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Investigators Launch Study to Review Novel Cancer Vaccine in Patients With Advanced Solid Tumors

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A clinical trial just launched to study Vaxinia — a novel cancer vaccine — in patients with previously treated advanced solid tumors.

A new phase 1 cancer vaccine clinical trial officially launched, as the first patient has been injected with Vaxinia (CF33-hNIS). The trial will analyze the vaccine in patients with advanced solid tumors that have previously been treated with two or more lines of standard therapy.

“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,” Dr. Daneng Li, principal investigator and assistant professor in the Department of Medical Oncology & Therapeutics Research at City of Hope in Duarte, California, said in a press release.

Pre-clinical animal studies have shown that Vaxinia can shrink lung, breast, ovarian and pancreatic tumors. The virus therapy works by infecting, replicating inside and killing cancer cells. The vaccine may also increase the level of the PD-L1 protein in cancer cells, making them more susceptible to immunotherapy agents.

In the multicenter clinical trial, patients will receive a low dose of Vaxinia either intravenously or injected directly into the tumor. If this early phase of the trial shows that the vaccine is safe, then patients will receive Vaxinia in combination with Keytruda (pembrolizumab), an immunotherapy agent that targets PD-1.

“Now is the time to further enhance the power of immunotherapy, and we believe (Vaxinia) has the potential to improve outcomes for our patients in their battle with cancer,” Li said.

Researchers on the trial hope to recruit approximately 100 patients across 10 clinical trial sites in the United States and Australia. Recruitment is still ongoing, so if patients are eligible and interested, they can talk to their health care providers to see if the trial is a right fit for them.

This is not the first time a vaccine is being used to treat cancer. In 2021, the personalized cancer vaccine, AV-GBM-1, was shown to improve outcomes for patients with glioblastoma — a type of brain cancer — compared to standard of care.

“Interestingly, the same characteristics that eventually make cancer cells resistant to chemotherapy or radiation treatment actually enhance the success of oncolytic viruses, such as (Vaxinia),” said Dr. Yuman Fong, the Sangiacomo Family Chair in Surgical Oncology at City of Hope and the main developer of the genetically modified virus, in the release. “We are hoping to harness the promise of viralogy and immunotherapy for the treatment of a wide variety of deadly cancers.”

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