Scancell Holdings Plc (LON:SCLP) said it is working closely with the US drugs regulator to address questions raised ahead of the launch of a phase II clinical study of its cancer immunotherapy.a
The UK group is planning to use its SCIB1 in harness with Merck’s Keytruda to treat patients with advanced melanoma.
Ahead of granting investigational new drug status, America’s Food & Drug Administration has requested some additional information.
Focus on TriGrid
The queries are focused on a technology called TriGrid, a delivery system developed by Ichor Medical Systems that is also part of the combination therapy.
Chief executive Cliff Holloway said: "We are working closely with Ichor and the FDA to address the questions they have raised and we are confident we can respond to these in a timely manner.
“We continue to advance the operational processes and procedures to ensure a rapid start to the study once approval is obtained."
Subject to regulatory sign-off, Scancell expects patient enrolment to begin in the first half of next year.