GTL001 + imiquimod

GTL001 + imiquimod is a combination therapy for the treatment of women infected with human papillomavirus (HPV) types 16 and/or 18 who have normal or mildly abnormal cervical cytology (NILM, ASCUS, or LSIL). The therapy combines GTL001, a bivalent therapeutic vaccine containing recombinant HPV16 and HPV18 E7 proteins fused to a detoxified adenylate cyclase (CyaA) from Bordetella pertussis, with topical imiquimod, an immune response modifier. GTL001 is designed to induce an antigen-specific immune response by targeting CD11b-positive antigen-presenting cells, leading to the activation of CD8+ T cells specific for HPV16/18 E7, resulting in clearance of HPV-infected cells. Imiquimod serves as a topical adjuvant, enhancing the immune response at the injection site. Together, the combination was intended to eradicate persistent HPV infection and prevent progression to high-grade cervical lesions, though phase 2 trial data did not show statistical improvement in viral clearance over placebo[1][2][3][4].