Scancell Holdings plc, the developer of novel immunotherapies for the treatment of cancer, announces today that 25 patients in cohort 1, receiving SCIB1 in combination with ipilimumab and nivolumab, have reached the 25-week landmark point of the SCOPE trial. These patients are showing progression free survival (PFS) of 80% at 6 months, with 5 (20%) complete responders (CR). 21 of 25 patients (84%) have shown disease control (stable disease or tumour regression, DCR). 18 out of 25 patients have shown a clinical response which is an objective response rate (ORR) of 72%, with many patients continuing to show tumour shrinkage over time. These responses have been verified in all patients with further scans at 19 and 25 weeks.
These results compare favourably with reported outcomesfrom the double checkpoints alone, namely PFS of 65%, CR of 16%, DCR of 58% and ORR of 48%, respectively. The PFS and accumulating number of complete responders indicates that the combination of SCIB1 with double checkpoints gives sustained and durable responseswhich are improved when compared to double checkpoints alone. To date, cohort 1 of the SCOPE trial has recruited 42/43 patients, and it is anticipated that all of these patients will reach week 25 during H1 2025.
Dr Heather Shaw, Medical Oncologist, University College Hospital, London, UK commented: “Based upon the emergent striking PFS, DCR and ORR results from cohort 1 so far and the lack of toxicity relating to the agent itself, SCIB1 is a promising product that would be a significant addition to ipilimumab and nivolumab and would be an important step forward in improving first line therapy for advanced melanoma patients.”
Cohort 2, investigating SCIB1 in combination with pembrolizumab, has recruited 9/43 patients and cohort 3,investigating the next generation, iSCIB1+ in combination with ipilimumab and nivolumab has recruited 33/43 patients. The iSCIB1+ cohort has predominantly recruited the non-HLA.A2 matched patients as these patients are being enrolled in cohort 1. Once recruitment in cohort 1 is complete, HLA.A2 patients will be recruited to completecohort 3 to give a representative sample of the advanced melanoma patient population. It is anticipated that allcohort 3 patients will reach week 25 during H2 2025. This will allow us to select the best vaccine for our plannedphase 2/3 randomised, adapted registration trial.
Prof Lindy Durrant, Chief Scientific Officer, Scancell, commented: “The SCOPE study continues to yield excellent results with a PFS of 80% and five patients now achieving a complete response. We are particularly impressed with the progression free survival data as this will be the primary endpoint of the next trial, a phase 2/3 randomised, adapted trial, and the key outcome for product registration. We look forward to providing further updates on our progress given the extremely positive results to date.”