FDA clears IND application for Ph 3 trial of iSCIB1+ in advanced melanoma
Dr Phil L’Huillier, CEO of Scancell, 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. We are continuing our dialogue with regulators broadly as we continue to evaluate all financing options, including partnering discussions, for the Phase 3 trial.”
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