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SOTIO is developing a new active cellular immunotherapy platform, entitled SOTIO DCVAC, and has selected three product candidates: DCVAC/PCa for patients with prostate cancer, DCVAC/OvCa for patients with ovarian cancer, and DCVAC/LuCa for patients with lung cancer. SOTIO is currently testing the safety and efficacy of the SOTIO DCVAC products through multiple Phase I to Phase III clinical trials. No potential risks have been detected or confirmed in the ongoing clinical trials conducted by SOTIO. The overall safety profile of investigational products is favorable, supporting the ongoing clinical development of DCVAC.
The SOTIO process involves a personalized preparation of the treatment, tailored to a specific patient. The SOTIO DCVAC products are made from the cells of the patient’s immune system. For its manufacturing, a type of white blood cells called monocytes is used. During a standard immune response, monocytes can mature into dendritic cells. Dendritic cells then work together with other immune cells in the body so that they are able to activate an immune response to foreign substances. For more information about using dendritic cells for the treatment of cancer diseases see the Active Cellular Immunotherapy section.
The SOTIO® DCVAC is an autologous immunotherapy manufactured from a patient’s white blood cells. In the manufacturing of DCVAC, monocytes are harvested from the patient’s blood in a routine process called leukapheresis and differentiated into dendritic cells. During differentiation the dendritic cells are exposed to cancer cells killed by a proprietary method. The patient’s own dendritic cells engulf the dying tumor cells and present tumor cell parts (tumor antigens) on their surface. After administration of the antigen-presenting dendritic cells back into the patient, other immune system cells of the patient are encountered and an immune response to the tumor cells is initiated.
The SOTIO cancer immunotherapy is focused on combining immunotherapy with chemotherapy and other standard therapies to boost the efficiency of patients’ treatment.
After leukapheresis, the harvested cells are sent to the SOTIO GMP-certified laboratories where they are used for manufacturing of the SOTIO DCVAC product. Monocytes separated from the entire leukapheresis product are cultivated ex vivo into immature dendritic cells. The immature dendritic cells are then pulsed with tumor cells, in which immunogenic cell death was induced using high hydrostatic pressure. Subsequently, the pulsed dendritic cells are matured and the resulting product is frozen, stored in liquid nitrogen and shipped to the treatment site. Mature dendritic cells present tumor antigens and are reintroduced into the patient’s body in the form of immunotherapeutic vaccine to trigger the patient’s immune system’s required response against harmful tumor cells.
The first dose of the treatment can be administered to the patient approximately four weeks after the leukapheresis procedure. A single leukapheresis session yields up to 15 doses of DCVAC, which is sufficient to treat the patient for more than one year. After being thawed and diluted, DCVAC is administered subcutaneously at various treatment intervals (e.g. every 3-6 weeks), depending on the trial design.
SOTIO manufactures DCVAC for European and US patients in the SOTIO laboratories built in Prague in 2011. The SOTIO production facilities meet the most stringent requirements for the sterile production of cell therapy products and are among the largest cell therapy laboratories with clean room facilities in Europe. The SOTIO manufacturing process has been GMP-certified in the EU. In 2014, the company also opened similar laboratories meeting GMP standards in Beijing, China.
The production process encompasses multiple standardized control steps that guarantee the high quality of the investigational medicinal treatment. Observance of GMP guidelines includes the monitoring of the working environment, the validation of instruments, adherence to exact working procedures, the use of verified (certified) mediums, and the monitoring of transport conditions. SOTIO seeks to cooperate with suppliers who also meet the GMP requirements.