1 November 2023

Scancell Holdings plc

("Scancell" or the "Company")

Scancell announces late-breaking abstract presenting positive data from the first stage in its Phase 2 SCOPE trial to be presented at the 38^th Annual Meeting of the Society for Immunotherapy of Cancer

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, announces that data from the first stage in its Phase 2 SCOPE trial, investigating SCIB1 in combination with checkpoint inhibitors (CPIs) in advanced melanoma, has been selected for a poster presentation at the 38th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) taking place on 1-5 November 2023 in San Diego, CA.

Prof Lindy Durrant, Chief Executive Officer and Chief Scientific Officer of Scancell, commented: "We are pleased that our recently announced positive data from the first stage of our Phase 2 SCOPE trial has been selected for poster presentation at SITC. Better treatment outcomes are needed for patients with advanced melanoma and these highly impressive early results for SCIB1 combined with doublet CPI therapy demonstrate a meaningful improvement. The SCOPE trial is on track to complete recruitment by the end of 2023 with data available in H1 2024. We look forward to sharing more on these encouraging results at SITC and how this could make a significant impact on melanoma patient survival."

The title, timing and location of the poster presentation are as follows:

Poster presentation title           A DNA plasmid melanoma cancer vaccine, SCIB1, combined with nivolumab + ipilimumab in patients with advanced unresectable melanoma: Efficacy and safety results from the open-label Phase 2 SCOPE trial

Authors                                    Heather Shaw, Poulam Patel, Miranda Payne, Satish Kumar, Sarah Danson, Martin Highley, Clare Barlow, Robert Miller, Fayaz Master and Lindy Durrant

Abstract number                      1533

Session date and time              Friday, Nov. 3, 2023, 9am - 7pm EDT

Location                                   Exhibit Halls A and B1 - San Diego Convention Center

A copy of the poster will be available on Scancell's website following the conference at: https://www.scancell.co.uk/vaccine-publications

About the SCOPE Phase 2 clinical trial 

SCOPE is an open label, multicohort, multicentre, Phase 2 study of SCIB1 in patients with advanced unresectable melanoma receiving either nivolumab with ipilimumab or pembrolizumab. SCIB1 is a deoxyribonucleic acid (DNA) plasmid vaccine encoding two CD8 epitopes from the melanoma antigens tyrosinase-related protein-2 and glycoprotein 100 (gp100), plus two CD4 epitopes from gp100.   The purpose of the study is to determine whether the addition of SCIB1 to standard of care checkpoint inhibitors can improve the objective response rate (ORR) of patients with advanced melanoma relative to the checkpoint inhibitors alone. The ORR is defined as the proportion of patients with a complete or partial response at any time after the start of treatment.  During the first stage of the SCOPE trial reported here, patients received SCIB1 in combination with the best treatment currently available, namely the CPIs nivolumab and ipilimumab. The First Stage milestone was protocolled to demonstrate at least a 70% ORR with an 80% power ie at least 8/15 patients responding, assessed by radiological imaging. Further information relating to the clinical trial can be found on the Company's website at  https://www.scancell.co.uk

and at https://classic.clinicaltrials.gov/ct2/show/NCT04079166

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/