20 1.2.1 VGX-3100 (COMMON NAME) .................................................................................... 20 1.2.2 INO-9012 (COMMON NAME) ..................................................................................... 20 1.2.3 CELLECTRA®5P DEVICE FOR INTRAMUS CULAR ELECTROPORATIO N ....................... 20 1.3 PRECLINICAL DATA ....................................................................................................... 20 1.3.1 VGX-3100 PRECLINICAL DATA ................................................................................. 20 1.3.2 INO-9012 PRECLINICAL DATA................................................................................... 20 1.4 CLINICAL DATA ............................................................................................................. 21 1.4.1 VGX-3100 CLINICAL DATA ....................................................................................... 21 1.4.2 INO-9012 CLINICAL DATA ........................................................................................ 21 1.4.3 CELLECTRA® DEVICE CLINICAL USE ..................................................................... 21 1.5 DOSE RATIONALE AND RISK/BENEFITS .......................................................................... 22 1.5.1 DOSE RATIONALE ....................................................................................................... 22 1.5.2 RISKS/BENEFIT ASSESSMENT ..................................................................................... 23 2 STUDY OBJECTIVES ........................................................................................................23 2.1 PRIMARY OBJECTIVES .................................................................................................... 23 2.2 SECONDARY OBJECTIVES ............................................................................................... 24 2.3 EXPLORATORY OBJECTIVES ........................................................................................... 24 3 STUDY DESIGN ..................................................................................................................24 3.1 GENERAL DESIGN .......................................................................................................... 24 3.2 STUDY ENDPOINTS ......................................................................................................... 26 3.2.1 PRIMARY ENDPOINT ................................................................................................... 26 3.2.2 SECONDARY ENDPOINT .............................................................................................. 26 3.2.3 EXPLORATORY ENDPOINTS : CLINICAL RESPONSE CRI TERIA AS DETERMINED BY: ....... 28 4 SUBJECT SELECTION AN D WITHDRAWAL .............................................................28 4.1 INCLUSION CRITERIA ..................................................................................................... 28 4 Date: 8 April, 2016 v 2.1 INO-3112 UPCC # 39313 / HPV -005 Inovio Pharmaceuticals, Inc Clinical Protocol 4.2 EXCLUSION CRITERIA .................................................................................................... 29 4.3 SUBJECT RECRUITMENT AND SCREENIN G ......................................................................