SOTIO Biotech and MSD Announce Clinical Collaboration to Evaluate IL-15 Superagonist SOT101 in Combination with Keytruda for Multiple Solid Tumors

On December 8, 2021, SOTIO Biotech announced that it had reached a clinical trial collaboration agreement with MSD. According to the agreement, SOTIO will evaluate the efficacy and safety of its IL-15 superagonist SOT101 in combination with MSD’s key PD-1 inhibitor Keytruda (pembrolizumab) in patients with advanced/refractory solid tumors through an open-label, multi-center Phase 2 clinical trial. The trial is expected to begin in the first half of 2022.

The cytokine interleukin-15 (IL-15) plays a crucial role in the immune system by influencing the development, maintenance, and function of natural killer (NK) cells and immune T lymphocytes. SOT101 is a subcutaneously administered IL-15 superagonist that activates both innate and adaptive immune responses, expands the numbers of active NK cells and T cells, and achieves the effect of killing tumor cells.

▲SOTIO's IL-15 Superagonist Product Pipeline (Image Source: SOTIO Company Official Website)

Preclinical studies have demonstrated that SOT101 increases survival rates and induces tumor regression in various tumor models, accompanied by favorable toxicological profiles. In an ongoing Phase 1/1b clinical trial, SOT101 monotherapy has shown encouraging efficacy signals in patients with advanced/metastatic solid tumors, evidenced by increased CD8-positive T cells and NK cells in tumors correlating with tumor shrinkage. Current immuno-oncology therapies, such as immune checkpoint inhibitors, achieve successful treatment outcomes in only about 15-30% of patients. In this Phase 1/1b trial, SOT101 also exhibited positive synergistic effects when combined with Keytruda.

This Phase 2 trial plans to treat up to 300 patients with SOT101 in combination with the standard dose of Keytruda across six different indications: second-line non-small cell lung cancer, first- and second-line cutaneous squamous cell carcinoma, first-line microsatellite-high unstable colorectal cancer, second-line hepatocellular carcinoma, first-line metastatic castration-resistant prostate cancer, and second-line ovarian cancer.

References:

[1] SOTIO Announces Clinical Collaboration with MSD to Evaluate IL-15 Superagonist, SOT101, in Combination with Keytruda® (pembrolizumab) in Patients with Solid Tumors. Retrieved December 8, 2021, from https://sotio.com/news-publications/news/sotio-announces-clinical-collaboration-with-msd-to-evaluate-il-15-superagonist-sot101-in-combination-with-keytruda-r-pembrolizumab-in-patients-with-solid-tumors

[2] SOT101 Shows Clinical Benefit in Patients with Advanced Solid Tumors. Retrieved November 11， 2021，from https://www.ppf.eu/en/press-release/sot101-shows-clinical-benefit-in-patients-with-advanced-solid-tumors

(Original text has been abridged)

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