Nanobiotix has announced 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.”
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 commercialization 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.”