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Scancell gets FDA approval to move into final-stage trial for new melanoma treatment
Scancell gets FDA approval to move into final-stage trial for new melanoma treatment
26 January 2026
Scancell has received approval from the US Food and Drug Administration (FDA) to begin a large, late-stage clinical trial of its skin cancer treatment, iSCIB1+ Immunobody®.
The Phase 3 trial, which is planned to start this year, will test whether iSCIB1+ can help people with advanced melanoma live longer without their cancer getting worse.
Results from Scancell’s earlier Phase 2 study are very encouraging. Patients who received iSCIB1+ alongside standard immunotherapy treatment stayed cancer-free for significantly longer than those receiving standard treatment alone.
In this study, 74% of patients were still free from cancer progression after 16 months. By comparison, current standard treatments typically achieve around 50% at 11.5 months. This suggests that iSCIB1+ could meaningfully improve outcomes for many patients.
The trial involved 140 patients with advanced melanoma who had not received previous treatment. The results also showed benefits across several harder-to-treat patient groups, including those who normally respond less well to existing therapies.
Scancell has also identified which patients are most likely to benefit from iSCIB1+, meaning future trials can focus on the people most likely to respond. Around 80% of melanoma patients fall into this group.
Dr Phil L’Huillier, CEO of Scancell, said:
“This IND clearance creates a clear pathway for late-stage registrational development of our iSCIB1+ Immunobody®. Data from the Phase 2 SCOPE trial shows a significant improvement in progression free survival as well as emerging overall survival with iSCIB1+ compared to historic benchmarks. I take this endorsement of our program as a strong measure of the clinical benefit and safety of our very novel product as well as the quality of our manufacturing and preclinical work. We are continuing our dialogue with regulators broadly as we continue to evaluate all financing options, including partnering discussions, for the Phase 3 trial.”
If the upcoming Phase 3 trial is successful, iSCIB1+ could become a new standard treatment for people with advanced skin cancer.
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