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Scancell initiates new arm in SCOPE Phase 2 study
Scancell initiates new arm in SCOPE Phase 2 study.
About this update from Scancell Holdings Plc
[{"type":"text","content":"\n\n25 June 2025\n \nScancell Holdings plc\n \nScancell initiates new arm (Cohort 4) in SCOPE Phase 2 study to evaluate intradermal administration and an accelerated dosing regimen for iSCIB1+\nCohort 4 evaluates iSCIB1+ immunotherapy for the treatment of advanced melanoma\nNo significant adverse events observed in initial 8 patients dosed intradermally with SCIB1+\n \nAdditional data from Cohorts 1-3 expected in July 2025\n \nInterim data from Cohort 4 expected around the year end\n \nScancell Holdings plc (AIM: SCLP), the developer of novel immunotherapy products for the treatment of multiple cancers, announces today that dosing of patients has commenced in Cohort 4 of its Phase 2 clinical SCOPE study. This cohort will evaluate iSCIB1+ Immunobody® through intradermal administration and accelerated dosing in patients with advanced unresectable melanoma.\nThe initial 8 patients have now been safely dosed in the fourth cohort with iSCIB1+, including patients recruited through the NHS Cancer Vaccine Launch Pad. No significant adverse events have been observed with intradermal dosing. The trial remains on track, with data from Cohorts 1 through 3 expected in July 2025. With ongoing strong recruitment continuing in the iSCIB1+ Cohort 4, initial data in this cohort is expected around the end of 2025.\nDr Nermeen Varawalla, Chief Medical Officer of Scancell, said: \"The SCOPE data reported so far are highly encouraging, with SCIB1 immunotherapy showing excellent efficacy and long-term survival benefits that signal a meaningful improvement over standard of care. Initiation of Cohort 4 is an important milestone for our iSCIB1+ programme to evaluate intradermal administration on our path to towards randomised studies.\"\nSCOPE (NCT04079166) is a Phase 2, multi-centre open-label study, investigating SCIB1/iSCIB1+, with checkpoint inhibitors (CPIs) in late-stage melanoma and will enroll 140+ patients across four cohorts. Initial data from 25 patients in Cohort 1, receiving first-generation SCIB1 ImmunoBody® in combination with checkpoint inhibitors, ipilimumab and nivolumab, showed 84% disease control rate, 80% progression free survival (PFS), with a 20% complete response (CR) rate, and 72% ORR, demonstrating a significant improvement over standard of care treatment.\nCohort 3, receiving next generation iSCIB...