An Open-Label, Phase I, Escalating Dose Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of PDS0101

Inclusion Criteria

• •1. Written informed consent prior to initiation of any study-related procedures;
• •2. Nonlactating female between the ages of 21 to 65 years, inclusive;
• •3. Non-childbearing potential (defined as surgically sterile or at least 2 years postmenopausal) or practicing effective contraception (defined as 2 concurrent methods of contraception, 1 of which is a barrier method) and agrees to continue using effective contraception throughout the duration of the study;
• •4. Not pregnant based on a negative result on a serum human chorionic gonadotropin (HCG) test at screening Visit 1 and a negative urine pregnancy test prevaccination at Visit 2 (and at subsequent vaccination visits);
• •5. Pap test documenting atypical squamous cells of undetermined significance (ASCUS)/HPV+, atypical squamous cells high grade (ASC-H), low-grade squamous intraepithelial lesion (LSIL), or high-grade squamous intraepithelial lesion (HSIL) within 4 months prior to screening Visit 1;
• •6. History of pathologically confirmed CIN1 by colposcopically-directed punch biopsy, within 12 weeks prior to administration of first study vaccination (CIN 2/3 subjects will not be eligible);
• •7. For the diagnosis of CIN1, has a documented satisfactory colposcopy, ie, the entire lesion as well as the entire squamocolumnar junction is visualizible by colposcopy;
• •8. Confirmed high-risk HPV infection by a commercially available high-risk DNA assay (eg, Hybrid Capture II \[Qiagen\]);
• •9. Good health with adequate hematologic, renal, hepatic, and cardiac function, as determined by the Investigator, based upon medical history, physical examination, and laboratory test results at the screening visit (Visit 1):
• •* Bone marrow function: absolute neutrophil count ≥1,500/µL, and platelets ≥ 100,000/ µL;
• •* Renal function: creatinine ≤ 1.5 x institutional upper limit of normal (ULN);
• •* Hepatic function: total bilirubin ≤ 1.5 x ULN (Common Terminology Criteria for AEs \[CTCAE\] v4.0 grade 1) except patients with Gilbert's disease (up to 5.0 mg/dL). Aspartate aminotransferase (AST) and alkaline phosphatase ≤ 2.5 x ULN.
• •* Normal Cardiac function: as assessed by history and physical exam.