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Sotio Biotech Begins Phase II Trial of IL-15-Targeted Candidate in Solid Tumors

NEW YORK – Sotio Biotech this week said it has dosed the first advanced cancer patient in a Phase II trial of its IL-15-targeted therapy candidate SOT101 plus Merck's Keytruda (pembrolizumab).

The trial, called AURELIO-04, will enroll 320 patients with advanced or refractory colorectal, liver, prostate, ovarian, cutaneous squamous cell, and non-small cell lung cancers. In the castration-resistant prostate cancer cohort, researchers will explore several biomarkers of response, including changes in circulating tumor cell and prostate-specific antigen levels. Sotio, based in Prague, plans to enroll patients at 55 trial sites in Europe and the US.

SOT101 targets IL-15, a cytokine that plays a role in inflammatory and immune response. In data presented earlier this year from a small Phase I/Ib trial of SOT101 plus Keytruda in solid tumors, the combination led to four partial responses in patients with thyroid cancer, skin squamous cell cancer, skin melanoma, and cervix melanoma, along with one complete response in a mesothelioma patient.

"IL-15 has been widely favored as a promising cytokine in oncology, but IL-15-based approaches to date have fallen short of realizing this promise due to aberrant targeting and adverse events," Sotio Chief Medical Officer Richard Sachse said in a statement. "SOT101 in combination with Keytruda has shown encouraging early clinical efficacy in the AURELIO-03 Phase I study, and we look forward to building upon our findings to advance this innovative therapy for the potential benefit of patients battling cancer."

In April, Sotio began another Phase I/II clinical trial of SOT102, a Claudin-18.2-directed antibody drug conjugate, in patients with gastric and pancreatic cancer.