An experimental cancer-killing virus has been administered to a human patient for the first time, with hopes the testing will ultimately reveal evidence of a new means of successfully fighting cancer tumors in people's bodies.
The drug candidate, called Vaxinia, is an oncolytic virus that is designed to kill cancer cells while sparing healthy ones.
The modified pox virus works by entering cells and duplicating itself. The immune system is stimulated by the release of thousands of new virus particles that act as antigens.
In animal models, the drug can harness the immune system to hunt and destroy cancer cells, but until now no testing has been done in humans.
The City of Hope cancer care and research center in Los Angeles and Australia-based company Imugene are the co-developers of the drug.
Daneng Li, City of Hope oncologist and principal investigator, says that their previous research showed that oncolytic viruses can cause the immune system to respond to and kill cancer, as well as stimulating the immune system to be more responsive to other immunotherapies.
We believe that CF33-hNIS has the potential to improve outcomes for our patients.
The first phase of the trial will focus on the safety and tolerability of the drug, and if it is found to be safe for people to take, that will open the door to greater potential.
100 participants are expected to be adult patients with advanced solid tumors who have previously tried at least two lines of standard treatment.
These individuals will receive low doses of the experimental treatment via injection or IV.
If early results are positive and the drug is deemed safe and well-tolerated, additional tests will be conducted to see if the drug pairs with pembrolizumab, an existing treatment for cancer.
The version of the virus being clinically trialed produces a human sodium iodide symporter that allows researchers to image and monitor viral replication, as well as allowing an additional way to damage the cancer cells.
Before efficacy is determined, researchers will first be looking to see how well the drug is handled by patients, recording the frequency and severity of any adverse effects, and also investigating how well participants fare as low doses are escalated.
Secondary measures will be analyzed later on, but with the trial expected to take two years across multiple anticipated clinical sites, it will likely be some time before we know.
We should keep our expectations in check, because promising results in pre-clinical experiments don't guarantee similar results in subsequent research involving human patients.
If the drug does turn out to be safe and well-tolerated, we could be looking at a powerful new tool for fighting tumors, because of how potent it is and because of its ability to recruit and activate immune cells.
She said in 2020 that the oncolytic virus trains the immune system to target a specific cancer cell.
The immune system will be ready if a cancer cell tries to regrowth.
If it can, it will be the second FDA-approved oncolytic virus therapy for cancer, following on the heels of a drug called Talimogene laherparepvec.
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