Additional details are provided in the Study Procedures Manual. 5.1.3 Packaging and Labeling PolyPEPI1018 peptide solutions will be supplied in pre-labeled boxes by the sponsor and the labels will be compliant with country specific regulatory requirements. Each box will contain vials of PolyPEPI1018-Mix1 and vials of PolyPEPI1018-Mix2 that needs to be stored in the freezer (-20oC). Each box will contain a label firmly attached to the box, with the company name, lot number, storage temperature, expiry date and a statement that the box contains vials of PolyPEPI1018-Mix1 and PolyPEPI1018- Mix2, respectively. Vials themselves will have label containing the vaccine name and lot number, content of the vial, strength of the solution, route of administration and storage temperature. One vial of each box will be used per subject for the pre paration of the vaccine product at the clinical site. Adjuvant Montanide™ will be shipped by Seppic in pre-labeled boxes that need to be stored at room temperature (15ºC to 30ºC). Each box will contain 3 mL vials labeled as Montanide™ ISA 51 VG sterile, lot number, composition, manufacturer and expiration date. One vial will be used per peptide mixture, 2 vials per subject. 5.1.4 Supply, Distribution , and Pharmacy The following study supplies are needed and will be provided as described below: • PolyPEPI 1018 vials will be distributed by the sponsor as described in Section 5.1.3. • Montanide™ adjuvant will be distributed by the supplier, Seppic SA, as described in Section 5.1.3. • Single use plastic equipment for PolyPEPI1018 vaccine emulsification procedure will be supplied by the Sponsor. Syringes, I-connector and vial adapters will be packaged together without harming the individual sterile packing of the devices. Each set will contain enough supplies for one emulsification procedure. Each package contains: o 2 pieces of Disposable latex, silicone and rubber free syringe (3 ml B.Braun, Injekt® Solo, VWR cat nr.: 720-2522). Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 41 of 81 CONFIDENTIAL o 1 piece of I -connector (Double Female Luer Lock Adapter, Promepla, Ref: ODG0015ST). o 2 pieces of Vial adaptors (West Pharma, 13 mm, L uer Lock, sterile). 5.1.5 Storage 5.1.5.1 PolyPEPI 1018 Intact vials containing PolyPEPI1018 should be stored between -25ºC and -15ºC. Thawed vials may be stored for up to 3 hours at room temperature. Re- freezing is not allowed. Records must be available showing periodic temperature checks of storage freezer material. Vaccine emulsions consisting of peptide admixed with Montanide™ are stable for 4 hours at 4ºC, but should be administered as soon as possible following preparation. 5.1.5.2 Adjuvant Montanide™ should be stored between 15ºC and 30ºC. 5.2 Reference Therapy Not applicable 5.3 Investigational Product Ac countability The investigator will ensure that the IP (i.e., PolyPEPI 1018 and Montanide™) is stored as specified in Section 5.1.5 and that the storage area is secured, with access limited to authorized study personnel. The investigator will maintain records that the IP was received, including the date received, drug identity code, date of manufacture or expiration date, amount recei ved and disposition. The IP must be dispensed only at the study site or other suitable location. Records will be maintained that includes the subject identification code (SIC), dispensation date, and amount dispensed. All remaining partially used and/or unused IP(s) will be returned to the sponsor or sponsor’s representative after study completion/termination, or destroyed with the permission of the sponsor in accordance with applicable laws and study site procedures. If IP(s) is to be destroyed, the invest igator will provide documentation in accordance with sponsor’s specifications. Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 42 of 81 CONFIDENTIAL 5.4 Concomitant Medications A concomitant medication is defined as any prescription or over-the-counter preparation, including vitamins and supplements. All concomitant medications from the initiation of the first-line CRC therapy until 85 days after the subject’s vaccination must be recorded on the eCRF. 5.4.1 Required Medications Subjects must be on maintenance therapy with a fluoropyrimidine (5-fluorouracil or capecitabine) plus the s ame biologic agent (bevacizumab, cetuximab or panitumumab) used during induction, prior to Day 1 ( Week 0, Visit 2) . Modifications may be allowed for toxicity/tolerability reasons, but must be approved by the medical m onitor to determine whether the subject can remain on study treatment/on study. 5.4.2 Prohibited Medications The concomitant use of the following immunomodulator therapies, which have potential putative effects on immunologic and/or virologic indices, are prohibited while on study: • Systemic (intravenous and oral) corticosteroids • Thalidomide • Cyclosporine • Interferons • Interleukins • IgG-containing products • Cimetidine (Tagamet) • Acetylcysteine (NAC) • Sargramostim (GM -CSF) • Dinitrochlorobenzene (DNCB) • Thymosin alpha 1 (thymosin alpha) • Thymopentin • Inosiplex (Isoprinosine) • Polyribonucleoside (Ampligen) Treos Bio ZRT OBERTO -101 Amendment 3 Product: PolyPEPI 1018 Colorectal Cancer Vaccine Page 43 of 81 CONFIDENTIAL • Ditiocarb sodium (Imuthiol) • Hydroxyurea • Checkpoint Inhibitors • Experimental vaccines • Investigational agents 5.4.3 Precautionary Medications The following medications may be used during the study with caution: • Treatment with topical corticosteroids is allowed except at the proposed vaccination sites within 2 weeks prior to vaccination • Use of local skin treatments is allowed, except in the targeted vaccination sites, within 2 weeks prior to vaccination. During the vaccination period, subjects should avoid manipulation of vaccinated areas to enable monitoring of possible vaccine-related toxicity.