Imugene, a clinical stage immuno-oncology company, and City of Hope, one of the largest cancer research and treatment organizations in the United States, announced that the first patient was dosed in a Phase 1 clinical trial evaluating the safety of novel cancer-killing virus CF33-hNIS VAXINIA when used in people with advanced solid tumors. The City of Hope-developed oncolytic virus has been shown to shrink colon, lung, breast, ovarian and pancreatic cancer tumors in preclinical laboratory and animal models.

“Our previous research demonstrated that oncolytic viruses can stimulate the immune system to respond to and kill cancer, as well as stimulate the immune system to be more responsive to other immunotherapies, including checkpoint inhibitors,” said Daneng Li, M.D., principal investigator and assistant professor of City of Hope’s Department of Medical Oncology & Therapeutics Research. “Now is the time to further enhance the power of immunotherapy, and we believe CF33-hNIS has the potential to improve outcomes for our patients in their battle with cancer.”

Oncolytic virus therapy is made possible once viruses found in nature are genetically modified to infect, replicate in and kill cancer cells, while sparing healthy cells. While immune checkpoint inhibitors have been effective in certain cancers, patients often relapse and eventually stop responding to or develop resistance to this type of treatment. Early research shows oncolytic viruses can prime a person’s immune system and increase the level of PD-L1 in tumors, making immunotherapy more effective against cancer.

The multicenter Phase 1 trial will start by delivering a low dose of CF33-hNIS to cancer patients with metastatic or advanced solid tumors who have had at least two prior lines of standard of care treatment. The investigational treatment will be delivered either as an injection directly into tumors or intravenously.

Once patients in the single therapy group have been treated with the lowest doses of CF33-hNIS and acceptable safety has been demonstrated, certain new study participants will receive the experimental oncolytic virus in combination with the immunotherapy pembrolizumab, an engineered antibody that improves the immune system’s ability to fight cancer-causing cells. The study aims to recruit 100 patients across approximately 10 trial sites in the United States and Australia.

City of Hope exclusively licensed patent rights covering CF33 to Imugene Limited, a company developing novel therapies that activate the immune system against cancer. Imugene has given CF33-hNIS the name Vaxinia.