**Summary**
Scancell Holdings plc announced on January 26, 2026, that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a global Phase 3 trial of its iSCIB1+ Immunobody® in advanced melanoma. This clearance paves the way for a registrational Phase 3 trial planned to start in 2026, with progression-free survival (PFS) as the agreed surrogate endpoint.
Data from the Phase 2 SCOPE trial demonstrated iSCIB1+’s potential to redefine the standard of care (SoC) for advanced melanoma. Interim results showed a 24%-point improvement in PFS compared to real-world SoC and historic controls. Specifically, PFS was 74% at 16 months in the target population, outperforming the current SoC (ipilimumab plus nivolumab) which reported 50% PFS at 11.5 months.
Scancell’s CEO, Dr. Phil LHuillier, highlighted the FDA’s endorsement as a strong validation of iSCIB1+’s clinical benefit, safety, and manufacturing quality. The company is exploring financing options, including partnering discussions, for the Phase 3 trial.
iSCIB1+ will be further developed for patients with specific human leukocyte antigen (HLA) alleles, representing 80% of melanoma patients. The favorable PFS results were consistent across key subgroups, including those with PD-L1 low, BRAF wildtype, and prior checkpoint inhibitor exposure.
Scancell, a clinical-stage biotechnology company, focuses on developing active immunotherapies for cancer, with iSCIB1+ as its lead product from the DNA ImmunoBody® platform. The company also has other programs, including Modi-1 and GlyMab Therapeutics Ltd., targeting various cancer types.
This announcement marks a significant milestone for Scancell, positioning iSCIB1+ as a potential game-changer in advanced melanoma treatment.