Supp Figures from Clinical and Immunologic Biomarkers for Histologic Regression of High-Grade Cervical Dysplasia and Clearance of HPV16 and HPV18 after Immunotherapy

Abstract

<p>Supplemental Figure 1 - Rates of CIN2/3 regression (primary endpoint) or CIN2/3 regression concomitant with clearance of HPV16 and/or HPV18 infection (secondary endpoint) in the Per Protocol population of the Phase IIb study of VGX-3100 for the treatment of biopsy proven CIN2/3 with documented HPV16 and/or HPV18 infection. Supplemental Figure 2 - Immunohistochemical analysis of CD8 infiltration at study start. The left panel shows the frequency of CD8 positive cells/mm2 as broken out by achievement of the primary endpoint of histopathological regression of CIN2/3 to CIN1 or WNL. The right panel shows the frequency of CD8 positive cells/mm2 as broken out by achievement of the primary endpoint of histopathological regression of CIN2/3 to CIN1 or WNL concomitant with elimination of HPV16/18 infection. Supplemental Figure 3 - CD137 is a marker for antigen specificity and activation on CD8+ T cells. A representative patient stain is shown for CD137 expression prior to (top) and following dosing (bottom) with VGX-3100. Whole unfractionated PBMCs were incubated with DMSO (vehicle control), OVA peptide (peptide control) HPV16 antigens, HPV18 antigens or Concanavalin A (positive control) for 120 hours. Supplemental Figure 4 - Breakdown of HPV16 and HPV18 positivity at enrollment of the study. Patients are represented as being HPV16 positive only (HPV16+ and HPV18-), HPV18 positive only (HPV16- and HPV18+) or positive for both viruses (HPV16+ and HPV18+). The bottom row represents the total patients in the study. Columns are broken into placebo and VGX-3100 cohorts and total patients in the study.</p>