CEO's Operational Report
Nanobiotix is focused on the development of NanoXray, its first-in-class
proprietary technology, which is at the forefront of a new era of nanomedicine,
where nanoparticles are not just a vehicle for targeted drug delivery, but have
become the principal active element. Nanobiotix is developing three different
products that can be administered either by direct injection into the tumor
(NBTXR3), intravenous injection (NBTX-IV) or topical application to fill tumor
cavities during surgery (NBTX-TOPO). Currently, NBTXR3 is regarded as a medical
device in Europe and a drug in the United States (US).
During HY1 2013, we have made strong progress on delivering the commitments made
at the time of the IPO in October 2012. Most notably, we achieved clinical proof
of concept of our lead product, NBTXR3, in Phase I trials for soft tissue
sarcoma (STS). With the authorization of the French National Security Agency for
Medicines and Health Products (ANSM), we are planning to start a new clinical
trial in head and neck cancer in the second half of the year. These achievements
have helped to strengthen interest from the scientific and financial community
in our technology.
Beyond these developments, Nanobiotix has been able to accelerate the
development of its pipeline faster than expected. Notably with the €2.8 million
funding received after the post period end from Bpifrance that will allow us to
expand NBTXR3 development in liver cancer. We have also entered into
collaboration with the National Cancer Institute (NCI) in the US to initiate
preclinical development of NBTX-IV, the second product from the NanoXray
The Company aims to establish its pipeline of NanoXray products, as cancer
nanomedicine reference points in the oncology market and is working closely with
national and scientific bodies to promote the nanomedicine sector as a whole.
Product development - NBTXR3
NBTXR3 is our most advanced product in the clinic and comprises nanoparticles
designed for direct injection into the tumor. The potential indications for
NBTXR3 are primary head and neck cancers, liver cancer, glioblastoma (a specific
form of brain cancer), rectal and prostate cancer.
Soft tissue sarcoma (STS)
STS is a form of cancer that develops in soft, supporting tissues of the body.
The cancer can occur in cells and tissues such as fat cells, muscles, joints and
in any other tissues that support, surround, and protect organs of the body.
Patients with high grade STS have poor prognoses, with many undergoing
radiotherapy prior to surgery to remove the tumor.
Treatment with a combination of NBTXR3 nanoparticles and radiotherapy aims to
destroy tumors locally and more effectively, in order to facilitate surgery and
complete the removal of the malignant tissue.
NBTXR3 achieved proof-of-concept in a Phase I trial of soft tissue sarcoma and
represents the successful transition of the NanoXray platform from preclinical
models into the clinic. We expect to see the next group of patients treated in
Head and neck cancer
Head and neck cancer represents a group of biologically similar cancers that
appear in the mouth, the nose, the sinuses and at the top of the aerodigestive
tract. If detected early, the survival rate for this type of cancer is high, and
treatment is usually via surgery or radiation therapy. However, surgery can have
a detrimental effect on the patient's function, in terms of swallowing,
breathing or speech, and cosmetic appearance.
This will be the second indication for NBTXR3 in radiation therapy with the aim
to improve tumor destruction, and to maintain the patients' function and
appearance after treatment. We have received authorization from the ANSM, to
start a clinical trial at Institut Curie, Paris, France.