FDA Clears Path for Scancell's Global Phase 3 Advanced Melanoma Study
Oxford, Monday, 26 January 2026.
Authorization paves the way for a 2026 registrational trial, driven by Phase 2 results showing a 74% progression-free survival rate compared to the 50% standard.
Regulatory Green Light for Late-Stage Development
Scancell Holdings (GB:SCLP) has achieved a pivotal regulatory breakthrough with the U.S. Food and Drug Administration (FDA) clearing its Investigational New Drug (IND) application for iSCIB1+, the company’s lead immunobody candidate [1][2]. announced on January 26, 2026, this clearance authorizes the biotechnology firm to proceed with a global registrational Phase 3 trial for the treatment of advanced melanoma, which is scheduled to commence later in 2026 [1]. The trial design has been established as a double-blind adaptive study, utilizing progression-free survival (PFS) as the agreed primary surrogate endpoint [1][3]. This regulatory alignment follows strategic discussions held in late 2025 regarding the potential for accelerated approval pathways [3].
Clinical Data Driving the Decision
The push toward a Phase 3 trial is underpinned by compelling efficacy data from the Phase 2 SCOPE trial. Updated results from the study’s third cohort revealed that iSCIB1+ achieved a progression-free survival rate of 74% at 16 months within the target population [1]. This performance represents a distinct improvement over the current standard of care—ipilimumab combined with nivolumab—which typically demonstrates a 50% progression-free survival rate at 11.5 months [1]. The difference in durability of response is notable, with the Scancell therapy extending the observation window by 4.5 months compared to the standard of care benchmark [1].
Strategic Outlook and Financial Context
Dr. Phil L’Huillier, CEO of Scancell, described the IND clearance as establishing a “clear pathway” for the therapy’s registrational development [1]. As the company transitions into this capital-intensive phase, management is actively evaluating financing options, including potential partnering discussions, to support the global trial [1]. Investors expect further clarity on the company’s fiscal health and operational roadmap when Scancell publishes its interim financial results for the six months ending October 31, 2025, alongside a business update on January 29, 2026 [2].
Market Performance and Valuation
Scancell shares, listed on the London Stock Exchange, were last recorded at a closing price of 13.20p [3]. Over the preceding year, the stock has experienced significant volatility, trading within a range of 6.625 pence [3]. Current market sentiment appears cautious but watchful; the most recent analyst rating for the stock is a “Hold” with a price target of £13.50, while automated analysis tools characterize the stock as “Neutral” due to a balance between weak historical financial performance and the improved cash burn and regulatory progress seen heading into 2026 [2].