Scancell's 'SCIB1' clears latest regulatory hurdle in US
Cancer immunotherapy developer Scancell announced on Monday that its investigational new drug (IND) application to the United States Food and Drug Administration (FDA) for ‘SCIB1’ has been approved.
The AIM-traded firm said that as a result, it would begin the US arm of the phase 2 clinical trial of SCIB1 in patients with metastatic melanoma, who were also receiving the checkpoint inhibitor ‘pembrolizumab’, or ‘Keytruda’, using Ichor's ‘TriGrid 2.0’ electroporation delivery device.
It said the phase 2 study was designed to assess whether the addition of SCIB1 to pembrolizumab would result in an improvement in the tumour response rate, progression-free survival and overall survival in 25 patients with advanced melanoma, who were also eligible for treatment with pembrolizumab.
“Although checkpoint inhibitor combinations have improved outcomes for patients with melanoma, the toxicity of combinations such as ipilimumab plus nivolumab means that there remains a need to develop combinations with other investigational agents such as SCIB1, which have the potential to improve response rates without increasing toxicity,” said Dr Keith Flaherty, professor of medicine at Harvard Medical School and director of clinical research at Massachusetts General Hospital Cancer Center, and clinical advisor to Scancell.
Patient screening was started in the UK, with professor Poulam Patel - professor of clinical oncology at the University of Nottingham - as the chief investigator for the global study.
US site initiation activities and patient enrolment would begin alongside clinical site expansion in the UK, the company explained.
“We are delighted that our IND is now open, allowing us to progress our SCIB1 phase 2 trial in the US as well as the UK,” said Scancell chief executive officer Dr Cliff Holloway.
“Approval will allow us to increase our overall patient recruitment rate and determine whether the addition of SCIB1 to current, standard of care treatment with pembrolizumab increases the anti-cancer response rate in patients with metastatic melanoma.”
At 1349 GMT, shares in Scancell Holdings were up 9.64% at 7.51p.