Scancell Holdings PLC (AIM:SCLP, OTC:SCNLF, FRA:SCP) confirmed plans to launch a global Phase III trial of its lead cancer immunotherapy, iSCIB1+, as it posted interim results showing a strong balance sheet for current and imminent clinical developments.
The company reported a narrowed operating loss of £8.9 million for the six months to 31 October 2025, with cash levels standing at £8.6 million at the end of October.
A further £3 million in R&D tax credits was received after the reporting period, with Scancell saying it has funding into the second half of 2026 and remains in talks over partnerships and financing for iSCIB1+.
Following encouraging Phase 2 data and regulatory clearance from the US regulator, the company said the next stage of trials for iSCIB1+ in advanced melanoma would begin this year with potential read-out and commercialisation in 2029.
The trial will use progression-free survival (PFS) as the primary endpoint, as agreed with the US Food and Drug Administration.
In its Phase 2 study, iSCIB1+ combined with checkpoint inhibitors achieved a 74% PFS rate at 16 months, which was 24 percentage points higher than standard-of-care benchmarks.
A biomarker has also been identified to help select likely responders for the Phase 3 trial.
Alongside this, data is expected in the first half of 2026 for Phase II trials of cancer vaccine Modi-1 for renal and head and neck cancers.
The company also advanced its antibody platform through its GlyMab subsidiary, with early-stage lung cancer drug SC134 showing potential and partner Genmab progressing two licensed programmes.