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Shares in Scancell rose 5.3% to 13.69p on Tuesday after the cancer immunotherapy developer delivered two pieces of positive news, including an FDA Fast Track Designation for its lead programme and updated clinical data showing its advantage over the current standard of care is widening.
Scancell said it has received FDA Fast Track Designation for iSCIB1+, and it also updated clinical data from its melanoma programme.
The company reported progression-free survival (PFS)—the proportion of patients whose cancer has not worsened within a given period—of 77% at 20 months in the target patient group.
Scancell’s results were compared with 43% PFS at the same time point for patients receiving ipilimumab and nivolumab alone, a commonly used checkpoint inhibitor combination.
The difference has widened from 28 percentage points at 16 months. Panmure Liberum described the trend as consistent with iSCIB1+’s mechanism of action as a cancer vaccine designed to prevent tumour regrowth over the longer term, potentially supporting remission.
Panmure Liberum maintained its “buy” rating and a 32p target price, implying more than 130% upside from Tuesday’s share price.
However, the broker said it has not yet upgraded its success probability to the phase III level of 60%, keeping it at 40% until the financing route for the pivotal trial is secured.
Scancell expects to launch a global registrational phase III trial in the second half of this year. The company said the gating factor is funding, and it is evaluating options including a partnership deal.
The FDA Fast Track Designation, which provides more frequent regulatory engagement and can open the door to accelerated and priority review pathways, is expected to strengthen Scancell’s position in those discussions. Scancell also noted it secured IND (Investigational New Drug) clearance in January, which validated its manufacturing process and dosing strategy.
Further PFS data and early overall survival figures are expected in the first half of 2027.
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