Scancell Holdings PLC (AIM:SCLP, OTC:SCNLF) CEO Phillip L’Huillier talked with Proactive about new clinical data from its phase two melanoma study, known as the SCOPE trial, featuring its lead ImmunoBody candidate, iSCIB1+.
L’Huillier highlighted that the trial has achieved the objectives set out for it, confirming the parameters for the company’s upcoming registrational phase three study. The findings now provide clarity on dosing, patient population, and trial design. “Our SCOPE study…has met the objectives that we set out for it,” he said.
A key point of the discussion focused on the data, which showed a 74% progression-free survival rate at 16 months for iSCIB1+. This compares to 46% at 12 months for the standard of care, which typically includes dual checkpoint inhibitors Ipilimumab and Nivolumab. L’Huillier noted this as a "really strong and durable benefit" on top of existing treatments.
He also addressed how iSCIB1+ performed across patient subgroups where existing therapies are typically less effective—such as BRAF, PD-L1 status, and those with prior checkpoint treatment, with results showing clinically meaningful benefit across all.
Scancell now plans to begin its phase three trial in late 2026, having received supportive regulatory feedback. L’Huillier also said the data has materially strengthened the company’s case for partnering and financing opportunities as part of a dual-track strategy to either partner or proceed independently.
Proactive: Phil, very good to speak with you. You’ve just released an update on your lead trial in melanoma, which will be the focus of your presentation at ESMO IO on Thursday. Can you summarise the key takeaways, please?
Phillip L’Huillier: I'd like to make three points about our announcement. Firstly, I'm very pleased to say that our SCOPE study — our phase two study testing our lead ImmunoBody agent iSCIB1+ — has met the objectives we set out for it. This exploratory study has enabled us to define the parameters for the next phase, the registrational study.
We now know how to give our therapy, at what dose, and which patient population to take forward. So we've got the parameters defined for the next study.
Secondly — and importantly — it's all about the data. In today’s competitive industry, data is key. Our data is consistently showing good durable benefit in patients. We’re now seeing a 74% progression-free survival at 16 months for iSCIB1+, compared with 46% at 12 months for the standard of care, which is a combination of Ipilimumab and Nivolumab. So, we’re seeing a really strong and durable benefit on top of standard of care.
Additionally, we’re sharing further data showing benefit in patient populations where checkpoint therapies are historically less efficacious — such as those with BRAF mutations, PD-L1 status, and those who’ve had prior checkpoint therapy. iSCIB1+ is showing good, clinically meaningful benefit across these subgroups.
Thirdly, we’re reinforcing the value of HLA type as a predictive marker. We see a clear difference between the target population — which represents 80% of advanced melanoma patients — and the non-target population. We’re also seeing T-cell responses, including memory-like responses, which correlate with clinical benefit. Taken together, we’re seeing immune responses translating into clinical benefit across broad melanoma subtypes.
Proactive: Phil, what does this new update mean for Scancell, practically speaking?
Phillip L’Huillier: Practically, this moves our program from a proof-of-concept study into late-stage development. We now know the parameters for designing our phase three study and have had supportive feedback from regulators. This will help us finalise the design of our registrational study, which we plan to kick off later in 2026.
It’s also materially strengthened our proposition for partnering and refinancing. The maturity of the data supports these conversations.
Proactive: What's next then, Phil?
Phillip L’Huillier: Next is to focus on regulatory conversations to gain full alignment on the phase three study design. In parallel, we’ll accelerate discussions with potential partners and financiers to fund the phase three study. We’re executing a two-pronged strategy — being opportunistic with partnerships, while also ensuring the organisation has the talent, resources, and vendor relationships to go it alone if needed.
Proactive: Phil, I hope you’ll continue to keep us updated on your progress. With that, thank you very much for taking the time today.