24 July 2024

Scancell Holdings plc

("Scancell" or the "Company")

Scancell Provides Update from iSCIB1+ Clinical Advisory Meeting to Strengthen Plans for Phase 2/3 Registration Clinical Trial

A panel of international key opinion leaders in the treatment of Melanoma convened in Chicago to offer strategic guidance in the design of Scancell's Phase 2/3 seamless adaptive registration study.

The SCIB1 stage 1 clinical data poster was very well received at ASCO.

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer, today announces that a group of leading medical oncologists in the field of melanoma treatment reviewed and strengthened Scancell's plan for a Phase 2/3 registration study following completion of the ongoing SCOPE study.

Scancell's plans to conduct an adaptive randomised controlled Phase 2/3 SCOPE-2 trial is supported by a panel of experts. The study is expected to have an early interim analysis of Overall Response Rate (ORR) based on a blinded independent centralised review of CT/MRI scans before advancing to the Phase 3 component where the primary endpoint of progression-free survival will be analysed at a predetermined landmark.  

The panel comprised the following members:

A poster, presenting the first stage of the SCOPE study, was also very well received at ASCO with Prof Durrant, Dr Heather Shaw, Dr Robert Miller and Mr Fayaz Master discussing the results for three hours with oncologists, pharmaceutical companies and commercial enterprises.

Scancell continues to recruit to the SCOPE study, which includes patients treated with SCIB1 as well as iSCIB1+.  32/43 patients have been recruited into the SCIB1 cohort and 22/43 into the iSCIB1+ cohort, with clinical results expected in Q4 2024 and Q1 2025, respectively.

Prof Lindy Durrant, Chief Executive Officer, Scancell said: "We are very grateful to the esteemed panel for their interest in our SCOPE results and their input into our further clinical study. The panel felt that the data was compelling enough to proceed to the Phase 2/3 randomised registration study upon the completion of the SCOPE study. We were also overwhelmed by the interest in the poster, which is the most significant response I have seen in my career."

Dr. Wolchok serves as an uncompensated consultant for Scancell Limited.

Dr. Chapman serves as a compensated consultant for Scancell Limited.

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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/