Scancell Holding plc (SCLP) announced that the U.S FDA has cleared its Investigational New Drug Application for a global Phase 3 trial evaluating iSCIB1+ in advanced melanoma.
Melanoma remains one of the most aggressive forms of skin cancer, and despite progress with checkpoint inhibitors, many patients continue to face limited long-term treatment durability.
iSCIB1+ is a next-generation DNA vaccine designed to stimulate potent T-cell responses against melanoma antigens. In a Phase 2 study, dubbed SCOPE, the therapy was administered needle-free and combined with nivolumab plus ipilimumab.
According to Scancell, interim data showed a 24%-point improvement in progression-free survival (PFS) compared with real-world standard-of-care benchmarks, with durability signals emerging across key patient subgroups. The company also identified an HLA-based selection marker expected to enrich the Phase 3 population.
The FDA's clearance enables Scancell to move forward with a registrational Phase 3 trial planned to begin in 2026, using PFS as the agreed surrogate endpoint. Updated SCOPE data highlighted a 74% PFS rate at 16 months in the target population, compared with historical PFS of 50% at 11.5 months for Ipilimumab plus Nivolumab alone.
Safety findings from the Phase 2 program were consistent with expectations for combination immunotherapy, and Scancell noted that iSCIB1+ demonstrated a favorable profile when added to checkpoint inhibitors.
Scancell's CEO Dr. Phil L'Huillier, said the IND clearance "creates a clear pathway for late stage registrational development," adding that the company continues discussions with regulators and is evaluating financing and partnering options to support the Phase 3 program.
The company's broader pipeline includes the Moditope platform and GlyMab antibody assets, two of which are licensed to Genmab. But iSCIB1+ now stands at the forefront as Scancell's most advanced candidate, positioned to enter pivotal testing with the potential to reshape the treatment landscape for advanced melanoma.
SCLP.L has traded between GBp 7.26 and GBp 14.00 over the past year. The stock is currently trading at GBp 14.02, up 6%.
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