SOTIO Completes Enrolment of Phase III VIABLE Study

SOTIO, a biotechnology company owned by the PPF Group, recently announced the enrolment of the last patient into the VIABLE study, a global Phase III clinical trial evaluating DCVAC/PCa in combination with docetaxel in patients with metastatic castration resistant prostate cancer (mCRPC).

The VIABLE study (Eudra CT: 2012-002814-38: IND: 015255) is a randomized, double blind, multicenter, parallel-group Phase III study to evaluate the efficacy and safety of DCVAC/PCa as an add-on therapy to first-line standard of care chemotherapy in men with metastatic castration resistant prostate cancer (mCRPC). The study is being conducted in around 200 clinical sites in 21 European countries and the US. Since its launch in 2014, 1182 patients were randomized in the VIABLE study. Data on the overall survival of patients in this study are expected in 2020.

Ladislav Bartonicek, CEO of SOTIO, said “The completion of the patient enrolment to the VIABLE study is an important milestone. It is a major step toward registration of our active cellular immunotherapy and making it available for routine clinical use. We are grateful to all our medical partners, the patients and their families for their ongoing support of this study. After finalization of treatment and follow-up period we expect to finalize the primary analysis of the data in 2020.”

“This pivotal clinical trial is building on many years of scientific research at Charles University and University Hospital in Motol in Prague and intensive development efforts of SOTIO,” said Radek Spisek, Chief Scientific Officer of SOTIO. “Completing the enrollment underlines the significant progress SOTIO has made in the assessment of the innovative, dendritic cell-based active cellular immunotherapy for late-stage prostate cancer and other cancer indications. We believe that adding DCVAC/PCa to standard chemotherapy can prolong patients’ lives and slow down disease progression.”

DCVAC is an active cellular immunotherapy treatment that is produced individually for each patient using the patient’s own dendritic cells (that are part of the immune system), to induce an immune reaction against tumor antigens. SOTIO is developing three product candidates using the DCVAC platform to affect multiple different cancers in various stages of disease – DCVAC/PCa for patients with prostate cancer, DCVAC/OvCa for patients with ovarian cancer and DCVAC/LuCa for patients with lung cancer. DCVAC/PCa was the first SOTIO investigational medicinal product to enter clinical research. The company is currently evaluating the safety and efficacy of DCVAC in multiple Phase I to Phase III clinical trials.

SOTIO is an international biotechnology company leading the efforts of PPF Group to build a diverse biotechnology portfolio through its own research & development, collaborations, in-licensing, investments, mergers and acquisitions. The company is developing new medical therapies, focusing on the treatment of cancer and autoimmune diseases. SOTIO’s most advanced project is its proprietary platform of active cellular immunotherapy (ACI) based on dendritic cells. SOTIO is conducting multiple Phase I to Phase III clinical trials verifying the safety and efficacy of its DCVAC products. SOTIO is also collaborating with NBE Therapeutics on the development of novel antibody-drug conjugate products (ADC), with Cytune Pharma on developing novel IL15-based immunotherapies for the treatment of cancer and with LDC and Max Planck on an oncology program addressing a novel target in tumor metabolism. SOTIO has facilities in Europe, the United States, China, and Russia.