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]

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].