The AIM-listed biotech reports 77% progression-free survival at 20 months, well ahead of the standard of care
Scancell Holdings PLC (AIM:SCLP, OTC:SCNLF, FRA:SCP), the cancer immunotherapy developer, has secured a Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its lead drug candidate, iSCIB1+, in advanced melanoma.
The designation, awarded to investigational therapies that show meaningful advantages over existing treatments, gives the company's researchers more frequent engagement with regulators and opens the door to accelerated approval pathways, potentially shortening the time it takes to bring the drug to market.
The news comes alongside an update from the company's phase II SCOPE trial, which is testing iSCIB1+ alongside the established checkpoint inhibitor combination of ipilimumab and nivolumab, drugs that work by releasing the immune system's natural brakes to help it attack cancer cells.
Progression-free survival (PFS), the proportion of patients whose cancer has not worsened or who have not died within a given period, reached 77% at 20 months in the target patient group.
That compares with 43% at the same point for patients receiving ipilimumab and nivolumab alone, the current standard of care, representing a gap of more than 30 percentage points.
Scancell expects additional PFS data and early overall survival figures from the SCOPE study in the first half of 2027.
The company anticipates launching a global registrational phase III trial, the large-scale study typically required before a drug can seek full regulatory approval, in the second half of 2026.
Chief executive Dr Phil L'Huillier said the FDA designation was a major achievement and important recognition of both the drug's potential and the need for improved treatment options for advanced melanoma patients.
iSCIB1+ is the lead candidate from Scancell's DNA ImmunoBody platform, which is designed to train the immune system to identify and attack tumour cells.