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.”

About nanrilkefusp alfa and IL-15 Superagonist Technology

Nanrilkefusp alfa (previously known as SOT101) is the lead candidate from SOTIO’s IL-15 technology platform. Nanrilkefusp alfa is a subcutaneously administered IL-15 superagonist that is fused to the sushi+ domain of the IL-15 receptor alpha chain. Nanrilkefusp alfa has demonstrated strong preclinical in vivo efficacy in various tumor models showing increased long-term survival and tumor regression, as well as a favorable toxicology profile. Nanrilkefusp alfa has been shown in preclinical models to synergize with checkpoint inhibitors and antibody therapies exerting antibody dependent cellular cytotoxicity (ADCC).

Along with Interleukin-2 (IL-2), IL-15 activity is known to increase the number of cytotoxic T cells and NK cells, the two most important cells for driving an anti-cancer immune response. This T and NK cell expansion is the result of IL-15 binding to its IL-15 alpha chain receptor in conjunction with binding to its shared IL-2/IL-15 beta gamma receptor on the surface of T and NK cells. Nanrilkefusp alfa has been precisely designed and optimized for its use as a potent immunotherapy by addressing two important design issues that limit current IL-2 and IL-15 approaches. These include selectively binding only to cytotoxic T and NK cells, while avoiding other cell types associated with adverse events, and stimulating T and NK cells through pulses in cytokine concentrations rather than tonic stimulation.

About SOTIO Biotech

SOTIO Biotech is shaping the future of cancer immunotherapies by translating compelling science into patient benefit. The robust SOTIO clinical pipeline includes a differentiated superagonist of the attractive immuno-oncology target IL-15, nanrilkefusp alfa, currently being tested in phase II clinical trials, SOT102, a next generation Claudin-18.2-targeted antibody-drug conjugate (ADC) which entered the clinical phase in 2022, and SOT106, a novel ADC which is currently in preclinical studies. BOXR1030, a GPC3-targeted CAR-T based on proprietary technology designed to improve on the efficacy of CAR-T therapies in the tumor microenvironment, is entering the clinical phase. SOTIO is a member of the PPF Group.

SOTIO is a registered trademark of SOTIO Biotech a.s. in selected countries.