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SCG Cell Therapy to Begin Phase I Trial of T-Cell Receptor Therapy in HPV-Associated Solid Tumors

NEW YORK – SCG Cell Therapy on Sunday said the US Food and Drug Administration cleared its investigational new drug (IND) application, granting it permission to begin a Phase I/II trial of SCG142, its HPV E7-specific T-cell receptor-engineered T-cell therapy, in patients with human papillomavirus (HPV)-associated solid tumors.

SCG142 is a T-cell receptor-engineered T-cell (TCR T) therapy combined with a TGFβRII-41BB chimeric switch receptor. The therapy was developed using SCG's GianTCR platform.

Singapore-based SCG presented preclinical data for SCG142 earlier this year, showing it had better CD8-positive and CD4-positive TCR T-cell proliferation and tumor inhibition than a TCR T therapy without the chimeric switch receptor. The study also showed that SCG142 could recognize both the HPV-16 and HPV-52 genotypes with no alloreactivity or off-target toxicity.

"By armoring the TCR T cells with the chimeric switch receptor, it overcomes the hostile tumor microenvironment and converts inhibitory effects into a co-stimulatory signal," SCG Cell Therapy CSO Ke Zhang said in a statement. "This process is essential for effective immunotherapy treatment of solid tumors."

The FDA's IND clearance allows SCG to take its second therapeutic candidate into clinical trials. The firm is studying its lead candidate, SCG101, in ongoing clinical trials in hepatitis B virus-associated liver and bile duct cancer. SCG also has a preclinical TCR T therapy candidate in development for Epstein-Barr virus-associated tumors.