Targovax has announced that the first patient has been dosed in a phase Ib/II clinical trial evaluating ONCOS-102 for the treatment of malignant pleural mesothelioma (MPM), a rare type of cancer in the lining of the lung, in combination with pemetrexed and cisplatin.
“New therapies are needed to provide better care for patients with mesothelioma, a highly malignant cancer with poor prognosis” says Dr Magnus Jaderberg, CMO of Targovax. “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.,
“In addition, treating the first patient in the first oncolytic virus trial of the merged company is of course an exciting moment for Targovax and all its stakeholders” adds Dr Jaderberg.
The trial is a randomized phase I/II clinical trial of 30 patients, with a phase Ib safety lead-in cohort of six patients, in first line and second line MPM patients who are eligible for treatment with pemetrexed and cisplatin. The trial’s main objectives are determination of safety, immune activation at lesional level and in peripheral blood, clinical response and the correlation between clinical outcome and the immunological activation. Several investigational sites in Europe will participate in this study. In addition to this trial, Targovax plans to initiate three immunotherapy combination trials with ONCOS-102 and one with its RAS peptide vaccine TG02 during the second half of 2016.
Malignant mesothelioma is a rare type of cancer often caused by exposure to asbestos. There are no curative treatments although surgery, chemotherapy and radiotherapy can sometimes help to improve patient prognosis and life expectancy. Pemetrexed and cisplatin is the only standard of care chemotherapy for malignant mesothelioma, but the median PFS/OS (progression-free survival/overall survival) from the initiation of treatment is only approximately 12 months.
ONCOS-102 is a purposefully engineered human serotype 5/3 adenovirus coding for human GM-CSF optimized to induce systemic anti-tumor T cell response in cancer patients. In a previous Phase I trial, ONCOS-102 treatment induced tumor specific immune activation both at systemic and lesional level. The immune activation was associated with clinical benefit.