Scancell announces FDA clearance for Phase 3 advanced melanoma trial

Scancell Holdings plc, the developer of active immunotherapies to treat cancer, announces the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for a registrational Phase 3 trial of its iSCIB1+ Immunobody® in advanced melanoma, with progression free survival as the agreed surrogate endpoint.

Scancell has completed the 140-patient SCOPE Phase 2, open-label, multi-centre study evaluating ImmunoBody® immunotherapies (SCIB1 and iSCIB1+) in combination with nivolumab plus ipilimumab in previously untreated unresectable stage IIIB/IV melanoma. In addition to demonstrating potentially best-in-class efficacy and durability, from the data analysis we have 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.

Results from the SCOPE Phase 2 trial have enabled Scancell to select iSCIB1+, administered needlefree intramuscularly, for further development in patients with selected human leukocyte antigen (HLA) alleles, representing 80% of melanoma patients. This profile is reflected within Cohort 3 of the SCOPE trial. Updated data in this cohort show PFS was 74% at 16 months in the target population. This compares favourably to PFS reported with ipilimumab plus nivolumab alone, the current standard of care, of 50% at 11.5 months1. The favourable PFS remains consistent across key subgroups analysed including PD-L1 low, BRAF Wildtype and prior checkpoint inhibitor exposure, who might be expected to have worse outcomes.