1 April 2025

Scancell Holdings plc

("Scancell" or the "Company")

Scancell to Present Clinical Data from the Ongoing Phase 2 SCOPE Trial of SCIB1 at 2025 AACR Annual Meeting

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapy products for the treatment of multiple cancers, today announce clinical data from the ongoing Phase 2 SCOPE trial will be presented at the American Association for Cancer Research (AACR) Annual Meeting, taking place in Chicago, Illinois on 25-30 April 2025.

SCIB1 is a potent, targeted DNA melanoma cancer vaccine, that effectively activates high-avidity T cells, leading to a potent, lasting immune response by creating an immune memory that prevents the cancer from recurring.

The SCOPE study (NCT04079166) is a Phase 2, Multicentre Open-Label, Study, investigating SCIB1/ iSCIB1+, with double checkpoint inhibitors ("CPIs") in late-stage melanoma. The first cohort includes 43 patients receiving SCIB1 in combination with ipilimumab and nivolumab. Initial data in 25 patients has shown

·      84% disease control rate;

·      80% progression free survival, with 20% complete response rate; and

·      72% objective response rate.

Scancell CMO Nermeen Varawalla will present the SCOPE clinical trial program, preliminary results of cohort 1 and their correlation with T cell responses. These data along with those expected from ongoing study cohorts, 3 & 4 will determine the design for the planned follow-on randomised registration clinical trial.  

The AACR conference is an internationally recognised annual meeting, bringing together world-leading experts to share the latest advances in oncology.

Phil L'Huillier, Chief Executive Officer, Scancell, commented: "We are excited to share these SCOPE trial results with the scientific community at AACR. The strong disease control and response rate, with an excellent safety profile reinforces the potential of our vaccine to transform melanoma treatment. Our next generation vaccine iSCIB1+ is also being evaluated in a broader patient population within other cohorts of the study. The findings from the overall study will inform the design of our planned global randomized control registration trial."

Presentation Details:

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

Session: LBPO.CL01 - Late-Breaking Research: Clinical Research 1

Session Date and Time: Monday 28 April, 2:00 - 5:00 PM

Location: McCormick Place Convention Center - Section 53

Published Abstract Number: LB214 / 11

Presenter: Nermeen Varawalla

Authors: Heather Shaw, Poulam Patel, Miranda Payne, Satish Kumar, Sarah Danson, Martin Highley, Clare Barlow, Kellati Prasad, Ioannis Karydis, Maria Marples, Kate Young, Pippa Corrie, Robert Miller, Georgia Goodhew, Samantha Paston, Gaelle Cane, Joe Chadwick, Lindy Durrant and Nermeen Varawalla

About SCIB1/iSCIB1+ 

SCIB1 is the lead product from the Company's ImmunoBody® DNA Vaccine platform, which uses the body's immune system to identify, attack and destroy tumours. 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.  

About the SCOPE Study 

The SCOPE Study (NCT04079166) is a Phase 2, Multicentre, Open-Label, Umbrella Study of SCIB1 and iSCIB1+ in Patients With Advanced Unresectable Melanoma Receiving Nivolumab With Ipilimumab or SCIB1 With Pembrolizumab to determine the response rate and safety and tolerability of intramuscular SCIB1 or iSCIB1+ when added to nivolumab (Opdivo) with ipilimumab (Yervoy) or SCIB1 with pembrolizumab (Keytruda). Conducted across approximately 15 sites in the United Kingdom, this multi-site trial aims to demonstrate durable and potent anti-tumour activity and ORR of SCIB1/Iscib1+ in addition to standard of care checkpoint inhibitors. Additional endpoints include duration of response (DOR), progression free survival (PFS), overall survival (OS), safety, and tolerability. Participants receive up to 10 doses of either SCIB1 or iSCIB1+ using PharmaJet Stratis® needle-free injection device system in the upper arm or upper leg. up to 85 weeks, in combination with nivolumab with ipilimumab or SCIB1 with pembrolizumab. More information on this trial can be found at clinicaltrials.gov or www.clinicaltrialsregister.eu. 

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. 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/