Scancell Holdings PLC (AIM:SCLP, OTC:SCNLF, FRA:SCP) said the U.S. Food and Drug Administration has cleared its Investigational New Drug application for a registrational Phase 3 trial of iSCIB1+ in advanced melanoma. The company said progression-free survival will be the agreed surrogate endpoint.
Scancell said it has completed its 140-patient Phase 2 SCOPE study evaluating SCIB1 and iSCIB1+ in combination with nivolumab plus ipilimumab in previously untreated unresectable stage IIIB/IV melanoma. It said the analysis identified a selection marker intended to enrich the Phase 3 trial for responders.
Chief executive Phil L’Huillier said: “This IND clearance creates a clear pathway for late-stage registrational development of our iSCIB1+ Immunobody.”
"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. I take this endorsement of our program as 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."
Scancell said iSCIB1+ is administered needle-free intramuscularly and will be developed in patients with selected human leukocyte antigen alleles, which it said represent 80% of melanoma patients.