ONCOS-102 triggered an immune response against mesothelioma and was safe, the initial results of a Phase 1/2 clinical trial of a combo therapy shows.
Targovax designed its virus-based ONCOS-102 to strengthen the immune system’s response to advanced malignant pleural mesothelioma.
The trial (NCT02879669) is testing ONCOS-102 and standard chemotherapy in patients unable to have surgery. The results that Targovax announced cover the trial’s initial safety phase.
ONCOS-102 consists of a harmless virus engineered to kill tumor cells by triggering an anti-tumor response across the body. The therapy strengthens immune response against tumors that are already responding to immunotherapies. And it bolsters responses against tumors the immune system is less likely to recognize.
The study is assessing the combo’s ability to mount an immune response against a tumor, its ability to rein in the cancer, and its safety, compared with chemotherapy alone. The comparison chemotherapies are Alimta (pemetrexed) and Platinol (cisplatin).
Targovax’s initial review of the combo’s safety involved six patients. The satisfactory findings prompted an independent trial review board to recommend that the trial continue.
Researchers are hoping to recruit 24 patients for the next phase of the trial, which will evaluate the combo’s effectiveness and safety, compared with chemo alone.
Preliminary results covering three patients showed that the combo triggered pro-inflammatory cytokines, or signalling molecules, against tumors. It also led to an increase in tumor-infiltrating cytotoxic immune T-cells in two patients who had biopsies before and after treatment.
Together, the results support ONCOS-102’s ability to activate the immune system, researchers said. The combination also makes the tumor more susceptible to an immune attack, they said.
“We are very pleased that the safety lead-in cohort [of six patients] was completed without any concerns, and that we now can move into the randomized part of the trial,” Magnus Jäderberg, Targovax’s chief medical officer, said in a press release.
“The systemic and lesional [tumor] immune activation are in line with what we saw in the mesothelioma patients from our Phase 1 trial, in which there was an associated clinical response,” he said. “It will therefore be interesting to follow what clinical [disease-fighting] benefits may be seen in the subsequent randomized part of the ongoing trial.”