(ORDO NEWS) — An experimental cancer-killing virus has been injected into a patient for the first time, and it is hoped that trials will provide evidence of a new agent to successfully fight cancer in humans.
A drug called CF33-hNIS (aka Vaxinia) is a so-called oncolytic virus – a genetically modified virus designed to selectively infect and destroy cancer cells while sparing healthy cells.
In the case of CF33-hNIS, the modified variola virus works by entering cells and duplicating itself. Eventually, the infected cell bursts, releasing thousands of new viral particles that act as antigens, stimulating the immune system to attack nearby cancer cells.
Previous studies in animal models have shown that the drug can use the immune system to search for and destroy cancer cells, but so far no human trials have been conducted.
Now the situation has changed: co-developers of the drug – the oncology and research center City of Hope in Los Angeles and the Australian biotechnology company Imugene – have announced the start of the first clinical trials in humans.
“Our previous research has shown that oncolytic viruses can stimulate the immune system to respond to and kill cancer, as well as stimulate the immune system to better respond to other immunotherapies,” said oncologist and City of Hope Principal Investigator Daneng Lee.
“We believe that CF33-hNIS has the potential to improve outcomes for our patients.”
Unleashing this potential will primarily depend on how safe CF33-hNIS is in humans, and the first phase of the trial will focus on the safety and tolerability of the drug.
The study is expected to enroll a total of 100 people, each of whom will be an adult patient with metastatic or advanced solid tumors who has previously tried at least two lines of standard treatment.
Once enrolled in the study, these people will receive low doses of the experimental drug either by direct injection or intravenously.
If initial results are successful and CF33-hNIS is found to be safe and well tolerated, additional trials will investigate how the drug is combined with pembrolizumab, an existing antibody that is already being used in cancer immunotherapy.
The version of the virus currently in clinical trials produces the human sodium iodide symporter (hNIS), a protein that allows researchers to image and control viral replication, and to further damage cancer cells by adding radioactive iodine.
However, before determining the drug’s effectiveness, researchers will first test how well the drug is tolerated by patients, record the frequency and severity of any side effects, and examine how well participants tolerate low doses of the drug as they are increased.
Secondary metrics, including an assessment of how effectively CF33-hNIS reduces the size of treated tumors, will be analyzed later, but as the study is expected to take two years at several proposed clinical sites, it will likely be some time before we know the results. in details.
This does not mean that we cannot rejoice in the wide potential of the drug; we just have to keep our expectations in check, because promising results in preclinical experiments do not necessarily guarantee the same success in future patient studies.
If the drug does indeed prove to be safe and well tolerated, we could be facing a powerful new tumor-fighting drug that, according to surgical oncologist Suzanne Warner, who previously led a team studying CF33’s effects on tumors in mice, “will be a game-changer due to its strength and ability to attract and activate immune cells.”
“Our oncolytic virus trains the immune system to target a specific cancer cell,” she said in 2020.
“This means that if such a cancer cell tries to grow back, the immune system will be ready and waiting to destroy it.”
While no one knows for sure whether CF33-hNIS will work the same miracles in humans, but if so, it will only be the second oncolytic viral drug for cancer treatment approved by the US Food and Drug Administration, after a drug called Talimogene laherparepvec (T-VEC), a modified version of the herpes simplex virus used to treat melanoma.
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