FDA clears Scancell's application for phase three trial

(Sharecast News) - Scancell said on Monday that the US Food and Drug Administration had cleared its investigational new drug application for a registrational phase three trial of its 'iSCIB1+ Immunobody' in advanced melanoma, paving the way for a global late-stage study planned to begin in 2026. The AIM-traded firm said the agreed surrogate endpoint for the trial would be progression-free survival.

It said the clearance followed completion of the 140-patient SCOPE phase two open-label, multi-centre study evaluating SCIB1 and iSCIB1+ in combination with nivolumab plus ipilimumab in previously untreated unresectable stage IIIB/IV melanoma.

Scancell said the phase two data demonstrated potentially best-in-class efficacy and durability and enabled identification of a selection marker to enrich the phase three population for responders.

"This IND clearance creates a clear pathway for late-stage registrational development of our iSCIB1+ Immunobody," said chief executive Phil L'Huillier.

"Data from the Phase 2 SCOPE trial shows a significant improvement in progression free survival as well as emerging overall survival with iSCIB1+ compared to historic benchmarks."

He added that the clearance was "a strong measure of the clinical benefit and safety of our very novel product as well as the quality of our manufacturing and preclinical work," and said the company was continuing discussions with regulators while evaluating financing options, including partnering, for the phase three trial.

Scancell said results from the SCOPE study supported selection of iSCIB1+, administered needle-free intramuscularly, for further development in patients with selected human leukocyte antigen alleles, representing about 80% of melanoma patients.

Updated data from the target population showed progression-free survival of 74% at 16 months, compared with 50% at 11.5 months reported for the current standard of care combination of ipilimumab plus nivolumab.

The company said the benefit was consistent across key subgroups, including PD-L1 low, BRAF wildtype and patients with prior checkpoint inhibitor exposure.

At 1350 GMT, shares in Scancell Holdings were up 3.03% at 13.6p.

Reporting by Josh White for Sharecast.com.