Scancell reports Phase 2 data showing strongly improved outcomes in Late-Stage Melanoma with its Immunobody® iSCIB1+

Core Insights - The SCOPE trial of SCIB1/iSCIB1+ shows promising results in treating advanced unresectable melanoma, indicating a potential new benchmark for efficacy, durability, immune responses, and safety [2][3][5] Efficacy and Safety - The overall response rate (ORR) for iSCIB1+ was 69% for target HLA type patients, significantly higher than the 48-50% ORR for standard care [1][4] - The 12-month progression-free survival (PFS) for Cohort 1 was 64.6%, and for Cohort 3, it was 80.8%, compared to 43.9% for ipilimumab plus nivolumab [4] - The combined ORR for evaluable patients in Cohorts 1 and 3 was 68.6%, with a disease control rate (DCR) of 88.0% and a complete response rate (CR) of 17.9% [3][4] Future Development Plans - iSCIB1+ has been selected for further development, with plans for a registrational Phase 2b/3 global study being accelerated [1][7] - The study aims to evaluate the efficacy, safety, and durability of SCIB1 or iSCIB1+ in combination with standard-of-care checkpoint inhibitors in late-stage melanoma [7] Biomarker Potential - The data provides a potential patient selection biomarker for future registrational studies, with CD8 T cell responses linked to improved clinical outcomes [5][6] - iSCIB1+ targets HLA class 1 alleles present in 80% of the population, enhancing its efficacy across a broader patient demographic compared to SCIB1 [6] Market Context - In the U.S., ipilimumab plus nivolumab holds a market share of 65-70% among metastatic melanoma patients, indicating a significant opportunity for iSCIB1+ [7]