Scancell Holdings has received clinical trial authorisation (CTA) from the UK Medicines and Healthcare products Regulatory Agency (MHRA) for a Phase III trial evaluating its ImmunoBody, iSCIB1+, in advanced melanoma patients.
The placebo-controlled registrational, double-blind, randomised study will enrol 550 participants with stage III or IV unresectable melanoma.
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It will take place at around 90 sites across Australia, Canada, the EU, the UK, and the US.
Patients will be randomly assigned in a 1:1 ratio to receive either 8mg iSCIB1+ in combination with ipilimumab and nivolumab or a placebo alongside the same checkpoint inhibitors.
The primary endpoint is progression-free survival (PFS), with overall survival (OS) as a secondary endpoint.
The PFS outcome is intended to support a submission for accelerated approval, while OS data may support an application for full approval at a later stage.
Study design was informed by data from the previous Phase II SCOPE trial in which iSCIB1+ combined with ipilimumab and nivolumab showed a sustained PFS rate of 77% after 22 months, and an OS rate of 87.4% at 18 months in the targeted population.
Scancell’s lead product candidate, iSCIB1+, is a deoxyribonucleic acid (DNA) ImmunoBody administered by needle-free intramuscular injection.
It encodes an antibody that targets melanoma-associated antigens gp100 and tyrosinase related protein 2 (TRP-2) to stimulate T cell responses against tumours.
Initiation of the Phase III trial follows clearance of an investigational new drug application by the US Food and Drug Administration in January 2026.
Scancell anticipates the trial will begin by 2026-end, with initial PFS data targeted for the second half of 2028.
Scancell CEO Dr Phil L’Huillier said: “Our regulatory strategy continues to build momentum. The MHRA CTA for the Phase III 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.”
iSCIB1+ remains an investigational product without regulatory approval for melanoma or any other indication. Its safety and efficacy have not yet been established by the MHRA, the FDA, or other authorities.
