The patient was enrolled in Prague, Czech Republic. According to Sotio, this is the first trial of a combination of cellular immunotherapy and viral therapy conducted by a company from Central and Eastern Europe (called the CEE). Patient recruitment in the SP015 study (2015-004314-15) is also expected in the U.K.
Specifically, the SP015 trial (NCT03514836) is testing the safety and immune activation of DCVAC/PCa plus ONCOS-102 in men with metastatic castration-resistant prostate cancer.
Sotio plans to enroll up to 15 patients whose disease worsened after initial treatment with either hormone therapy or chemotherapy. Targovax, the developer of ONCOS-102, is collaborating in the study.
The trial’s primary goal is to determine the length of time before a patient’s prostate cancer worsens. Secondary objectives include overall survival, safety, time until PSA levels rise, and time without disease worsening on imaging scans.
“We are very happy to have succeeded in initiating such a complex trial, the first of its kind ever conducted in the Czech Republic and the CEE region,” Radek Spisek, CEO of Sotio, said in a press release.
“The SP015 clinical trial will help us to gather critical evidence necessary to develop innovative immunotherapies for the treatment of a cancer that threatens 1 in 5 men globally,” he added.
DCVAC/PCa is an immunotherapy based on the activation of a type of immune cell called dendritic cells, which are responsible for bringing harmful elements to cancer-fighting T-cells. The treatment uses the patient’s own cells and aims to produce an immune reaction against tumor antigens.
ONCOS-102 consists of a harmless type of virus called an adenovirus to selectively kill tumor cells by inducing a systemic anti-cancer response. This approach was designed to boost response to tumors that are already responding to immunotherapies and also to increase the immune system’s efficiency against tumors less likely to be recognized.
Sotio is testing the hypothesis that ONCOS-102 may boost the anti-cancer responses induced by DCVAC/PCa, helping to overcome the tumor’s evasion strategies from the immune system.
“SP015 will examine the safety and efficacy of combining our active cellular immunotherapy with a promising adenovirus-based product,” said Ludek Sojka, chief operating officer of Sotio. “We believe the results of this study will move us closer to developing new therapy combinations that produce synergistic effects and bring clear benefits to patients.”
Sojka added that tests of an oncolytic virus, such as ONCOS-102, were successful in other cancer indications. “We hope to broaden the portfolio of indications in future,” he said.
Besides the SP015 study, Sotio is conducting five Phase 2 clinical trials and the global, double-blind VIABLE Phase 3 trial (NCT02111577) in prostate cancer patients. The company is also assessing DCVAC in Phase 2 and Phase 1/2 studies in ovarian cancer and lung cancer.