier field of cell therapy. Encouragingly, SCG142 has successively obtained approval from the U.S. Food and Drug Administration (FDA) and Singapore’s Health Sciences Authority (HSA) for Phase I/II new drug clinical trials (IND), and was quickly approved in China at the same time. These important milestones indicate that the global clinical trial layout of SCG142 is accelerating comprehensively, bringing new hope to patients with HPV-related malignant tumors worldwide. More importantly, following SCG101 (HBV-specific TCR-T cell therapy), which became China's first clinically approved TCR-T cell therapy drug for liver cancer treatment, SCG142 is another TCR-T product from SCG SCIENCE that has gained simultaneous approval from regulatory authorities in the United States, China, and Singapore. This demonstrates our ability to develop diverse TCR-T products, offering new therapeutic options for different cancer patients. Behind this achievement lies the strong technical support of SCG SCIENCE’s world-leading and unique TCR discovery platform, laying a solid foundation for the superior performance of its products.
SCG (StarCross Biopharma) is a leading biotechnology company focused on developing novel immunotherapies for infections and their associated cancers. The company is developing a broad and unique range of TCR-T cell therapies targeting the most common cancer-causing infections: Helicobacter pylori, human papillomavirus, and hepatitis B, with the goal of preventing and curing infections and their related cancers. Headquartered in Singapore, SCG's R&D center is located at the IZB Innovation Center in Munich, Germany. The company leverages regional advantages across Singapore, China, and Germany, covering the complete industry value chain from innovative drug discovery, manufacturing, clinical trials, to commercialization. For more information about SCG, please visit www.scgcell.com.References
[1] World Health Organization official website: Human Papillomavirus and Cancer
[2] National Cancer Center, National Clinical Research Center for Cancer: Chinese Expert Consensus on the Use of Human Papillomavirus Nucleic Acid Testing for Cervical Cancer Screening (2022)
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