Scancell Holdings has announced that it has received UK regulatory approval to start its Phase II trial assessing SCIB1 in patients with metastatic melanoma.

The study is assessing those who are also receiving the checkpoint inhibitor Keytruda (pembrolizumab).

The drug in question has already completed a Phase I/II clinical trial in patients with Stage III/IV malignant melanoma, where it 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.

Also, 14 of 16 resected patients receiving 2-4 mg doses survived for more than five years, as reported in February 2018.

The Phase II study is 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 the advanced melanoma who are also eligible for treatment with Keytruda.

“This is a major milestone in the clinical advancement of our SCIB1 programme and we look forward to initiating this important Phase II study”, said Dr Cliff Holloway, chief executive of Scancell.

He continued, “Our preclinical research has indicated that SCIB1 administration with an immune checkpoint inhibitor has the potential to offer even greater efficacy than when either agent is given alone and this new study is designed to evaluate the safety and efficacy of this approach in patients with inoperable disease.”

Discussions with the FDA are on-going and we continue to work with Ichor towards IND approval to open our US study centres.”