FDA Clears IND for Phase 3 Trial of iSCIB1+ in Advanced Melanoma

The FDA cleared the investigational new drug (IND) application for a global phase 3 registrational trial of iSCIB1+, a DNA plasmid vaccine, in patients with advanced melanoma, scheduled to commence in 2026, according to a news release from Scancell Holdings.¹

“This IND clearance creates a clear pathway for late-stage registrational development of our iSCIB1+ Immunobody,” said Phil L’Huillier, PhD, MBA, CEO of Scancell. “Data from the phase 2 SCOPE trial shows a significant improvement in progression-free survival [PFS] as well as emerging overall survival with iSCIB1+ compared to historic benchmarks.”

Building on Checkpoint Inhibition

Investigators previously studied SCIB1 and iSCIB1+, immunotherapies designed to allow Fc targeting of activated dendritic cells, in 140 patients as monotherapy and in combination with nivolumab (Opdivo) and ipilimumab (Yervoy). In the open-label, multi-center phase 2 SCOPE trial (NCT04079166), iSCIB1+ was evaluated in combination with the current standard of care of doublet checkpoint inhibition in previously untreated patients with unresectable stage IIIB/IV melanoma.

The phase 3 trial will evaluate patients with selected human leukocyte antigen (HLA) alleles representing 80% of patients with melanoma, who were evaluated in Cohort 3 of the SCOPE trial. In this cohort, the rate of PFSat 16 months was 74%. The historic benchmark for dual checkpoint inhibition in the CheckMate 06 trial was 50% at 11.5 months. Subgroup analysis showed consistent favorable PFS in PD-L1 low, BRAF wild-type and prior checkpoint inhibitor exposure groups.

In combined data from 67 patients in cohorts 1 and 3, which used SCIB1 and iSCIB1+, respectively, the overall response rate was 68.6%, the complete response rate was 17.9%, and the disease control rate was 88.0%, reflecting favorably compared with historic trial and real-world use of nivolumab/ipilimumab.²

Precision Medicine and Broad Applicability

iSCIB1+ is the lead product from Scancell’s DNA ImmunoBody platform, designed to generate long-lasting, tumor-specific immunity. The therapy is administered needle-free intramuscularly, offering a potentially less invasive delivery method for patients. With additional epitopes, iSCIB1+ gave it efficacy in a potential 80% of the patient population compared with 40% with SCIB1. In the SCOPE trial, all 6 epitopes in iSCIB1+ generated targeted T cell responses, and CD8 cell responses could be predicted using HLA class 1 alleles.

With the focus on the HLA class 1 allele–targeted population, the upcoming phase 3 trial puts a focus on precision medicine using a selection marker to enrich the trial for likely responders. The agreed surrogate end point for the trial is PFS. L’Huillier noted that the IND clearance validates the clinical benefit, safety, and manufacturing quality of the iSCIB1+ program.¹

“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,” he stated.

References

1. Scancell announces FDA clearance of IND application for global Phase 3 trial of iSCIB1+ in advanced melanoma. News release. Scancell. January 26, 2026. Accessed January 26, 2026. https://tinyurl.com/54uysjuj

2. Scancell reports phase 2 data showing strongly improved outcomes in late-stage melanoma with its Immunobody iSCIB1+. News release. Scancell. July 22, 2025. Accessed January 26, 2026. https://tinyurl.com/2u4tjb4u