Scancell Holdings PLC (AIM:SCLP, OTC:SCNLF) has received the go-ahead from UK medical regulator MHRA to add another group of patients to its ongoing SCOPE skin cancer trial.
This third cohort will comprise 43 advanced unresectable melanoma patients who will receive Scancell’s iSCIB1+ with doublet therapy, consisting of existing blockbuster cancer treatments ipilimumab (Yervoy) plus nivolumab (Opdivo).
iSCIB1+ is a modified version of SCIB1, developed using Scancell's AvidiMab platform, that the company believes can be effective in a patient population beyond the 40% of patients with the tissue type treatable by the original formulation.
Results from the first 13 patients receiving SCIB1 in the ongoing SCOPE trial, where the objective response rate was 85%, indicate a high probability of success in this new cohort, Scancell added.
Recruitment into the iSCIB1+ cohort is expected to be complete by the end of this half-year, with early data expected in the third quarter.
Once results from both the SCIB1 and iSCIB1+ cohorts have been received, Scancell said it will decide on a randomised Phase 2/3 adapted registration programme in patients with unresectable melanoma, which represents a potential US$1.5 billion per annum market.
The Phase 2 part of the adapted trial is anticipated to take 18 months, with the potential to generate attractive licensing opportunities, added the statement.
Lindy Durrant, Scancell’s chief executive, commented: “We anticipate that iSCIB1+ will be as effective as SCIB1 and, with its potentially increased potency and broader patient profile, make it a promising candidate for registration studies.”