NANOBIOTIX, a clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer, announces today its development plan for the CE marking of NBTXR3, the first product from the NanoXray pipeline.
The positive results from the pilot phase of NBTXR3 in patients with advanced soft tissue sarcoma (STS), allow Nanobiotix to finalize and to announce its development plan for the launch of NBTXR3 on the market.
It is with this first indication, advanced STS, that NBTXR3 could be CE marked as early as 2016, brought forward from the Company's initial estimate of 2017. To achieve this, the product registration phase (pivotal) will begin in late 2014.
On 10 February 2014, the Independent Data Monitoring Committee (IDMC) met and gave a positive assessment of the recent pilot STS data which showed that NBTXR3 had a good safety profile, which is infrequent in oncology. Expert opinions, combined with encouraging signs of efficacy, have led to further product development in this indication.
The aim of NBTXR3 is to facilitate complete tumor resections and provide a significant clinical benefit to patients.
With the support of Bpifrance under the NICE project, Nanobiotix is pursuing the non-clinical evaluation phase of NBTXR3 with a view to initiating a clinical trial of NBTXR3 in patients suffering from liver cancer. In this population of patients, the aim of using NBTXR3 is to increase and prolong patients' survival rates. The non-clinical evaluation phase is expected to be finalized in Q2 2014.
Nanobiotix also continues to progress the clinical development of NBTXR3 in elderly patients with head and neck cancers through 2014. The pilot trial aims to assess the patient's tolerance to the product in the perspective of providing better control of the disease and an improved quality of life.
Laurent Levy, CEO of Nanobiotix said, "We are now in the final stages of development of our first product from the NanoXray pipeline: NBTXR3. Through its ability to enhance the effect of radiotherapy without increasing damage to the surrounding tissue, this product is designed to address a significant unmet medical need for advanced STS patients. We have progressed development faster than expected, which is good news for the patients who may benefit sooner from our breakthrough technology. This is a major milestone for the company, made possible through the work of our teams and our partners."
European development plan for NBTXR3, first product from the NanoXray pipeline
In 2014, Nanobiotix will pursue its partnership policy for the development and market access of NBTXR3 outside Europe.
For its development in Asia, Nanobiotix signed its first licensing contract of up to US$57 million with the Taiwanese company, PharmaEngine, in August 2012, to cover the development and commercialization of NBTXR3 in the Asia-Pacific region. This program is expected to start in H2 2014 with two indications, advanced rectal cancer and advanced mouth cancer.
For NBTXR3's development and commercialisation in the United States, Nanobiotix is investigating the possibility of partnering the product in 2014 as announced during the IPO.
In Europe, the Company will focus on market access and the preparation for a commercial launch of NBTXR3.
Underlying these activities, Nanobiotix has developed numerous partnerships with hospitals, clinics and cancer treatment centers in France and internationally.
"The completion of this new step for NBTXR3 helps to de-risk the development and enables us to consider the applications of NanoXray products in STS and other cancer indications," added Dr. Elsa Borghi, CMO of Nanobiotix. "For many oncology patients, tumor removal can have a significant impact on their treatment outcome. We are now entering a pivotal stage in NBTXR3's development to establish whether we have an effective therapy for this unmet need, in STS and in other cancer indications."
About NBTXR3 in Soft Tissue Sarcomas
Soft tissue sarcomas are cancers arising from different types of tissues such as fat cells, muscles, joint structures, small vessels, etc. Patients with high risk STS have poor prognoses. Surgery is required to remove the tumor(s) which can affect their quality of life quite significantly. The only standard of care therapeutic option before surgery is radiotherapy which means there is an important unmet medical need for these patients. Treatment with NBTXR3 nanoparticles and radiotherapy aims to destroy the tumor(s) more efficiently, to facilitate surgery and enable complete malignant tissue extraction during surgery.
About the IDMC
The Independent Data Monitoring Committee (IDMC) consists of three independent members (oncology surgeon, radiation oncologist and statistician). The members of the IDMC do not participate in the trial. The committee has the responsibility to check the data of the phase I study at regular intervals and has the responsibility of ensuring the safety of all patients enrolled in the study, the quality of the data collected and the continued scientific validity of the study design. The IDMC has the authority to recommend changes to the study, to temporarily halt the patient enrolment and to discontinue or to continue the trial as planned.
Nanobiotix (Euronext: NANO / ISIN: FR0011341205) is a clinical-stage nanomedicine company pioneering novel approaches for the local treatment of cancer. The Company's first-in-class, proprietary technology, NanoXray, enhances radiotherapy energy to provide a new, more efficient treatment for cancer patients. NanoXray products are compatible with current radiotherapy treatments and are meant to treat a wide variety of cancers via multiple routes of administration.
Nanobiotix's lead product NBTXR3, based on NanoXray, is currently under clinical development for soft tissue sarcoma and locally advanced head and neck cancer. The Company, based in Paris, France, has partnered with PharmaEngine for clinical development and commercialization of NBTXR3 in Asia.
Nanobiotix is listed on the regulated market of NYSE Euronext in Paris (ISIN: FR0011341205, Euronext ticker: NANO, Bloomberg: NANO: FP).