NEW YORK – City of Hope and Imugene said on Tuesday that they have begun a Phase I trial of the oncolytic virus CF33-hNIS for metastatic solid cancers.
In the trial, the partners will evaluate the safety and maximum tolerated dose of the agent, dubbed Vaxinia, in patients with solid tumors who have received at least two lines of therapy. Initially, a group of patients will receive Vaxinia, either via an injection straight to the site of the tumor or intravenously, at the lowest dose. After investigators have determined the oncolytic virus is safe, they will administer Merck's checkpoint inhibitor Keytruda (pembrolizumab).
City of Hope initially developed the oncolytic virus, which has been shown to shrink colon, lung, breast, ovarian, and pancreatic tumors in preclinical studies, and licensed it to Sydney-based Imugene. The firms expect it to make tumors responsive to immunotherapy by increasing PD-L1 expression on tumors.
In the Phase I trial, investigators will assess the preliminary efficacy of the Vaxinia and Keytruda regimen as well as patients' PD-L1 expression changes from baseline, including in tumor tissue and circulating tumor cells. In preclinical studies, the CF33-hNIS oncolytic virus caused tumor PD-L1 expression to increase and stimulated responses to checkpoint inhibitors like Keytruda.
In total, City of Hope and Imugene expect to enroll roughly 100 patients across 10 sites in the US and Australia in the Phase I trial.
City of Hope has also licensed to Imugene patents to CF33-hNIS-antiPDL1 as a treatment for metastatic triple-negative breast cancer patients and to CF33-CD19, or onCARlytics, to boost CAR T-cell therapy efficacy for solid tumors.