Scancell Holdings Regulatory News (SCLP)

10 November 2023

Scancell Holdings plc

("Scancell" or the "Company")

Scancell presents positive data from the first stage in its Phase 2 SCOPE trial at the 20th International Congress of the Society for Melanoma Research

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, was presented at the 20th International Congress of the Society for Melanoma Research which took place on 6-9 November 2023 in Philadelphia, PA.

The title, timing and location of the 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

Presenting Author Fayaz Master

Session name Late breaking Clinical Abstracts

Session date and time  ?11:00am - 11:15am EDT, Thursday November 9th, 2023

The abstract of the presentation will be made available on Scancell's website 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 CPIs can improve the objective response rate (ORR) of patients with advanced melanoma relative to the CPIs 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 designed to demonstrate at least a 70% ORR with an 80% power i.e. at least 9/15 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/