Panmure Liberum holds its 'buy' rating and 32p target as FDA fast-track status adds regulatory momentum to compelling trial data.
Scancell Holdings PLC (AIM:SCLP, OTC:SCNLF, FRA:SCP) shares rose 5.3% to 13.69p on Tuesday as the cancer immunotherapy developer delivered a double dose of positive news.
In one announcement, it weighed in with FDA Fast Track Designation for its lead drug iSCIB1+ and updated clinical data showing its advantage over the current standard of care continues to widen.
The progression-free survival (PFS) figure, which measures the proportion of patients whose cancer has not worsened within a given period, reached 77% at 20 months in the target patient group.
This compares with 43% for patients receiving ipilimumab and nivolumab alone, a commonly used checkpoint inhibitor combination that works by releasing the immune system's brakes to attack cancer cells.
That gap has widened from 28 percentage points at 16 months, a trend Panmure Liberum described as consistent with iSCIB1+'s mechanism of action as a cancer vaccine designed to prevent tumour regrowth over the longer term, potentially resulting in remission.
The broker, which acts as corporate broker to Scancell, maintained its 'buy' rating and 32p target price, implying more than 130% upside from Tuesday's price.
But it noted 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, but the gating factor is funding, with the company evaluating options including a partnership deal.
The FDA Fast Track Designation, which grants more frequent regulatory engagement and opens the door to accelerated and priority review pathways, should strengthen Scancell's hand in those discussions, as should the IND (Investigational New Drug) clearance secured in January, which validated the manufacturing process and dosing strategy.
Further PFS data and early overall survival figures are expected in the first half of 2027.