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mHTV-03E2 is a therapeutic mRNA-lipid nanoparticle (LNP) vaccine candidate designed to treat malignancies and precancerous lesions caused by high-risk human papillomavirus (HPV) types 16 and 18. Developed by researchers at the Institute of Medicinal Biotechnology of the Chinese Academy of Medical Sciences and RinuaGene Biotechnology, the vaccine encodes the E2, E6, and E7 antigens of both HPV16 and HPV18. To enhance safety and immunogenicity, the E6 and E7 proteins are reshuffled to eliminate oncogenic potential while preserving T-cell epitopes. The mRNA sequence is further fused with a tPA signal peptide and the extracellular domain of Flt3L at the N-terminus to facilitate protein secretion and antigen presentation. Preclinical studies indicate that mHTV-03E2 induces robust antigen-specific CD8+ T-cell responses and E2-specific humoral immunity, leading to significant tumor regression and long-term immunological memory in mouse models.
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