Clinical-stage biotechnology company Diakonos Oncology Corp announced on Wednesday that the US Food and Drug Administration (FDA) has granted Fast Track designation to DOC1021 (dubodencel), its first-in-class, patient-derived double-loaded dendritic cell investigational therapy, for the treatment of unresectable or metastatic cutaneous melanoma.

Diakonos says that it now plans to advance DOC1021 through ongoing and upcoming clinical studies, including the Phase 1/2 trial in refractory melanoma, which is now recruiting.

DOC1021 combines tumour lysate and amplified tumour-derived mRNA. The immunotherapy is made with a patient's dendritic cells combined with mRNA and proteins prepared from freshly obtained patient tumour specimens.

Diakonos currently has three actively enrolling clinical trials evaluating DOC1021, including a Phase 1 pancreatic cancer study, a Phase 2 glioblastoma (GBM) study, and a Phase 1/2 study in refractory melanoma supported by the Cancer Prevention and Research Institute of Texas (CPRIT).

The US FDA has granted Fast Track designation to DOC1021 for the treatment of pancreatic cancer, GBM, and unresectable or metastatic cutaneous melanoma, reflecting the significant unmet medical need across these indications. Diakonos also received Orphan Drug Designation for the GBM program in January 2024.