ISCIB1+ Ph3 design2 Jun 2026 19:19
The upcoming Phase 3 registrational trial for Scancell's lead immunotherapy, iSCIB1+, is scheduled to begin in the second half of 2026. It builds directly on parameters defined during the successful Phase 2 SCOPE study.Core Design ElementsTarget Population: Patients with previously untreated, unresectable stage IIIB/IV (advanced) melanoma.Precision Medicine Enrichment: The trial will utilize a specific HLA class 1 allele selection marker to enrich the study for likely responders. This targeted population covers approximately 80% of all advanced melanoma patients.
Primary Endpoint: Progression-Free Survival (PFS) has been formally agreed upon with the US FDA as the primary surrogate endpoint for registration.Scope & Scale: It is designed as a global, multinational, multi-centre study spanning key medical centers across the US, UK, and Europe. Industry analysts expect enrollment to target roughly 450 to 500 patients.Treatment ProtocolCombination Regimen: iSCIB1+ will be administered alongside the current standard of care (SoC) dual checkpoint inhibitors, ipilimumab (Yervoy) and nivolumab (Opdivo).Delivery Method: The vaccine will be delivered intramuscularly via a needle-free injection device (PharmaJet system), targeting the upper arm or leg. This avoids invasive delivery while directly activating dendritic cells to induce a long-lasting memory T-cell response.
Regulatory & Commercial MilestonesThe study design, manufacturing quality, and dosing strategy have been fully aligned with the US FDA via IND clearance. Combined with its April 2026 FDA Fast Track Designation, Scancell may utilize pre-specified interim data read-outs to pursue accelerated approval pathways while the trial runs to completion.
Sign In
Follow the stocks
