Based in Prague, Czech Republic, Sotio is developing personalised dendritic cell vaccines (DCVACs) based on dendritic cells cultivated from a patient’s blood monocytes and used to induce an immune response against tumour cells. Its lead product, DCVAC/PCa, is in Phase III trials to treat patients with prostate cancer.
Yesterday the firm announced enrolment has begun for a Phase I/II clinical trial to determine safety and efficacy of the vaccine DCVAC/LuCa in combination with standard chemotherapy in patients with lung cancer, with the trial being carried out by local contract research organisation (CRO) Accord Research.
Michael Kracht, Medical Science Lead at Sotio, told Outsourcing-pharma.com the most important decision for selecting Accord - a CRO owned by the PFF Group, which is also Sotio’s parent body – was the geographical location.
With trials planned to be run in the Czech Republic and “maybe in Germany at a later stage,” Michael Kracht, Medical Science Lead at Sotio, told this publication the most important decision for selecting Accord - a CRO owned by the PFF Group, which is also Sotio’s parent body – was the geographical location.
“For our big multinational phase-III prostate cancer trial we have hired Chiltern as CRO,” he said. “For the smaller ovarian cancer and lung cancer Phase-II trials we use Accord Research, a CRO based in Prague.”
There are no plans for now to involve further EU or US regions in the lung cancer investigation, and thus Chiltern will not be involved, but he added “it may look different at a time when we move into phase III again.”
Dendritic Cell Vaccine
The treatments involved a personalised preparation of the drug candidate using the dendritic cells, taken from the patient and manufactured by Sotio in vitro in large quantities. These cells process antigen material and present it on the cell surface to the T cells of the immune system, acting as messengers between the innate and the adaptive immune systems.
Tumour cells (from cancer cell lines) killed by High Hydrostatic Pressure (HHP) are engulfed in these dendritic cells, before being reintroduced into the patient’s body in the form of immunotherapeutic vaccine to trigger the required response from the patient’s immune system against the harmful tumour cells.
The company says the dendritic cells pulsed with the dead tumour cells have an increased ability to induce cytotoxic T cell responses, which increases the probability of inducing efficient immune response in the body.
Currently the vaccines are being tested in combination standard chemotherapy on patients with ovarian cancer, as well as prostate and lung cancer.