Scancell Holdings PLC (LON:SCLP) shares rose on Thursday as the firm said it is to kick off the UK arm of the phase II clinical trial of its flagship skin cancer drug within weeks, after receiving approval from regulators.
The study will test the safety and efficacy of SCIB1 in 25 metastatic melanoma patients who are also receiving Merck’s blockbuster checkpoint inhibitor Keytruda.
Earlier research carried out by Scancell suggested that combining SCIB1 with a checkpoint inhibitor could have a bigger impact than if it were administered on its own.
“This is a major milestone in the clinical advancement of our SCIB1 programme and we look forward to initiating this important phase II study,” said chief executive Cliff Holloway.
“Our preclinical research has indicated that SCIB1 administration with an immune checkpoint inhibitor has the potential to offer even greater efficacy than when either agent is given alone, and this new study is designed to evaluate the safety and efficacy of this approach in patients with inoperable disease.”
‘Compelling’ phase I/II performance
Scancell’s immunotherapy, which targets and stimulate existing cells that make up the body’s defence mechanisms, has already shown itself to be safe and well-tolerated in a prior phase I/II study.
In that same trial, SCIB1 also demonstrated its potential to improve survival rates, with 14 of 16 patients with resected skin cancer (i.e. some or all the tumour has been surgically removed in the past) remaining alive for more than five years after diagnosis.
Typically, only around 20% of people with advanced melanoma – stage III/IV – make it that far.
Discussions ongoing with US regulators
The UK arm of the trial is scheduled to get underway before the end of June, and CEO Holloway and his team are working to secure approvals from US regulators so trials can also start across the pond.
In October, the US Food and Drug Administration (FDA) requested some more information around TriGrid – a delivery system developed by a third party – before granting SCIB1 investigational new drug status.
Holloway said: “Discussions with the FDA are ongoing and we continue to work with Ichor towards IND approval to open our US study centres.”
In afternoon trading, shares in Scancell were 2,6% higher at 5.30p.
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