Scancell Holdings Regulatory News (SCLP)

11 April 2022

Scancell Holdings plc

("Scancell" or the "Company")

Modi-1 Phase 1/2 clinical trial open for recruitment

First-in-human clinical trial in patients with triple negative breast cancer, ovarian cancer, head and neck cancer, and renal cancer

Early safety and immunogenicity data expected to be available in H2 2022

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, today announces that its Phase 1/2 clinical trial with Modi-1 (ModiFY) is open for recruitment.

In addition, the UK's Medicines and Healthcare Products Regulatory Authority (MRHA) has approved a protocol amendment which is aimed at accelerating patient recruitment and shortening study timelines. The study is a first-in-human clinical trial in patients with triple negative breast cancer, ovarian cancer, head and neck cancer, and renal cancer. Modi-1 will be administered alone and in combination with checkpoint inhibitors (CPIs) in patients where the CPI is standard of care. As previously announced, the Company expects early safety and immunogenicity data to be available in H2 2022 and potential efficacy data in 2023.

Leading oncology clinical research sites and investigators across the UK have agreed to contribute patients to the ModiFY study. The first wave of clinical sites is now open for recruitment and in due course the Company expects up to 20 sites to be open and recruiting patients.

Modi-1, the first candidate in Scancell's Moditope® platform, consists of three citrullinated tumour-associated peptides exploiting the normal immune response to stressed cells, which is largely mediated by cytotoxic CD4 T cells. The peptides are linked to AMPLIVANT®, a potent adjuvant which, in preclinical models, enhanced the immune response of Modi-1 10-to-100 fold and resulted in highly efficient tumour clearance, including protection against tumour recurrence. AMPLIVANT® is the subject of a worldwide licensing and collaboration agreement with ISA Pharmaceuticals for the manufacturing, development and commercialisation of Modi-1.

Prof Lindy Durrant, Chief Executive Officer, Scancell, commented: "The opening of recruitment for patients into our ModiFY clinical trial is a major step forward for the Company. We are very excited about the prospects for Modi-1 based on the dramatic regression of large tumours in our preclinical models and look forward to accelerating recruitment over the coming months and analysing the early safety and immunogenicity data later this year."

Professor Christian Ottensmeier at The Clatterbridge Cancer Centre and University of Liverpool, commented: "As the principal investigator for this first-in-human clinical trial I am delighted to be working with Scancell to explore how this novel immunotherapy, Modi-1, could improve the prognosis for patients with hard-to-treat tumours."

Professor Kees Melief, Chief Scientific Officer, ISA Pharmaceuticals, commented: "This is an important milestone further cementing the productive collaboration we have with Scancell. The trial provides a further opportunity to demonstrate the potent adjuvant properties that AMPLIVANT® confers on therapeutic vaccines to potentiate the immune response needed to attack these cancers effectively."

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

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/