Scancell Holdings plc (SCLP.L), a clinical-stage biotechnology company, announced on Tuesday that the U.S. Food and Drug Administration (FDA) had granted a fast track designation to iSCIB1+ for the treatment of advanced melanoma. It also provided updates on the Phase 2 SCOPE trial.
The company's lead drug iSCIB1+ was developed on the DNA ImmunoBody platform to treat advanced unresectable melanoma. The treatment delivery is through the PharmaJet needle-free injection.
The Phase 2 trial is a multicenter, open-label study evaluating SCIB1 or iSCB1+, administered in up to 11 doses with a standard-of-care therapy like Nivolumab plus Ipilimumab, or Pembrolizumab. Safety and efficacy of the drug will be measured using endpoints like disease control rate (DCR), duration of response (DOR), progression free survival (PFS) and overall survival (OS). Scancell reported a PFS of 77% at 20 months in the target population treated with the drug, a 30% increase from the 43% PFS of the placebo cohort.
Additional PFS and OS data from the Phase 2 SCOPE trial is expected by the first half of 2027.
SCLP.L is currently trading at £13.50, up 3.85%
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