14 April 2025

Scancell Holdings plc

("Scancell" or the "Company")

Partnership with NHS Cancer Vaccine Launch Pad Enabling

Fast-Tracked Access for Melanoma Patients

Scancell Holdings plc (AIM: SCLP), the developer of novel immunotherapy products for the treatment of multiple cancers, announces a partnership with the NHS Cancer Vaccine Launch Pad (CVLP) to fast-track access for NHS patients into the fourth cohort of the Company's Phase 2 clinical SCOPE study. This cohort will evaluate intradermal administration of Scancell's iSCIB1+, potent, targeted "off-the-shelf" Immunobody® second generation DNA cancer vaccine, in patients with advanced unresectable melanoma receiving standard of care immunotherapy treatments.

The CVLP, launched in May 2024, is a world-leading NHS trial "matchmaking" service to help find new life-saving treatments. NHS Hospitals across the country will be able to take part in this transformational study, with eligible patients from around the UK being referred to a participating NHS site. The partnership is being coordinated and run by the Southampton Clinical Trials Unit, with the first patients expected to be referred from May. Scancell is the first British company to join the CVLP, and iSCIB1+ is the first DNA vaccine to be part of this initiative.

Melanoma is the fifth most common cancer in the UK, accounting for around 4% of all new cancer cases. While immunotherapy is a standard treatment for advanced melanoma patients, only about half of patients respond well, leaving the rest at risk of disease progression and metastases. iSCIB1+ precisely targets activated antigen presenting cells via CD64 and effectively activates high-avidity T cells, leading to a potent, lasting immune response thereby creating an immune memory that may prevent the cancer from recurring. As a part of the trial, patient tissue type or "HLA" type will need to be determined by using a blood test to look for the presence or absence of genes which control how the immune system works.

Dr Nermeen Varawalla, Chief Medical Officer, Scancell, said: "Cancer vaccines have the potential to transform immunotherapy, redefine treatment options and ultimately save lives. Recent clinical data has demonstrated that our potent, tumour-targeted 'off-the-shelf' cancer vaccine delivers strong efficacy, with the potential for meaningful long-term survival benefits in patients with advanced metastatic melanoma. Our partnership with the CVLP will give patients expedited access to this landmark study and is an important step in accelerating the clinical development of this important new treatment."

NHS national cancer director Professor Peter Johnson said: "Skin cancer can have a devastating impact, and we know that cancer vaccines have the potential to revolutionise cancer care for patients in this country and across the world - and to save more lives. It's incredibly exciting that the NHS is expanding its world-leading programme so more patients with different types of cancer could benefit from the development of new vaccines that could stop their cancer coming back."

The SCOPE study will enrol over 140 patients across four cohorts. Reported phase 2 clinical data from 25 patients in cohort 1 receiving the first-generation vaccine SCIB1 i.m. in combination with checkpoint inhibitors, ipilimumab and nivolumab, have shown 80% progression free survival (PFS) and 20% complete response rate (CR). Cohort 3, investigating the next generation iSCIB1+i.m. in combination with ipilimumab and nivolumab, has now completed recruitment of 45 patients and the fourth cohort, to be recruited in partnership with CVLP, will evaluate intradermal administration of iSCIB1+

Data from all study cohorts in the SCOPE trial will inform the design of the upcoming randomised trial, which is planned for in H2 2026, either by Scancell or in partnership. Clinical data from SCIB1 in cohort 1 and iSCIB1+ in cohort 3 is expected around mid-2025, while clinical data from iSCIB1+ in cohort 4, following the partnership with CVLP, is expected late 2025.

Phil L'Huillier, Chief Executive Officer, Scancell, commented: "We are delighted to announce our partnership with the CVLP. This partnership offers melanoma patients in the UK faster access to our developmental cancer vaccine, iSCIB1+, that we see is bringing long term immune control of the tumours to these advanced melanoma patients. It additionally underscores the potential benefit of iSCIB1+ to advanced stage melanoma patients and the longer-term market opportunity. Data from the SCOPE study will allow us to implement a robust development plan for the next phase towards registration in 2026."

About SCIB1/iSCIB1+ 

SCIB1 is the lead product from the Company's ImmunoBody® DNA Vaccine platform, which uses the body's immune system to identify, attack and destroy tumours. iSCIB1+ is a modified version of SCIB1 developed using Scancell's AvidiMab® platform to enhance its potency compared to SCIB1. iSCIB1+ also includes additional melanoma-specific epitopes so it has the potential to be effective in a broader patient population beyond the 40% of patients with the tissue type treatable with SCIB1, where treatment is human leukocyte antigen (HLA) dependent.  

About the SCOPE Study 

The SCOPE Study (NCT04079166) is a Phase 2, Multicentre, Open-Label, Umbrella Study of SCIB1 and iSCIB1+ in Patients With Advanced Unresectable Melanoma Receiving Nivolumab With Ipilimumab or SCIB1 With Pembrolizumab to determine the response rate and safety and tolerability of intramuscular SCIB1 or iSCIB1+ when added to nivolumab (Opdivo) with ipilimumab (Yervoy) or SCIB1 with pembrolizumab (Keytruda). Conducted across approximately 15 sites in the United Kingdom, this multi-site trial aims to demonstrate durable and potent anti-tumour activity and ORR of SCIB1/iSCIB1+ in addition to standard of care checkpoint inhibitors. Additional endpoints include disease control rate (DCR), duration of response (DOR), progression free survival (PFS), overall survival (OS), safety, and tolerability. Participants receive up to 10 doses of either SCIB1 or iSCIB1+ using PharmaJet Stratis® needle-free injection device system in the upper arm or upper leg. up to 85 weeks, in combination with nivolumab with ipilimumab or SCIB1 with pembrolizumab. More information on this trial can be found at clinicaltrials.gov or www.clinicaltrialsregister.eu. 

About Scancell 

Scancell (LSE:SCLP) develops immunotherapies for a Cancer-free future by enhancing long-lasting tumour specific immunity. As a clinical stage biotechnology company with deep roots in cancer immunology and translational research, Scancell develops tumour targeted off-the-shelf vaccines, with highly favourable safety and durable systemic immune responses. Scancell's lead product, iSCIB1+, a DNA vaccine, is currently showing strong promise on top of checkpoint therapies in a multi-arm phase 2 study in first-line melanoma. The second vaccine Modi-1 is being investigated in a phase 2 study in a broad range of solid tumours. Scancell is also developing a pipeline of high affinity antibodies targeting tumour specific glycans using its proprietary platforms. Two of these antibodies are now being developed in major biopharma partnerships and a further two antibodies targeting lung and epithelial cancers, are actively being developed in-house.

https://www.scancell.co.uk