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Key months ahead for Nanobiotix as trial data comes through

Data from the European head and neck trial with lead product NBTXR3 will be presented at the ASCO meeting in June
picture of Paris
Nanobiotix is based n the French capital

Euronext-listed Nanobiotix (EPA:NANO) has stepped up the pace of its phase I/II head and neck cancer trial to get the results back in time for the American Society of Clinical Oncology (ASCO) annual meeting.

Data from the European head and neck trial with lead product NBTXR3 will be presented at the ASCO meeting ahead of the next stage of clinical trials, which will be influenced by the data to be presented in June.

In addition, Nanobiotix is to expand its Immuno-Oncology program that aims to turn ‘cold tumours’ into ‘hot tumours’, which can then be recognised and attacked by the body’s immune system.

 

Hafnium oxide nanoparticles

The Paris-based group is pioneering the use of hafnium oxide nanoparticles to boost the effectiveness of radiotherapy.

Using its technology, radiotherapy doses are targeted much more precisely, reducing the damage to surrounding healthy tissue and shrinking tumours so they can be more easily removed by surgery.

NBTX R3, the most advanced product, is currently being tested in indications accessible to intra-tumour injections such as liver, prostate cancers as well as head & neck and soft tissue sarcomas.

Nanobiotix will present the first clinical data from the immune-oncology program mid-year having started an exploratory clinical biomarkers study using data from its phase II/III trial in soft tissues sarcoma.

This phase II/IIItrial is ongoing, having just been recommended to continue by an Independent Data Monitoring Committee (IDMC) that evaluated the safety and efficacy data of two thirds of the patients in the “Act.in.Sarc” study.

The completion of the patient recruitment process for this trial is expected by the end of the second quarter of 2017 with data expected by the end of the year.

 Other trials underway for NBTXR3 in other indications include prostate cancer (Phase I/II), liver cancers (Hepatocellular Phase I/II and liver cancer metastases Phase I/II), rectum cancer (Phase I/II – by partner PharmaEngine) and head and neck cancers in patients receiving chemotherapy (Phase I/II – by PharmaEngine).

 

Results due

In the second half of 2017, the prostate cancer indication should deliver preliminary safety and feasibility data.

Additionally, before the end of 2017, Nanobiotix aims to complete patient recruitment for the Phase I in liver cancers, and may proceed to select the patient population for the dose-expansion part of the trial (Phase II).  

In parallel, Nanobiotix is accelerating its market preparations for NBTXR3’s launch on the European market. The first approval (CE marking) in Europe is expected in the second half of 2017.

 

Undervalued believes Bryan Garnier

The French broker has started coverage of the nanotechnology pioneer with a buy recommendation and target price for the Euronext-listed shares of €35. That compares to €16.80 currently.

The current RTx market is already sizeable (50-60% of cancer patients are already treated with this modality) says Bryan Garnier, but it believes that Nanobiotix should not only occupy a privileged position in it, but can also contribute to its expansion in two phases.

“Firstly, by demonstrating a significant therapeutic benefit in indications where RTx is little used for the moment (like liver cancers).

“Then, in view of the multiple synergies between its platform and agents destined for treatment of more advanced tumours/metastasis, such as immunotherapies and a number of targeted new therapies (in particular PARP inhibitors). “

 

 

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