SOTIO Receives Positive VHP Decision for SC103, a First-in-Human Clinical Trial in Patients with Advanced/Metastatic Solid Tumors
SOTIO, a biotechnology company belonging to the PPF Group, announces today that it received a positive decision further to the EU Voluntary Harmonisation Procedure (VHP) for the review of clinical trial application for the first-in-human clinical trial, study SC103, with its lead oncology asset SO-C101, a human fusion protein of IL-15 and the high-affinity binding domain of IL-15Rα. Study SC103 is a phase I/Ib study to evaluate the safety and preliminary efficacy of SO-C101 in patients with selected advanced/metastatic solid tumors. SOTIO expects to initiate the trial as soon as the concerned national (France and Spain) regulatory agencies and ethics committee approvals are granted. Enrolment of the first patient is planned in May 2019.
February 4, 2019
Source: Press Release, Prague