Scancell: Phase 2 clinical trial of lead immunotherapy product commences

• First patient dosed in SCIB1 Phase 2 clinical trial
• Trial to assess whether the addition of SCIB1 to pembrolizumab (Keytruda^®) will result in an improvement in the tumour response rate and overall survival in patients with advanced melanoma

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapies for the treatment of cancer and infectious disease, today announces the enrolment and treatment of the first patient in its multicentre SCIB1 Phase 2 clinical trial at the Churchill Hospital, Oxford University Hospitals Trust, UK. The Phase 2 study is designed to assess whether the addition of SCIB1 to pembrolizumab (Keytruda^®) will result in an improvement in the tumour response rate, progression-free survival and overall survival in patients with advanced melanoma, who are also eligible for treatment with pembrolizumab.

As a result of the COVID-19 pandemic, screening and recruitment into the study was paused due to the prioritisation of COVID-19 patients in UK hospitals. Patient screening has now been re-initiated in the UK, with Professor Poulam Patel, Professor of Clinical Oncology at the University of Nottingham as the Chief Investigator. The Nottingham site, along with the Oxford centre, Velindre Hospital and Mount Vernon Hospital are actively screening subjects, with additional centres due to come online in the coming months.

SCIB1 is the lead product from the Company’s ImmunoBody^® immunotherapy platform, which uses the body’s immune system to identify, attack and destroy tumours. This is achieved by delivering a DNA plasmid using Ichor’s TriGrid^® 2.0 electroporation delivery device to enhance the uptake and presentation of cancer antigens to harness high avidity T cell responses. In a Phase 1/2 clinical trial, survival following SCIB1 monotherapy was superior to historical survival rates, with 14 of 16 resected patients surviving for more than five years. Although pembrolizumab is an approved therapy for advanced melanoma, response to treatment is limited to only a subset of patients (circa 30%). The Phase 2 study is therefore designed to assess whether the addition of SCIB1 treatment to pembrolizumab will result in an improvement in patient outcomes.

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

Professor Lindy Durrant, Chief Executive Officer, Scancell, commented: “We are delighted to have started our SCIB1 Phase 2 trial in the UK as we believe that SCIB1 administration in combination with an immune checkpoint inhibitor such as pembrolizumab has the potential to offer greater efficacy than when either agent is used alone.”

Professor Poulam Patel, Chief Investigator, commented: “As the Chief Investigator for this combination study, I am delighted to be working with Scancell again to determine if the addition of SCIB1 to current, standard treatment with pembrolizumab improves response rates.”

Dr Miranda Payne, Principal Investigator, Oxford University Hospitals commented: “Although checkpoint inhibitor combinations have improved outcomes for patients with melanoma, there remains a need to develop combinations with other investigational agents such as SCIB1, which have the potential to improve response rates without increasing toxicity. We are therefore very pleased to have recruited the first patient into this Phase 2 study.”