Scancell Reports Positive Phase 2 Data and Financial Results for FY 2025

Scancell’s FY25: standout melanoma data, early Modi-1 signals, and a clearer path to registration

Scancell’s full-year update mixes punchy Phase 2 data with a steadier financial picture and clearer plans for late-stage development. The headline is iSCIB1+, the next-generation DNA ImmunoBody for advanced melanoma, which continues to look like a credible add-on to checkpoint inhibitors. There is also early promise from Modi-1 in head and neck cancer, plus a bigger push on the antibody side with Genmab. Cash now reaches into the second half of 2026, albeit with a going concern flag to keep on your radar.

iSCIB1+ melanoma data: compelling PFS and a larger patient reach

The SCOPE Phase 2 programme continues to deliver. Scancell’s focus is the defined HLA target population, which is a genetic “address label” that determines who responds to the vaccine. In that group, iSCIB1+ added to doublet checkpoint therapy delivered a strong progression-free survival (PFS) signal and robust response rates.

SCOPE results investors should know

• 11-month PFS in the target HLA population: 78% with iSCIB1+ plus ipilimumab and nivolumab, versus historic 12-month PFS of 46% for the doublet alone.
• Across Cohorts 1 and 3 combined, 22-month PFS in the target HLA population: 69%.
• Cohort 3 target HLA population: disease control rate (DCR) 81% and overall response rate (ORR) 65%.
• Cohort 1 (SCIB1 plus doublet) ORR 63%, DCR 83%, and PFS at 23 months of 56%.
• Cohort 2 (SCIB1 plus pembrolizumab) PFS at 12 months of 57% versus 35% for pembrolizumab alone. DCR 70%.
• Safety across 100+ patients remains favourable, with fewer high-grade events attributed to SCIB1/iSCIB1+ than to checkpoint inhibitors.

PFS is the company’s planned registration endpoint, which matters because it can shorten time to a pivotal readout. Crucially, iSCIB1+ broadens potential coverage to around 80% of late-stage melanoma patients (vs 30-40% for first-generation SCIB1) and comes with a longer patent life to 2039. That combination of clinical signal, scale of addressable population and IP protection is the meat of the investment case here.

Manufacturing, delivery, and regulatory path

• Commercial-scale GMP process in place for iSCIB1+, with long-term stability at -20°C. That eases logistics and cost by avoiding ultra-cold storage.
• Strategic supply partnership with PharmaJet’s Stratis needle-free device. No lipid nanoparticles needed.
• Regulatory meetings with FDA, MHRA and EMA slated for 2025, with randomised registration-path studies anticipated to start in 2026.
• Cohort 4 will test an accelerated dosing schedule and intradermal delivery. Initial data expected in Q4 2025, intended to refine, not delay, the plan.

Modi-1 Moditope: early clinical validation in head and neck cancer

Modi-1 is a peptide vaccine from the Moditope platform. In a small head and neck cancer cohort, combining Modi-1 with pembrolizumab delivered an ORR of 43% (3/7 partial responses), which compares favourably to historic single-agent checkpoints (pembrolizumab 19%, nivolumab 13%). It is early and low-n, but it validates the combination concept and justifies pushing on.

Recruitment in renal cell carcinoma with doublet checkpoint therapy is going well, with further data expected in Q4 2025. The team has also optimised the formulation and moved to a robust, scalable GMP process. Patent protection has been strengthened, including approval by the USPTO.

Antibodies: Genmab validation and GlyMab subsidiary

Two deals with Genmab now sit behind Scancell’s GlyMab platform. The second licence for SC2811 brought $6 million in upfront payments and up to $630 million in potential milestones plus low single-digit royalties. Development of the first partnered antibody, SC129, remains on track with further milestone payments anticipated in the near-term. Combined, potential milestones across both Genmab deals reach up to $1.25 billion.