A nanomedicine designed to help amplify and focus radiation treatment on hard to treat soft tissue sarcoma cells has achieved positive Phase II/III trial results for French-American biotech Nanobiotix.
“Data are exceptional and show without any doubt an improvement of radiation therapy impact,” commented Sylvie Bonvalot, Head of Sarcoma and Complex Tumor Surgery Unit at Institut Curie, Paris, who was a Principal Investigator for the trial. “This innovation will play a role in many other indications and particularly where radiotherapy is used alone.”
The particles are designed to be injected into the tumor prior to radiotherapy and are then activated by exposure to radiation. They bind to the tumor cells and allow the tumor, but not the surrounding healthy tissue, to absorb more radiation.
The Phase II/III trial included 180 adult patients with soft tissue sarcoma, a difficult to treat cancer that affects connecting tissue such as fat and muscle cells. Overall, 16.1% of participants who received an injection of the nanotherapy achieved a complete response, defined as having 5% or less detectable residual cancer cells. In comparison, only 7.9% of participants who received radiotherapy alone had a complete response.
In those who had surgery to remove their tumors, significantly more patients who received a nanotherapy injection had cancer-free surgical margins after treatment than those who did not. In general, there were no major side effects linked to the nanotherapy and, as hoped, patients who had the injection had less long-term toxic effects as a result of radiotherapy than those who did not.
Nanobiotix is aiming to use the positive results from the trial to further its quest for a marketing authorization in Europe. It is also testing its radioenhancer technology for treatment in a number of other cancers including head and neck and severe liver cancer, but these trials are at an earlier stage.
The nanomedicine space is not huge, but there are other players including Cristal Therapeutics and Topas Therapeutics, which are targeting a number of diseases including cancer with their nanotherapies.
The market has responded positively to yesterday’s announcement from Nanobiotix with a more than 50% increase in its share price. We will continue to watch this company with interest!
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