Scancell Holdings Regulatory News (SCLP)

02 June 2023

Scancell Holdings plc

("Scancell" or the "Company")

Scancell to present ModiFY Phase 1/2 cancer vaccine clinical trial protocol and early efficacy data at the American Society of Clinical Oncology Meeting

ModiFY trial progressing through monotherapy expansion cohorts and combination safety cohorts

First patient dosed in Cohort 4 to test high dose Modi-1 in combination with CPI

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, announces it will present a poster entitled "Modi-1, anti-citrullinated neoepitope vaccine alone and combined with checkpoint inhibitors in patients with head and neck, breast, renal and ovarian cancers: protocol for the ModiFY Phase 1/2 basket clinical trial: report after completion of monotherapy dose-finding" at the American Society of Clinical Oncology Meeting (ASCO) 2023 Annual Meeting taking place at McCormick Place, Chicago, US between 2-6 June 2023.

The poster, being presented by Dr Robert Miller, Medical Director, describes the protocol and presents the results after completion of the monotherapy dose-finding and provides an update on patients recruited into the monotherapy dose expansion cohorts and into the checkpoint inhibitor (CPI) combination dose-finding cohort. ModiFY is a first-in-human Phase 1/2 basket trial investigating the use of Modi-1, the first candidate from Scancell's Moditope® platform, to treat four different types of cancer: high grade serous ovarian carcinoma (HGSOC), triple negative breast cancer (TNBC), head and neck squamous cell carcinoma (SCCHN) and renal cell carcinoma (RCC). Data is included up until the date of the poster acceptance by ASCO and concludes that Modi-1 is well tolerated and that the early efficacy data from the monotherapy arms of the trial remain encouraging.

The ModiFY study is ongoing and recruiting patients into the Phase 2a sub-study investigating Modi-1 monotherapy in dose expansion cohorts. In tandem, recruitment into Cohort 3 to receive treatment with low-dose Modi-1 in combination with standard of care CPI therapy has been completed. Based on review of the safety data from Cohort 3, dose escalation to Cohort 4 has been approved by the Safety Review Board and the first patient has been dosed.

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

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

About the ModiFY Phase 1/2 clinical trial

ModiFY is an open-label, multicohort, multicentre, adaptive Phase 1/2 trial of Modi-1 in patients with unresectable HGSOC, SCCHN, TNBC or RCC. The Modi-1 peptides are linked to AMPLIVANT®, a potent adjuvant which is the subject of a worldwide licensing and collaboration agreement with ISA Pharmaceuticals for the manufacturing, development, and commercialisation of Modi-1. Modi-1 stimulates CD4 T cells which may directly impact tumour growth; however, in some patients these T cells may need to be protected by CPIs if the tumour environment is highly immunosuppressive. Patients are therefore treated with Modi-1 alone or, if eligible for standard of care CPI, with Modi-1 plus a CPI. 

Cohort 1 of the study confirmed the safety profile of a low dose of two citrullinated vimentin peptides. The objective for Cohort 2 of the trial was to assess the safety of the two citrullinated vimentin peptides plus an enolase peptide at a higher dose. Based on the safety data from Cohort 2, the ModiFY trial was expanded at this recommended Phase 2 dose for Modi-1 monotherapy in all four tumour types. In parallel, Cohort 3 recruited patients to receive low dose Modi-1 plus a CPI to assess safety of the combination prior to testing the higher dose of Modi-1 in Cohort 4.

Further information relating to the clinical trial can be found on the Company's website at https://www.scancell.co.uk and at https://clinicaltrials.gov/ct2/show/NCT05329532   

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/