SOTIO is a biotechnology company developing a new Active Cellular Immunotherapy (“ACI”) based on activated dendritic cells for the treatment of cancer and autoimmune diseases. SOTIO continues to develop new therapies to address unmet medical needs using its immunotherapy platform and proprietary cell-based technologies.
In SOTIO’s state-of-the-art cell therapy manufacturing facility, located in Prague, Czech Republic, the company focuses on understanding the role of dendritic cells in the therapeutic activations of the body’s immune system and its effectiveness in treating cancer and autoimmune diseases.
SOTIO has an active presence in Europe, the United States, Russia and China. Due to its central location, SOTIO’s GMP (Good Manufacturing Practice) certified production facility in Prague can manufacture and supply product to meet the needs of its clinical development programs in both Europe and the United States. In Beijing, China, SOTIO manufactures product in its dedicated production facility, built in 2014. SOTIO’s Beijing facility manufactures and supplies investigational product for cooperative research projects conducted by leading Chinese hospitals.
SOTIO’s philosophy of research into ACI for the treatment of cancer and autoimmune diseases is based on the following:
- Use of SOTIO’s proprietary ACI-MAP (Active Cellular Immunotherapy Multiple Antigen Presentation) technology. Following this proprietary ACI-MAP method, the patient’s own dendritic cells, are activated by a broad range of tumor antigens, to induce a complex immune response. (For example, PSA, MAGE 3, etc.).
- Concept of combination therapy. While immunotherapy alone is an area focusing on early stage patients, SOTIO ACI-MAP is also being investigated in advanced cancer with multiple treatments to be orchestrated in a synergistic way to control disease progression. (For example, combination agents, docetaxel, carboplatin, gemcitabine).
- Long-term boosting of the immune response. SOTIO’s ACI involve treating the patient at various intervals (e.g. 3-6 weeks) for more than one year. This concept is supported by experimental evidence and clinical observations that one apheresis yields enough DCVAC for continuous immune boosting which leads to long-term stimulation of the patient’s immune response.
Combinations of the above-mentioned principles are being tested in current clinical trials and are expected to result in more effective Active Cellular Immunotherapy in those patients who have limited treatment options.
SOTIO’s clinical program currently focuses on developing a new ACI for the treatment of prostate cancer, which we call DCVAC/PCa. Phase II clinical trials, involving several hundred patients with prostate cancer at various stages are ongoing.
In May 2014, SOTIO launched its Global Phase III clinical trial, called the VIABLE Study, to investigate the safety and efficacy of DCVAC/PCa in patients with metastatic castrate resistant prostate cancer. The VIABLE Study is expected to enroll more than one thousand patients worldwide.
In October 2013, SOTIO launched three Phase II clinical trials to assess the safety and efficacy of its investigational ACI when combined with the standard of care treatments in patients with epithelial ovarian cancer (DCVAC/OvCa). These clinical trials assessing combination treatments with DCVAC/OvCa, take place at investigational sites in the Czech Republic, Germany and Poland, and include patients at various stages of their disease, with different response to standard therapies.
In December 2014, SOTIO launched Phase I/II clinical trial to assess the use of active cellular immunotherapy (DCVAC/LuCa). This clinical trial will focus on determining, the safety and efficacy of the DCVAC/LuCa in combination with standard chemotherapy treatment for patients with advanced metastasis of non-small cell lung carcinoma (NSCLC).
Part of PPF Group
SOTIO is a part of PPF Group, one of the largest investment groups in Central and Eastern Europe (please see www.ppf.eu).