2011;25(1):57- 62. Treos Bio ZRT Trial Number: OBERTO -101 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 78 of 81 CONFIDENTIAL APPENDIX A. SCHEDULE OF STUDY ASSESSMENTS Assessment Period Screening Vaccination and Evaluation Visit Number 1 2 3 4 5 6 End of Week -3 to -1 0 3 6 9 12 Day -21 to -1 1 22 ±2 43 ±2 64±2 85±2 Informed Consent X Inclusion/Exclusion Criteria X ECOG Performance Status X Medical History X Medication History X Concomitant Medications X X X X X Complete Physical Exam X X X X Targeted Physical Exam X X Vital Signs X X X X X X Vaccine Site Evaluation X X X X X Evaluation of Response to First -line Therapy X Buccal Swab X Vaccine Administration/ 1 -hour Observation X Distribute Diary1 X Collect Diary X Cancer Biopsy/ Tumor Infiltrating Lymphocytes Analysis X X CT and RECIST (irRECIST) Assessment X X X Hematology & Blood Chemistries X X X X Tumor Biomarkers X X X X Urinalysis X X X X Urine Pregnancy Test X X X X Blood Collection for PBMC and Immunogenicity Assays (ELISpot and PHPC) X X X X X X Abbreviations: ECOG = Eastern Cooperative Oncology Group; CT = computerized tomography 1. The Patient Diary will be used to collect local signs related to the injection sites, physical fatigue, and body temperatu re Treos Bio ZRT Trial Number: OBERTO -101 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 79 of 81 CONFIDENTIAL Assessment Period Vaccination and Evaluation Visit Number 7 8 9 10 11 End of Week 13 16 19 22 25 Day 92 ±2 113 ±2 134 ±2 155 ±2 176 ±2 Informed Consent for additional vaccinations2 X Concomitant Medications X X X X X Complete Physical Exam X X X Targeted Physical Exam X X Vital Signs X X X X X Vaccine Site Evaluation X X X X X Vaccine Administration/ 1 -hour Observation X Distribute Diary1 X Collect Diary X Cancer Biopsy/ Tumor Infiltrating Lymphocytes Analysis X CT and RECIST (irRECIST) Assessment X X Hematology & Blood Chemistries X X Tumor Biomarkers X X Urinalysis X X Urine Pregnancy Test X X Blood Collection for PBMC and Immunogenicity Assays (ELISpot and PHPC) X X X X Abbreviations: CT = computerized tomography 1. The Patient Diary will be used to collect local signs related to the injection sites, physical fatigue, and body temperature 2. Only for those subjects who had originally signed an Informed Consent Form for a single vaccination Treos Bio ZRT Trial Number: OBERTO -101 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 80 of 81 CONFIDENTIAL Assessment Period Vaccination and Evaluation Visit Number 12 13 14 15 16 End of Week 26 29 32 35 38 Day 183 ±2 204 ±2 225 ±2 246 ±2 267 ±2 Concomitant Medications X X X X X Complete Physical Exam X X X Targeted Physical Exam X X Vital Signs X X X X X Vaccine Site Evaluation X X X X X Vaccine Administration/ 1 -hour Observation X Distribute Diary1 X Collect Diary X Cancer Biopsy/ Tumor Infiltrating Lymphocytes Analysis X CT and RECIST (irRECIST) Assessment X X Hematology & Blood Chemistries X X Tumor Biomarkers X X Urinalysis X X Urine Pregnancy Test X X Blood Collection for PBMC and Immunogenicity Assays (ELISpot and PHPC) X X X X Abbreviations: CT = computerized tomography 1. The Patient Diary will be used to collect local signs related to the injection sites, physical fatigue, and body temperature Note: At the end of the follow up period (that is 12 weeks after each vaccination), ideally one week rest period should be ob served before the next vaccination, as d escribed in the above SoA. However, up to 1 month rest period is allowed. Treos Bio ZRT Trial Number: OBERTO -101 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 81 of 81 CONFIDENTIAL APPENDIX B. THE WORLD ALLERGY ORGANIZATION SUBCUTANEOUS IMMUNOTHERAPY SYSTEMIC REACTION GRADING SYS TEM See attached Article (13 pages) by Cox L.