First iSCIB1+ patient dosed

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, announces today that the first patient has been dosed with iSCIB1+ and doublet checkpoint inhibitor therapy, consisting of ipilimumab (Yervoy®) plus nivolumab (Opdivo®), in the SCOPE trial's new cohort.

Prof Lindy Durrant, Chief Executive Officer, Scancell, commented: "Following approval earlier this year from the Medicines and Healthcare products Regulatory Agency (MHRA) to add a third cohort to the SCOPE trial, we are very pleased to announce that the first patient has been dosed with iSCIB1+ with doublet therapy in line with our previous guidance on timing. As we have previously communicated, we anticipate that iSCIB1+ will be as effective as SCIB1 and could be a promising candidate for registration studies. We look forward to progressing the trial and to providing further updates to the market in due course."

Dr L S Prasad Kellati, Consultant Medical Oncologist from the Royal Preston Hospital, UK commented: "We are very excited to have dosed our patient in the iSCIB1+ in combination with doublet checkpoint cohort of the SCOPE trial. With its potentially increased potency and applicability to a broader patient profile, we believe iSCIB1+ represents a major step forward in providing more metastatic melanoma patients the potential benefits of combining standard of care checkpoint therapy with Scancell' s innovative cancer vaccines."

iSCIB1+ is a modified version of SCIB1 developed using Scancell's AvidiMab® platform to enhance its potency compared to SCIB1. 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 human leukocyte antigen (HLA) dependent.

As iSCIB1+ is very similar to SCIB1 it is anticipated that it should show the same exceptional results as SCIB1 with an objective response rate of 85% but in a broader range of melanoma patients. Recruitment into the iSCIB1+ cohort is expected to be complete by the end of Q3 2024. Early data from this cohort is expected in Q4 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 seamless adaptive registration programme in patients with unresectable melanoma, which represents a potential $1.5 billion per annum market. The Phase 2 part of the adaptive trial is anticipated to take 18 months and will likely generate significant partner interest.