SCG142 Demonstrates 100% Disease Control Rate in First-in-Human Trial for HPV-Associated Cancers
核心洞察
SCG Cell Therapy (搜索) reported that all seven patients treated with SCG142, an HPV E7 (搜索)-specific TCR T cell therapy, experienced tumor shrinkage in a Phase I trial for recurrent or metastatic HPV-associated carcinomas (搜索).
Four patients (57%) achieved greater than 30% tumor reduction, including two confirmed partial responses and two unconfirmed partial responses, with no dose-limiting toxicities reported.
The therapy targets HLA-A*02:01-positive patients with advanced HPV16- or HPV52-positive carcinomas (搜索) who have progressed on prior systemic therapy.
SCG Cell Therapy (搜索) has announced promising first-in-human clinical results for SCG142, a novel HPV E7 (搜索)-specific T-cell receptor-engineered T (TCR T) cell therapy, showing a 100% disease control rate in patients with recurrent or metastatic HPV-associated carcinomas (搜索). The data was presented at the European Society for Medical Oncology (ESMO) Congress 2025 in Berlin on October 18, 2025.
Clinical Trial Results Show Universal Tumor Response
The ongoing Phase I trial (NCT06544720) evaluated SCG142 in seven patients with advanced HPV16- or HPV52-positive carcinomas (搜索). All treated patients experienced tumor shrinkage, resulting in a disease control rate of 100%. Notably, four patients (57%) achieved greater than 30% tumor reduction, including two confirmed partial responses and two unconfirmed partial responses.
The therapy demonstrated a favorable safety profile, with no dose-limiting toxicities or serious adverse events reported as of the data cut-off. This safety profile supports the continued clinical development of SCG142 for HPV-associated malignancies.
Novel TCR T Cell Therapy Design
SCG142 is engineered as an HPV E7 (搜索)-specific TCR T cell therapy equipped with a TGFβRII-41BB (搜索) chimeric switch receptor. The therapy was developed using SCG's proprietary GianTCR™ screening platform, which identifies fully natural TCRs with high affinity and high avidity properties while maintaining a lower risk of off-target toxicity.
"We are delighted that the excellent preclinical profile of our HPV-E7-specific TCR - including high avidity and dual functionality in both CD8+ and CD4+ T cells - has translated into clinical activity with SCG142," said Dr. Susanne Wilde, VP, Head of Preclinical Research of SCG Cell Therapy (搜索).
Patient Population and Trial Design
The trial enrolled HLA-A*02:01-positive patients with advanced HPV16- or HPV52-positive carcinomas (搜索) who had progressed on or were intolerant to at least one prior systemic therapy. Key endpoints include safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity.
Prof. Dr. Yang Li, Director of Medical Oncology at The First Affiliated Hospital of Guangxi Medical University, commented: "SCG142 is a novel and differentiated HPV-specific TCR T cell therapy with promising clinical activity. We're excited that tumor shrinkage was observed in all seven treated patients and that SCG142 was well tolerated."
Addressing Significant Medical Need
HPV infection represents a major global health burden, accounting for more than 90% of anal and cervical cancers, about 70% of vaginal and vulvar cancers, and 60% of penile and oropharyngeal cancers. The virus causes an estimated 690,000 cancers worldwide each year, making it the most common sexually transmitted infection with significant oncological implications.
Broader Pipeline Development
Beyond SCG142, SCG Cell Therapy (搜索) is advancing SCG101, a hepatitis B virus (HBV)-specific TCR T cell therapy for the treatment of HBV-related hepatocellular carcinoma (搜索). The company focuses on developing immunotherapies targeting the most common cancer-causing infections: HPV, HBV, and EBV, utilizing their comprehensive platform that covers the entire value chain from target discovery through manufacturing and clinical development.