Key Takeaways:
- Scancell's iSCIB1+ granted FDA Fast Track for advanced melanoma.
- Phase 2 data shows 77% progression-free survival at 20 months.
- Phase 3 trial planned for H2 2026, more data in H1 2027.
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Scancell's melanoma drug gets FDA fast track with 77% PFS rate
Scancell Holdings plc received FDA Fast Track designation for its lead immunotherapy candidate, iSCIB1+, for the treatment of advanced melanoma, a move that could accelerate the drug's path to market. The decision follows the release of promising data from the company's Phase 2 SCOPE trial, which showed a 77 percent progression-free survival (PFS) rate at 20 months.
"This designation is a major achievement for Scancell and important recognition not only of the potential of iSCIB1+, but also of the significant need for new and improved treatment options for patients with advanced melanoma," Dr. Phil L'Huillier, CEO of Scancell, said.
The Phase 2 data shows a significant improvement over the current standard of care. The 77 percent PFS rate in the target patient group for iSCIB1+ combined with ipilimumab and nivolumab is more than 30 percentage points higher than the 43 percent PFS rate reported for ipilimumab and nivolumab alone. The target population represents about 80 percent of melanoma patients in the trial's third cohort.
The Fast Track designation is designed to expedite the review of drugs for serious conditions and can lead to a rolling review, priority review, and accelerated approval. Scancell plans to initiate a global registrational Phase 3 trial for iSCIB1+ in the second half of 2026, with additional data from the Phase 2 study expected in the first half of 2027.
SCOPE Trial and Next Steps
The SCOPE study is a Phase 2, open-label trial evaluating the efficacy and safety of iSCIB1+ when added to standard of care therapies for advanced unresectable melanoma. The study's endpoints include disease control rate, duration of response, progression-free survival, and overall survival.
Beyond iSCIB1+, Scancell is developing other immunotherapy platforms. Its Moditope platform's lead candidate, Modi-1, is in a Phase 2 study for a broad range of solid tumors. The company's GlyMab platform is developing antibodies targeting tumor-specific glycans, with two licensed to Genmab A/S.
The Fast Track status and strong Phase 2 results significantly de-risk the development path for iSCIB1+, potentially attracting further investment and partnerships. Investors will be closely watching for the additional Phase 2 data in H1 2027 and the initiation of the Phase 3 trial in H2 2026.
This article is for informational purposes only and does not constitute investment advice.
[1] Scancell receives FDA Fast Track Designation for iSCIB1+ in advanced melanoma and provides data update from its SCOPE Phase 2 study[2] Scancell receives FDA Fast Track Designation for iSCIB1+ in advanced melanoma and provides data update from its SCOPE Phase 2 study[3] Gene Editing Candidate Lonvo-z Meets Endpoints in Phase 3 HAE Study[4] Replimune to Present at the 2026 American Society of Clinical Oncology (ASCO) Annual Meeting
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