The trial medication may not be used for any purpose other than the present trial, since the insurance coverage shall otherwise become null and void. After the trial is completed, all unused trial medication must be destroyed by the pharmacy after sponsor’s approval. The Investigators will be responsible for the storage, dispensing, inventory, and accountability of all clinical supplies. An accurate, timely record of the disposition of all clinical supplies must be maintained. The supplies and inventory must be available for inspection by the designated representatives of the Sponsor (Targovax) on request, and must include the information below: • the identification of the patient to whom the drug was dispensed • the date(s) and quantity of the drug dispensed to the patient • the product lot number. The preparation of the Study Drugs must be documented on a ‘Drug Preparation and Dispensing Log Form’. A copy of the inventory record and a record of any clinical supplies that have been destroyed must be submitted by the Investigators to the Sponsor (Targovax). This form must include the information below: • the number of administered units • the number of unused units • the number of units destroyed at the end of the trial • the date and method of destruction and the location. 4.2 Assignment of patients to treatment Patients are to be registered and assigned to treatment after written informed consent has been obtained and all pre -trial evaluations have been completed. Patient eligibility should be documented on the patient eligibility CRF page. 4.3 Preparation of trial treatment 4.3.1 TG01 TG01 is provided in 2R glass vials containing 2.1 mg of TG01 and the content of one vial of TG01 shall be dissolved in 0.3 mL of sterile water for injection (7 mg/mL) . The solution is to be used within 6 hours after reconstitution. 4.3.2 GM-CSF GM-CSF is provided in vials containing 0.1 mg and the content of one vial shall be dissolved in 0.33 mL of sterile water for injection (0.30 mg/mL) . The solution is to be used within 6 hours after reconstitution. 4.3.3 Chemotherapy Gemcitabine will be administered at a dose of 1000 mg/m2. The drug will be provided in vials of 200 mg and 1 g for reconstitution in saline to be given via intravenous injection. If gemcitabine is replaced by 5-FU and Leucovorin: CT TG01 -01 Version v 10.0 27 June 2018 Confidential 54 / 87 - 5-FU will be administered at 500mg/m2 - Leucovorin will be administered at 60mg/m2 or 100mg 5-FU/Leucovorin will be prepared in accordance with the standard procedur e at the institution. 4.3.4 DTH The content of one vial of TG01 shall be dissolved in 0.3 mL sterile water for injection . The solution is to be used within 6 hours after reconstitution. 4.4 Dosage and administration of trial treatment 4.4.1 GM-CSF /TG01 dose and administr ation Phase I and phase II part - main group : GM-CSF/TG01 will be given on days 1, 3, 5, 8, 15, 22 and every 2 weeks until end of chemotherapy (with day 1 defined as the first day of TG01 treatment which should be 1-8 weeks after surgery). For those patients who do not receive chemotherapy vaccination will continue as above until week 10 and then 4-weekly. Phase II part – concomitant treatment group : GM -CSF/TG01 will be given on days 1, 3, 5, 8, 15 and every 2 weeks until end of chemotherapy (with day 1 de fined as the first day of GM -CSF/TG01 treatment which should be 9-12 weeks after surgery). Phase II part – modified vaccination group : GM-CSF/TG01 will be given on days 1, 8, 15, 22 and 36 then if chemotherapy hasn’t started, 4- weekly until the start of chemotherapy at which point vaccination will be put on hold until the end of chemotherapy treatment . Patients who do not start chemotherapy at all will continue to receive 4 -weekly vaccinations from week 10 to week 52. Main group and concomitant group: After the end of chemotherapy , in patients who have not shown recurrence during the study treatment period, further booster injections will be given every 4 weeks until week 52 and then every 12 weeks for up to 2 years or until withdrawal of consent or toxici ty whichever is the earliest . In patients who recur and a positive immune response has been seen during the treatment period, further booster injections should be given every 4 weeks until week 52 and then every 12 weeks for up to 2 years or until withdrawal of consent or toxicity whichever is the earliest. For all these GM -CSF/TG01 booster injections the patients should be give n prophylactic treatment , 30 minutes prior to the GM- CSF injection (see section 4.5.3). Modified vaccination group : after the end of chemotherapy, GM-CSF/TG01 will be given 4 weeks and 5 weeks after end of chemotherapy and then every 4 weeks from week 8 post -chemotherapy until week 52 and then every 12 weeks for up to 2 years or until withdrawal of consent or toxicity whichever is t he earliest. In patients who recur and a positive immune response has been seen during the treatment period, further booster injections should be given as per schedule for up to 2 years or until withdrawal of consent or toxicity whichever is the earliest. No prophylactic treatment will be required unless an allergic reaction occurs and further vaccinations will be given. The TG01 dose is 0.70 mg ( 0.10 mL injection of a TG01 solution at 7 mg/mL ) reconstituted in water for injection GM -CSF dose is 0.03 mg (- 0.10 mL injection of a GM-CSF solution at 0.3 mg/mL ) reconstituted in water for injection CT TG01 -01 Version v 10.0 27 June 2018 Confidential 55 / 87 Both study drugs will be intradermal injection s into the back of the upper arm with GM-CSF administered 10- 15 min before the injection of TG01. Patients should be observed for at least 30 minutes after all vaccinations . 4.4.2 Chemotherapy Phase I and phase II part - main group and modified vaccination group : Patients will receive chemotherapy starting at least 3 weeks after initiation of GM-CSF/TG01 (Day 22, 36 or 50 of t he initial treatment period) and in the main group chemotherapy should not start later than 12 weeks from the date of surgery ; the day of the first dose will be considered Day 1 of the chemotherapy treatment period . In part II, patients for whom chemotherapy timing cannot be assured will start vaccination as soon as the vaccination schedule can be adhered to and will receive chemotherapy or not according to their needs. Phase II part – concomitant group: patients who for medical reasons cannot start vaccination early will start chemotherapy at the same time as GM -CSF/TG01 and not later than 12 weeks from the date of surgery; the day of the first dose will be considered Day 1 of the chemotherapy treatment period. Gemcitabine will be given as 1000 mg/m 2 iv over 30 minutes on days 1, 8 and 15 of a four week cyc le for 6 cycles in total. If 5-FU/leucovorin needs to be substituted this will be given as 500 mg/m 2 iv on days 1 and 2 every 2 weeks of a four week cycle for 6 cycles in total. Leucovorin will be gi ven prior 5 -FU as 60 mg/m 2 or 100 mg iv on days 1 and 2 every 2 weeks of a four week cycle for 6 cycles in total. 4.4.3 DTH Phase I and phase II part - main group : During the initial period, TG01 will be given on days 1, 8, 15, 22, 36, 50, and 64 in the lower area of the contralateral arm. TG01 will then be administered at the 2nd GM-CSF/TG01 injection after the end of chemotherapy (8 weeks after the last chemotherapy injection) for patients receiving chemotherapy and at week 52 for all patients . At post- chemotherapy visits prophylactic treatment should be given 30 minutes prior the DTH injection (see section 4.5.3). Phase II part – concomitant group : During the initial treatment period, TG01 will be given on days 1, 8, 15, 29, 43, 57, and 71 in the lower area of the contralateral arm. TG01 will then be administered at the 2 nd GM-CSF/TG01 injection after the end of chemotherapy (8 weeks after the last chemotherapy injection) and at week 52. At post- chemotherapy visits prophylactic treatment should be given 30 minutes prior the DTH injection (see section 4.5.3). Phase II part – Modified vaccination group : During the initial period, TG01 will be given on days 36 and 50 in the lower area of the contralateral arm. TG01 will then be administered at the 3 rd GM-CSF/TG01 injection after the end of chemotherapy (8 weeks after the last chemotherapy injection) . For patients not receiving chemotherapy a n additional TG01 injection will be given at week 52 . CT TG01 -01 Version v 10.0 27 June 2018 Confidential 56 / 87 The DTH -test dose must be prepared on the day of treatment and is to be given 30 minutes before GM -CSF/TG01 injection (GM-CSF is to be administered 10- 15 mi n before the injection of TG01 in the main group and in the concomitant group and 15-20 min before the injection of TG01 in the modified vaccination group). DTH dose: 0.10 mL of TG01 at 7 mg/mL water for injection solution must be prepared for intradermal injection in a sterile syringe. 4.4.4 Chemotherapy dosing criteria Gemcitabine: Before the administration of gemcitabine at the start of each new treatment cycle patients must b e assessed to ensure that they satisfy the gemcitabine prescribing information of the country where the study is conducted or should follow the below criteria if no instructions are available . • Granulocytes count > 1.5 x 109/L for 1st cycle and > 1 x 109/L for following cycles • platelets > 100 x 109/L • Laboratory evaluation of renal and hepatic function, including serum creatinine should be within 1.5 x UNL 5-FU and Leucovorin: Dosing criteria should follow the s tandard procedure at the institution 4.5 Management of Toxicity 4.5.1 Anticipated toxicity and management TG01 or its individual peptides have been given only to patients with pancreatic or colorectal cancer. Therefore, the majority of adverse events and serious adverse events have been related to progression of their disease or concomitant medications.