Update on SCOPE trial

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, announces today that following further discussions with the Medicines and Healthcare products Regulatory Agency (MHRA), it has now received approval to add a third cohort to the SCOPE trial. This cohort will recruit 43 advanced unresectable melanoma patients who will receive iSCIB1+ with doublet therapy, consisting of ipilimumab (Yervoy®) plus nivolumab (Opdivo®).

iSCIB1+ is a modified version of SCIB1 developed using Scancell's AvidiMab® platform to enhance its potency compared to SCIB1 and gives 15 years of extended patent protection. iSCIB1+ also includes additional melanoma-specific epitopes so it has the potential to be effective in a broader patient population beyond the 40% of patients with the tissue type treatable with SCIB1, where treatment is HLA dependent.

Exceptional results from the first 13 patients receiving SCIB1 in the ongoing SCOPE trial, with an objective response rate of 85%, indicate a high probability of success in this cohort which should complete in Q2 2024. Recruitment into the iSCIB1+ cohort is expected to be complete by the end of Q2 2024, with early data expected in Q3 2024.

The results from these SCIB1 and iSCIB1+ cohorts, administered in combination with doublet therapy, will enable the Company to make a data-led decision regarding initiation of a randomised Phase 2/3 adapted registration programme in patients with unresectable melanoma, which represents a potential $1.5 billion per annum market. The Phase 2 part of the adapted trial is anticipated to take 18 months, with the potential to generate attractive licensing opportunities.

Prof Lindy Durrant, Chief Executive Officer, Scancell, commented: "Thanks to the excellent work done by the Scancell team, working hand in hand with a responsive MHRA, we are pleased to report today that we have received approval to include a third cohort of patients in the SCOPE trial who will now receive iSCIB1+ in combination with doublet checkpoints. We anticipate that iSCIB1+ will be as effective as SCIB1 and, with its potentially increased potency and broader patient profile, make it a promising candidate for registration studies. We look forward to providing further updates on our progress given the extremely positive results to date."