SCG Cell Therapy Announces FDA IND Clearance for SCG142, a Next-Generation HPV E7-Specific TCR-T Therapy for HPV-Associated Solid Tumors

Recently,SCG SCIENCE（SCG Cell Therapy) announced that the U.S. Food and Drug Administration (FDA) has approved its Investigational New Drug (IND) application for SCG142, allowing the initiation of Phase 1/2 clinical trials for SCG142. SCG142 is aNovel Next-Generation HPV E7-Specific T Cell Receptor Engineered T Cell (TCR-T) Therapy for Patients with HPV-Related Solid Tumors。

Human Papillomavirus (HPV) is a spherical DNA virus that can cause various benign or malignant tumors. E7 is the major oncogene encoded by HPV, so TCR-T targeting HPV E7 is a key option for treating HPV-related advanced malignant tumors, with significant value for product development and application.。

SCG142, as a new drug under development, isNext-Generation Chimeric Switch Receptor-Enhanced TCR-T Cell Therapy Product. Core technology isUtilizing its exclusive GianTCR^TMTechnical Platform Successfully Screens and Isolates Natural High-Affinity HPV-Specific TCRCompared with traditional TCR-T cell therapy, it can significantly enhance T-cell proliferation and tumor suppression effects, demonstrating specific tumor-killing activity against various tumors related to HPV-16 and HPV-52 genotypes, such as cervical cancer. It is suitable for various malignant tumors caused by HPV, including cervical cancer, oropharyngeal cancer, head and neck cancer, vaginal cancer, vulvar cancer, and penile cancer.

SCG SCIENCEThingCEO Christy Ma stated, "This is another IND application for our TCR-T cell therapy candidate approved by the FDA, which is...SCG SCIENCEThing"This is an important milestone, marking the progress of our TCR-based therapeutic program. We are ready to initiate a multi-center Phase 1/2 clinical trial to evaluate the potential benefits for patients through our proprietary TCR-T technology."

▲ TCR-T Cell Therapy Platform       

In May this year, at the "27th Annual Meeting of the American Society of Gene & Cell Therapy" held in Baltimore, USA,SCG SCIENCEObjectThe research data of SCG142 was announced in the form of an oral presentation.Results ShowSCG142 TCR-T Cell Therapy Demonstrates Excellent Antitumor Activity and Good Safety in HPV-Related Tumor Models。SCG142 can dual-activate CD8+ and CD4+ TCR-T cells independently of CD8 co-receptor signaling, trigger potent anti-tumor activity in an immunosuppressive tumor microenvironment, and promote the long-term persistence of memory T cells, which are key factors for achieving durable efficacy in immune cell therapy.In addition, SCG142'sHigh AffinityFeatures: Effectively identify various HPV virus-related tumors induced by HPV-16 and HPV-52 genotypes, significantly improving patient population coverage.

SCG SCIENCEThingDr. Zhang Ke, Chief Scientific Officer, stated: "SCG142 is a novel and differentiated HPV-specific TCR-T cell therapy. ThroughEquipping T cells with chimeric switch receptors overcomes the adverse tumor microenvironment, converting inhibitory effects into costimulatory signals.. This process is crucial for the effective treatment of solid tumors with immunotherapy. It represents a breakthrough innovation, converting our internal discovery platform into clinical applications."

SCG SCIENCEObjectSCG SCIENCE （DALIAN）CO.,LTD is a leading biotechnology company focused on developing novel immunotherapies to treat infections and their associated cancers. The company has developed a broad and unique range of TCR-T cell therapies targeting the most common carcinogenic infections: Helicobacter pylori, HPV, HBV, and EBV, with the goal of preventing and curing infections and their related cancers.SCG SCIENCEThingHeadquartered in Singapore, with its R&D headquarters located at the IZB Innovation Center in Munich, Germany, the company leverages the regional advantages of Singapore, China, and Germany, covering the complete industrial value chain from innovative drug research and development, production, clinical trials, to commercialization.