Scandinavian-based Targovax recently recruited the first patient for the Phase Ib/II study examining ONCOS-102 in combination with pemetrexed and cisplatin for the treatment of malignant pleural mesothelioma (MPM), a rare, aggressive cancer that develops in the thin layer of tissue surrounding the lungs known as the pleura. There is currently no cure for MPM but surgery, chemotherapy and radiotherapy can help improve patient prognosis and life expectancy.
According to a press release, pemetrexed with cisplatin is the only standard of care chemotherapy for MPM. The median PFS/OS (progression-free survival/overall survival) from the initiation of treatment is around 12 months.
“New therapies are needed to provide better care for patients with mesothelioma, a highly malignant cancer with poor prognosis,” Dr. Magnus Jaderberg, Targovax’s chief medical officer, said in the press release. “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.”
Jaderberg added that treating the first patient, in the first oncolytic virus trial of the merged company, is exciting for Targovax and all company stakeholders.
The randomized trial will evaluate the performance of ONCOS-102, an engineered human adenovirus designed to induce systemic, anti-tumor responses in 30 patients with MPM. Researchers are administering the immunotherapy drug as first-line therapy in combination with chemotherapy using pemetrexed and cisplatin.
The trial aims to determine the safety, immune activation at lesional level and in peripheral blood, clinical response, and the correlation between clinical outcome and immunological activation. The study is being conducted in several sites across Europe.
The company also plans to begin three immunotherapy combination clinical trials evaluating ONCOS-102 and its RAS peptide vaccine TG02 during the second half of the year.
ONCOS-102 is an engineered human serotype 5 adenovirus optimized to induce systemic anti-tumor T-cell response in patients with cancer. Results from a Phase I clinical trial, show that treatment with ONCOS-102 induced tumor specific immune activation both at systemic and lesional level. ONCOS-102 has been granted orphan drug status in Europe and the U.S. for soft tissue sarcoma and ovarian cancer.