The trial is testing the safety and efficacy of SCIB1 in 25 metastatic melanoma patients who are also receiving Merck’s blockbuster checkpoint inhibitor Keytruda.
UK regulators gave the study the green light back in April, but it is yet to get underway because of delays in receiving approval from the US Food and Drug Administration, which was needed before recruitment could start.
Last October, the FDA requested more information around TriGrid – a delivery system developed by a third party – before deciding whether to grant SCIB1 investigational new drug (IND) status.
Despite “extensive dialogue” between the two parties, a resolution has yet to be agreed, so Scancell has temporarily withdrawn its US IND application in order to allow the UK arm of the trial to proceed “immediately”.
Bosses will re-submit the application at a “later date” after US officials have had more time to look at the TriGrid 2.0 delivery device and make sure they are happy with it.
“We are pleased to be able to advance our SCIB1 Phase 2 trial in the UK as we believe that SCIB1 administration with an immune checkpoint inhibitor such as pembrolizumab has the potential to offer greater efficacy than when either agent is used alone,” said chief executive Cliff Holloway.
“Whilst it is disappointing that discussions in the US have taken longer than anticipated, we will continue our dialogue with both Ichor and the Agency, and plan to resubmit the IND as soon as possible.”
Shares were down 3.5% to 7p in early deals on Monday.