Norwegian-based immuno-oncology company Targovax has dosed the first patient in the Phase Ib/II combination trial of a combination pemetrexed and cisplatin with ONCOS-102 to treat malignant pleural mesothelioma (MPM).
ONCOS-102 is a human serotype 5/3 adenovirus coding for human GM-CSF, designed to create systemic anti-tumour T-cell response in cancer patients.
The study is a randomised, Phase I/II clinical trial with 30 patients involving Phase Ib safety lead-in cohort of six patients, in first line and second line MPM patients who are qualified to become treated with pemetrexed and cisplatin.
The trial is designed to determine ONCOS-102’s safety, immune activation at lesional level and in peripheral blood, clinical response and the correlation between clinical outcome and the immunological activation.
Targovax chief medical officer Dr Magnus Jaderberg said: "New therapies are needed to provide better care for patients with mesothelioma, a highly malignant cancer with poor prognosis.
"This clinical trial will provide data to evaluate the efficacy and safety of ONCOS-102 in first and second line mesothelioma patients, and we hope that our immunotherapy can provide additional benefit to chemotherapy, the existing standard of care."
It will be conducted across several sites in Europe.
In an earlier Phase I trial, ONCOS-102 has resulted in tumour-specific immune activation both at systemic and lesional level, which thereby has facilitated a clinical benefit.
Targovax is also planning to undertake three immunotherapy combination trials with ONCOS-102 and one with its RAS peptide vaccine TG02 at the end of this year.
Image: CT scan displaying mesothelioma on the left side. Photo: courtesy of Frank Gaillard via Wikipedia.