Melanoma Vaccine Receives FDA Fast Track Designation

The FDA has granted fast track designation to iSCIB1+, an investigational DNA plasmid cancer vaccine, for the treatment of patients with advanced melanoma, according to a press release from Scancell.¹

The press release highlighted data from the phase 2 SCOPE trial (NCT04079166), which showed a progression-free survival (PFS) rate of 77% at 20 months using iSCIB1+ compared with 43% for ipilimumab (Yervoy) plus nivolumab (Opdivo).² Additionally, this represents a 30-plus percentage point improvement over the standard of care.

During the first half of 2027, additional PFS and overall survival (OS) data are expected to be presented.

"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. We are very pleased with how the phase 2 SCOPE data [are] maturing and are advancing plans for a global registrational phase 3 trial, which we expect to initiate in the second half of 2026,” Phil L'Huillier, chief executive officer of Scancell, said in the press release.¹

SCOPE Trial: High Response Rates in Unresectable Disease

The open-label phase 2 SCOPE study is evaluating the safety and efficacy of SCIB1 or iSCB1+ in combination with standard-of-care (SOC) doublet immunotherapy. End points consisted of disease control rate (DCR), duration of response, PFS, and OS.³

Previously reported data showed the PFS rate in cohort 1 was 55.6% at 23 months with an overall response rate (ORR) of 63.4% and a DCR of 83.0%. The PFS rate in cohort 2 at 6 months was 80% with an ORR and DCR of 70%, respectively.

In cohort 3, the PFS rate was 77.8% at 11 months with an ORR of 64.5% and a DCR of 80.6%. For those in cohort 3 with nonmatched human leukocyte antigen haplotypes, there was a PFS rate of 45.5% at 12 months, an ORR of 27.3%, and a DCR of 54.5%.

SCOPE Trial Safety and Treatment Dosing

The trial found that the vaccines were well-tolerated, with no meaningful increases in adverse effects (AEs). Of note, there were 163 treatment-emergent AEs that were grade 3 or higher, with 30 of those relating to the vaccines, and 113 were related to the checkpoint inhibitors.

Patients were given SCIB1 or iSCIB1+ up to 11 times for 85 weeks. iSCIB1+ was given in combination with nivolumab/ipilimumab. For those receiving SCIB1, pembrolizumab (Keytruda) was given in combination. Of note, SCIB1 or iSCIB1+ injections were given using PharmaJet needle-free injection to either the upper arm or upper leg. After the initial study dose, nivolumab/ipilimumab or pembrolizumab was initiated.

If patients had a histologically confirmed diagnosis of unresectable stage III or stage IV melanoma, no receipt of prior systemic treatment for advanced disease, a known BRAF status, and at least 1 measurable lesion, they were eligible for treatment.

Patients were not included in the study if they had a diagnosis of mucosal, acral, or ocular melanoma; had central nervous system disease or carcinomatous meningitis; had previously received a treatment to block cytotoxic T lymphocyte–associated protein; were expected to require any other forms of systemic or localized anticancer therapy while on the study; or were taking any systemic steroid therapy within 1 week of the first study dose or had been receiving any other form of immune suppressant medication.

The FDA announced a clearance of an investigational new drug application for iSCIB1+ in January 2026.⁴

References

1. Scancell receives FDA Fast Track Designation for iSCIB1+ in advanced melanoma and provides data update from its SCOPE Phase 2 study. News release. April 28, 2026. Accessed April 28, 2026. https://tinyurl.com/3jnm9yay
2. Varawalla N, Shaw H, Corrie P, et al. 1325 SCOPE, an open label phase 2 parallel multi cohort clinical trial evaluating an off-the-shelf DNA plasmid vaccine in first line advanced melanoma combined with checkpoint blockade – interim read-out. J Immunother Cancer. 2025;13(suppl 3):A1564-A1565. doi:10.1136/jitc-2025-SITC2025.1325
3. SCIB1 and iSCIB1+ in melanoma patients receiving nivolumab with ipilimumab or SCIB1 with pembrolizumab (the SCOPE study). ClinicalTrials.gov. Updated December 19, 2025. Accessed April 28, 2026. https://tinyurl.com/4dxk6vxw
4. Scancell announces FDA clearance of IND application for global phase 3 trial of iSCIB1+ in advanced melanoma. News release. Scancell Holdings. January 26, 2026. Accessed April 28, 2026. https://tinyurl.com/yrptcj7c