Demographics and baseline disease characteristics of the patients are listed in table 1 and consort table overview of screened patients is listed in online supplemental table 2. As previously reported, five patients were enrolled at dose level 1. Of these, four patients were in cohort A (anti- PD- 1 naïve) while one patient was in cohort B (SD on anti- PD- 1).To augment the effect of ICI treatment, we have devel- oped a process for identifying and manufacturing a personalized cancer vaccine comprising cancer- specific neoantigens, EVX- 01. Included neoantigens were iden- tified based on genomic sequencing data from tumor tissue, genomic sequencing data from healthy tissue, and the patient’s HLA type. We delivered the neoanti- gens as long peptides (neopeptides) with the liposomal adjuvant CAF09b to maximize the effect. In the current study, patients with metastatic melanoma were enrolled and treated with EVX- 01- CAF09b in addition to anti- PD- 1 treatment. The clinical protocol dictated six injections of EVX- 01 CAF09b to each patient at 2 weeks intervals: three IP followed by three IM injections. During vaccine production lead time, patients received anti- PD- 1 therapy, which continued during the vaccination period and beyond until progressive disease (PD), stable remission, or intolerable toxicity. Manufacturing time was between 6 and 8 weeks, however, as the first dose was to be admin- istered on the same day as a dose of anti- PD- 1, time from baseline biopsy until first vaccination ranged from 51 to 70 days (table 1). Three dose levels were tested; dose level 1 with 500 µg total peptide and 0.25 mL CAF09b in 5 patients (results previously reported in Mørk et al,9 dose level 2 with 1000 µg total peptide and 0.5 mL CAF09b in hree patients, and dose level 3 with 2000 µg total peptide and 1.0 mL CAF09b in four patients. EVX-01-CAF09b in combination with anti-PD-1 has no major safety concerns All AEs observed at dose level 1 were grade 1, except for patient 2, who experienced grade two fatigue after the first vaccination.9 At dose level 2, three patients were enrolled, all in cohort B, who received all six vaccinations. One patient experienced grade 2 abdominal pain after IP injection. No severe vaccine- related AEs were observed at this dose level. Table 1 Patient characteristics Disease stage Baseline LDH PD- L1 receptor BRAF mutation Dosage Days from biopsy until first vaccine M1b 259 PD- L1>1% and <50% Mutation 500 µg 56 M1c 147 PD- L1>1% Mutation 500 µg 51 M1c 118 PD- L1>1% and < 2% Negative 500 µg 53 M1a 184 PD- L1 5% Mutation 500 µg 57 M1b 835 PD- L1<1% Negative 500 µg 60 M1a 116 PD- L1<1% Mutation 1000 µg 62 M1b 239 PD- L1>1% Negative 1000 µg 56 M1a 180 PD- L1<1% Mutation 1000 µg 60 M1b 160 PD- L1>50% Positive 2000 µg 53 M1c 201 PD- L1>50% Negative 2000 µg 70 M1a 210 PD- L1 negative Positive 2000 µg 57 M1c 223 PD- L1>1% Positive 2000 µg 56 8 Mørk SK, et al. J Immunother Cancer 2024;12:e008817.