e: At 52 weeks f: Every 12 weeks g: Given on Day 1 and 2 every 2 weeks. 5- FU/Leucovorin should be used as an alternative if required due to raised ALT. h: CT -scan to be done at baseline (if possible), then every 6 months from the start of vaccination (+/ - 4 weeks’ time window) and at end of the study vis it. i: at 2nd GM-CSF/TG01 injection after end of chemotherapy (8 weeks after last chemotherapy injection) j: at week 13 only (day 1 of cycle 4) prior study treatment administration k: For patients who discontinue before the 2 years, a survival follow -up w ill be performed where possible at week 104. l: For all GM -CSF/TG01 administrations after chemotherapy the patients should be give prophylactic treatment (30 minutes before treatment) to prevent possible occurr ence of allergic reactions. At visits where the patients will receive a DTH injections (TG01) before the GM-CSF/TG01 administration then the prophylactic treatment should be given 30 minutes prior the D TH injection . *: +/- 1 day window for visits in the initial treatment period and for other wee kly visits (Initial treatment period or chemotherapy treatment period) **: window of +/ - 1 week for 4 week ly injections and 12 weekly injections CT TG01 -01 Version v10.0 27 June 2018 Confidential 42 / 87 Table 3: Schedule of visits – Modified vaccination group Page in protocol Screenin g Initial Treatment Period* Repeat Cycles with chemotherapy* After chemo to W52 *** W52- 104 Patient e nd of study visit** Survival FU Study Week 1 2 3 4 5 6 7 8 9 10 1 5 9 13 17 21 2 6 10 14 18 22 3 7 11 15 19 23 4 8 12 16 20 24 Every 4 weeks ** Every 12 weeks ** W104 or 4 weeks after last GMCSF/TG01 Every 6 months and at study end** Thereafter ~every 12 months Study Day -56 to -7 -7 1 8 15 22 29 36 43 50 57 64 Cycle D1 Cycle D8 Cycle D15 Cycle D22 GM-CSF /TG01 a 51 to 59 x x x x x xb xc x DTH injectiond 51 to 59 x x xe Gemcitabinef 51 to 59 x x x 5-FU and Leucovoring 51 to 59 x x Informed Consent 60 x Patient eligibility 60 x Demography/Medical history 60 x Resect pancreas 60 x Tumour sample 60 x ECG 61, 68 x <----------------------------------------------------- ------------- --------- As clinically indicated ----------- ------------------------------------------------------  Physical Exam/ PS 61, 68 x x xh Xn x Vital Signs 61 x x x x x x x xl x x x xh x x Haematology/Chemistryi 61, 68 x x x x x x xl x x x xh x x Pregnancy test 61 x Concurrent illness 61 x DTH assessmentd 55, 66 x x xe Immunology samplei 65, 66 x x xi,j Xn x CA19.9 / other biomarkersi 67 x x xm Xn x Urinalysis 61, 68 x <--------------------- --------------------------- ------ ----------------- As clinically indicated ------------------------ -------- ---------------------------------  CT/MRI / assess diseasek 61, 66 x <---------------------------------------------- ------------------ ------------ - Every 6 months ---------------------------------------------------  x Adverse events 67, 71 <------------------------------------------------------------- ----------- ----- As clinically indicated ------------------------ ------- ------------------------ --------- Concomitant medications 60, 61 x <------------------------------------------------------- ------------- --------- As clinically indicated ------------------------------------------------- --------------- Survival follow -up 51 to 59 x CT TG01 -01 Version v10.0 27 June 2018 Confidential 43 / 87 a: Start as soon as possible after surgery. GM -CSF given 15-20 min before TG01. Patients should be observed for at least 30 minutes after each vaccinations b: Patients that have not started chemotherapy by week 10 will receive GM- CSF/TG01 4 -weekly, star ting at week 10 and until start of chemotherapy or week 52 or withdrawal of consent, toxicity or the need for additional treatment for pancreatic cancer whatever comes first. c: After end of chemotherapy, GM -CSF/TG01 treatment will be given 4 and 5 weeks after last chemotherapy injection and thereafter every 4 weeks from 8 weeks post - chemotherapy up to 1 year (week 52) or until withdrawal of consent, toxicity or the need for additional treatment for pancre atic cancer whichever is the earliest. d: DTH injection should be performed 30 minutes before the GM -CSF injection. Assessment of DTH injection site to be done 48 hours (+/ - 4 hours) after the TG01 and GM -CSF injections. e: After end of chemotherapy, a DTH injection and DTH assessment will be done at 3rd vaccination post -chemotherapy (8 weeks post chemotherapy). For patients not starting chemotherapy at all, the DTH test and assessment are to be done at week 52 f: Start preferably 3 weeks after start of vaccination and preferably at Study Day 22, 36 or 50 (once patients are able to receive chemotherapy see repeated cycles) although can start later g: Given on Day 1 and 2 every 2 weeks . 5-FU/Leucovorin should be used as an alternative if required due to raised ALT. h: Every 12 weeks i: When blood samples are to be taken these should be done prior to all treatments. J: only 4 weeks after last chemotherapy injection (at 1st post -chemotherapy vaccination) k: CT-scan to be done at baseline, then every 6 months from the start of vaccination (+/ - 4 weeks’ time window) and at end of the study visit. CT scans may be done at other times if clinically indicated l: If patient hasn’t started chemotherapy m: Only for patients not starting chemotherapy at all and to be done prior each vaccination (eve ry 4 weeks) n: at week 52 only *: +/- 1 day window for visits in the initial treatment period and for other weekly visits (Initial treatment period or chemotherapy treatment period) **: window of +/ - 1 week for 4 weekly injections and 12 weekly injections ***: Applies also to patients not starting chemotherapy at all and the period will be from week 10 to week 52 CT TG01 -01 Version v 10.0 27 June 2018 Confidential 44 / 87 3.2 Rationale for t rial design, doses and s top decisions 3.2.1 Trial design Whilst not registered, gemcitabine is the main chemotherapy used as adjuvant treatment following resection of pancreatic adenocarcinoma. It is rational therefore, to see whether the use of immunotherapy added to this regimen can improve on the disease -free survival and potential overall survival of this condition.