Date: 2016-07-01
Type of information: Treatment of the first patient
phase: 1-2
Announcement: treatment of the first patient
Company: Targovax (Norway)
Product: ONCOS - 102
Action
mechanism: oncolytic virus/immunotherapy product. 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. The adenovirus knob protein targeting the virus into the host cells is replaced with a protein from different adenovirus (serotype 3) to facilitate the specific entrance of ONCOS-102 into tumor cells. One of the genes affecting virus replication in the host cells is inactivated (D24 deletion). As a result, the virus cannot replicate in normal cells, but can do so in tumor cells. A gene coding for GM-CSF, a drug stimulating the immune response, inserted into the virus genome and expressed during the virus replication in the tumor cells.
ONCOS-102 has Orphan drug designation with the FDA and EMA in mesothelioma, ovarian cancer and soft tissue sarcoma.
Disease: malignant pleural mesothelioma
Therapeutic area: Cancer - Oncology
Country: Spain
Trial
details: The trial is an open-label, parallel group, multicentre trial that will recruit a total of 30 patients with malignant pleural mesothelioma. The trial will be conducted in 2 phases: a non-randomised safety phase and a randomised phase. The safety phase will consist of a lead-in cohort of 6 patients treated with ONCOS 102 and pemetrexed/cisplatin. The randomised phase will not commence until the DSMB has deemed the safety lead-in data appropriate for continuation. A total of 24 patients will be included in the randomised phase; 14 patients will be randomised to receive ONCOS 102 and pemetrexed/cisplatin, and 10 patients will receive pemetrexed/cisplatin alone. The trial's main objectives are determination of safety, immune activation, clinical response and the correlation between clinical outcome and the immunological data. (NCT02879669)
Latest
news: * On July 1, 2016, Targovax 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, in combination with pemetrexed and cisplatin. 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 malignant pleural mesothelioma patients who are eligible for treatment with pemetrexed and cisplatin. 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. * On June 9, 2016, Targovax received regulatory approval to conduct a study in Spain to assess its ONCOS-102 product in combination with chemotherapy in patients with malignant pleural mesothelioma. In a completed Phase I study, ONCOS-102 induced local immune activation at lesions demonstrated by the increased number of TILs (tumor infiltrating lymphocytes) in 11/12 patients in a mixed population of solid tumors including malignant pleural mesothelioma. In addition, the treatment initiated a systemic tumor specific immune response in two patients, as tumor specific CD8+ T cells were detected in blood samples collected after treatment, but not before the treatment.
