Scancell Holdings plc Scancell holds oral presentation of positive Phase 2 data on Immunobody® iSCIB1+ in late-stage melanoma at SITC 2025 Data from SCOPE trial show a potential new benchmark in efficacy, durability, immune responses and safety Progression-free survival (PFS) for iSCIB1+ in target population at 11 months is 78%, compared with historic 12 months PFS of 46% with doublet checkpoint therapy of ipilimumab and nivolumab Development plans for iSCIB1+ accelerated including regulatory and partner ...

Core Viewpoint - Scancell Holdings plc has made significant progress in developing its active immunotherapies, particularly the DNA ImmunoBody iSCIB1+ and Moditope Modi-1, showing promising clinical results in treating advanced melanoma and head and neck cancer, respectively. The company is accelerating its development plans and preparing for future regulatory studies and partnerships [10][16][21]. Clinical Development - Positive data from the Phase 2 SCOPE trial indicates that iSCIB1+ in combination with checkpoint inhibitors can potentially set a new standard for advanced melanoma treatment, with an 11-month progression-free survival (PFS) of 78% compared to 46% for standard doublet therapy [5][23][34]. - The overall response rate (ORR) for iSCIB1+ is 64%, exceeding the 48%-50% reported for existing checkpoint therapies [22][23]. - Early results from the Phase 2 ModiFY trial show that Modi-1 combined with a single checkpoint inhibitor yields an ORR of 43% in head and neck cancer, significantly higher than historical rates [43][45]. Manufacturing and Regulatory Plans - A commercial-scale GMP manufacturing process for iSCIB1+ has been developed, ensuring high-quality formulation and long-term stability, which reduces costs and improves accessibility [24][39]. - The company plans to initiate randomized studies for iSCIB1+ in 2026, with ongoing discussions with regulatory bodies in the US, UK, and Europe [25][40]. Financial Overview - For the year ending April 30, 2025, Scancell reported an operating loss of £15.0 million, a decrease from £18.3 million in 2024, with a cash balance of £16.9 million [13][62]. - The company raised £11.3 million in late 2024, contributing to a cash runway extending into the second half of 2026 [11][59]. Corporate Developments - Scancell has strengthened its leadership team with key appointments, including Phillip L'Huillier as CEO, enhancing its capabilities for late-stage development [20][57]. - The establishment of GlyMab Therapeutics Limited as a wholly owned subsidiary aims to focus on antibody assets and platforms, with a second commercial license agreement with Genmab valued at $6 million and potential milestones of up to $630 million [11][27][49].

Core Insights - Scancell Holdings plc has reported significant clinical progress and financial results for the year ending April 30, 2025, highlighting advancements in its immunotherapy products, particularly iSCIB1+ and Modi-1, which show promising efficacy in treating advanced melanoma and head and neck cancers respectively [1][10][11]. Clinical Developments - Positive data from the Phase 2 SCOPE trial indicates that iSCIB1+ in combination with checkpoint inhibitors has a progression-free survival (PFS) of 78% at 11 months, significantly higher than the historical 12-month PFS of 46% for standard doublet therapy [5][10][22]. - The overall response rate (ORR) for iSCIB1+ is reported at 64%, exceeding the 48-50% range for existing checkpoint inhibition treatments [22][23]. - Early results from the Phase 2 ModiFY trial show that Modi-1 combined with a single checkpoint inhibitor yields an ORR of 43% in head and neck cancer, surpassing historical rates for single-agent therapies [11][44][45]. Manufacturing and Development Plans - A commercial-scale GMP manufacturing process for iSCIB1+ has been developed, ensuring high-quality formulation and long-term stability, which enhances global accessibility and reduces costs [24][40]. - The company plans to initiate randomized studies for iSCIB1+ in 2026, with ongoing discussions with potential partners for future development [10][25][41]. Financial Performance - Scancell reported an operating loss of £15.0 million for the year, a decrease from £18.3 million in the previous year, with a cash balance of £16.9 million as of April 30, 2025 [13][61]. - The company secured a second commercial license with Genmab for SC2811, which includes $6 million in upfront payments and potential milestones totaling $630 million [11][27]. Corporate Developments - The leadership team has been strengthened with key appointments, including Phillip L'Huillier as CEO, enhancing the company's capabilities for late-stage development [20][56]. - The establishment of GlyMab Therapeutics Limited as a wholly owned subsidiary aims to focus on antibody assets and platforms, providing strategic optionality for further development [11][49].

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+ in target HLA type patients was 69%, 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 the standard treatment [4][5] - The safety profile of SCIB1/iSCIB1+ combinations was consistent with that of ipilimumab and nivolumab alone, indicating no additional safety concerns [4][6] 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 enroll over 140 patients and evaluate the efficacy, safety, and durability of SCIB1/iSCIB1+ in combination with standard checkpoint inhibitors [7][9] Biomarker Potential - The data suggests the possibility of a patient selection biomarker based on HLA class I alleles, which could enhance participant selection for future studies [5][6] Market Context - The combination of ipilimumab and nivolumab currently holds a market share of 65-70% among metastatic melanoma patients in the US, highlighting the competitive landscape [7]