Scancell phase 2 shows improved PFS with iSCIB1+ in advanced melanoma
Scancell Holdings, the developer of active immunotherapies to treat cancer, announces updated positive data from the SCOPE Phase 2 trial of iSCIB1+ in combination with ipilimumab and nivolumab, current standard of care (SoC).
A late-breaking abstract on the data has been released, and an additional poster presentation will be made during an oral session at the ESMO Immuno-Oncology Congress 2025 (ESMO IO) conference on 11 December 2025. Results from SCOPE to date have enabled Scancell to select Immunobody iSCIB1+, administered needle-free intramuscularly, for further development in patients with selected human leukocyte antigen (HLA) alleles (“the target population”), representing 80% of melanoma patients. This profile is reflected within Cohort 3 of the SCOPE trial.
Updated data in this cohort show progression free survival (PFS) was 74% at 16 months in the target population. This compares favourably to PFS reported with ipilimumab plus nivolumab alone 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. Cohort 3 comprised a total of 50 patients of which 39 were in the target HLA population, 10 outside the target HLA population and one was non-evaluable due to active brain metastases. Data in this cohort from the non-target population support the use of HLA as a biomarker for a registrational trial, with PFS of 20% at 14 months and overall response rate of 20%, albeit in a small number of patients.
Dr Heather Shaw, lead for the Medical Oncology Skin Cancer Service at University College London Hospital, London and principal investigator of the SCOPE trial at Mount Vernon Cancer Centre, said:
The prolonged progression free survival demonstrates iSCIB1+ in combination with checkpoint inhibitors has potential to redefine standard of care. This therapy combination increases the number of advanced melanoma patients who would benefit and improves the duration of their clinical response versus equivalent timepoints with checkpoint inhibition alone, thus representing an important step forward for patient outcomes.
Overall response rate for the target population in Cohort 3 was 56%, with a disease control rate of 79%. iSCIB1+ specific T cell responses correlated positively with clinical benefit, seen in 72% of patients mounting a T-cell response to both GP100 and TRP2 epitopes, thereby overcoming immune escape. A memory T-cell response phenotype was also characterised in these patients. Early overall survival (OS) data, most advanced for SCIB1, shows a 14% improvement at 26 months over SoC.
Dr Nermeen Varawalla, Chief Medical Officer of Scancell, said:
iSCIB1+, in combination with checkpoint inhibitors, is showing a significant 24% improvement in PFS over standard of care and more efficacy than the first generation SCIB1. This provides additional confidence in the Immunobody® being taken forward towards registrational trials. The translational data backing these clinical outcomes is also compelling, showing that iSCIB1+ drives a powerful durable T-cell response.
The Company has held positive discussions with the U.S Food and Drug Administration (US FDA) and other regulatory agencies. The feedback received to date supports our plans to move to Phase 3 registrational development with iSCIB1+ with alignment on trial design, dose, manufacturing and progression free survival as the expected registrational endpoint. The Company will continue active partnering, whilst assessing options to finance the next stage of development.
Dr Phil L’Huillier, CEO of Scancell, said:
These results give further momentum to our advanced planning for late-stage clinical development. We are continuing our positive discussions with the US FDA and other regulators, with feedback supporting our plans to move iSCIB1+ to late-stage development in 2026. The positive and growing durability of responses with iSCIB1+ delivered intramuscularly demonstrate that this method of administration is the optimal form to be investigated in late-stage development, and as a result we have decided not to continue with Cohort 4, with iSCIB1+ delivered intradermally. In parallel, we are also in active discussions with potential partners as we assess the optimal options to finance this next stage.
