Scancell Holdings (LSE:SCLP) has received authorisation from the UK Medicines and Healthcare Products Regulatory Agency to proceed with a Phase 3 registrational trial of iSCIB1+, its lead DNA ImmunoBody therapy for advanced melanoma.
The regulatory clearance represents another important step towards launching the global study, following earlier Investigational New Drug clearance from the U.S. Food and Drug Administration. Scancell is targeting initiation of the Phase 3 programme by the end of 2026.
The trial is expected to recruit 550 patients with stage III or stage IV unresectable melanoma across approximately 90 clinical sites in the U.S., European Union, UK, Canada and Australia. Participants will receive either iSCIB1+ in combination with checkpoint inhibitors ipilimumab and nivolumab or placebo alongside the same two therapies.
Scancell has designed the study using an adaptive approach, with progression-free survival serving as the primary endpoint and potentially supporting an accelerated approval pathway. Overall survival will be assessed as a secondary endpoint and is intended to provide evidence supporting full regulatory approval.
The Phase 3 programme builds on results from Scancell’s Phase 2 SCOPE study, which demonstrated sustained progression-free and overall survival outcomes with iSCIB1+. Importantly, the company reported no additional checkpoint inhibitor-related toxicity associated with adding its therapy to the treatment regimen.
Initial progression-free survival data from the Phase 3 trial are expected during the second half of 2028. A successful study could provide the foundation for regulatory approval and eventual commercialisation of iSCIB1+ as a treatment for patients with advanced melanoma.
Scancell is also preparing a separate Phase 2 study evaluating iSCIB1+ in the neo/adjuvant melanoma setting, potentially extending the therapy into earlier stages of the disease. These clinical programmes are progressing alongside development of the company’s wider immuno-oncology pipeline and its proposed business combination with Neuphoria Therapeutics.
Scancell’s investment outlook remains constrained by continued losses, cash consumption, negative equity and the valuation challenges associated with negative earnings. These financial risks are partly balanced by strengthening clinical and regulatory momentum and a clearly defined Phase 3 development pathway for iSCIB1+. Technical indicators point to an upward trend in the shares, although strongly overbought readings could increase the potential for near-term volatility.
More About Scancell Holdings
Scancell Holdings is a late-stage clinical immuno-oncology and biotechnology company developing targeted, off-the-shelf active immunotherapies for difficult-to-treat cancers.
Its pipeline is based around the ImmunoBody and Moditope technology platforms. Lead candidate iSCIB1+ is being developed for melanoma, while Modi-1 is being investigated in cancers including head and neck and renal cancer. Scancell has also developed its GlyMab antibody platform, with two antibodies licensed to Genmab.
The company’s therapies are designed to stimulate durable immune responses capable of targeting and destroying tumour cells. Earlier clinical studies of iSCIB1+ have demonstrated encouraging activity and a favourable safety profile both as a standalone therapy and when used alongside checkpoint inhibitors.
In addition to advancing iSCIB1+ in advanced melanoma, Scancell plans to explore its potential in the neo/adjuvant setting while continuing to develop its wider pipeline through internal programmes and pharmaceutical partnerships.
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