Safety/tolerability and AE data will be presented in individual listings. Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 65 of 81 CONFIDENTIAL 9.5.2 PEPI and Immunogenicity Analyses Each of the 6 peptides in PolyPEPI1018 contain 2 epitopes (for a total of 12 epitopes) selected to elicit a T cell response in a high portion of subjects . The PEPI Test identifies which epitope represents a PEPI (that is capable of inducing a T cell response) in each subject. A PEPI is unique and is based on the subject’s HLA genotype. T herefore, a selected epitope encoded in PolyPEPI1018 might be a PEPI for 1 individual and not for others, and vice versa. A subject may have more than 1 PEPI , or no PEPI. The PEPI Test (described in Section 6.6.1) will be performed in each subject who is enrolled in the study from the results of the HLA genotyping. The ELISPOT assay (described in Section 6.6.2) and the PHPC assay (described in Section 6.6.3) measure effector and memory responses, respectively . These assays will be performed in each subject from blood samples collected during a time course from B aseline until the Last Visit. Based on the results of the PEPI Test and the immunogenicity tests (ELISPOT and PHPC) the secondary outcome measures will be analyzed as described in Section 3.2.2. Immunogenicity analyses may be performed at any time during the trial, however, t he results of the PEPI Test will be obtained before the results of the corresponding immunogenicity tests are available. F inal analysis will be based on all data up to Day 85 (Week 12, Visit 6) for all study subjects (data from the start of study treatment of the last accrued subject through Day 85 [Week 12, Visit 6]). 9.5.3 Efficacy Analyses Efficacy will be evaluated as 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. RECIST and irRECIST criteria will be used.