Scancell Holdings Regulatory News (SCLP)

27 November 2023

Scancell Holdings plc

("Scancell" or the "Company")

Update on SCOPE trial

- 11 out of 13 patients have responded increasing the ORR to 85%

- One patient has achieved complete response following treatment

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, announces today it has two further responders on the SCOPE study, bringing the number of responders to 11 out of 13 patients. This is an objective response rate (ORR) of 85%. These responses have been verified in nine patients with a second scan at 19 weeks. Significantly, one of the patients has achieved a complete response following treatment. The two recent responders are scheduled to have their response confirmed in a subsequent scan.

The SCOPE trial has now successfully transitioned into the second stage, which will recruit a further 27 patients (for a total of 43). The aim is to achieve at least 18 further responses (i.e., 27 responses in total) which would statistically demonstrate that SCIB1, in combination with doublet therapy, exceeds currently achievable ORRs. Recruitment is on track with data available in H1 2024. Based upon the first 13 patients there is a greater than 90% probability that the second phase will also be successful.

If validated in the second stage of the SCOPE trial this will provide confidence to initiate a randomised phase 2/3 adapted registration programme in patients with unresectable melanoma which represents a potential $1.5 billion per annum market. The Phase 2 part of the adapted trial should take 18 months and will likely generate significant partner interest.

Scancell has also received MHRA correspondence requesting a preclinical mouse safety study with iSCIB1+ prior to resubmission of the amendment to the current trial protocol to include a new parallel cohort with the double CPIs with iSCIB1+. Management do not see any potential issue with this regulatory request having previously completed identical studies with SCIB1. The iSCIB1+ cohort is now expected to start in Q1 2024.

Prof Lindy Durrant, Chief Executive Officer, Scancell, commented: "The SCOPE study continues to yield excellent results with two more responders and one of the previous patients now achieving a complete response. Following routine communication from the MHRA we now anticipate the iSCIB1+ cohort to commence in Q1 2024. We look forward to providing further updates on our progress given the extremely positive results to date."

-ENDS-

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/

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