First patient receives injection of new cancer-killing virus in phase 1 clinical trial

LOS ANGELES — A new cancer-killing virus is entering clinical trials after tests show it can successfully shrink advanced tumors. Researchers at City of Hope National Medical Center say the experimental drug can treat several forms of cancer, including colon, lung, breast, ovarian, and pancreatic tumors.

As the anti-cancer injection moves closer to reality, a team from immuno-oncology company Imugene Limited and City of Hope have dosed the first patient in a Phase 1 clinical trial with the virus, called CF33-hNIS VAXINIA. Their study will look to recruit around 100 patients at 10 different trial sites in the United States and Australia.

“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,” says Daneng Li, M.D., principal investigator and assistant professor of City of Hope’s Department of Medical Oncology & Therapeutics Research, in a media release.

“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.”

How can a virus kill cancer?

Oncolytic virus therapy works by genetically modifying viruses from nature to target and kill cancer cells instead of healthy ones. While treatments like immune checkpoint inhibitors work against certain forms of cancer, patients often see these tumors return and develop a resistance to future treatments.

However, previous studies show that oncolytic viruses actually prime a patient’s immune system and increase the amount of PD-L1 inside cancerous tumors. This protein acts like a “brake” which keeps the body’s immune system under control.

The Phase 1 trial will give patients with metastatic or advanced solid tumors a low dose of CF33-hNIS through an injection or intravenously. From there, researchers will view the safety of the drug before giving new study participants a combination of the experimental oncolytic virus and the immunotherapy pembrolizumab. This engineered cancer antibody boosts the immune system’s ability to fight cancer cells.

“Interestingly, the same characteristics that eventually make cancer cells resistant to chemotherapy or radiation treatment actually enhance the success of oncolytic viruses, such as CF33-hNIS,” says Yuman Fong, M.D., the Sangiacomo Family Chair in Surgical Oncology at City of Hope and the key developer of the genetically modified virus. “We are hoping to harness the promise of virology and immunotherapy for the treatment of a wide variety of deadly cancers.”

Study authors expect the trial to run for 24 months.

“The dosing of the first patient in our VAXINIA study is a significant milestone for Imugene and clinicians faced with the challenge of treatment for metastatic advanced solid tumors. Professor Yuman Fong and the City of Hope team have provided outstanding research. In addition to the positive preclinical results, we’re incredibly eager to unlock the potential of VAXINIA and the oncolytic virotherapy platform,” Imugene M.D. and CEO Leslie Chong concludes.

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