On May 26, 2022 SOTIO Biotech, a clinical stage immuno-oncology company owned by PPF Group, reported 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 (Press release, SOTIO, MAY 26, 2022, View Source [SID1234626226]). Data from the study show that SOT101 has a favorable safety profile. The recommended Phase 2 dose was defined at 12 µg/kg SOT101.
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The AURELIO-03 study is an open label, single arm Phase 1/1b dose escalation study to determine the recommended Phase 2 dose and to evaluate the preliminary efficacy of SOT101 in patients with advanced solid tumors either as a monotherapy or in combination with pembrolizumab. SOT101 is administered subcutaneously on days 1, 2, 8, and 9 of every three-week cycle. 30 patients were treated on monotherapy dose levels 0.25 to 15 μg/kg and twenty-one patients on combination therapy dose levels 1.5 to 12 μg/kg.
Interim results of SOT101 as a monotherapy demonstrated four patients pretreated with checkpoint inhibitor (CPI) with confirmed stable disease. A partial response was confirmed in one patient with skin squamous cell carcinoma whose tumor was CPI-refractory. The preliminary efficacy is currently being further evaluated in an ongoing monotherapy extension in skin squamous cell carcinoma, melanoma, and renal cell cancer.
In 19 patients with at least one post-baseline tumor assessment across all dose levels who were treated with SOT101 in combination with pembrolizumab, one complete response in a patient with mesothelioma, four partial responses and 10 confirmed stable diseases have been reported.
The adverse event profile of SOT101 in combination with pembrolizumab was in line with the adverse event profile of either compound as monotherapy. No additive toxicity was seen when combining SOT101 with pembrolizumab. For both monotherapy and combination treatment, the recommended Phase 2 dose of SOT101 was established at 12 μg/kg.
This data will be presented by principal investigator Dr. Elena Garralda from the Vall D’Hebron Institute of Oncology, Barcelona, Spain at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Illinois on Saturday, June 4, 2022.
"Despite decades of progress in clinical oncology, the difficulty of treating solid tumors has remained a significant challenge for physicians," said Radek Spisek, M.D., Ph.D., chief executive officer of SOTIO. "Given the promising results from our first-in-human study of SOT101, we are greatly encouraged to have observed excellent preliminary safety and efficacy data both as a monotherapy and in combination with pembrolizumab. We look forward to initiating a basket study of SOT101 in combination with KEYTRUDA to evaluate efficacy and safety in patients with selected advanced or refractory solid tumors. This large Phase 2 AURELIO-04 trial in collaboration with MSD will be initiated in the coming weeks."
Dr. Garralda added: "The patients in this study are some of the hardest to treat, some with up to nine prior lines of therapy, so the clinical benefit observed in the AURELIO-03 study is especially encouraging. These data highlight the potential impact of SOT101 on the treatment landscape for solid tumors."
The presentation from ASCO (Free ASCO Whitepaper) is available below:
ASCO 2022 – AURELIO-03 results.pdf
About SOT101:
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.