Scancell Holdings plc (LSE: SCLP), a clinical-stage biotechnology company headquartered in Oxford, United Kingdom, announced receipt of US FDA Fast Track Designation for iSCIB1+, a DNA-based active immunotherapy developed on its ImmunoBody platform, for the treatment of advanced melanoma. The designation was accompanied by an updated data release from the Phase II SCOPE trial, which reported a 77% progression-free survival (PFS) rate at 20 months in an HLA-matched target population receiving iSCIB1+ in combination with ipilimumab and nivolumab.
Fast Track Designation enables more frequent FDA interactions during development, rolling review eligibility, and potential access to Priority Review and Accelerated Approval pathways. No prior expedited designation has been reported for iSCIB1+.
The SCOPE study (NCT04079166) is a Phase II, multicentre, open-label trial enrolling patients with advanced unresectable melanoma across 16 UK clinical sites. The trial evaluates SCIB1 or iSCIB1+ added to standard-of-care checkpoint regimens, including nivolumab plus ipilimumab and pembrolizumab. The target population is defined by the presence of specific human leukocyte antigen (HLA) alleles, estimated to be present in approximately 80% of melanoma patients, and represents the population Scancell intends to select for its planned Phase III trial.
The 77% PFS figure at 20 months in the HLA-matched cohort compares to a 43% PFS rate at 20 months reported for ipilimumab plus nivolumab alone in the pivotal CheckMate 067 trial, a difference of more than 30 percentage points on a descriptive basis. Across evaluable patients in Cohorts 1 and 3 combined, the objective response rate (ORR) was 68.6% (46 of 67 patients), the disease control rate (DCR) was 88.0%, and the complete response rate was 17.9% (12 of 67 patients). Cohort 3 alone, the HLA-matched group, reported an ORR of 64.5% and a DCR of 80.6%. These figures were drawn from the April 28, 2026 data package; no formal p-values were reported, consistent with the non-comparative, single-arm Phase II design. The PFS trajectory has shown consistent maturation across earlier readouts, moving from 80.8% at 11 months to 74% at 16 months, as reported in a December 2025 update, to the current 77% at 20 months. Additional PFS data and early overall survival (OS) data from SCOPE are expected in H1 2027.
Scancell received FDA Investigational New Drug (IND) clearance for a global Phase III trial of iSCIB1+ in advanced melanoma in January 2026, with initiation of that registrational study anticipated in H2 2026. HLA-matched status is expected to serve as the patient-selection biomarker in the Phase III design.
This article was generated with AI assistance and reviewed and edited by the AllSci editorial team
Explore more at AllSci News: https://allsci.com/news/