• AURELIO-04 will enroll up to 320 patients and test the combination in multiple solid tumor indications
  • Clinical collaborator, MSD (Merck & Co., Inc., Rahway, NJ, USA), will supply KEYTRUDA for the study that is being conducted in Europe and the US

BASEL, Switzerland I July 26, 2022 I 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-04 combination trial of SOT101, an IL-15 superagonist and MSD’s (Merck & Co., Inc., Rahway, NJ, USA) anti-PD-1 therapy KEYTRUDA® (pembrolizumab), in patients with selected advanced/refractory solid tumors.

“The initiation of this Phase 2 study is a significant milestone for the clinical development of SOT101,” said Richard Sachse, M.D., Ph.D., Chief Medical Officer of SOTIO and Managing Director of SOTIO Biotech in Switzerland. “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. SOT101 in combination with KEYTRUDA has shown encouraging early clinical efficacy in the AURELIO-03 phase 1 study and we look forward to building upon our findings to advance this innovative therapy for the potential benefit of patients battling cancer.”

The Phase 2 trial (NCT05256381) is an open-label, single-arm, multicenter study of SOT101 in combination with pembrolizumab to evaluate efficacy and safety in patients with selected advanced/refractory solid tumors. The initiation of AURELIO-04 is based on encouraging data from the Phase 1/1b AURELIO-03 study of SOT101 which showed encouraging early efficacy signals in combination with pembrolizumab, and as single-agent treatment. The Phase 2 trial will enroll up to 320 patients targeting multiple solid tumor indications across 55 trial sites in Europe and the US. SOTIO entered into a clinical trial collaboration and supply agreement with MSD (a tradename of Merck & Co., Inc., Rahway, NJ, USA) last year in December. MSD will supply KEYTRUDA for the study.

The first patient was dosed at the Masaryk Memorial Cancer Institute, Brno, Czech Republic, under the supervision of Peter Grell, M.D., Ph.D., as principal investigator.

Stéphane Champiat, M.D., Ph.D., Head of the Inpatient Unit at the Drug Development of Gustave Roussy Cancer Center and coordinating investigator of AURELIO-04 trial commented: “The continued clinical development of SOT101 is crucial as we still face a significant need to provide more effective therapeutic options for patients with solid tumors. Validated by promising Phase 1/1b AURELIO-03 data, AURELIO-04 will aim to confirm safety and demonstrate efficacy of SOT101 in combination with pembrolizumab in additional indications.”

KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA.

About SOT101 and IL-15 Superagonist Technology:

SOT101 is the lead candidate from SOTIO’s technology platform. SOT101 (SO-C101) is a subcutaneously administered IL-15Rβγ superagonist that is fused to the sushi+ domain of the IL-15 receptor α chain. SOT101 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. SOT101 has been shown in pre-clinical models to synergize with checkpoint inhibitors and antibody therapies exerting ADCC.

Along with Interleukin-2 (IL-2), IL-15 activity increases 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. SOT101 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 that are associated with adverse events and stimulating T and NK cells through pulses in cytokine concentrations rather than tonic stimulation.