Nanobiotix, an emerging nanomedicine company, announced today that preclinical follow-up data regarding long-term toxicity evaluation suggests that its patented NBTXR3 nanoparticles are designed to be a safe and effective treatment for radiosensitive and radioresistant tumors. The preclinical studies were performed at NAMSA Biomatech. NAMSA is registered with the CDER and CBER divisions of the FDA.
Nanobiotix is using technology that it calls ‘nanoXray therapeutics’ to resolve radiation therapy’s biggest drawback: destruction of healthy tissue and its subsequent deleterious side effects when a high dose of xray is necessary. The Company believes that nanoXray therapeutics offer a dramatic innovation in cancer therapy, based on a technology that is designed to allow destruction of cancer cells only—a new treatment weapon that could be used alone, or in concert with existing anticancer protocols: chemotherapy, surgery, and immunotherapy. Because NBTXR3 is comprised of crystalline nanoparticles, it does not have deleterious effects on healthy cells, unlike chemotherapy or other systemic anticancer agents.
“Our nanotechnology is designed to allow for the precise destruction of cancer cells via the controlled application of an outside-the-body energy source—in this case, an xray. We have aggressively worked to achieve our goal of completing this preclinical program in order for Nanobiotix to be able to start the first-in-man clinical trial by the end of this year. We are highly encouraged by these latest results, with confirmation of good tolerance and negligible toxicity observed in animals,” said Laurent Lévy, Ph.D., President and CEO of Nanobiotix and Co-President of the French Technology Platform on Nanotechnology (FTPN).
“These preclinical results strongly suggest that NBTXR3 activated by ionizing radiation may represent a safe, solid-tumor treatment option capable of enhancing existing therapeutic options. These data also suggest that NBTXR3-based treatment can be used for patients with kidney or liver dysfunctions, resulting in potentially better clinical benefit in specific populations where pharmaceuticals and biologicals cannot be used,” added Elsa Borghi, M.D., Chief Medical Officer for Nanobiotix.
One in four deaths in the United States is from cancer, making it the second-leading cause of death after heart attack. Radiation therapy—also called radiotherapy, xray, or irradiation—is typically used to kill cancer cells and shrink tumors. Radiation therapy injures or destroys cells in the area being treated by damaging their genetic material, making it impossible for these cells to continue to grow and divide. The goal of radiation therapy is to damage as many cancer cells as possible, while limiting harm to nearby healthy tissue. About half of all cancer patients receive some type of radiation therapy, which may be used alone or in combination with other cancer treatments, such as chemotherapy or surgery. Radiation therapy may be used to treat almost every type of solid tumor.
NBTXR3 is a suspension of inert crystalline nanoparticles of hafnium oxide with a simple coating that is formulated in water for injection. These nanoparticles have a simple composition: the hafnium oxide core represent the therapeutic source, but only when its electrons are excited by the application of an external beam of xray. Of note: the crystalline structure of the nanoparticles prevents metabolization by living organisms. NBTXR3 works according to an “on-off” activity status: When the nanoparticles are not activated, they do not have any effect because they are inert. Under standard external beam xray activation, xrays are absorbed by NBTXR3 nanoparticles exactly as ionizing radiations are absorbed by water molecules, leading to emission of electrons losing energy and the subsequent creation of free radicals. In both cases, xray energy will generate electrons with kinetic energy that will be released into the medium and will generate free radicals. The nanoparticles do not react directly with any biological recipient cell and tissue.