The DCVAC medicinal product

SOTIO is developing a new Active Cellular Immunotherapy medicinal product, entitled DCVAC/PCa, for prostate cancer patients, and DCVAC/OvCa, for epithelial ovarian cancer patients and DCVAC/LuCa, for lung cancer patients.

The possibility of combining immunotherapy treatment with current standard procedures produces synergic effects and has the potential to enhance the overall therapeutic effects. Unlike other chemotherapy combinations, DCVAC can be administered without difficulty and without increasing the toxicity of concurrently-administered treatment. The testers have not registered any serious undesirable side-effects or reactions related to DCVAC application in the clinical trials conducted so far.

You can find more information about Active Cellular Immunotherapy of cancer diseases using dendritic cells in the Research section.

Preparation and Administration

DCVAC is an autologous immunotherapy manufactured from patient’s white blood cells collected during a leukapheresis procedure at an apheresis center. 

After leukapheresis, the harvested cells are sent to SOTIO’s GMP certified laboratories where they are manufactured into the DCVAC immunotherapy.  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 killed by immunogenic cell death through the use of 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. 

The first dose of the treatment is available for administration to the patient four weeks after the leukapheresis procedure has taken place. A single leukapheresis session yields multiple doses (up to 15 doses) of DCVAC, which is sufficient to treat the patient for more than one year. After being thawed and diluted, the ACI is administered subcutaneously at various treatment (e.g. 3-6 week) intervals depending on the trial design.

The production process encompasses multiple standardized control steps that guarantee the high quality of the investigational medicinal products. The SOTIO manufacturing process has been GMP certified in EU.