No clinically relevant abnormal hematology, blood chemistry, urinalysis, or physical findings were observed. Regression of CIN was noted in a number of patients (Figure 2B). Regression was seen in CIN related to a variety of HPV types including HPV -16, HPV -18 as well as other high- risk HPV types. The 3-mg R-DOTAP PDS0101 dose (containing 2.7 mg HPV -16 E6 & E7 antigens) has been chosen for further evaluation in larger Phase II trials given it seems to afford the best combination of safety and potency. The original dose of HPV -16 E6 & E7 antigens has been minimally increased from 2.4 mg to 2.7 mg for planned phase II studies. This was done due to some concern with possible oxidation of one of the peptides at the original lower dose . For simplicity the dose of all peptides has been minimally increased. 13 Abbreviated Title: Combo Immunotx in HPV Cancers Version Date: 05.12.2023 Figure 2 A (top). ELISpot responses in patients treated with PDS0101. B (bottom).