Core Insights - Scancell Holdings plc presented positive Phase 2 data for its iSCIB1+ Immunobody in late-stage melanoma, indicating a potential new benchmark in treatment efficacy, durability, immune responses, and safety [2][3][4] Efficacy and Safety - The SCOPE trial results show a progression-free survival (PFS) rate of 78% at 11 months for iSCIB1+, significantly higher than the historic 12-month PFS of 46% for the combination of ipilimumab and nivolumab [3][4] - Combined data for the defined HLA target population across Cohorts 1 and 3 indicate a 22-month PFS of 69%, representing a meaningful improvement over historic doublet checkpoint therapy [4][5] - The overall response rate (ORR) and disease control rate (DCR) for iSCIB1+ demonstrate superiority when combined with either doublet or single checkpoint therapy, with a favorable safety profile observed in over 100 patients [4][5] Development Plans - Development plans for iSCIB1+ have been accelerated, including regulatory and partnering discussions, with randomized studies expected to begin in 2026 [5][6] - The company aims to expand the addressable patient population to approximately 80% of late-stage melanoma patients, indicating a longer patent life for iSCIB1+ [5][8] Clinical Trial Details - The SCOPE trial is an open-label Phase 2 study evaluating SCIB1/iSCIB1+ in combination with checkpoint inhibitors in late-stage melanoma, enrolling over 140 patients across four cohorts [6][7] - The trial aims to assess the efficacy, safety, and durability of SCIB1 or iSCIB1+ DNA Immunobody therapies in combination with standard of care checkpoint inhibitors [6][7]