SOTIO, a biotechnology company owned by the PPF Group, announces today that the first patient was enrolled to the SP015 clinical trial of a combination of DCVAC/PCa, an active cellular immunotherapy, and ONCOS-102, an immune-priming engineered human serotype 5 adenovirus, for patients with prostate cancer. The trial is planned for the United Kingdom and the Czech Republic. SOTIO is collaborating with Targovax, a clinical stage immuno-oncology company developing ONCOS-102.
The first patient has been enrolled in the clinical trial SP015 by the principal investigator Dr. Ladislav Jarolím at Motol University Hospital (Prague, Czech Republic). Patients’ recruitment is planned also in the UK. It is the first time that a clinical trial combining cellular immunotherapy based on dendritic cells with an oncolytic virus therapy is realized by a biotechnology company in the region of Central and Eastern Europe (CEE).
SP015 (Eudra CT: 2015-004314-15) is a Phase I/II, single-arm clinical trial to evaluate the safety and immune activation of the combination of DCVAC/PCa, an active cellular immunotherapy, and ONCOS-102, an immune-priming adenovirus, in men with advanced metastatic castration-resistant prostate cancer. In total up to 15 patients are planned to be enrolled into the trial. The trial builds on the hypothesis that ONCOS-102 may enhance the anti-tumor immune responses generated by dendritic cells loaded with tumor antigens and thus help the immune system to overcome evasion strategies employed by tumors.
Radek Spisek, CEO of SOTIO, said: “By combining an autologous active cellular therapy with an oncolytic virus, we had to overcome various regulatory and operational challenges. 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. 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.”
Ludek Sojka, Chief Operating Officer of SOTIO, said: “SP015 will examine the safety and efficacy of combining our active cellular immunotherapy with a promising adenovirus-based product. 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. The use of an oncolytic virus in the treatment of cancer was previously successfully tested in different cancer indications and we hope to broaden the portfolio of indications in future.”