First Human Trial of Revolutionary Cancer-Killing Virus Starts

VAXINIA (oncolytic virus CF33-hNIS) has been shown to shrink cancer tumors in animal models. The first human trial of this vaccine starts to evaluate its safety and tolerability.

City of Hope and Imugene Limited announced on May 18, 2022, that in Phase 1 clinical trial, the first patient was given a dose of VAXINIA, the novel cancer-killing virus CF33-hNIS. The trial aims at assessing the safety and efficacy of Vaxinia when used in patients diagnosed with metastatic solid tumors. The oncolytic vaccine showed the properties of killing lung, colon, ovarian, breast, and pancreatic cancer cells in preclinical labs and animal models. It was initially developed by the City of Hope, which licensed patent rights to Imugene covering CF33.

The multicentre trial will evaluate the safety and tolerability of CF33-hNIS in adults suffering from advanced solid tumors given intravenously or intratumorally as monotherapy or in combination with pembrolizumab (immunotherapy drug). The trial intends to enroll 100 people across the centers in Australia and the USA. As per the experts, a low dose of VAXINIA will be administered to the subjects who had received at least two lines of standard therapies.

After administering the virus’ lowest dose to the subjects and noting acceptable toxicity, certain new subjects will be administered the oncolytic virus in combination with pembrolizumab. In the US portion, patient recruitment and study site activation is underway.

The oncolytic virus CF33-hNIS treatment is made possible through the genetic modification of viruses found in nature. These viruses have shown some reliable properties of infecting and killing cancer tumors without causing harm to the normal cells.

Phase I trials are designed to determine the safety and optimal dose of this experimental medication, not to establish that it works decisively. However, over the following several years, the researchers will track whether patients appear to respond to Vaxinia if their tumors grow, and their survival rate—data that will make or break any plans for further clinical testing. By early 2025, the study is expected to be completed.

Imugene CEO Leslie Chong, M.D., said that the first patient in their Vaxinia research has been dosed, which is a big milestone for Imugene and doctors dealing with metastatic advanced solid tumors. Professor Yuman Fong and the City of Hope research team have done remarkable work. They are very excited to uncover the potential of Vaxinia and the oncolytic virotherapy platform, in addition to the promising preclinical outcomes.