SOTIO Doses First Patient in AURELIO-05 Phase 2 Trial of Nanrilkefusp Alfa in Combination with Cetuximab

SOTIO Doses First Patient in AURELIO-05 Phase 2 Trial of Nanrilkefusp Alfa in Combination with Cetuximab

BASEL, Switzerland, January 19, 2023 / B3C newswire / -- SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, announced today that the first patient was dosed in its Phase 2 AURELIO-05 combination trial of nanrilkefusp alfa (previously known as SOT101), an IL-15 superagonist, and cetuximab in patients with colorectal cancer.

“The initiation of this Phase 2 study is an important step in the clinical development of nanrilkefusp alfa. In addition to our previous and ongoing studies to determine the efficacy of nanrilkefusp alfa in combination with checkpoint blockers, we now aim to determine its ability to enhance the antibody dependent cellular cytotoxicity exerted by cetuximab,” said Richard Sachse, M.D., Ph.D., chief medical officer of SOTIO. “If replicated in patients, the increased anti-tumor activity and proliferation of CD8⁺ T-cells that has been observed in colorectal cancer models treated with IL-15 superagonists could position nanrilkefusp alfa as a safe and effective therapy in combination with cetuximab in this indication. We look forward to evaluating this potential benefit.”

The Phase 2 AURELIO-05 trial (NCT05619172) is an open-label, single-arm, multicenter study to evaluate the efficacy and safety of nanrilkefusp alfa in combination with cetuximab in up to 52 patients with RAS wild-type colorectal cancer who are relapsed/refractory or intolerant to prior treatment with irinotecan- and oxaliplatin-containing chemotherapy. The trial will be conducted in approximately 20 specialized sites across Europe. The first patient was dosed at the Gent University Hospital (Belgium), under the supervision of Professor Karen Geboes, head of the Department of Gastrointestinal and Intestinal Diseases.

Professor Eric van Cutsem, head of Digestive Oncology at the University Hospital in Leuven (Belgium) and coordinating investigator of the AURELIO-05 trial commented: “Despite recent advances in oncology, patients with advanced refractory colorectal cancer still have poor long term survival rates. Having already demonstrated promising signs of safety and efficacy not only in monotherapy, but also in combination with another approved monoclonal antibody, pembrolizumab, we are pleased to have initiated this critical study to evaluate the potential benefit of nanrilkefusp alfa in combination with cetuximab in this highly underserved patient population.”