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.