SOTIO Provides Update on Interim Data from Clinical Trials of Nanrilkefusp Alfa

October 13, 2023
Source: Press Release, Basel

  • Ongoing clinical trials of nanrilkefusp alfa will be discontinued due to insufficient efficacy;
  • SOTIO plans to explore combinations of nanrilkefusp alfa with other modalities;
  • SOTIO to continue to advance its immunocytokine platform including next-generation SOT201 program.

SOTIO Biotech, a clinical-stage immuno-oncology company owned by PPF Group, today announced it will discontinue the currently ongoing clinical trials of nanrilkefusp alfa as monotherapy and in combinations with pembrolizumab and cetuximab. Interim data from SOTIO’s clinical trials of nanrilkefusp alfa have shown insufficient efficacy to warrant further development in larger randomized trials in these specific indications and combinations. Interim data revealed no major safety issues in any of the trials. SOTIO is exploring options for alternative clinical development paths for nanrilkefusp alfa, including in combination with cell therapies, which has already generated promising preclinical data.

Based upon the interim data, effective immediately, enrollment in the AURELIO-03, AURELIO-04, and AURELIO-05 clinical trials will be stopped. SOTIO will continue to fulfill its obligations to patients currently enrolled in these trials, who will be able to continue treatment under the current protocol at the discretion of their principal investigator.

“While we are disappointed with this outcome, we will continue to gather and analyze the full body of data from these studies to inform our future development plans for nanrilkefusp alfa, especially its potential utility in combination with other cancer immunotherapies,” said Richard Sachse, M.D., Ph.D., chief medical officer of SOTIO. “We are grateful to the patients, families and investigators that participated in these trials and whose contributions are essential to improving the standard of care for solid tumor cancers.”

SOTIO will continue to advance its immunocytokine platform including preclinical development of SOT201, a next-generation PD-1-inhibiting cytokine that is on track to enter Phase 1 clinical development in the second quarter of next year. SOTIO will also continue to explore nanrilkefusp alfa with partners who are developing treatment modalities with a synergizing mode of action. 

“SOTIO remains committed to developing immuno-oncology therapies that can improve outcomes for patients with solid tumors. With SOT201 we are advancing an even more differentiated program toward the clinic, combining checkpoint inhibition with IL-15 activation to produce a dual-acting therapy of great potential,” said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO. “We will continue to actively advance current and additional programs across our three platforms, and as such we believe SOTIO to be well-positioned for success with our diversified pipeline of next-generation immunotherapies.”