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February 4, 2019
Source: Press Release, Prague
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.
SOTIO submitted the trial documentation as part of the European Voluntary Harmonisation Procedure (VHP). Following the positive VHP decision, SOTIO plans to submit an Investigational New Drug (IND) application to the US Food and Drug Administration (FDA).
The SC103 clinical trial will be initiated in France and Spain and will enroll patients at the Goustave Roussy Institute of Oncology (France) and Vall d’Hebron (Spain). After obtaining all the necessary US regulatory approval, SOTIO plans to enroll US patients at the Yale Cancer Center and MD Anderson Cancer Center in Houston.
SC103 (Eudra CT: 2012-002814-38): A multicenter open-label phase 1/1b study to evaluate the safety and preliminary efficacy of SO-C101 as monotherapy and in combination with pembrolizumab in selected patients with advanced/metastatic solid tumors.
Molecule SO-C101 (RLI-15) is a human fusion protein of IL-15 and the high-affinity binding domain of IL-15Rα which acts as a specific agonist of the intermediate-affinity IL-2/IL-15Rβγ. It is a novel immunotherapeutic approach with potential applications in a variety of oncology indications. In preclinical experiments, SO-C101 has been shown to stimulate and induce proliferation of immune effector cells, such as cytotoxic T cells and NK cells, without expanding the CD4+ T regulatory cells. Based on the preclinical experiments, SO-C101 is more potent and better tolerated compared to the unmodified IL-15 or IL-2. SO-C101 and other products based on this platform allow for combinations with other immunotherapeutic strategies, including checkpoint inhibitors.
The Voluntary Harmonisation Procedure is a procedure which makes it possible to obtain a coordinated assessment of an application for a clinical trial that is to take place in several European countries. The assessment is conducted and coordinated between the national competent authorities (medicines agencies) of the countries in which the trial is to take place following which the application is submitted to the countries involved. It is an offer through which sponsors can obtain a harmonised assessment of an application. The actual trial must still be authorised at national level, and it is therefore not a centralised authorisation. Provided that the VHP assessment reaches consensus, the scientific content of the application must not be changed when submitted to the national competent authorities.