Scancell Holdings PLC (AIM:SCLP, OTC:SCNLF, FRA:SCP), the cancer immunotherapy developer, has won UK regulatory approval to run a late-stage trial of its lead drug in advanced melanoma.
The Medicines and Healthcare products Regulatory Agency (MHRA) has granted a clinical trial authorisation for the phase III registrational study of iSCIB1+.
A registrational trial is the final stage of testing used to seek marketing approval.
The clearance follows approval from the US Food and Drug Administration (FDA) in January, with further applications under way in the European Union, Canada and Australia.
The trial will enrol 550 patients with stage III or IV melanoma across about 90 sites in the US, EU, UK, Canada and Australia.
Participants will be split evenly between iSCIB1+ combined with two established immunotherapy drugs, ipilimumab and nivolumab, and a placebo given alongside the same two drugs.
Its main goal is to measure progression-free survival, the time patients live without their cancer worsening, which the company hopes will support an accelerated approval.
Overall survival is the secondary goal, intended to underpin a later application for full approval.
The design draws on the earlier phase II SCOPE trial, in which iSCIB1+ and the two immunotherapies kept 77% of patients progression-free at 22 months.
The same trial found 87.4% of patients were alive after 18 months.
iSCIB1+ is a DNA-based treatment given by needle-free injection that primes the immune system to attack melanoma.
The drug already holds Fast Track status from the FDA, a designation meant to speed development of promising therapies.
"Our regulatory strategy continues to build momentum," said chief executive Phil L'Huillier.
The trial is expected to start by the end of 2026, with initial survival data targeted for the second half of 2028.
Scancell is also pursuing a proposed merger with Neuphoria Therapeutics, a US biotechnology company.
