SOTIO Announces First Patient Dosed in Part B of Phase 1/1b Study with SO-C101 in Combination with Pembrolizumab in Patients with Solid Tumors

July 14, 2020
Source: Press Release

SOTIO, a clinical stage immuno-oncology company owned by PPF Group, today announced that the first patient has been dosed in Part B of the ongoing Phase 1/1b study of IL-15 superagonist, SO-C101, for the treatment of patients with advanced/metastatic solid tumors. Part B will examine SO-C101 in combination with PD-1 inhibitor pembrolizumab. The trial is conducted in partnership with Cytune Pharma.

Early results from the ongoing Part A of the Phase 1/1b trial investigating SO-C101 monotherapy dose escalation to date have shown encouraging biological activity, activating NK cells and CD8 T cells in various solid tumors. Part B now allows for the pembrolizumab combination phase of this dose-escalation study to progress. “Given its mechanism of action as a pure IL-15 receptor agonist, SO-C101 has promising potential for a combination approach with checkpoint inhibitors. We are pleased to have reached this important milestone and look forward to investigating SO-C101 in combination with pembrolizumab,” said Radek Špíšek, Ph.D., chief executive officer of SOTIO.

Dr. David Bechard, president and chief operations officer of Cytune Pharma, added, “We are thrilled to be advancing our collaboration with SOTIO and begin enrolling patients in this important phase of the clinical trial. There remains a high unmet medical need to evaluate novel potent immunotherapies for patients with cancer.”

The ongoing multicenter, open-label Phase 1/1b study, SC103 (NCT04234113), is evaluating the safety and preliminary efficacy of SO-C101 as monotherapy (Part A) and in combination with pembrolizumab (Part B) in patients with selected relapsed/refractory advanced/metastatic solid tumors.

Cytune Pharma is responsible for the clinical development of SO-C101, SOTIO is a sponsor of the Phase 1 clinical trial. Both companies are owned by PPF Group.