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RBLO16.1 is an investigational therapeutic mRNA vaccine developed by the University Hospital Southampton NHS Foundation Trust for the treatment of human papillomavirus (HPV)-driven malignancies. The vaccine specifically targets HPV type 16, encoding the E6 and E7 oncoproteins which are constitutively expressed in HPV-associated cancer cells and are essential for oncogenesis. By delivering these antigens via mRNA, RBLO16.1 aims to prime and expand tumor-specific CD8+ and CD4+ T-cell responses. In clinical development, notably the Phase 1 HARE trial, RBLO16.1 is administered via ultrasound-guided intranodal injection to optimize delivery to secondary lymphoid organs. The vaccine is being evaluated both as a monotherapy and in combination with Chi Lob 7/4, an agonistic anti-CD40 monoclonal antibody designed to enhance dendritic cell maturation and T-cell activation, in patients with HPV16-positive squamous cell carcinomas of the head and neck, cervix, penis, and anogenital region.
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