Scancell secures UK clearance for late-stage melanoma trial

Health Pharma & Biotech Written by: Ian Lyall 07:11 Wed 19 Aug 2026 --> Proactive has a commercial relationship with Scancell Holdings PLC. This article was produced independently under Proactive's Editorial Standards Policy . Disclaimer No investment advice About this content Editorial Standards & Policies Share article About this content × About Ian Lyall Ian Lyall, a seasoned journalist and editor, brings over three decades of experience to his role as Managing Editor at Proactive. Overseeing Proactive's editorial and broadcast operations across six offices on three continents, Ian is responsible for quality control, editorial policy, and content production. He directs the creation of 50,000 pieces of real-time news, feature articles, and filmed interviews annually. Prior to Proactive, Ian helped lead the business output at the Daily... Read more About the publisher Proactive financial news and online broadcast teams provide fast, accessible, informative and actionable business and finance news content to a global investment audience. All our content is produced independently by our experienced and qualified teams of news journalists. Proactive news team spans the world’s key finance and investing hubs with bureaus and studios in London, New York, Toronto, Vancouver, Sydney and Perth. We are experts in medium and small-cap markets, we also keep our community up to date with blue-chip companies, commodities and broader investment stories. This is content that excites and engages motivated private investors. The team delivers news and unique insights across the market including but not confined to: biotech and pharma, mining and natural resources, battery metals, oil and gas, crypto and emerging digital and EV technologies. Use of technology Proactive has always been a forward looking and enthusiastic technology adopter. Our human content creators are equipped with many decades of valuable expertise and experience. The team also has access to and use technologies to assist and enhance workflows. Proactive will on occasion use automation and software tools, including generative AI. Nevertheless, all content published by Proactive is edited and authored by humans, in line with best practice in regard to content production and search engine optimisation. Scancell Holdings PLC ( AIM:SCLP OTC:SCNLF ) View Price & Profile Scancell secures UK clearance for late-stage melanoma trial Published: 07:11 19 Aug 2026 BST 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. Continue reading