Scancell Holdings (LON: SCLP), the clinical-stage biopharmaceutical company, said this morning that the MHRA has granted Clinical Trial Authorisation for a Phase 3 registrational trial of its lead melanoma immunotherapy, iSCIB1+. The shares rose on the news.
Scancell traded around 9.8p in early dealing, up roughly 3.2% from Tuesday’s close of 9.5p. That leaves the stock well below its 52-week high of 29.5p, reached in May.
The UK clearance, granted by the Medicines and Healthcare products Regulatory Agency, follows US FDA clearance of the trial’s IND application in January, with further submissions under way in the EU, Canada and Australia. The Phase 3 study, a registrational trial designed specifically to support a marketing approval application, will enrol 550 patients with stage III/IV unresectable melanoma across around 90 sites in the US, EU, UK, Canada and Australia, randomising them to iSCIB1+ alongside the drugs ipilimumab and nivolumab, versus those drugs with a placebo.
The design was informed by the earlier Phase 2 SCOPE trial, in which the combination produced progression-free survival, meaning patients living without their cancer worsening, of 77% at 22 months, and overall survival of 87.4% at 18 months. The primary endpoint is designed to support accelerated approval, a faster regulatory route based on early efficacy signals, with overall survival as a secondary endpoint to support full approval. The trial is expected to start by the end of this year, with initial progression-free survival data not due until the second half of 2028.
“Our regulatory strategy continues to build momentum,” said Dr Phil L’Huillier, Scancell’s chief executive. “The MHRA CTA for the Phase 3 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.”
The modest share reaction reflects the milestone’s procedural nature: it clears a regulatory hurdle rather than delivering new clinical data. With trial data not due until 2028, the next major share-price catalyst remains some years off.