Scancell Wins FDA Nod for Phase 3 Melanoma Trial of iSCIB1+ After Strong Phase 2 Data

Scancell Holdings ( (GB:SCLP) ) has shared an update.

Scancell has secured FDA clearance for an Investigational New Drug application to run a global registrational Phase 3 trial of its iSCIB1+ Immunobody in advanced melanoma, using progression-free survival as the surrogate endpoint, and aims to initiate the study in 2026. The decision follows completion of the 140-patient Phase 2 SCOPE trial, where iSCIB1+ in combination with checkpoint inhibitors delivered potentially best-in-class efficacy, including a 74% progression-free survival rate at 16 months in a genetically defined target population versus 50% at 11.5 months for current standard-of-care ipilimumab plus nivolumab, positioning the therapy as a potential new standard and providing Scancell with a clearer late-stage development path and partnering and financing opportunities.

The most recent analyst rating on (GB:SCLP) stock is a Hold with a £14.00 price target. To see the full list of analyst forecasts on Scancell Holdings stock, see the GB:SCLP Stock Forecast page.

Spark’s Take on GB:SCLP Stock

According to Spark, TipRanks’ AI Analyst, GB:SCLP is a Neutral.

The score is held back primarily by weak financial performance (ongoing losses, negative equity, and cash burn), only partly offset by improved burn in 2025. Technicals show an uptrend but are extremely overextended, adding pullback risk. The latest earnings call was comparatively supportive due to strengthened liquidity/runway and pipeline/regulatory progress, while valuation remains difficult to justify using traditional metrics because the company is loss-making.

To see Spark’s full report on GB:SCLP stock, click here.

More about Scancell Holdings

Scancell Holdings plc is a clinical-stage biotechnology company developing targeted, off-the-shelf active immunotherapies designed to generate durable, tumour-specific immune responses against cancer. Its lead DNA ImmunoBody product, iSCIB1+, has shown meaningful clinical benefit in melanoma, including when combined with checkpoint inhibitors, while peptide vaccine Modi-1 is in Phase 2 for a range of solid tumours. The group also owns GlyMab Therapeutics, which is advancing a pipeline of high-affinity antibodies targeting tumour-specific glycans, with two assets already licensed to Genmab.

Average Trading Volume: 1,299,588

Technical Sentiment Signal: Buy

Current Market Cap: £137M

See more insights into SCLP stock on TipRanks’ Stock Analysis page.