Update on SCOPE trial

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, announces today it has two further responders on the SCOPE study, bringing the number of responders to 11 out of 13 patients. This is an objective response rate (ORR) of 85%. These responses have been verified in nine patients with a second scan at 19 weeks. Significantly, one of the patients has achieved a complete response following treatment. The two recent responders are scheduled to have their response confirmed in a subsequent scan.

The SCOPE trial has now successfully transitioned into the second stage, which will recruit a further 27 patients (for a total of 43). The aim is to achieve at least 18 further responses (i.e., 27 responses in total) which would statistically demonstrate that SCIB1, in combination with doublet therapy, exceeds currently achievable ORRs. Recruitment is on track with data available in H1 2024. Based upon the first 13 patients there is a greater than 90% probability that the second phase will also be successful.

If validated in the second stage of the SCOPE trial this will provide confidence to initiate 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 should take 18 months and will likely generate significant partner interest.

Scancell has also received MHRA correspondence requesting a preclinical mouse safety study with iSCIB1+ prior to resubmission of the amendment to the current trial protocol to include a new parallel cohort with the double CPIs with iSCIB1+. Management do not see any potential issue with this regulatory request having previously completed identical studies with SCIB1. The iSCIB1+ cohort is now expected to start in Q1 2024.

Prof Lindy Durrant, Chief Executive Officer, Scancell, commented: "The SCOPE study continues to yield excellent results with two more responders and one of the previous patients now achieving a complete response. Following routine communication from the MHRA we now anticipate the iSCIB1+ cohort to commence in Q1 2024. We look forward to providing further updates on our progress given the extremely positive results to date."