Scancell Holdings PLC (AIM:SCLP, OTC:SCNLF) has received approval from the Medicines and Healthcare Products Regulatory Agency (MHRA) to expand its ModiFY trial to include 44 new patients with untreated renal cell carcinoma, a form of kidney cancer.
They will receive Scancell's Modi-1 cancer vaccine combined with two checkpoint inhibitors ipilimumab (Yervoy) and nivolumab (Opdivo).
Early results from Modi-1 alone have shown stable disease and good immune responses, with no severe side effects.
The new trial will test if adding Modi-1 improves the response rate in kidney cancer patients. This expansion also aims to see if the combination can work better together, or synergistically, as shown in Scancell's previous studies.
"We greatly appreciate the supportive and helpful discussions with the MHRA and are thrilled to have received approval to expand ModiFY into a cohort of patients who will now receive Modi-1 in combination with double checkpoint inhibitors," said Scancell CEO, Professor Lindy Durrant.
"This approval marks another milestone for Scancell, and the promising efficacy, safety and tolerability study generated from earlier cohorts underscore our belief that our Modi-1 cancer vaccine has the potential to deliver a step change in the treatment of renal and other hard-to-treat cancers."