Targovax , along with SOTIO, has dosed the first patient in a Phase I/II clinical trial investigating the safety and immune activation of ONCOS-102 in combination with DCVAC/PCa for the treatment of men with advanced metastatic castration-resistant prostate cancer.
The patient has been dosed with ONCOS-102 at the Motol University Hospital in Prague, Czech Republic, by the trial’s principal investigator Dr Ladislav Jarolím.
Up to 15 patients are expected to be enrolled in the single-arm trial across various centres in the Czech Republic and the UK.
The trial’s primary goal is to examine the safety of DCVAC/PCa and ONCOS-102 combination primed with cyclophosphamide (CPO) in the advanced metastatic castration-resistant prostate cancer, which have progressed following initial therapy with either hormonal manipulation or chemotherapy.
Its secondary goals include the time to disease progression demonstrated by prostate-specific antigen (PSA) levels, as well as radiographic progression-free survival by radiographic evidence of disease progression per Response Evaluation Criteria In Solid Tumors (RECIST) version 1.1, overall survival, and objective response rate.
Targovax CMO Magnus Jäderberg said: “Finding the right combination treatments is crucial to boost the response rate to immunotherapies, and in this particular trial we are testing the hypothesis of whether intratumoral delivery of ONCOS-102 and its transgene payload, GM-CSF, can provide a trafficking signal that enhances recruitment of the DCVAC dendritic cells to the prostate tumour site.”
Targovax’s ONCOS-102 is the company’s lead adenovirus-based pipeline product, which is a purposefully engineered human serotype 5 adenovirus optimised to induce systemic anti-tumour T-cell responses in cancer patients.
DCVAC/PCa is developed by SOTIO and as an active cellular immunotherapy treatment for prostate cancer patients.