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.
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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."
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By GlobalDataIt 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.
