130 Preclinical results of ProCervix, a first in class, first in indication therapeutic vaccine targeting HPV16/18 infected women

Immune responses and protection against Streptococcus pneumoniae elicited by recombinant Bordetella pertussis adenylate cyclase (CyaA) carrying fragments of pneumococcal surface protein A, PspA

“…CyaA-E7 induced strong cytotoxic T lymphocyte responses and Th1 responses, with secretion of IFN-. In a therapeutic approach, this vaccine led to the regression of tumors induced by TC-1 cells in 100% of mice [35,45]. The success of this strategy supported a phase 1 clinical trial with a CyaA-E7 vaccine targeting HPV16 and 18 (GL0001) in infected women, which showed to be immunogenic and safe [46].…”

GTL001, A Therapeutic Vaccine for Women Infected with Human Papillomavirus 16 or 18 and Normal Cervical Cytology: Results of a Phase I Clinical Trial

“…Imiquimodactivated and matured antigen-presenting cells allow the induction of a strong CD8 þ T-cell immune response (32). In this study, we applied 5% imiquimod cream 15 minutes and 24 hours after vaccination because we previously showed that this timing and dose of imiquimod increases the frequency of HPV16 E7 and HPV18 E7-specific T-cell responses in mice (19) and because other studies have shown that multiple applications of imiquimod are needed for optimal effects (33). In this study, we found that topical imiquimod cream enhanced the cellular immune response but did not have a noticeable effect on reactogenicity.…”

“…In the antigenpresenting cells, the E7 proteins are processed and presented as CD4 þ and CD8 þ T-cell epitopes to T lymphocytes (16). Vaccination of mice with a recombinant CyaA bearing the HPV16 E7 antigen has been shown to induce an anti-HPV E7-specific T-cell response and to eliminate established HPV16 E7-expressing tumors (17)(18)(19). Here, we report the results of a phase I study examining the safety, tolerability, and immunogenicity of GTL001 in women infected with HPV16 or HPV18 who have normal cervical cytology.…”