Scancell Holdings (AIM:SCLP) has secured Clinical Trial Authorization from the UK's Medicines and Healthcare Products Regulatory Agency for the Phase 3 registrational trial of its lead ImmunoBody, iSCIB1+, in advanced melanoma.
The AIM-listed clinical-stage immuno-oncology company designs active immunotherapies intended to strengthen the immune system's response to hard-to-treat cancers.
The randomised, double-blind, placebo-controlled trial will enrol 550 patients with stage III or IV unresectable melanoma across roughly 90 sites in the US, EU, UK, Canada and Australia.
Patients will receive either 8mg of iSCIB1+ alongside the checkpoint inhibitors ipilimumab and nivolumab, or placebo with the same combination, randomised 1:1.
Progression-free survival is the primary endpoint, designed to support accelerated approval, with overall survival as a secondary endpoint intended to underpin a full approval application.
The design draws on the Phase 2 SCOPE trial, where iSCIB1+ combined with ipilimumab and nivolumab produced progression-free survival of 77% at 22 months and overall survival of 87.4% at 18 months.
The MHRA authorisation follows IND clearance from the US FDA in January, with additional filings underway in the EU, Canada and Australia.
"The MHRA CTA for the Phase 3 trial of our lead asset iSCIB1+ in patients with advanced melanoma is an important milestone bringing us one step closer to delivering iSCIB1+ to patients in a global registrational trial setting," said chief executive Dr Phil L'Huillier.
The trial is on track to begin by the end of 2026, with initial progression-free survival data expected in the second half of 2028.
News Intelligence what this means for the company
Scancell has cleared a regulatory hurdle: the UK MHRA has authorised its Phase 3 trial of iSCIB1+, a 550-patient registrational study in advanced melanoma that will run across 90 sites in five regions. The trial design is anchored to Phase 2 data showing 77% progression-free survival at 22 months, and initial progression-free survival data is expected in the second half of 2028—a material de-risking event for a clinical-stage company, though the path to approval remains multi-year and binary.
Regulatory clearance removes a near-term execution risk and validates the trial design against Phase 2 efficacy signals, but the investment case hinges entirely on Phase 3 readout in late 2028. The company raised £13.0m gross in July 2026; cash runway and financing needs through data readout will be critical to monitor.
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