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Sotio Biotech


November 2021 Review of news from the most innovative therapeutic areas and the business development transactions

by Jakub Jarolím, Business Intelligence Department  

Antibody-Drug Conjugates

Sacituzumab govitecan shows promise in treating the most aggressive type of breast cancer

A unique ADC, which delivers a high dose of a cancer-killing drug to tumor cells through a targeted antibody, has been found in a global phase 3 clinical study to nearly double the survival time of patients with refractory metastatic triple-negative breast cancer. The study of the ADC drug sacituzumabgovitecan (SG), reported superior outcomes compared to single-agent chemotherapy, the standard for treating metastatic triple-negative breast cancer. The phase 3 results of the study, known as ASCENT, were published in the New England Journal of Medicine. SG, which was developed and is manufactured by Immunomedics, a subsidiary of Gilead Sciences, received accelerated approval by the U.S. Food and Drug Administration in April 2020 on the basis of favorable phase 1/2 clinical trials, with full approval contingent on the confirmatory phase 3 results. ASCENT is a global study to evaluate the safety and efficacy of the antibody drug conjugate compared to chemotherapy in 529 patients with metastatic triple-negative breast cancer whose cancer had relapsed or was resistant to at least two other forms of therapy. The investigators found that median progression-free survival with the ADC agent was 5.6 months compared to 1.7 months with chemotherapy, and that median overall survival was 12.1 months with the ADC agent compared to 6.7 months with chemotherapy. The study also found that the response rate – that is, shrinkage in the size of the metastatic tumor sites – was 35% after administration of ADC compared to 5% with chemotherapy.

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Interleukin-15 and Interleukin-2

SOTIO’s IL-15 superagonist shows clinical benefit in patients with advanced solid tumors

SOT101 shows clinical benefit in patients with advanced solid tumors

SOTIO Biotech announced new data from the ongoing Phase 1/1b AURELIO-03 study of SOT101, an IL-15 superagonist, as a monotherapy and in combination with pembrolizumab in patients with advanced/metastatic solid tumors.In a combination of SOT101 with pembrolizumab in the AURELIO-03 study, the majority of the 13 patients with advanced/metastatic solid tumors had clinical benefit, including in checkpoint inhibitor (CPI) refractory patients. In this dose escalation study, investigators to date have observed three confirmed partial responses and four instances of long-lasting stable disease. These patients had a median of two lines of prior therapy (range 1-6). In addition, SOT101 in combination with pembrolizumab was generally well tolerated. Dose escalation in this study is ongoing. A SOT101 monotherapy arm of the study demonstrated encouraging efficacy signals in the 30 patients with advanced/metastatic solid tumors, including in CPI refractory patients. To date, there has been one confirmed clinical and radiological response and confirmed stable disease in four patients. Additionally, one patient had a partial response on SOT101+pembrolizumab combination therapy after experiencing a relapse on SOC101 monotherapy. SOT101 was well tolerated, and the majority of treatment emergent adverse events were Grade 2 or less. Patients in this dose escalation study have had a median of three lines of prior therapy (range 1-9). The recommended Phase 2 dose has been defined at 12 μg/kg and a Phase 2 monotherapy expansion study at this dose is ongoing in selected tumor indications.

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