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NEWS

SOTIO Doses First Patient in AURELIO-04 Phase 2 Trial of SOT101 in Combination with KEYTRUDA® (pembrolizumab)

  • 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

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.

NEWS

Data from SOTIO’s Phase 1/1b AURELIO-03 Trial of SOT101 Demonstrate Clinical Benefit in Patients with Solid Tumors

  • Data demonstrate that SOT101 monotherapy and SOT101 in combination with pembrolizumab have a favorable safety profile;
  • Encouraging efficacy signals were observed for both SOT101 monotherapy and SOT101 in combination with pembrolizumab, even in patients with checkpoint-inhibitor relapsed and refractory tumors;
  • 15 out of 19 patients receiving SOT101 in combination with pembrolizumab had observed clinical benefit across all dose-levels;
  • Updated results will be presented as an oral presentation at this year’s ASCO meeting by Dr. Elena Garralda from the Vall D’Hebron Institute of Oncology, Barcelona, Spain;
  • AURELIO-04, a global Phase 2 study trial of SOT101 in combination with pembrolizumab in six distinct tumor types is expected to start in the coming weeks.

SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, announces updated interim safety and efficacy data from its Phase 1/1b AURELIO-03 dose escalation study of the IL-2/IL-15 receptor βγ superagonist, SOT101, as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors. Data from the study show that SOT101 has a favorable safety profile. The recommended Phase 2 dose was defined at 12 µg/kg SOT101.

NEWS

Oral Presentation of Interim Data from the AURELIO-03 Study of SOT101 at the 2022 ASCO Annual Meeting

  • SOTIO will share interim safety and efficacy results from SOTIO’s AURELIO-03 study on Saturday, June 4
  • AURELIO-03 is a Phase 1/1b dose escalation study of the interleukin-15 superagonist SOT101 as monotherapy and in combination with pembrolizumab in patients with advanced solid tumors

SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, announced today that it will deliver an oral presentation featuring interim safety and efficacy data from the Phase 1/1b AURELIO-03 study with its IL-15 superagonist, SOT101, as monotherapy and in combination with pembrolizumab at the upcoming American Society of Clinical Oncology (ASCO) Annual Meeting 2022, taking place in Chicago, Illinois from June 3-7, 2022.