PDC*mel (previously named GeniusVac-Mel4), first candidate produced from PDC*line has been assessed through a first-in-human fesasibility clinical trial conducted in France from 2012 to 2017 and sponsored by CHU Grenoble, before PDC*line Pharma creation: “Dose-escalation study to assess the safety and tolerability of subcutaneous injections of GeniusVac-Mel4 in patients with melanoma.”  (https://clinicaltrials.gov/show/NCT01863108). N°EudraCT: 2012-003124-20.

PDC*Mel is a drug product composed of PDC*line loaded with four melanoma peptides derived from Melan-A, gp100, tyrosinase and MAGE-A3. The product was injected 3 times on a weekly basis, via subcutaneous administration route.

The target population was: patients with metastatic melanoma (Stage IIIC or IV) not surgically resectable, after failure of at least one line of systemic treatment.   

Three dose levels were assessed: 4, 20, 60 million of PDC*mel cells and it was planned to include at least 3 patients per cohort. A follow-up period of 48 weeks was scheduled.

Two sites have actively participated to the recruitment (CHU Grenoble and CHU Nantes). Nine patients in total (all grade IV melanoma, 3 per cohort as planned) have been included and treated (receiving each their 3 injections of PDC*Mel as per protocol).