Scancell Holdings has announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a registrational Phase 3 trial of iSCIB1+ Immunobody in advanced melanoma. The trial will use progression free survival (PFS) as the agreed surrogate endpoint.

The decision follows completion of the 140-patient SCOPE Phase 2 study, a UK-based, multi-centre, open-label trial evaluating SCIB1 and iSCIB1+ in combination with nivolumab plus ipilimumab in previously untreated unresectable stage 3B/IV melanoma. Analysis of the Phase 2 data indicated potentially best-in-class efficacy and durability, and identified a selection marker to enrich the Phase 3 trial for responders.

Dr Phil L’Huillier, CEO of Scancell, said: “This IND clearance creates a clear pathway for late-stage registrational development of our iSCIB1+ Immunobody. Data from the Phase 2 SCOPE trial shows a significant improvement in progression free survival as well as emerging overall survival with iSCIB1+ compared to historic benchmarks. I take this endorsement of our program as a strong measure of the clinical benefit and safety of our very novel product as well as the quality of our manufacturing and preclinical work. We are continuing our dialogue with regulators broadly as we continue to evaluate all financing options, including partnering discussions, for the Phase 3 trial.”

Updated results from Cohort 3 of the SCOPE trial, which enrolled patients with selected human leukocyte antigen (HLA) alleles representing 80% of melanoma patients, showed PFS of 74% at 16 months. This compares with the current standard of care—ipilimumab plus nivolumab alone—reporting 50% PFS at 11.5 months. The benefit remained consistent across key subgroups including PD-L1 low, BRAF wildtype, and patients with prior checkpoint inhibitor exposure.

iSCIB1+ is administered needle-free intramuscularly and is part of Scancell’s Immunobody platform, which aims to induce strong, durable anti-tumour immunity. SCOPE is designed to evaluate the efficacy, safety, and durability of SCIB1 and iSCIB1+ therapies in combination with standard checkpoint inhibitors and to define parameters for a Phase 3 registration trial.