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."

About DCVAC/PCa
DCVAC/PCa was the first SOTIO product to enter clinical research. SOTIO DCVAC/PCa is an active cellular immunotherapy treatment for prostate cancer patients; DCVAC/PCa 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 has been sponsoring five Phase II clinical trials and one global Phase III (VIABLE) clinical trial in patients with prostate cancer. Other Phase II and Phase I/II clinical trials with products using the same dendritic cells based platform (DCVAC) are conducted in ovarian cancer and lung cancer indications.

About Targovax and ONCOS-102
Targovax is a clinical stage company focused on developing and commercializing novel immuno-oncology therapies to target, primarily, treatment-resistant solid tumors. The company's development pipeline is based on two novel proprietary platforms. The first platform, ONCOS, uses oncolytic viruses as potential multi-target, neo-antigen therapeutic cancer vaccines. ONCOS uses an adenovirus that has been engineered to be an immune activator that selectively targets cancer cells. The second platform, TG, are neo-antigen cancer vaccines designed to specifically treat tumors that express mutated forms of the RAS protein. The Targovax development pipeline has three novel therapeutic candidates in clinical development covering six indications.

ONCOS-102 is the lead adenovirus-based pipeline product of Targovax – a purposefully engineered human serotype 5 adenovirus optimized to induce systemic anti-tumor T cell responses in cancer patients. Targovax has completed a Phase I clinical study with this product and continues to test it in further combination clinical trials in several solid tumor indications.

About SOTIO
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. The most advanced project is the SOTIO 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 the Max Planck Society on an oncology program addressing a novel target in tumor metabolism. SOTIO has facilities in Europe, the United States, China and Russia.

SOTIO is a registered trademark of SOTIO a.s. in selected countries.

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