The timing of the s tudy assessments and procedures are summarized in the Schedule of Study Assessments (SoA) in Appendix A . Figure 3. Study Design Schema Five subjects in Italy will follow the original Study Design Ten Subjects in the USA will follow the amended Study Design ; those who have already signed an Informed Consent Form for the original Study Design will be asked to sign a new Informed Consent Form at the end of the first 12-week follow-up period. Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 31 of 81 CONFIDENTIAL 3.2 Outcome Measures 3.2.1 Primary Outcome Measures • The incidence and severity of all adverse events (AEs), related AEs, all SAEs, related SAEs, and temporally- associated AEs according to the National Cancer Institute- Common Terminology C riteria for Adverse Events (NCI -CTCAE) versio n 4.0 (v4.0) • Change from baseline in clinical laboratory safety parameters and vital signs • Number and proportion of subjects with any clinically significant change in vital signs (i.e., blood pressure, pulse rate, respiratory rate, body temperature) during the vaccine administration or within 60 min utes following administration 3.2.2 Secondary Outcome Measures • PEPIs as identified by the PEPI Test • Effector T cell response against 12 selected epitopes of PolyPEPI1018 as measured by interferon (IFN)-ga mma Enzyme -Linked ImmunoSpot (ELISPOT ) assay for the following: o Number and proportion of subjects with 0, ≥1, ≥2, ≥3, ≥4, ≥5 effector T cell responses, respectively, detected at the Baseline Visits (Week -3 to -1 and Week 0) and at 3, 6-, 9-, and 12- weeks after administration of the vaccine o For each subject, the number of effector T cell responses o For each subject, the time course of effector T cell response at Baseline Visits (Week -3 to -1 and Week 0) and at 3-, 6-, 9-, and 12- weeks after administration of the vaccine Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 32 of 81 CONFIDENTIAL • Memory T cell response against 12 selected epitopes of PolyPEPI1018 as measured by the Precursors with High Proliferation Capacity (PHPC) assay for the following: o Number and proportion of subjects with 0, ≥1, ≥2, ≥3, ≥4, ≥5 memory T cell response, respe ctively, detected at the Baseline Visits (Week -3 to -1 and Week 0) and at 3-, 6-, 9-, and 12- weeks after administration of the vaccine o For each subject, the number of positive memory T cell responses o For each subject, the time course of memory T cell resp onse at Baseline Visits (Week -3 to -1 and Week 0) and at 3-, 6-, 9-, and 12- weeks after administration of the vaccine • Objective Response Rate (ORR) measured by CT scan at Screening Visit (Week -3 to -1), and at 6-, and 12- weeks after administration of each dose of the vaccine 3.2.3 Exploratory Outcome Measures • Correlation s between PEPIs identified by the PEPI Test and effector and memory T cell responses measured by ELISPOT and PHPC immunogenicity assays • Change in relative counts of TILs in accessible tumor biopsies at Baseline (Week -3 to -1) and at Week 12 as measured by immunohistochemistry • Correlation between PEPIs identified by the PEPI Test and infiltrating lymphocyte in tumor biopsies measured by immunohistochemistry • Correlations between T cell responses measured by ELISPOT and PHPC and infiltrating lymphocyte in tumor biopsies measured by immunohistochemistry • Correlation s between PEPIs identified by the PEPI Test and effector and ORR • Correlations between T cell responses measured by ELISPOT and PHPC and ORR 3.3 Estimated Study Duration Four out of ten subjects have already been accrued under the original single-dose Study Design, the first one be ing accrued in May 2017. These subjects will be asked to sign a new informed consent for multiple dosing and it is anticipated that they will be willing to agree .