SOTIO Announces Clinical Collaboration with MSD to evaluate IL-15 Superagonist, SOT101, in Combination with KEYTRUDA® (pembrolizumab) in Patients with Solid Tumors

• The Phase 2 AURELIO-04 study is expected to enroll up to 300 patients across six different indications
• The study will be conducted in the US and selected European countries and will begin in the first half of 2022

“SOT101 in combination with KEYTRUDA has shown promising clinical efficacy across multiple indications in our ongoing phase 1/1b AURELIO-03 study,” said Radek Špíšek, Ph.D., Global CEO of SOTIO. “We are excited to collaborate with MSD, a global leader in oncology, to continue studying the combination as part of the AURELIO-04 study for the treatment of certain patients with solid tumors while exploring the full potential of SOT101. We look forward to advancing SOT101 to the benefit of patients globally.”

Under the terms of the agreement, SOTIO will conduct a Phase 2 open-label, multicenter study of SOT101 in combination with KEYTRUDA to evaluate efficacy and safety in patients with selected advanced or refractory solid tumors. The study is expected to treat up to 300 patients with a combination of SOT101 and a standard dose of KEYTRUDA. The study will enroll patients in the U.S. and selected European countries across six different indications, including second line non-small cell lung cancer, first and second line cutaneous squamous cell carcinoma, first line microsatellite instability-high colorectal cancer, second line hepatocellular carcinoma, first line metastatic castration-resistant prostate cancer, and second line ovarian cancer. MSD will supply KEYTRUDA for the study.

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