26 March 2024

Scancell Holdings plc

("Scancell" or the "Company")

Update on SCOPE trial

The first patient has been dosed with iSCIB1+ in the SCOPE trial

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.

-ENDS-

About Scancell

Scancell is a clinical stage biopharmaceutical company that is leveraging its proprietary research, built up over many years of studying the human adaptive immune system, to generate novel medicines to treat significant unmet needs in cancer and infectious disease. The Company is building a pipeline of innovative products by utilising its four technology platforms: Moditope^® and ImmunoBody^® for vaccines and GlyMab^® and AvidiMab^® for antibodies.

Adaptive immune responses include antibodies and T cells (CD4 and CD8), both of which can recognise damaged or infected cells. In order to destroy such cancerous or infected cells, Scancell uses either vaccines to induce immune responses or monoclonal antibodies (mAbs) to redirect immune cells or drugs. The Company's unique approach is that its innovative products target modifications of proteins and lipids. For the vaccines (Moditope^® and ImmunoBody^®) this includes citrullination and homocitrullination of proteins, whereas its mAb portfolio targets glycans or sugars that are added onto proteins and / or lipids (GlyMab^®) or enhances the potency of antibodies and their ability to directly kill tumour cells (AvidiMab^®).

For further information about Scancell, please visit: https://www.scancell.co.uk/

This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).