SOTIO has enrolled its first ovarian cancer patient in a Phase 2 clinical trial evaluating its immunotherapy DCVAC/OvCa.
The SOV06 trial will look at the therapy’s effectiveness as an add-on to standard chemotherapy in women who responded to first-line platinum-based chemo but eventually relapsed. The standard chemotherapies will be two Bristol-Myers Squibb products, Paraplatin (carboplatin) and Taxol (paclitaxel).
Positive results from other trials have also prompted Prague-based SOTIO to expand its ongoing Phase 2 SOV01 trial, which is testing DCVAC/OvCa plus chemotherapy as a first-line treatment for ovarian cancer.
“SOV06 and the expansion of SOV01 represent a significant broadening of our Phase 2 program for ovarian cancer,” Radek Spisek, SOTIO’s chief scientific officer, said in a press release. “From ongoing clinical trials we see indications that DCVAC/OvCa in combination with first-line chemotherapy could be beneficial for patients.” Expanding the program and testing DCVAC/OvCa in combination with standard chemo in patients whose cancer has returned are logical next steps, he said.
The SOV06 trial will cover 30 ovarian cancer patients who have had their first relapse after chemo. SOTIO will collaborate with the Central and Eastern European Gynecological Oncology Group to conduct the trial at seven centers in the region.
The trial is an “exceptional study” for the oncology group for a number of reasons, said Professor David Cibula, lead investigator of the trial at the General University Hospital in Prague. “The active substance was developed in the Czech Republic, where the sponsor, the biotechnology company SOTIO, is headquartered; the mechanism of action is innovative; and the results of studies conducted so far are promising in the area [of relapsed ovarian cancer], which still has the worst results in our field of gynecological oncology.”
DCVAC/OvCa activates immune dendritic cells to boost the anti-tumor activity of immune T-cells.
Dendritic cells teach T-cells what substances to recognize as harmful, such as cancer proteins. The immunotherapy takes advantage of dendritic cells’ natural activity to expose T-cells to cancer-specific antigens, optimizing their punch against cancer cells.
The new approach requires collecting dendritic cells from a patient, activating them in the company’s laboratories by exposing them to dead cancer cells, then returning them to the body.
In another Phase 2 trial, SOV01 (NCT02107937), SOTIO is evaluating the effectiveness of a combination of its immunotherapy and chemo in newly diagnosed ovarian cancer patients who have had surgery to remove most of their tumor.
Researchers have already enrolled 99 Czech, Polish, and German women in the study. The primary objective is to see whether the combo is better than chemo alone at keeping the cancer at bay.
The team will add 30 more patients to the trial as it continues testing the treatments’ safety and effectiveness.
SOTIO has also conducted two other Phase 2 trials, SOV02 (NCT02107950) and SOV03 (NCT02107378), to evaluate DCVAC/OvCa as an add-on therapy to standard chemo in patients with platinum-resistant epithelial ovarian cancer.
“Positive signals from the clinical trials with DCVAC/OvCa encouraged us to launch an additional Phase 2 trial with larger numbers of patients to confirm its efficacy,” said Ladislav Bartonicek, SOTIO’s CEO.
SOTIO is also developing dendritic-cell-based immunotherapies for prostate and lung cancer.