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PEK + GPI-0100 is an investigational therapeutic cancer vaccine composed of a recombinant fusion protein (PEK) and a semi-synthetic saponin adjuvant (GPI-0100). The PEK component is a fusion of the Human Papillomavirus type 16 (HPV16) E6 and E7 oncoproteins, linked to a signal peptide (P1) and an endoplasmic reticulum (ER) retention signal (KDEL). This specific molecular architecture is designed to direct the viral antigens to the ER, thereby enhancing their processing and presentation via the MHC class I pathway to stimulate a robust CD8+ T-cell response. GPI-0100 serves as an adjuvant to further augment cellular (Th1) and humoral immune responses while minimizing the toxicity typically associated with traditional saponins like QS-21. The vaccine has been primarily evaluated in Phase 1 clinical trials for the treatment of HPV16-positive cervical intraepithelial neoplasia (CIN), including low-grade and high-grade squamous intraepithelial lesions (LSIL/HSIL).
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