Targovax has submitted a study protocol to the regulatory authorities in Spain to assess its ONCOS-102 product in combination with chemotherapy in patients with malignant pleural mesothelioma (MPM), a rare type of lung cancer associated with exposure to asbestos.
Spain is expected to become an important country in this study, therefore submission to the competent authorities in Spain is an important step in the clinical development plan.
MPM is highly malignant with a 5-year survival of only 5 to 10%. Most patients are diagnosed too late for surgical intervention for whom standard of care chemotherapy will provide a median overall survival of approximately 1 year.
In a recently completed phase I study, ONCOS-102 was seen to induce TILs (tumor infiltrating lymphocytes) in 11/12 patients in a mixed population of solid tumors including MPM and detection of tumor specific T-cells in peripheral blood demonstrating systemic and profound immune activation at lesional level.
The study is a randomized phase II study with a phase Ib safety lead in cohort of 30 patients with first line MPM patients and second line patients who are eligible for treatment with pemetrexed and cisplatin, the standard of care chemotherapy in this indication. The study'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, which is expected to start during the first half of 2016.
ONCOS-102 has orphan drug status in Europe and the USA in MPM.
