Partnership with NHS Cancer Vaccine Launch Pad enabling fast-tracked access for melanoma patients

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:

We know that cancer vaccines have the potential to revolutionise cancer treatment for patients and save lives, so it’s fantastic that the NHS is expanding its world-leading clinical trial platform, which means more patients with different types of cancer could benefit from the development of new vaccines that could stop their cancer coming back. We want to work with a range of industry partners and as more trials get up and running, we want to make sure as many eligible NHS patients as possible are able to access them.

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.