Scancell’s dilemma delayed

Scancell had once hoped this year to make a decision between its two immunotherapy contenders, SCIB1 and iSCIB1+, but a verdict has been put off until the latter half of 2025. The UK company, already facing questions about how it would fund an upcoming phase 2/3 trial, could now have an even greater existential crisis.

At last count Scancell had £14.8m in the bank, enough to get it into the third quarter of 2025 – while data on the most likely candidate to progress, iSCIB1+, are due in the second half of next year.

Long Scope

The two projects are both DNA-based immunotherapies; iSCIB1+ is said to be more potent than SCIB1, and is designed for use in all-comers, while SCIB1 is restricted to the 40% of patients with a specific haplotype, HLA.A2.

iSCIB1+ is therefore expected to be better, but this is being put to the test in the uncontrolled Scope study in first-line melanoma, in which both assets are being combined primarily with Opdivo plus Yervoy. The most promising contender is set to be taken into an adaptive phase 2/3 trial, which had been slated for 2025.

Now this isn't expected to start until early 2026, a Scancell spokesperson told ApexOnco. 

The company had previously announced plans to report data from 43 patients apiece in the SCIB1 and iSCIB1+ cohorts in the third and fourth quarters of 2024 respectively. In September, in its full-year earnings release, it disclosed a slight delay, to the fourth quarter of 2024 for SCIB1 and first quarter of 2025 for iSCIB1+.

On Monday, this lengthened further. Data with SCIB1 are now due in the first half of 2025, and iSCIB1+ in the second half of next year.

Slow recruitment

When asked about the delay, the spokesperson conceded that “recruitment has been slightly slower than previously predicted due to some NHS issues”, without elaborating on what these issues had been. Currently, 42 of the target 43 SCIB1 patients and 33 of 43 iSCIB1+ patients have been enrolled.

Scancell tried to put a brave face on the setback, leading with updated results from 25 patients in the SCIB1 plus Opdivo/Yervoy cohort in Scope: 18 patients achieved an objective response (72%) and five patients had a complete response (20%).

The group previously reported an ORR of 85% among 13 patients receiving SCIB1 plus Opdivo/Yervoy, and has said that anything over 63% would be a win.

But the results, however promising, weren’t enough to reassure Scancell investors, who sent the group's stock down 6% on Monday.