Scancell Holdings has secured the UK regulatory, ethical and legal approvals needed to initiative a Phase 2 of SCIB1 in patients with advanced melanoma.
Specifically, the trial will assess the safety and efficacy of SCIB1 in patients who are also receiving Merck’s Keytruda.
The UK arm of the study is therefore expected to start during the second quarter of this year, as planned.
SCIB1 has completed a Phase 1/2 clinical trial in patients with Stage III/IV malignant melanoma.
In this study SCIB1 was shown to have a favourable safety profile with no dose-limiting toxicities and no serious adverse events related to study drug or delivery device.
Survival with SCIB1 treatment appears superior to historical survival rates, with 14 of 16 resected patients receiving 2-4 mg doses surviving for more than five years (as reported in February 2018).
Although pembrolizumab is an approved checkpoint inhibitor therapy for advanced melanoma, response to treatment is limited to only a subset of patients (circa 30%).
The Phase 2 study is therefore designed to assess whether the addition of SCIB1 treatment will result in an improvement in the tumour response rate, progression-free survival and overall survival in 25 patients with advanced melanoma who are also eligible for treatment with pembrolizumab.
SCIB1 will be administered using Ichor’s TriGrid v2.0 electroporation delivery system.