Commercial Times / China Times 2023.11.20
https://www.chinatimes.com/newspapers/20231120000253-260210?
Nanoray Biotech recently announced that its Auger Molecular Therapy has received approval from Taiwan’s TFDA for IND review, and the Phase I clinical trial will be conducted at Taipei Medical University, opening new opportunities for cancer treatment.
Nanoray Biotech has been committed to developing specialized spectrum X-ray technology, which can be broadly applied across industrial inspection, medical imaging, and cancer therapy. The Auger Molecular Therapy project was launched at the end of 2016. The Auger effect occurs when a vacancy in an atom’s inner electron shell is filled by an outer electron, releasing energy that ejects another outer electron from the atom (called an Auger electron). This effect has drawn decades of interest from cancer researchers because its highly localized action can effectively destroy cancer cell DNA while sparing surrounding healthy tissue. Previous studies used monochromatic synchrotron X-rays to induce the Auger effect in animal models, but regulatory and facility limitations hindered its clinical translation.
Nanoray Biotech’s special penetrating-target X-ray module can generate a spectrum similar to synchrotron X-rays, inducing the Auger effect when combined with specific heavy-atom drugs. Its compact size and low energy consumption allow the therapy to be delivered as a portable X-ray source in standard hospital settings for cancer irradiation treatment.
This innovative technology received U.S. FDA approval for Phase I clinical trials in September 2022, and has now also obtained Taiwan FDA approval for Phase I human trials. As no Auger-effect-based therapy has entered clinical trials in the past 20 years, the results of Nanoray Biotech’s clinical study are expected to be highly landmark, paving the way for new international milestones in biomedical technology.
Auger Molecular Therapy’s human clinical trial plan has been approved by Taiwan’s TFDA under IND review and will proceed with Phase 1 clinical trials at Taipei Medical University.
Provided by NanoRay Biotech