Scancell's DNA Immunotherapy Shows 74% Progression-Free Survival in Advanced Melanoma Phase 2 Trial
Key Insights
Scancell (search)'s iSCIB1+ (search) DNA immunotherapy delivered via PharmaJet's needle-free injection system achieved 74% progression-free survival at 16 months in advanced melanoma (search) patients.
The Phase 2 SCOPE trial results significantly outperformed standard checkpoint inhibitor therapy, which showed 50% progression-free survival at 11.5 months.
Based on these promising results, Scancell (search) plans to initiate a registrational Phase 3 study in the second half of 2026.
Scancell (search)'s iSCIB1+ (search) DNA immunotherapy has demonstrated significant clinical promise in advanced melanoma (search), achieving a 74% progression-free survival rate at 16 months when delivered using PharmaJet's needle-free injection system in the Phase 2 SCOPE trial. The results, presented at the ESMO Immuno-Oncology Congress 2025, represent a substantial improvement over standard-of-care checkpoint inhibitor therapy alone, which showed 50% progression-free survival at 11.5 months.
Clinical Trial Results and Significance
The SCOPE Phase 2 study evaluated Scancell (search)'s iSCIB1+ (search) DNA immunotherapy delivered intramuscularly using PharmaJet's Stratis needle-free injection system in patients with unresectable advanced melanoma (search). The therapy was administered in combination with immune checkpoint inhibitors (search), targeting a patient population with significant unmet medical needs.
Advanced melanoma (search) continues to present substantial clinical challenges, with five-year survival rates of less than 23% for Stage IV patients and an estimated 58,000 deaths annually. While immune checkpoint inhibitors (search) have improved outcomes for many patients, approximately half either fail to respond or experience non-durable benefits, highlighting the critical need for novel therapeutics that can extend and deepen clinical responses.
Technology Platform and Delivery System
The iSCIB1+ (search) immunotherapy represents the lead product from Scancell (search)'s DNA ImmunoBody platform, designed to generate safe and long-lasting tumor-specific immunity. The therapy was delivered using PharmaJet's Stratis needle-free injection system, which has U.S. FDA 510(k) clearance and CE mark in Europe for intramuscular and subcutaneous delivery of medications and vaccines.
"PharmaJet's Needle-free Injection System is an effective delivery device for iSCIB1+ (search) and we are delighted with the latest results in the Phase 2 study," said Dr. Phil L'Huillier, CEO of Scancell (search). "Patients and providers alike prefer the needle-free system over conventional needle and syringe. We have significant experience with Stratis and its ability to consistently deliver our product in a more comfortable and convenient way."
Development Timeline and Regulatory Path
Based on the positive Phase 2 results, Scancell (search) has indicated plans to initiate a registrational Phase 3 study in the second half of 2026. The company has outlined plans to advance iSCIB1+ (search) toward potential commercialization by 2029, subject to regulatory outcomes and achievement of clinical endpoints.
Wouter Latour, CEO of PharmaJet, emphasized the technology's advantages: "Stratis is designed to provide consistent, reproducible intramuscular delivery of DNA-based therapies, offering a needle-free alternative to traditional injections which can be inefficient for DNA delivery, and to electroporation, which is often uncomfortable for patients."
Broader Pipeline Development
Beyond iSCIB1+ (search), Scancell (search) is developing Modi-1, the lead peptide immunotherapy from their Moditope platform, which is being investigated in a Phase 2 study across a broad range of solid tumors (search). The company's wholly owned subsidiary, GlyMab Therapeutics (search) Ltd., is developing high affinity GlyMab antibodies targeting tumor-specific glycans, with two products already licensed to Genmab A/S for development.