Scancell announces FDA clearance of IND application for global Phase 3 trial of iSCIB1+ in advanced melanoma

Core Insights - Scancell Holdings plc has received FDA clearance for its Investigational New Drug application for a Phase 3 trial of iSCIB1+ Immunobody® in advanced melanoma, with progression-free survival as the primary endpoint [1][3] - The Phase 2 SCOPE trial demonstrated a 24% improvement in progression-free survival (PFS) for iSCIB1+ compared to the standard of care and historical controls [1][4] - The SCOPE trial involved 140 patients and evaluated the efficacy of iSCIB1+ in combination with nivolumab and ipilimumab for previously untreated unresectable stage IIIB/IV melanoma [2][5] Company Developments - Scancell has identified a selection marker to enrich the Phase 3 trial for responders, focusing on patients with specific human leukocyte antigen (HLA) alleles, which represent 80% of melanoma patients [3] - Updated data from the SCOPE trial show that PFS for the target population was 74% at 16 months, significantly higher than the 50% PFS reported for the current standard of care (ipilimumab plus nivolumab) at 11.5 months [4] - The company is exploring various financing options, including potential partnerships, to support the Phase 3 trial [3] Product Pipeline - iSCIB1+ is part of Scancell's DNA ImmunoBody® platform, which aims to generate safe and long-lasting tumor-specific immunity [6] - The company is also developing Modi-1, a peptide immunotherapy from its Moditope® platform, currently in a Phase 2 study for a range of solid tumors [6] - Scancell's subsidiary, GlyMab Therapeutics Ltd., is focused on developing high-affinity GlyMab® antibodies targeting tumor-specific glycans [6]